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 Textbook of Research
Methodology

ISBN - 978-93-94198-18-0

Published and printed by Dr. E. Kamatchi Mahalakshmi

Dr. S Sriranjani Mokshagundam
Dr.J.Thirumagal
Dr.S.Sheeba
SALIHA PUBLICATIONS
Dr.M.M.Malini
 TEXTBOOK OF
RESEARCH METHODOLOGY

First Edition
ISBN - 978-93-94198-18-0

Dr.E. Kamatchi Mahalakshmi

Dr. S Sriranjani Mokshagundam

Dr.J.Thirumagal

Dr.S. Sheeba

Dr. M.M.Malini

Published and printed by

SALIHA PUBLICATIONS
All rights reserved. No part of this book may be reproduced or reprinted without
the prior written permission of the publisher or authors.

First Edition: 2023

ISBN - 978-93-94198-18-0

Published and printed by

SALIHA PUBLICATIONS

Vaniyambadi, Tirupattur District, Tamil Nadu, INDIA

https://salihapublications.wordpress.com/
E. mail: salihapublications2016@gmail.com
 AUTHORS PROFILE
They have sufficient teaching and
research experience with expertise in
Research Methodology. They have written
this book for the benefits of
undergraduate and postgraduate students.
 Author’s Profile
Dr.E.Kamatchi Mahalakshmi,
Assistant Professor,
Department of Management,
Rathinam Institute of Management,
Rathinam College of Arts & Science,
Eachnari, Coimbatore.
Email: kamatchimuthulakshmi.mba@rathinam.in
Dr. S Sriranjani Mokshagundam,
Professor of Management,
Sri Jagadguru Balagangadhara College of Management Studies
(SJBCMS),
Bangalore.
Email id: mokshagundam89@gmail.com
Dr.J.Thirumagal,
Head and Assistant Professor,
Department of Biochemistry,
K.M.G.College Of Arts And Science,
Gudiyattam, Tamil Nadu
Email: thirumagaljai123@gmail.com
Dr. S.Sheeba
Assistant Professor,
Department of Obstetrics and Gynaecology,
Sarada Krishna Homoeopathic Medical College,
Kulasekharam, Kanyakumari District, Chennai, Tamil Nadu.
Email: sheeba.syduu@gmail.com
Dr.M.M.Malini,
Former Research Scholar,
Department of Zoology,
S.T.Hindu College, Nagercoil.
Email: malinimm23@gmail.com
 PREFACE
The first edition of “Textbook of Research
Methodology “this book was written to help students to
learn about the scientific method is the process of
objectively establishing facts through testing and
experimentation. The basic process involves making an
observation, forming a hypothesis, making a prediction,
conducting an experiment and finally analyzing the
results.
We welcome comments by readers of Textbook of
Scientific Research Methodology for ways to improve the
book and to increase its value. Such suggestions will be
seriously considered in the preparation of subsequent
editions.
 CONTENTS PAGE NO
Importance and Need for Research, Ethics in
Scientific research, Designing a Research work,
1-49
Formulation of Hypothesis, Scientific writing
Research and Review article. Logical format for
Dissertation–Title, Certificate, Declaration,
Acknowledgement, Contents, Abstract, Introduction,
Review of Literature, Materials and Methods,
Results, Discussion, Summary, Conclusion,
Appendix and References–Harvard and Vancouver
systems.
Collection and Classification of Data, Diagrammatic 50-64
and Graphic representation of data, Measurement of
Central tendency, Standard Deviation-Normal
distribution-test of significance based on large
samples and small samples, Student ‘t’ test,
Correlation and Regression.
Introduction and Scope of Bioinformatics, Role of
Computers in Biology. Useful search engines
65-123
Boolean searching, Search engine algorithms.
Finding scientific articles in Google scholar, Science
Direct, Scopus, Web of Science and UGC-CARE.
Laboratory animals used for Life science research.
Ethics in animal experimentation. CPCSEA
124-180
guidelines Animal care and technical personnel
environment, animal husbandry, feed, bedding,
water, sanitation and cleanliness, waste disposal,
anaesthesia and euthanasia.
Composition of institutional Ethical Committee
(IEC), General ethical issues. Specific principles for
181-198
chemical evaluation of drugs and human genetics
research, Ethics in food and drug safety.
Environmental release of microorganisms and
genetically engineered organisms.
TEXTBOOK OF RESEARCH METHODOLOGY ISBN - 978-93-94198-18-0

CHAPTER–I

Importance and Need for Research, Ethics in Scientific

research, designing a Research work, Formulation of
Hypothesis, Scientific Writing−Research and Review article.
Logical format for Dissertation–Title, Certificate, Declaration,
Acknowledgement, Contents, Abstract, Introduction, Review
of Literature, Materials and Methods, Results, Discussion,
Summary, Conclusion, Appendix and References–Harvard
and Vancouver systems.

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INTRODUCTION TO RESEARCH
Introduction
The ultimate goal of any national health-development process
is to enable its people to reach a level of health that enables
them to make meaningful participation in the social and
economic life of the community in which they live. To attain
this objective, countries should decide on the best approaches
to adopt. However, this requires detailed and accurate
information on the existing health systems of these countries.
Unfortunately, such information is often lacking, inadequate,
or unreliable. As a result, decisions are based on assumptions
and unjustified conclusions and often result in inappropriate
policy choices. In this regard, the search for scientific
knowledge and information should be strongly supported.
Research in the context of public health thus aims to provide
all aspects of information necessary for planning and the
effective implementation of a health system. For all
communities, whether affluent or poor, health research is the
top priority. The research questions are formidable: how to
join with policy makers and communities in assessing priority
needs, planning, financing and implementing programs, and

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evaluating them in terms of coverage, efficiency and

effectiveness.
Definition and characteristics of research Definition:
Research is a scientific inquiry aimed at learning new facts,
testing ideas, etc. It is the systematic collection, analysis and
interpretation of data to generate new knowledge and answer
a certain question or solve a problem.
Characteristics of research
• It demands a clear statement of the problem
• It requires a plan (it is not aimlessly “looking” for
something in the hope that you will come across a
solution)
• It builds on existing data, using both positive and
negative findings
• New data should be collected as required and be
organized in such a way that they answer the research
question(s)

The significance of research cannot be understated. It is

integral to succeeding in school as well as in many
professions, such as law, writing, and finance. The main
purposes of research are to inform action, gather evidence for

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theories, and contribute to developing knowledge in a field of

study. This article discusses the significance of research and
the many reasons why it is important for everyone—not just
students and scientists.Understanding that research is
important might seem like a no-brainer, but many people
avoid it like the plague. Yet, for those who like to learn,
whether they are members of a research institution or not,
conducting research is not just important—it's imperative.

Why Research Is Necessary and Valuable

1. It's a tool for building knowledge and facilitating
learning.
2. It's a means to understand issues and increase public
awareness.
3. It helps us succeed in business.
4. It allows us to disprove lies and support truths.
5. It is a means to find, gauge, and seize opportunities.
6. It promotes a love of and confidence in reading, writing,
analysing, and sharing valuable information.
7. It provides nourishment and exercise for the mind.
1. Research expands your knowledge base
The most obvious reason to do research is that you’ll learn
more. There’s always more to learn about a topic, even if you
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are already well-versed in it. If you aren’t, research allows

you to build on any personal experience you have with the
subject. The process of research opens up new opportunities
for learning and growth.
2. Research gives you the latest information
Research encourages you to find the most recent information
available. In certain fields, especially scientific ones, there’s
always new information and discoveries being made. Staying
updated prevents you from falling behind and giving info
that’s inaccurate or doesn’t paint the whole picture. With the
latest info, you’ll be better equipped to talk about a subject
and build on ideas.
3. Research helps you know what you’re up against
In business, you’ll have competition. Researching your
competitors and what they’re up to helps you formulate your
plans and strategies. You can figure out what sets you apart.
In other types of research, like medicine, your research might
identify diseases, classify symptoms, and come up with ways
to tackle them. Even if your “enemy” isn’t an actual person or
competitor, there’s always some kind of antagonist force or
problem that research can help you deal with.

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4. Research builds your credibility

People will take what you have to say more seriously when
they can tell you’re informed. Doing research gives you a
solid foundation on which you can build your ideas and
opinions. You can speak with confidence about what you
know is accurate. When you’ve done the research, it’s much
harder for someone to poke holes in what you’re saying. Your
research should be focused on the best sources. If your
“research” consists of opinions from non-experts, you won’t
be very credible. When your research is good, though, people
are more likely to pay attention.
5. Research helps you narrow your scope
When you’re circling a topic for the first time, you might not
be exactly sure where to start. Most of the time, the amount of
work ahead of you is overwhelming. Whether you’re writing a
paper or formulating a business plan, it’s important to narrow
the scope at some point. Research helps you identify the most
unique and/or important themes. You can choose the themes
that fit best with the project and its goals.
6. Research teaches you better discernment
Doing a lot of research helps you sift through low-quality and
high-quality information. The more research you do on a

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topic, the better you’ll get at discerning what’s accurate and

what’s not. You’ll also get better at discerning the gray areas
where information may be technically correct but used to
draw questionable conclusions.
7. Research introduces you to new ideas
You may already have opinions and ideas about a topic when
you start researching. The more you research, the more
viewpoints you’ll come across. This encourages you to
entertain new ideas and perhaps take a closer look at yours.
You might change your mind about something or, at least,
figure out how to position your ideas as the best ones.
8. Research helps with problem-solving
Whether it’s a personal or professional problem, it helps to
look outside yourself for help. Depending on what the issue is,
your research can focus on what others have done before. You
might just need more information, so you can make an
informed plan of attack and an informed decision. When you
know you’ve collected good information, you’ll feel much
more confident in your solution.
9. Research helps you reach people
Research is used to help raise awareness of issues like climate
change, racial discrimination, gender inequality, and more.

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Without hard facts, it’s very difficult to prove that climate

change is getting worse or that gender inequality isn’t
progressing as quickly as it should. The public needs to know
what the facts are, so they have a clear idea of what “getting
worse” or “not progressing” actually means. Research also
entails going beyond the raw data and sharing real-life stories
that have a more personal impact on people.
10. Research encourages curiosity
Having curiosity and a love of learning take you far in life.
Research opens you up to different opinions and new ideas. It
also builds discerning and analytical skills. The research
process rewards curiosity. When you’re committed to
learning, you’re always in a place of growth. Curiosity is also
good for your health. Studies show curiosity is associated with
higher levels of positivity, better satisfaction with life, and
lower anxiety.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it

should come as no surprise that many different professional
associations, government agencies, and universities have
adopted specific codes, rules, and policies relating to research

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ethics. Many government agencies have ethics rules for

funded researchers.
Ethical Principles

The following is a rough and general summary of some

ethical principles that various codes address:
Honesty
Strive for honesty in all scientific communications. Honestly
report data, results, methods and procedures, and publication
status. Do not fabricate, falsify, or misrepresent data. Do not
deceive colleagues, research sponsors, or the public.

Objectivity
Strive to avoid bias in experimental design, data analysis, data
interpretation, peer review, personnel decisions, grant writing,
expert testimony, and other aspects of research where
objectivity is expected or required. Avoid or minimize bias or
self-deception. Disclose personal or financial interests that
may affect research.
Integrity
Keep your promises and agreements; act with sincerity; strive
for consistency of thought and action.

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Carefulness
Avoid careless errors and negligence; carefully and critically
examine your own work and the work of your peers. Keep
good records of research activities, such as data collection,
research design, and correspondence with agencies or
journals.

Openness
Share data, results, ideas, tools, resources. Be open to
criticism and new ideas.
Transparency
Disclose methods, materials, assumptions, analyses, and other
information needed to evaluate your research.
Accountability
Take responsibility for your part in research and be prepared
to give an account (i.e. an explanation or justification) of what
you did on a research project and why.
Intellectual Property
Honor patents, copyrights, and other forms of intellectual
property. Do not use unpublished data, methods, or results
without permission. Give proper acknowledgement or credit
for all contributions to research. Never plagiarize.

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Confidentiality
Protect confidential communications, such as papers or grants
submitted for publication, personnel records, trade or military
secrets, and patient records.

Responsible Publication
Publish in order to advance research and scholarship, not to
advance just your own career. Avoid wasteful and duplicative
publication.
Responsible Mentoring
Help to educate, mentor, and advise students. Promote their
welfare and allow them to make their own decisions.
Respect for Colleagues
Respect your colleagues and treat them fairly.
Social Responsibility
Strive to promote social good and prevent or mitigate social
harms through research, public education, and advocacy.
Non-Discrimination
Avoid discrimination against colleagues or students on the
basis of sex, race, ethnicity, or other factors not related to
scientific competence and integrity.

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Competence
Maintain and improve your own professional competence and
expertise through lifelong education and learning; take steps
to promote competence in science as a whole.

Legality
Know and obey relevant laws and institutional and
governmental policies.
Animal Care
Show proper respect and care for animals when using them in
research. Do not conduct unnecessary or poorly designed
animal experiments.
Human Subjects protection
When conducting research on human subjects, minimize
harms and risks and maximize benefits; respect human
dignity, privacy, and autonomy; take special precautions with
vulnerable populations; and strive to distribute the benefits
and burdens of research fairly.
Types of study designs
A study design is the process that guides researchers on how
to collect, analyse and interpret observations. It is a logical
model that guides the investigator in the various stages of the

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research. Several classifications of study types are possible,

depending on what research strategies are used.
1. Non-intervention (Observational) studies in which the
researcher just observes and analyses researchable objects or
situations but does not intervene;
2. Intervention studies in which the researcher manipulates
objects or situations and measures the outcome of his
manipulations (e.g., by implementing intensive health
education and measuring the improvement in immunisation
rates.) Study designs could be exploratory, descriptive or
analytical
a. Exploratory studies An exploratory study is a small-scale
study of relatively short duration, which is carried out when
little is known about a situation or a problem. It may include
description as well as comparison.
For example: A national AIDS Control Programme wishes to
establish counselling services for HIV positive and AIDS
patients, but lacks information on specific needs patients have
for support. To explore these needs, a number of in-depth
interviews are held with various categories of patients (males,
females, married and single) and with some counsellors
working on a programme that is already under way. When

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doing exploratory studies we describe the needs of various

categories of patients and the possibilities for action. We may
want to go further and try to explain the differences we
observe (e.g., in the needs of male and female AIDS patients)
or to identify causes of problems. Then we will need to
compare groups. If the problem and its contributing factors
are not well defined it is always advisable to do an
exploratory study before embarking on a large-scale
descriptive or comparative study.
b. Descriptive studies: Descriptive studies may be defined as
studies that describe the patterns of disease occurrence and
other health-related conditions by person place and time.
Personal variables include basic demographic factors, such as
age, sex marital status or occupation, as well as the
consumption of various types of food or medication use.
Characteristics of place refer to the geographic distribution of
disease, including variation among countries or within
countries, such as between urban and rural areas. With regard
to time, descriptive studies may examine seasonal patterns in
disease onset, etc.
Uses of descriptive studies
• They can be done fairly quickly and easily.

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• Allow planners and administrators to allocate resources

• Provide the first important clues about possible
determinants of a disease (useful for the formulation of
hypotheses)
a) Case reports and case series Case report: a careful,
detailed report by one or more clinicians of the profile of
a single patient. The individual case report can be
expanded to a case series, which describes characteristics
of a number of patients with a given disease.
Uses :
• Important link between clinical medicine and
epidemiology
• One of the first steps in outbreak investigation
• Often useful for hypothesis generating and
examining new diseases, but conclusions about
etiology cannot be made.

b) Ecological studies: data from entire populations are used

to compare disease frequencies between different groups
during the same period of time or in the same population at
different points in time.

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Example: Countries with low cigarette consumption have

lower lung cancer rates than those countries with high
cigarette consumption.
• Ecological studies are usually quick and easy to do
and can be done with already available information.
• Since ecological studies refer to whole populations
rather than to individuals, it is not possible to link an
exposure to occurrence of disease in the same person.

c) Cross-sectional studies: A cross-sectional (prevalence)

study provides information concerning the situation at a
given time. In this type of study, the status of an
individual with respect to the presence or absence of both
exposure and disease is assessed at the same point in
time.
• Usually involve collection of new data.
• In general, measure prevalence rather than incidence
• Not good for studying rare diseases or diseases with
short duration; also not ideal for studying rare
exposures. For factors that remain unaltered over
time, such as sex, blood group, etc., the crosssectional
survey can provide evidence of a valid statistical

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association. As can be noted from the above

explanation, a cross-sectional study can be either
analytical or descriptive, according to its purpose. If
data are collected both on exposures and outcomes of
interest, and if the data are analysed so as to
demonstrate differences either between exposed and
non-exposed groups, with respect to the outcome, or
between those with the outcome and those without the
outcome, with respect to the exposure, then this is an
analytical cross-sectional study. If the information
collected is purely of a descriptive nature, not
involving the comparison of groups formed on the
basis of exposure or outcome status, then this is a
descriptive cross-sectional study. Often a cross-
sectional study may have both descriptive and
analytical components. Nowadays, there is an
increasing emphasis on the value of longitudinal
studies in which observations are repeated in the same
community over a prolonged period (i.e., longitudinal
studies provide the required data at more than one
point in time unlike cross- sectional surveys).

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II. Analytic studies Analytic studies may be defined as studies

used to test hypotheses concerning the relationship between a
suspected risk factor and an outcome and to measure the
magnitude of the association and its statistical significance.
Analytic study designs can be divided into two broad design
strategies: Observational and intervention.
Observational studies:
• No human intervention involved in assigning study
groups; simply observe the relationship between
exposure and disease.
• Subject to many potential biases, but by careful design
and analysis, many of these biases can be minimized.
• Examples of observational studies: comparative cross-
sectional, cohort and casecontrol studies.
a) Comparative cross-sectional studies: Depending on the
purpose of a given study, a cross-sectional survey could have
an analytical component.
b) Cohort studies: Study groups identified by exposure status
prior to ascertainment of their disease status and both exposed
and unexposed groups followed in identical manner until they
develop the disease under study, they die, the study ends, or
they are lost to follow-up.

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c) Case-control studies: Group of subjects with the disease

(cases) and group of subjects without the disease (controls)
are identified. Information, about previous exposures are
obtained for cases and controls, and frequency of exposure
compared for the two groups.
Intervention studies In intervention studies, the researcher
manipulates a situation and measures the effects of this
manipulation. Usually (but not always) two groups are
compared, one group in which the intervention takes place
(e.g. treatment with a certain drug) and another group that
remains ‘untouched’ (e.g. treatment with a placebo).
The two categories of intervention studies are: • experimental
studies and • quasi-experimental studies
1. Experimental studies An experimental design is a study
design that gives the most reliable proof for causation. In an
experimental study, individuals are randomly allocated to at
least two groups. One group is subject to an intervention, or
experiment, while the other group(s) is not. The outcome of
the intervention (effect of the intervention on the dependent
variable/problem) is obtained by comparing the two groups.
A number of experimental study designs have been
developed. These are widely used in laboratory settings and

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in clinical settings. For ethical reasons, the opportunities for

experiments involving human subjects are restricted.
However, randomised control trials of new drugs are
common. At community level, where health research is
frequently undertaken, we experience not only ethical but
also practical problems in carrying out experimental studies.
In real life settings, it is often impossible to assign persons at
random to two groups, or to maintain a control group.
Therefore, experimental research designs may have to be
replaced by quasi-experimental designs.
2. Quasi-experimental studies In a quasi-experimental study,
one characteristic of a true experiment is missing, either
randomisation or the use of a separate control group. A quasi-
experimental study, however, always includes the
manipulation of an independent variable which is the
intervention.
One of the most common quasi-experimental designs uses
two (or more) groups, one of which serves as a control group
in which no intervention takes place. Both groups are
observed before as well as after the intervention, to test if the
intervention has made any difference. (This quasi-
experimental design is called the ‘non-equivalent control

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group design’ because the subjects in the two groups (study

and control groups) have not been randomly assigned.)
Another type of design that is often chosen because it is quite
easy to set up uses only one group in which an intervention is
carried out. The situation is analysed before and after the
intervention to test if there is any difference in the observed
problem. This is called a ‘BEFORE-AFTER’ study. This
design is considered a ‘pre-experimental’ design rather than a
‘quasi-experimental’ design because it involves neither
randomisation nor the use of a control group.
Formulation of a Hypothesis in research is an essential task in
the entire Research Process that comes in the third step. A
hypothesis is a tentative solution to a research problem or
question. Here, we will cover a functional definition of a
hypothesis & basic Steps in the formulation of hypotheses for
your research.
Research works, in fact, are designed to verify the hypothesis.
Therefore, a researcher, of course, would understand the
meaning and nature of the hypothesis in order to formulate a
hypothesis and then test the hypothesis.
What is Hypothesis in Research?

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A hypothesis is a tentative statement of a proposition that the

researcher seeks to prove. It’s basically a concrete
generalization. Of course, this generalization requires
essential characteristics that pertain to an entire class of
phenomena.
When a theory is stated as a testable proposition formally and
subjects to empirical verification we can define it as a
hypothesis. Researchers make a hypothesis on the basis of
some earlier theories and some rationale that is generally
accepted as true. The hypothesis test finally will decide
whether it is true or rejected.
So, to clarify a hypothesis is a statement about the relationship
between two or more variables. The researcher set out the
variables to prove or disprove. Hypothesis essentially includes
three elements. For example-

1. Variables
2. Population
3. Relationship between variables.
Example of Hypothesis

1. Rewards increase reading achievements

2. Rewards decrease reading achievements

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3. Or rewards have no effect on reading achievements

In the above examples- variables are- Rewards &
Achievements.
Logical format for Dissertation

Steps in Formulation of Hypothesis

A hypothesis is a tentative assumption drawn from practical
knowledge or theory. A hypothesis is used as a guide in the
inquiry of other facts or theories that a researcher does not
know. However, the formulation of the hypothesis is one of
the most difficult steps in the entire scientific research
process.
Therefore, in this regard, we intend to point out the basic steps
in the formulation of a hypothesis. We are pretty sure that this
guideline will be helpful in your research work.

1. Define Variables
At first, with a view to formulating a hypothesis, you must
define your variables. What do you want to test? Will you test
that rewards increase reading achievement? Or do rewards
decrease reading achievement? Whatever your goals are, they
need to be clearly defined, quantifiable, and measurable. This
will provide you with a clear idea of what to follow to achieve
results.
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2. Study In-Depth the Variables

If we do think that your variables are Rewards &
Achievements, then you need to intense study how rewards
increase reading achievements? An in-depth study, rigorous
questions, and data of rewards increase reading achievements
will make you able to confirm your hypothesis. Specify
dependent and independent variables.

3. Specify the Nature of the Relationship

Then, identify what relationship there exists between the
variables. What variable influences the other? That is what the
dependent variable is and what is the independent variable?
How do Rewards impact achievements? If reward plays a key
role in reading achievements, then reward is the independent
variable.

4. Identify Study Population

The population in research means the entire group of
individuals is going to study. If you want to test how rewards
increase reading achievements in the United Kingdom, you
need not study the whole population of the United Kingdom.
Because the total population does not involve in reading
achievements. Therefore, the researcher must identify the
study population.
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5. Make Sure Variables are Testable

Variables in your hypothesis must be testable. Otherwise, the
hypothesis would be worthless. Because your research study
must accept or reject a variable. So, variables you must need
to test. Testable variables can only be accepted or rejected.
Moreover, the sole aim of a research hypothesis is to test
variables in the long run.
Scientific writing−Research and Review article:
Scientific writing is a technical form of writing that
communicates scientific information to other scientists in a
document, book or presentation in written form. It requires a
lot of research and exact wording and can include grant
requests, peer reviews and summarized findings. While there
are many documents that fall under the category of scientific
writing, typically anything written in a research environment
is scientific writing. While there are many documents that fall
under the category of scientific writing, typically anything
written in a research environment is scientific writing.
When preparing the dissertation for submission, students must
follow strict formatting requirements. Any deviation from
these requirements may lead to rejection of the dissertation
and delay in the conferral of the degree.

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Language of the Dissertation

The language of the dissertation is ordinarily English,

although some departments whose subject matter involves
foreign languages may accept a dissertation written in a
language other than English.

Length

Most dissertations are 100 to 300 pages in length. All

dissertations should be divided into appropriate sections, and
long dissertations may need chapters, main divisions, and
subdivisions.

Page and Text Requirements

PAGE SIZE
• 8½ x 11 inches, unless a musical score is included

MARGINS
• At least 1 inch for all margins

SPACING
• Body of text: double spacing

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• Block quotations, footnotes, and bibliographies: single

spacing within each entry but double
spacing between each entry
• Table of contents, list of tables, list of figures or
illustrations, and lengthy tables: single spacing may be
used

FONTS AND POINT SIZE

Use 10-12 point size. Fonts must be embedded in the PDF file
to ensure all characters display correctly.

Recommended Fonts

If fonts are not embedded, non-English characters may not

appear as intended. Fonts embedded improperly will be
published to DASH as-is. It is the student’s responsibility to
make sure that fonts are embedded properly prior to
submission.

Instructions for Embedding Fonts

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Body of Text, Tables, Figures, and Captions

The font used in the body of the text must also be used in
headers, page numbers, and footnotes. Exceptions are made
only for tables and figures created with different software and
inserted into the document.
Tables and figures must be placed as close as possible to
their first mention in the text. They may be placed on a page
with no text above or below, or they may be placed directly
into the text. If a table or a figure is alone on a page (with no
narrative), it should be centered within the margins on the
page. Tables may take up more than one page as long as they
obey all rules about margins. Tables and figures referred to in
the text may not be placed at the end of the chapter or at the
end of the dissertation.
• Given the standards of the discipline, dissertations in the
Department of History of Art and Architecture and the
Department of Architecture, Landscape Architecture, and
Urban Planning often place illustrations at the end of the
dissertation.
Figure and table numbering must be continuous throughout
the dissertation or by chapter (e.g., 1.1, 1.2, 2.1, 2.2, etc.).
Two figures or tables cannot be designated with the same

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number. If you have repeating images that you need to cite

more than once, label them with their number and A, B, etc.
Headings should be placed at the top of tables. While no
specific rules for the format of table headings and figure
captions are required, a consistent format must be used
throughout the dissertation (contact your department for style
manuals appropriate to the field).
Captions should appear at the bottom of any figures. If the
figure takes up the entire page, the caption should be placed
alone on the preceding page, centered vertically and
horizontally within the margins.
Each page receives a separate page number. When a figure or
table title is on a preceding page, the second and subsequent
pages of the figure or table should say, for example, “Figure 5
(Continued).” In such an instance, the list of figures or tables
will list the page number containing the title. The word
“figure” should be written in full (not abbreviated), and the
“F” should be capitalized (e.g., Figure 5). In instances where
the caption continues on a second page, the “(Continued)”
notation should appear on the second and any subsequent
page. The figure/table and the caption are viewed as one

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entity and the numbering should show correlation between all

pages. Each page must include a header.
Landscape orientation figures and tables must be positioned
correctly and bound at the top so that the top of the figure or
table will be at the left margin. Figure and table
headings/captions are placed with the same orientation as the
figure or table when on the same page. When on a separate
page, headings/captions are always placed in portrait
orientation, regardless of the orientation of the figure or table.
Page numbers are always placed as if the figure were vertical
on the page.
If a graphic artist does the figures, GSAS will accept lettering
done by the artist only within the figure. Figures done with
software are acceptable if the figures are clear and legible.
Legends and titles done by the same process as the figures
will be accepted if they too are clear, legible, and run at least
10 or 12 characters per inch. Otherwise, legends and captions
should be printed with the same font used in the text.
Original illustrations, photographs, and fine arts prints may be
scanned and included, centered between the margins on a
page with no text above or below.
Use of Third-Party Content

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In addition to the student's own writing, dissertations often

contain third-party content or in-copyright content owned by
parties other than you, the student who authored the
dissertation. The Office for Scholarly
Communication recommends consulting the information
below about fair use, which allows individuals to use in-
copyright content, on a limited basis and for specific
purposes, without seeking permission from copyright holders.
Because your dissertation will be made available for online
distribution through DASH, Harvard's open-access repository,
it is important that any third-party content in it may be made
available in this way.
Fair Use and Copyright

Pagination
Pages should be assigned a number except for
the Dissertation Acceptance Certificate. Preliminary pages
(abstract, table of contents, list of tables, graphs, illustrations,
and preface) should use small Roman numerals (i, ii, iii, iv, v,
etc.). All pages must contain text or images.

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Count the title page as page i and the copyright page as page
ii, but do not print page numbers on either page.
For the body of text, use Arabic numbers (1, 2, 3, 4, 5, etc.)
starting with page 1 on the first page of text. Page numbers
must be centered throughout the manuscript at the top or
bottom. Every numbered page must be consecutively ordered,
including tables, graphs, illustrations, and bibliography/index
(if included); letter suffixes (such as 10a, 10b, etc.) are not
allowed. It is customary not to have a page number on the
page containing a chapter heading.
• Check pagination carefully. Account for all pages.

Dissertation Acceptance Certificate

A copy of the Dissertation Acceptance Certificate (DAC)

should appear as the first page. This page should not be
counted or numbered. The DAC will appear in the online
version of the published dissertation.

Title Page

The dissertation begins with the title page; the title should be
as concise as possible and should provide an accurate
description of the dissertation.

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• Do not print a page number on the title page: It is

understood to be page i for counting purposes only.

Copyright Statement

A copyright notice should appear on a separate page

immediately following the title page and include the copyright
symbol ©, the year of first publication of the work, and the
name of the author:
© [year] [Author’s Name] All rights reserved.
Alternatively, students may choose to license their work
openly under a Creative Commons license. The author
remains the copyright holder while at the same time granting
up-front permission to others to read, share, and (depending
on the license) adapt the work, so long as proper attribution is
given. (By default, under copyright law, the author reserves
all rights; under a Creative Commons license, the author
reserves some rights.)
• Do not print a page number on the copyright page. It is
understood to be page ii for counting purposes only.

Abstract

An abstract, numbered as page iii, should immediately follow

the copyright page and should state the problem, describe the

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methods and procedures used, and give the main results or

conclusions of the research. The abstract will appear in the
online and bound versions of the dissertation and will be
published by ProQuest. There is no maximum word count for
the abstract.
• The abstract text should be:
o double-spaced
o left-justified
o indented on the first line of each paragraph
• The top of the abstract page should include:
o The author’s name, right justified
o The words “Dissertation Advisor:” followed by the
advisor’s name, left-justified (a maximum of two
advisors is allowed)
o Title of the dissertation, centered, several lines
below author and advisor

Table of Contents

Dissertations divided into sections must contain a table of

contents that lists, at minimum, the major headings in the
following order:
1. Title page
2. Copyright
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3. Abstract
4. Table of Contents
5. Front Matter
6. Body of Text
7. Back Matter

Front and Back Matter

Front matter includes (if applicable):

• acknowledgements of help or encouragement from
individuals or institutions
• a dedication
• a list of illustrations or tables
• a glossary of terms
• one or more epigraphs.
Back matter includes (if applicable):
• appendices
• bibliography
• supplemental materials, including figures and tables
• an index (in rare instances).

Supplemental Material

Supplemental figures and tables must be placed at the end of

the dissertation in an appendix, not within or at the end of a

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chapter. If additional digital information (including audio,

video, image, or datasets) will accompany the main body of
the dissertation, it should be uploaded as a supplemental file
through ProQuest ETD. Supplemental material will be
available in DASH and ProQuest and preserved digitally in
the Harvard University Archives.

Dissertations Comprising Previously Published Works

As a matter of copyright, dissertations comprising the

student's previously published works must be authorized for
distribution from DASH. The guidelines in this section pertain
to any previously published material that requires permission
from publishers or other rightsholders before it may be
distributed from DASH. Please note:
• Authors whose publishing agreements grant the publisher
exclusive rights to display, distribute, and create
derivative works will need to seek the publisher's
permission for nonexclusive use of the underlying works
before the dissertation may be distributed from DASH.
• Authors whose publishing agreements indicate the
authors have retained the relevant nonexclusive rights to
the original materials for display, distribution, and the
creation of derivative works may distribute the
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dissertation as a whole from DASH without need for

further permissions.
It is recommended that authors consult their publishing
agreements directly to determine whether and to what extent
they may have transferred exclusive rights under copyright.
The Office for Scholarly Communication (OSC) is available
to help the author determine whether she has retained the
necessary rights or requires permission. Please note, however,
the Office of Scholarly Communication is not able to assist
with the permissions process itself.

Top Ten Formatting Errors

1. Missing Dissertation Acceptance Certificate. The first
page of the PDF dissertation file should be a scanned
copy of the Dissertation Acceptance
Certificate (DAC). This page should not be counted or
numbered as a part of the dissertation pagination.
2. Conflicts Between the DAC and the Title Page. The
DAC and the dissertation title page must
match exactly, meaning that the author name and the title
on the title page must match that on the DAC. If you use
your full middle name or just an initial on one document,
it must be the same on the other document.
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3. Abstract Formatting Errors. The advisor name should

be left-justified, and the author's name should be right-
justified. Up to two advisor names are allowed. The
Abstract should be double spaced and include the page
title “Abstract,” as well as the page number “iii.” There
is no maximum word count for the abstract.
4. Pagination
1. The front matter should be numbered using Roman
numerals (iii, iv, v, …). The title page and the
copyright page should be counted but not numbered.
The first printed page number should appear on the
Abstract page (iii).
2. The body of the dissertation should be numbered
using Arabic numbers (1, 2, 3, …). The first page of
the body of the text should begin with page 1.
Pagination may not continue from the front matter.
3. All page numbers should be centered either at the
top or the bottom of the page.
5. Figures and tables Figures and tables must be placed
within the text, as close to their first mention as possible.
Figures and tables that span more than one page must be
labeled on each page. Any second and subsequent page

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of the figure/table must include the “(Continued)”

notation. This applies to figure captions as well as
images. Each page of a figure/table must be accounted
for and appropriately labeled. All figures/tables must
have a unique number. They may not repeat within the
dissertation.
6. Horizontal Figures and Tables
1. Any figures/tables placed in a horizontal orientation
must be placed with the top of the figure/ table on
the left-hand side. The top of the figure/table should
be aligned with the spine of the dissertation when it
is bound.
2. Page numbers must be placed in the same location
on all pages of the dissertation, centered, at the
bottom or top of the page. Page numbers may not
appear under the table/ figure.
7. Supplemental Figures and Tables. Supplemental
figures and tables must be placed at the back of the
dissertation in an appendix. They should not be placed at
the back of the chapter.
8. Permission Letters Copyright. permission letters must
be uploaded as a supplemental file, titled

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‘do_not_publish_permission_letters,” within the

dissertation submission tool.
9. DAC Attachment. The signed Dissertation Acceptance
Certificate must additionally be uploaded as a document
in the "Administrative Documents" section when
submitting in Proquest ETD. Dissertation submission is
not complete until all documents have been received and
accepted.
10. Overall Formatting. The entire document should
be checked after all revisions, and before submitting
online, to spot any inconsistencies or PDF conversion
glitches.

8.3 Writing a research report

Writing a good report may take much time and effort. The
most difficult task is usually the preparation of the first draft.
The report should be easily intelligible. This requires clarity
of language, a logical presentation of facts and inferences, the
use of easily understood tables and charts, and an orderly
arrangement of the report as a whole. It should be no longer
than is necessary. Conventionally, a report usually contains
the following major components.

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• Title and cover page

The cover page should contain the title, the names of the
authors with their titles and positions, the institution that
is publishing the report, (e.g., Gondar College of
Medicine and Health Sciences) and the month and year
of publication. The title could consist of a challenging
statement or question, followed by an informative
subtitle covering the content of the study and indicating
the area where the study was implemented.
Abstract (Summary) The summary should be brief and
informative. A reader who has been attracted by the title
will usually look at the summary to decide whether the
report is worth reading. The summary should be written
only after the first or even the second draft of the report
has been completed. It should contain: — a very brief
description of the problem (WHY this study was needed)
— the main objectives (WHAT has been studied) — the
place of study (WHERE) — the type of study and
methods used (HOW) — major findings and
conclusions, followed by — the major (or all)
recommendations. The summary will be the first (and
for busy health decision makers most likely the only)

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part of your study that will be read. Therefore, its writing

demands thorough reflection and is time consuming.
Several drafts may have to be made, each discussed by
the research team as a whole Acknowledgements It is
good practice to thank those who supported you
technically or financially in the design and
implementation of your study. Also your employer who
has allowed you to invest time in the study and the
respondents may be acknowledged. Acknowledgements
are usually placed right after the title page or at the end
of the report, before the references.
Table of contents A table of contents is essential. It
provides the reader a quick overview of the major
sections of your report, with page references, so that
(s)he can go through the report in a different order or
skip certain sections. List of tables, figures If you have
many tables or figures it is helpful to list these also, in a
‘table of contents’ type of format with page numbers.
List of abbreviations (optional) If abbreviations or
acronyms are used in the report, these should be stated in
full in the text the first time they are mentioned. If there
are many, they should be listed in alphabetical order as

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well. The list can be placed before the first chapter of the
report. The table of contents and lists of tables, figures,
abbreviations should be prepared last, as only then can
you include the page numbers of all chapters and sub-
sections in the table of contents. Then you can also
finalise the numbering of figures and tables and include
all abbreviations.
• Introduction The introduction is a relatively easy
part of the report that can best be written after a first
draft of the findings has been made. It should
certainly contain some relevant (environmental/
administrative/ economic/ social) background data
about the country, the health status of the
population, and health service data which are related
to the problem that has been studied. You may
slightly comprise or make additions to the
corresponding section in your research proposal,
including additional literature, and use it for your
report. Then the statement of the problem should
follow, again revised from your research proposal
with additional comments and relevant literature
collected during the implementation of the study. It

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should contain a paragraph on what you hope(d) to

achieve with the results of the study. Global
literature can be reviewed in the introduction to the
statement of the problem if you have selected a
problem of global interest. Otherwise, relevant
literature from individual countries may follow as a
separate literature review after the statement of the
problem. You can also introduce theoretical
concepts or models that you have used in the
analysis of your data in a separate section after the
statement of the problem.
• Objectives The general and specific objectives
should be included as stated in the proposal. If
necessary, you can adjust them slightly for style and
sequence. However, you should not change their
basic nature. If you have not been able to meet some
of the objectives this should be stated in the
methodology section and in the discussion of the
findings. The objectives form the HEART of your
study. They determined the methodology you chose
and will determine how you structure the reporting
of your findings.

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• Methods The methodology you followed for the

collection of your data should be described in detail.
The methodology section should include a
description of:
• the study type;
• major study themes or variables (a more
detailed list of variables on which data were
collected may be annexed);
• the study population(s), sampling method(s) and
the size of the sample(s);
• data-collection techniques used for the different
study populations; • how the data were collected
and by whom;
• procedures used for data analysis, including
statistical tests (if applicable). If you have
deviated from the original study design presented
in your research proposal, you should explain to
what extent you did so and why. The
consequences of this deviation for meeting
certain objectives of your study should be
indicated. If the quality of some of the data is
weak, resulting in possible biases, this should be

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described as well under the heading ‘limitations

of the study’.
• Results: Findings should be presented
• Tables and graphs could be used (should be well
titled and captioned)
• The tables should be well constructed, and without
anomalies such as percentages which do not add up
to 100 percent
• Avoid too many decimal places
• Graphs should clarify and not complicate, and care
should be taken that they do not mislead
• If appropriate statistical tests are used, the results
should be included. P-values alone are not very
helpful. Confidence intervals and the type of tests
used should be indicated.
V) Discussion The findings can now be discussed
by objective or by cluster of related variables or
themes, which should lead to conclusions and
possible recommendations. The author interprets the
findings. Care should be taken not to introduce new
findings, i.e., findings not mentioned in the result
section. The discussion may include findings from

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other related studies that support or contradict your

own. Limitation of the study and generalizability of
the finding should also be mentioned.
VI) Conclusions and recommendations The
conclusions and recommendations should follow
logically from the discussion of the findings.
Conclusions can be short, as they have already been
elaborately discussed in chapter 5. As the discussion
will follow the sequence in which the findings have
been presented (which in turn depends on your
objectives) the conclusions should logically follow
the same order. It makes easy reading for an
outsider if the recommendations are again placed in
roughly the same sequence as the conclusions.
However, the recommendations may at the same
time be summarised according to the groups
towards which they are directed, for example:
• policy-makers,
• health and health-related managers at district or
lower level,
• health and health-related staff who could
implement the activities,

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• potential clients, and

• the community at large.

Remember that action-oriented groups are most

interested in this section. In making
recommendations, use not only the findings of your
study, but also supportive information from other
sources. The recommendations should take into
consideration the local characteristics of the health
system, constraints, feasibility and usefulness of the
proposed solutions. They should be discussed with
all concerned before they are finalised. VII)
References The references in your text can be
numbered in the sequence in which they appear in
the report and then listed in this order in the list of
references (Vancouver system). Another possibility
is the Harvard system of listing in brackets the
author’s name(s) in the text followed by the date of
the publication and page number, for example:
(Shan 2000: 84). In the list of references, the
publications are then arranged in alphabetical order
by the principal author’s last name. You can choose

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either system as long as you use it consistently

throughout the report.
VIII) Annexes or appendices: The annexes should
contain any additional information needed to enable
professionals to follow your research procedures
and data analysis.
Information that would be useful to special
categories of readers but is not of interest to the
average reader can be included in annexes as well.
Examples of information that can be presented in
annexes are:
• tables referred to in the text but not included in
order to keep the report short; • lists of hospitals,
districts, villages etc. that participated in the study; •
questionnaires or checklists used for data collection.

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CHAPTER–II

Collection and Classification of Data−Diagrammatic and

Graphic representation of data−Measurement of Central
Tendency−Standard Deviation-Normal distribution-test of
significance based on large samples and small samples,
Student ‘t’ test, Correlation and Regression.

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In this chapter, we will be looking into the aspects of data

collection and data analysis as a part of research. Once the
problem is defined and the research design is completed, data
collection is carried out. It is essential to collect data
regarding the research problem and the variables that are
involved in the research in order to better understand the
problem and it is even more essential to analyse the data using
the appropriate techniques for better reliability and validity.
We will discuss the data types, data collection methods and
techniques and tools used for analysis of the gathered data.
Collection and Classification of Data
Data is the processed form of information.To carry out any
research, data of one or the other form is required and this
data has to be collected from various sources.
Based on method of data collection: The data is classified as
primary data and secondary data.
➢ Primary data is the first-hand data that collected
directly from the respondents for the first time by
the researcher himself/herself. This is the data that
is collected expressly for the purpose of research
being carried out. Primary data can be collected by
using various methods:

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• Observation method: In this method, the data is

collected by the researcher through direct
observation of the respondents under certain
conditions rather than questioning the
respondents.
• Interview method: In this method, the
researcher or the interviewer directly or
directly collects data through verbally
questioning the respondent. This could either
be direct interview or indirect interview.
• Questionnaire: This method consists of
distributing a set of printed questions related to
the research topic, known as questionnaire, to
the respondents who then diligently write the
answers to the questions in the questionnaire
and return it to the researcher. This is a written
form of data collection.
• Other methods of primary data collection are
surveys, schedules, audits, panel interviews,
depth interviews, projection techniques such as
word association test, thematic appreciation
test etc.

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➢ Secondary data is the data that is not collected by

the researcher directly. It is adopted from other
sources of data which is already collected for
reasons other than that of the researcher’s purpose.
The sources of secondary data are
• Newspapers
• Magazines
• Trade Journals
• Government records
• Reports prepared by Government
• Reports prepared and published by private
entities
• Reports prepared by universities, schools of
research and research scholars.
• Internet and websites of companies

Diagrammatic and Graphic representation of data

Once the data is collected, it is then organized in a tabular
form, and is sometimes coded into analysis tools and software
such as SPSS, MS-Excel etc. This process is called data
cleaning and helps in making the analysis of data easier.

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Analysis of data can be as simple as studying a single variable

to as complex as studying the relationships among multiple
variables which are inter-related and providing insights based
on the analysis of data.
The simplest and the first method of data analysis is data
visualization. Data visualization is the process of presenting
the collected data in a visual format in the form of either
diagrams or graphs. The advantages of data visualization are:
• It helps in making comparisons easier.
• It is easier to understand as compared to blocks of
numbers.
• It converts complex numerical data to easy to understand
and attractive charts and graphs.
The data can be presented in two forms:
a) Diagrammatic representation of data: The data collected
can be represents as diagrams and charts. Generally, this
type of data visualization is used when studying the
changes of a single variable over a period of time or
when comparing two or more variables over a period of
time. For this purpose, bar charts, histograms, line charts
are used. Pie charts can be used to study the contribution
of various entities to a single factor.

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b) Graphical representation of data: The data is represented

as graphs if the relationship between two or more
variables needs to be studied. In this case, time series
analysis and correlation between variables are presented
in the form of graphs.
Measurement of Central tendency
Apart from data visualization, the data can be processed and
analyzed further. One of the basic analysis techniques used to
derive a solution is the measurement of central tendency.
Measures of Central Tendency are used to study the data
collected as a whole and aims to represent the whole range of
data with a single value like average of marks, CGPA,
Average monthly sales etc. There are three measures of
central tendency. They are:
• Mean: This measure of central tendency calculated the
average of all the data pertaining to a single variable or
aspect of data. For example, the performance of a class in a
test is calculated using the average of the marks scored by
all the students in that class.
∑x
x̅ =
N
Where x̅ is the mean
∑x is the sum of all the values of observations
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N is the total number of observations

• Median: It is the middlemost term in the data when it is

arranged in either ascending or descending order. In case,
of even number of terms, then the median is calculated as
the average of the two middlemost terms when arrange in
either ascending or descending order.
• Mode: This is the term that repeats most in the data
collected. It denotes the frequency of a repetition of the
value for a particular variable.
In addition to the measures of central tendency, measures of
dispersion are also used for analysis. The measures of
variance denote the variation over the data collected with
respect to a single variable. They include range, mean
deviation and standard deviation.
Standard Deviation
It is one of the most commonly used tests for measuring the
dispersion of data. It denotes how the data varies with respect
to the average of the data. It can be defined as the square root
of the average of the squares of deviations when the
deviations are calculated with respected to the average value
of the data.

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Standard deviation is the square root of variance.

Population Standard Deviation is given by:

∑(x − μ)2
σ=√
n

where σ = population standard deviation

x = the values of observations
μ = population mean
n = number of observations

Sample Standard Deviation is given by:

∑(x − x̅)2
s=√
n−1

where s = sample standard deviation

x = the values of observations
x̅ = sample mean
n = number of observations

Normal distribution
It is a probability distribution that is symmetric and centred
around the average value of the data collected. It is a bell
curve, in which the arithmetic mean or the average is the

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highest point and the graph is symmetric on either side of the

average. It describes how the values are distributed and the
probability of such values appearing in the data. It is to be
noted that the values of data cluster around the mean and
probabilities of values taper off equally on either side of mean
as the value is further away from the mean. The distance of
values from the mean is given by the standard deviation. The
below figure shows the probability of values when the data is
normally distributed.

fig: Normal distribution curve

test of significance based on large samples and small
samples

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Test of significance is used to either accept or reject claims

made with regards to the sample data. These claims are called
as hypothesis. Initially, a null hypothesis, denoted by H0 is
framed. This is an unbiased, neutral claim regarding the data
collected. In other words, it is an assumption made with the
help of the data. Then the test of significance is performed to
either accept the null hypothesis, if the results of the test of
significance supports the claim or to reject the null hypothesis,
if the test of significance proves otherwise.
The null hypothesis can be accepted or rejected with the help
of p-value. It denotes the significance of the data and is the
probability of obtaining the test results as extreme as the
sample data or the observed results of the statistical test
assuming that the null hypothesis is correct. If the p-value is
very less, then it suggests the null hypothesis is wrong and test
results will be different from the observed results of the
statistical test. If p-value is < 0.05, then it is considered to be
significant variation and the null hypothesis is rejected.
Various tests of significance are used based on the type of
data collected and the purpose of the research being carried.
One of the common tests of significance is the comparison of
means of two groups of sample data. Large sample is any

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sample that consists of more than 30 observations. In this

case, Z test is carried out. If the number of observations is less
than 30, then t-test can be carried out.
Few of them are t-test, correlation, regression analysis, chi-
square test and anova.
Student ‘t’ test
Student ‘t’ test, or simply known as ‘t’ test, is a test of
significance carried out to compare the means to two small
samples i.e., the number of observations is less than 30. In this
test, two groups of sample data are considered. For example,
let us consider the height of boys and girls in the class. T-test
is used to compare the average height of boys and average
height of girls in the class and determine if they are equal in
value. ‘t’-test provides the p-value, with the help of which the
null hypothesis can either be accepted or rejected.
t = variance between groups
variance within groups
(x̅1 − x̅2 )
t=
s21 s22
√ −n
n1 2

where t = student t-value

x̅1 = mean of sample 1
x̅2 = mean of sample 2
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s1 = standard deviation of sample 1

s2 = standard deviation of sample 2
n1 = number of observations in sample 1
n2 = number of observations in sample 2

Correlation and Regression

Correlation is the measure of relationship between two sets of
variables. The measure of correlation is given by the
correlation co-efficient denoted by ‘r’. The value of ‘r’ is
between -1 and 1. There is no relationship between the
variables if the ‘r’ value is zero and there is increasing
relationship between the variables as the value of ‘r’ increases
on either side of zero. While positive ‘r’ value represents a
strong positive correlation, negative ‘r’ value denotes a strong
negative correlation i.e., if the ‘r’ value is positive, then if one
variable increases in value, the other variable also increases in
value and vice-versa and if the ‘r’ value is negative, then if
one variable increases in value, then the other variable
decreases in value and vice-versa.
n(∑xy) − (∑x)(∑y)
γ=
√[nΣx 2 − (∑x)2 ][nΣy 2 − (∑y)]2
where γ = correlation co-efficient

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n = Quantity of Information
Σx = Total of the First Variable Value
Σy = Total of the Second Variable Value
Σxy = Sum of the Product of first & Second Value
Σx2 = Sum of the Squares of the First Value
Σy2 = Sum of the Squares of the Second Value

Regression test is the significance test carried out to find out

the impact independent variables have on a dependent
variable. The dependent variable is the variable that is being
studied. It is the variable that is influenced by or is dependent
on other variables. Independent variables are those variables
that do not depend on any other variable and their values are
independent of other variables. At the same time, some of the
independent variable might influence the values of the
dependent variable. Regression test helps in determining
which independent variable impact the dependent variable and
to what extent is the impact. Regression analysis is used for
prediction and forecasting of dependent variable and also is
used to infer causal relationships between the independent and
dependent variables.
Regression equation is in the form of

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y = a + bx
nΣxy−(∑x)(∑y)
where b = nΣx2 −(∑x)2
∑y−b(∑x)
a= n

b = Slope of the line.

a = Y-intercept of the line.
X = Values of the first data set.
Y = Values of the second data set.

Correlation analysis determines if there is a relationship

between two variables whereas regression analysis determines
the cause-effect relationship between independent and
dependent variables.

REFERENCE:
1. Kothari, C. R., & Garg, G. (2019). Research
methodology: Methods and techniques. New Age
International (P) Limited, Publishers.

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2. Laake, P., Benestad, H. B., & Olsen, B. R. (2007).

Research methodology in the medical and Biological
Sciences. Elsevier/AP.
3. GeorgiGeorgiev-Geo. “What Is a Significance Test (Test
of Significance)? | Glossary of Online Controlled
Experiments.” www.analytics-toolkit.com,
www.analytics-toolkit.com/glossary/significance-test.
4. “Normal Distribution.” Normal Distribution,
www.mathsisfun.com/data/standard-normal-
distribution.html.
5. “Chi-Square Test of Independence.” Chi-Square Test of
Independence | Introduction to Statistics | JMP,
www.jmp.com/en_au/statistics-knowledge-portal/chi-
square-test/chi-square-test-of-independence.html.

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CHAPTER-III

Introduction and Scope of Bioinformatics, Role of

Computers in Biology. Useful search engines−Boolean
searching, Search engine algorithms. Finding scientific
articles in Google scholar, Science Direct, Scopus, Web of
Science and UGC-CARE.

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DEFINITION

Bioinformatics is the combination of biology and

information technology. It is defined as the application of
computer technology to get the information that's stored in
biological data. This helps the scientists to submit, search and
analyse data. It provides tools for modelling, visualizing,
exploring and interpreting data. It converts complex data into
useful information and knowledge.

SCOPE OF BIOINFORMATICS:

• To understand the cell organizations, regulations and

functions of cell.
• To understand the function of genes.
• To analyse and interpret biological data like amino acid
sequences, protein domains, protein structures and three-
dimensional shapes of proteins.
• To develop evolutionary relationships.
• To develop new algorithms and statistics.
• To develop and implement tools.
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• To efficiently access and management of databases and

integrated mapping information.
• To sequence human genomes.
• To research and future applications in biology,
chemistry, health care industries, pharmaceuticals,
medicine, agriculture and biomedical research.
• To analyse the drug targets.
• To design the drug with relation to diseases.
• To diagnose genetic diseases and application in medical
genomics.
• To examine the characteristics of various diseases.
• To integrate and develop various tools for the
management of biological databases.
• To analyze microbes and computing.
• To provide tools for modelling, visualising, exploring
and interpreting data.

ROLE OF COMPUTERS IN BIOLOGY:

In Business:

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A computer has high speed of calculation, diligence,

accuracy, reliability and versatility. Hence, it has more
application in business organizations.

Computer is mainly used in business for:

• Payment calculations

• Budgeting

• Sales – Profit and loss analysis

• Maintenance of employee database

• Maintenance of stocks, etc.

In Banking:

Banking solely depends on computers.

• Online account–To check current balance, deposits,

overdrafts, checking interest charges, sharesetc.

• ATM machines- completely automated and easy for

customers.

In Insurance:

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Insurance companies maintain all the records up-to-date

with the help of computers.

Insurance companies, finance companies and stock

broking firms are widely using computers.

Insurance companies will maintainthe database of all

clients with informationslike:

• Procedure for policies

• Starting date of the policies

• Next due installment of a policy

• Maturity date

• Interests due

• Survival benefits

• Bonus

In Education:

The computer provides many facilities in the education

system.

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• The computer provides a tool in the education system

known as CBE (Computer Based Education).

• CBE involves control, delivery, and evaluation of

learning.

• It is used to prepare a database regarding the

performance of a student.

In Marketing:

In marketing, computer has several roles like:

• Advertising − With computers, the professionals create

art and graphics, write and revise copy, print and
disseminate ads for selling the products.

• Home Shopping − provide access to product

information and permit direct entry of orders to be filled
by the customers.

In Healthcare:

Computers have become an important part in hospitals,

laboratories, and dispensaries.

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They are used in hospitals to maintain the record of

patients and medicines.

It is also used in scanning and diagnosing different

diseases.

ECG, EEG, ultrasounds and CT scans, etc. are also done

by computerized machines.

Some major fields involves:

• Diagnostic System − Computers are used to collect

data and identify the cause of illness.

• Lab-diagnostic System − All diagnostics can be done

and the reports are prepared by computer.

• Patient Monitoring System − Used to check the

patient's signs and symptoms for abnormalities like
Cardiac Arrest, ECG, etc.

• Pharma Information System − Computer is used to

check drug labels, expiry dates, harmful side effects etc.

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• Surgery − Nowadays, computers are also used while

performing surgery.

In Engineering Design:

Computers are widely used for engineering purpose.

One of the major areas is CAD (Computer Aided

Design), that provides creation and modification of
images.

Some of the important fields are:

• Structural Engineering − Requires stress and strain

analysis for the design of ships, buildings, budgets, airplanes,
etc.

➢ Industrial Engineering − Computers deal with

design, implementation, and improvement of
integrated systems of people, materials, and
equipment.
➢ Architectural Engineering − Computers help in
planning towns, designing buildings, determining a
range of buildings on a site using both 2D and 3D
drawings.

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In Military:

Computers are largely used in defense like modern

tanks, missiles, weapons, etc.

Military also employs computerized control systems.

Some military areas where a computer has been used are:

➢ Missile Control
➢ Military Communication
➢ Military Operation and Planning
➢ Smart Weapons

In Communication :

Communication is a way to convey a message, an idea or

speech, that is received and understood clearly by the
person for whom it is meant.

Some main areas in this category are:

➢ E-mail
➢ Chatting
➢ File Transfer Protocol
➢ Telnet
➢ Video-conferencing

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In Government:

Computers play an important role in government

services.

Some major fields in this category are:

➢ Budgets
➢ Sales tax department
➢ Income tax department
➢ Computation of male/female ratio
➢ Computerization of voters lists
➢ Computerization of PAN card
➢ Weather forecasting

SEARCH ENGINES

Definition:

Search Engine is defined as a database of internet resources

such as web pages, newsgroups, programs, images etc. This
helps to locate information on World Wide Web.

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User can search for any information by passing query in form

of keywords or phrase. It then searches the relevant
information in its database and return to the user.

Components of Search Engine:

Generally there are three basic components of a search engine:

1. Web Crawler

2. Database

3. Search Interfaces

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Web crawler

It is also known as spider or bots. It is a software component

that traverses the web to gather information.

Database

All the information on the web is stored in database. It

consists of huge web resources.

Search Interfaces

This component is an interface between user and the database.

It helps the user to search through the database.
Working Mechanism of Search Engine:

Web crawler, database and the search interface are the major
component of a search engine that actually makes search
engine to work. Usually, search engines use Boolean
expression AND, OR, NOT to restrict and also widen the
search results.

Steps Involved:
• The search engine will search for the keyword in the
index for predefined database. It will not go to web for
searching the keyword.
• Later, it uses software to search for the information. This
software component is known as web crawler.
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• Once web crawler finds the pages, the search engine

shows the relevant web pages as a result.
• These retrieved web pages include title of the page, size
of text portion, starting sentences etc.
• The retrieved information is ranked as frequency of
keywords, relevancy of information, relevant links etc.
• Now, the user can click on any of the search results to
open it.

Architecture:

There are three basic layers:

• Content collection and refinement.
• Search core
• User and application interfaces

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BOOLEAN SEARCH

Boolean search is the advanced type of search that allows

users to combine the keywords with operators or modifiers,
such as AND, NOT and OR to get relevant results.

Eg: “school” AND “Delhi”. This will limit the search results
to only those documents with two keywords.

BOOLEAN SEARCH OPERATORS:

The search operator AND, NOT and OR should be in capital
letters.

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• Quotes - Use quotes to search for an exact

phrase. Example: “database management”

• Parenthesis - Combine modifiers to create complex s

• earch. Example: computer AND (keywords OR
phrases)
• AND - Includes two search items. Example network
AND data
• OR - Broaden thesearch with multiple
words. Example: “network director” OR “network
manager”
• NOT - Used to exclude a specific word. Example:
director NOT manager

Requirements for Boolean search:

• Enter the desired keywords within the quotation marks.
• Use appropriate Boolean search word from the list
below, but between the keywords.
• Select Boolean as the Keyword Option type.
• When all desired parameters are achieved, click Search .
• Results acquired.

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Boolean Search Symbols

• Or: The OR keyword tells the search to look for

instances with either of the phrases entered. For example,
searching for candidates who have "Java" OR "HTML"
in their profile.
• And: The AND keyword tells the search to look for
instances with both phrases entered. For example,
searching for candidates who have "Java" AND "HTML"
in their profile.
• Near: The NEAR keyword is similar to the AND
keyword in that it will only return instances where it
finds both phrases entered. However, the NEAR
keyword will also return results in order of proximity;

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the closer together the words are on the candidate’s

resume, the higher that candidate's profile will be ranked.
• And Not: The AND NOT keywords tell the search to
exclude certain text from the search. For example,
searching for candidates who have "Java" AND NOT
"JavaScript" in their profile.
• Quotation Marks: Use quotation marks to enclose
phrases. For example, typing system manager into a
Boolean search will return an error because the search
phrases (system and manager) are not recognized as
having been connected. Typing “system manager” will
return all instances where the search finds the
phrase system manager.
• Parentheses: Use parentheses to combine parts of a
complex search equation. For example, searching for
candidates who have "HTML" OR ("Java" AND NOT
"JavaScript") in their profile. As in mathematics, items
enclosed within parentheses are searched for first.
• Asterisk: The asterisk (*) serves as a wild card
character. Use it to search for words with a common
prefix or suffix. For example, typing in "link*" will
return all instances of link, linking, linked, etc.

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• Double Asterisks: Double asterisks (**) allow searching

for all forms of a word. For example, typing
in "sell**" will return all instances of sell, sold, selling,
etc.
Searching Data Using Boolean Search :

1. Click on the Search button, or select Tools Search.

2. The search pane opens.

3. Click on the “Browse” button to specify the subfolders

of the selected folder. Here,search will be performed.
4. Enter the keywords to search for in the block for
keywords. This will search throughout the sorted files.
5. Search parameters can be added, by clicking on the
radio buttons.

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6. Click the “Run Query” button. To find all sorted files,

leave all fields empty and click on the “Run Query”
button.
7. The search starts. The status shown in the Tasks pane
can be stopped, paused, and started from there. The
results of the finished searches are saved. They will be
stored until the task is removed from the Task Pool.
8. Search results are shown in the bottom part of the
search pane.

9. After double clicking on the search result, it will be

opened in the data viewer pane and can be viewed.

10. The results area of the search pane has the right-click
context menu, which contains the following commands:

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▪ Copy URL: copies the selected result URL to

the clipboard.
▪ Add bookmark: adds a bookmark pointing to
the selected result.
▪ Bookmark search results: adds a bookmark
to the results of the currently finished search.
▪ Navigate to URL: navigates to the selected
results in the “Data View” pane and “Case
Explorer” pane.
▪ Save to XML: saves the results of the search
to XML.
USES:
• Boolean searching is used to help find search results
faster.
• This gives more precision.
• Boolean searching uses operators words like AND, OR,
and NOT. These are logic-based words, will help search
engines narrow down or broaden search results.
SEARCH ENGINE ALGORITHMS:
• A search engine algorithm is a collection of formula that
determines the quality and relevance of a particular ad or
web page to the user’s query.

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• Searching Algorithms are designed to check or retrieve

an element from any data structure where it is being
stored.
• They search for a target key in the search space.

CLASSIFICATION:

Search engine algorithms are mainly classified

into 2 categories. They are:

1. Sequential Search: In this, the list or array is traversed

sequentially and every element is checked. For
example: Linear Search
2. Interval Search: These algorithms are specifically
designed for searching in sorted data-structures. These
type of searching algorithms are more efficient than
Linear Search method, as they repeatedly target the
center of the search structure and divide the search space
in 2 half. For Example: Binary Search.

TYPES OF SEARCHING ALGORITHMS:

• Linear Search
• Binary Search

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• Jump Search
• Interpolation Search
• Exponential Search
• Sublist Search (Search a linked list in another list)
• Fibonacci Search

Linear Search:
• A linear search or sequential search is a method for
finding an element within a list.
• This type of searching algorithms sequentially checks
each element of the list, until a match is found.
• A linear search runs in at worst linear time and makes at
most n comparisons, where n is the length of the list.
• If each element is equally likely to be searched, then
linear search has an average case of n+1/2 comparisons.
• Linear search is rarely practical because other search
algorithms, allow significantly faster searching for all but
short lists.

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Binary Search:
• A binary search is also known as a half-interval search or
logarithmic search.
• This type of searching algorithms is used to find the
position of a specific value contained in a sorted array.
• Binary search algorithm works on the principle of divide
and conquer. It is considered as the best searching
algorithms, because of its faster speed to search.
• It starts by searching in the middle of the array and going
down the first lower or upper half of the sequence.

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• If the median value is lower than the target value, the

search needs to go higher.
• If not, then look on the descending portion of the array.

Properties of binary search tree:

• The left subtree of a node contains only nodes with keys

lesser than the node’s key.
• The right subtree of a node contains only nodes with
keys greater than the node’s key.
• The left and right subtree each must also be a binary
search tree.
• There must be no duplicate nodes.
A binary search is a quick and efficient method of finding a
specific target value from a set of ordered items. By starting in
the middle of the sorted list, it can effectively cut the search
space in half by determining whether to ascend or descend the
list based on the median value compared to the target value.

Jump Search:
• Jump Search is one of the searching algorithms for
sorted arrays.

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• This will check fewer elements by jumping ahead, by

fixed steps.
• Sometimes, it may skip some elements in place of
searching all elements.

Interpolation Search:
• It was first described by W. W. Peterson in 1957.
• This method is an improved variant of binary search.
• This search algorithm works on the probing position of
the required value.
• Here, the data collection should be in a sorted form and
equally distributed.
• It is used for searching for a key in an array that has been
ordered by numerical values assigned to the keys.

Exponential Search:
• Exponential search is also known as doubling or
galloping search.
• This mechanism is used to find the range, where the
search key may present.
• If L and U are the upper and lower bound of the list, then
L and U both are the power of 2.

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• For the last section, the U is the last position of the list.
For that reason, it is known as exponential.
• After finding the specific range, it uses the binary search
technique to find the exact location of the search key.
Applications of Exponential Search:

1. It is particularly useful for unbounded searches, where

size of array is infinite.
2. It works better than Binary Search for bounded arrays,
and also when the element to be searched is closer to the
first element.

Sublist Search:
• Sublist search is used to detect a presence of one list in
another list.
• Suppose, if we have a single-node list (first list), and
have to ensure that the list is present in another list
(second list), then perform the sublist search to find it.

Fibonacci Search:
• Fibonacci search is a method, where a sorted array uses a
divide and conquer algorithm that narrows down possible
locations with the aid of Fibonacci numbers.

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• Here, the sorted array is divided into two equal-sized

parts, one of which is examined further.
• Fibonacci search divides the array into two parts, that
have sizes that are consecutive Fibonacci numbers.

GOOGLE SCHOLAR
Google Scholar is an interface of Google, that makes it easier
to do academic research than the standard Google interface.
It is designed to search for scholarly articles and case law,
though it can also uncover books through Google Books.

The Google Scholar Searches:

• Journal publisher websites

• Open Access repositories (university, discipline-based,
and government)
• Preprint services
• Academic social networks
• Google Books
• Anything else Google thinks is hosting scholarly
research

Features of Google Scholar:

• Search all scholarly literature from one convenient place

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• Explore related works, citations, authors, and publications

• Locate the complete document through library or on the
web
• Keep up with recent developments in any area of research
• Check the person citing your publications, create a public
author profile

Steps Involved In Finding Article:

1. Go to Google Scholar, enter the article title, and click

Search. For best results, put quote marks around the title.

2. If available, your article should appear as one of the first

few results:

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3. If you click an article's title, you may be taken to a

publisher's site that will ask you to pay for full text.
Instead, look for a PDF or HTML link to the right of the
article. This is a free, full-text copy.

If there is no link on the right:

• Click the article title. Though rare, you may get it free
from the publisher.
• Try searching regular Google.
• Buy the article.
• Use the Document Delivery Service. Usually, it can takes
7-10 business days to get an article from DDS.

CREATING A PROFILE ON GOOGLE SCHOLAR:

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• If the author wishing to submit their researchwork and

articles to Google Scholar, they must have their own
profile.
• For creating the profile, visit scholar.google.com website.
• Then select ‘My Citations’ option, which is visible on top
of the web page.
• Click this option.
• Immediately you can find out, whether you have a profile
on Google Scholar or not.
• In case if there is no profile, we have to create it by:

➢ specifying your affiliations

➢ areas of expertise and interest
➢ entering the link to the website
➢ adding a profile image
➢ making ther profile public so that it is visible to all

• After entering the information, move on to adding the

research articles and papers.

METHODS TO ENTER RESEARCH ARTICLES:

• There are two ways in which one can add their research
work to their profile.

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Manual Entry:

For adding articles manually:

• Firstly, choose the document type:

➢ a patent,
➢ a thesis,
➢ a book,
➢ chapter of a book,
➢ an issue of a journal,
➢ a conference article,
➢ a court case, etc.

• Secondly, provide specifics about the article:

➢ its title,
➢ the name(s) of the author(s),
➢ the date of publication,
➢ the volume or issue number of the journal
it was originally published in,
➢ the name of the publisher,
➢ the affiliated institution or organization
which sponsored the research, etc.
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• Lastly, click the ‘Save’ option.

• The user is notified that their article was successfully
added to their Google Scholar profile.

Submit An Entire Website:

• This method is more suitable for career academics and

researchers.
• To add a website to their Google Scholar profile:
• First, pick the sort of website that they wish to submit,
which may be a personal publication or other.
• Second, check all the boxes that are applicable to them,
which might include the option ‘My Inclusion Request Is
For My Personal Publications’;
• Third, enter in all the necessary details about the
webpage that is being added
• Lastly, include a couple of example articles the sort of
which may be found on the website. This includes one or
more PDF documents.
• Then click ‘Submit’ option.
• A message stating that the website was submitted for
consideration pops up.

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• This message states that the submitted website will be

scrutinized by Google’s crawl team. It will check:

➢ its originality,
➢ the significance of the findings
➢ the ingenuity of the research methods
employed
➢ the profoundness of the conclusions
• If it meets all the above criteria, the website and the
articles will appear on Google Scholar’s search results
within 4 to 6 weeks.
• User will receive emails about the updation of their
articles.
Advantages of using Google Scholar:

1. Google Scholar is familiar and relatively simple to use.

2. Google Scholar allows users to search wide variety of
articles, books, conference proceedings etc.
3. Google Scholar allows to see articles related to the one
that might interest, how many times an article has been
cited and by whom, and provides citations for articles in
a number of styles.
4. Google Scholar can display links to articles and books.

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5. Google Scholar allows to save both citations and articles

to read later.
Disadvantages of using Google Scholar:

1. Google Scholar's coverage is wide-ranging but not

comprehensive.
2. Google Scholar does not provide the criteria for what
makes its results "scholarly".
3. Results often vary in quality and it is upto the researcher
to determine, which of the results are suitable for their
purposes.
4. Google Scholar does not allow users to limit results to
either peer reviewed or full text materials or by
discipline.
5. Google Scholar does not provide notice about the
updation.
6. Google Scholar's citation tracker can be difficult to use
and inaccurate.

SCOPUS
Scopus is an abstract and indexing database with full-text
links that is produced by the Elsevier Co. The name, Scopus,
was inspired by the bird, Hammerkop (Scopus umbretta),
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which reportedly has excellent navigation skills. The database

was developed working with 21 research institutions and more
than 300 researchers and librarians.

Diversity of Source Types:

There are two different types namely – Serial and Non-serial

source type.

SERIAL SOURCE TYPE:

Book Series:

• Book series is a book with an overall title, an ISBN

(International Standard Book Number), and an ISSN
(International Standard Serial Number).
• Usually, they are published inconsistently.
• Each book is a monographic publication, with a title
separate from the series title and a different editor.

Journals:

• Most of the content in Scopus is made up of Journals.

• They have many physical formats like print, electronic
and more.
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• Content coverage policy plays a huge role in the

selection of titles.
• Any serial publication with an ISSN can be suggested for
a Scopus review, newsletters, secondary sources, or
patent publications.

Trade Journals:

• Trade journals are serial publications.

• They are dedicated to a particular industry, trade, or type
of business.
• Publications such as magazines with topical articles,
news items, and advertisements are there.
NON – SERIAL SOURCE TYPE:

• A non-serial source is also known as a monograph or

composed work.
• It is a publication with an ISBN.
• It may be a report, part of a book series, or patent. It can
have different physical formats (e.g., print, electronic).
• It also now includes edited volumes, monologues, major
reference books etc.

OTHER SOURCE TYPES:

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Secondary documents:

• Approximately 210 million records are non-core or

secondary documents. These are citations that appear in
Scopus core records but are not themselves indexed in
Scopus. Books and older journal articles are the most
highly cited of these non-core items.

Patents:

• More than 43.7 million patent records have been

procured from five patent offices that are a part of
Scopus:

1. World Intellectual Property Organization (WIPO)

2. European Patent Office (EPO)

3. US Patent Office (USPTO)

4. Japanese Patent Office (JPO)

5. UK Intellectual Property Office (IPO.GOV.UK)

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IMPORTANT DATAS:

1. Keywords and Index Terms: 80% of the index terms

added are acquired from thesauri, that Elsevier owns or
licenses and are added by Scopus’s manual efforts. The
controlled vocabularies are:

• MeSH (life sciences, health sciences)

• Ei Thesaurus (engineering, technology, physical
sciences)
• Emtree medical terms (life sciences, health sciences)

2. Affiliation Data: There is a tool available in Scopus,

wherein the Scopus Affiliation Identifier identifies and
compliments an organization with all of its research output.
This tool will search, based on affiliation data available on
Scopus, making it extremely relevant for researchers, project
leaders, faculty heads, etc., to complete a task in minutes.

3. Document Types: Some documents go as far back as 1960.

The main focus of Scopus lies in primary documents, and it
does not include secondary documents. Documents like
articles, books, data papers, etc., are included and other types
like letters, reviews, notes etc are not included.

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FEATURES OF SCOPUS:

• Links to both citing and cited documents, allowing the user

to go both forwards and backwards in time.

• Open access titles are included in the index

• Indexes web pages and patents, with a claim to over 167

million relevant web pages.

• Open URL compliant and works with any link resolver,

using image-based linking.

• Runs an entitlement check prior to returning a full-text

image if the article if available to the user.

• Can link to the publisher's web site to view the document.

• Developers claim that "citation accuracy is achieved by

using state-of-the-art technology, with 99% of citing
references and citing articles matched exactly."

• For statistics on usage, Scopus delivers customer-specific

usage reports which will be COUNTER compliant.

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• Offers both on- and off-site training as well as web-based

training and online tutorials. The database website offers
quick reference guides, tips, etc. (in English and other
languages) and offers online technical support.

• Works equally well with Internet Explorer, Netscape and

Foxfire.
SEARCH MODES FOR SCOPUS:
There are two search modes for Scopus – Basic and Advanced
Basic Search:

• The Basic Search uses fill-in and drop-down boxes to

search different fields.

• The search gives information about date, document type,

subject area or recent updates.

• Once the citations are retrieved, results can be excluded

according to set criteria.

• A particular author can be searched by name.

• After searching, the user will get a list of possible

matches.

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• One or more names can be selected from this list.

• The user can search for variants of a name and for parts
of a name.
Advanced Search:
The user can use Boolean operators and nesting using field
labels.
Article Search Algorithm:

• First, select the Search section,then documents and select

the Article Title field to enter the name of the document.
• Scopus Preview provides more number of documents.
• The service offers many filters: keywords; additional
terms; year of publication; type of document, etc.
• If the title contains brackets, replace them with spaces.
• After that, a certain number of articles will be displayed,
from that identify the specified work.
• We can also save the search query and turn for next time.
• If some articles are missing from the list, search using
the keywords in the title or abstract.
• Author Search enables search for all documents that link
to a specific article.

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• There is a sorting by the number of references to the

document.
• After finding the article, we can go to the page on which
there is a full description of the article.

Journal search
In search of the journal, we can go to the publication that
interests and see the main data, including the articles
published.

STARTING A DOCUMENT SEARCH:

Document Search:

This tab is the main search window of the homepage. To

begin, enter the search terms in the space provided.

Author Search:

Choose the Author search tab to search for a specific author

by name or by ORCID (Open Research and Contributor
Identifier) ID.

Affiliation Search:
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Choose the Affiliation search to search for a specific

affiliation.

Browse Sources:

Browse an alphabetical list of all journals, book series, trade

publications, and conference proceedings available in Scopus.

Compare Journals:

This option opens up compare journals to get the details.

Boolean Operators:

Select from AND, OR, AND NOT to combine search terms.

Search Items:

Select the specified fields to search.

Add Search Field:

To search using multiple keywords and search items, click

Add search field button.

Limit to Section:

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Control search by limiting to: published years, recently

added, document type and subject areas.

Search History:

After carrying out a search, the search history will be

displayed at the bottom. The search history will be cleared for
each new search.

Combine Queries:

In the Combine queries bar in Search history, we can enter

the list number of each search for combining, using the #
symbol and the AND, OR, and AND NOT operators.

Set Alerts or RSS Feeds:

Many options like Set alert (to receive email alerts), Set feed
(to receive RSS updates), Save query, Edit query, or Delete
query are used.

OPTIONS FOR SORTING:

Set Alert:

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This alert will notifies when a new article matches the search
conditions by email.

Analyze Search Results:

Click to see an analysis of the results, showing the number of

documents broken down by various criteria, including year,
source, author, affiliation, and so on.

Number of Search Results:

This option displays the number of documents results.

Search within Results:

Add additional terms to the search by directly entering them

here.

Results:

Use the Refine Results pane to limit the results list to certain
categories of documents.

Display Document Details Page:

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Click the article title to view the document of the article. The
search result will show the following links: • View at
Publisher • Show abstract • Related documents

Link to Full Text:

By clicking View at Publisher, we can link to the full text on

each publisher’s website if authorized.

Sort Options:

By default, search results are listed by date. Sort on Cited by,

relevance, author name and source title are options.

View references:

Displays all documents referenced by the article.

Add to my list:

This option will add the articles to a temporary list. Later,

they can be checked from My List menu or save the list under
a new name.

Create bibliography:

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Change the output to typical reference list format.

Email:

This option helps to send the articles as an email.

Print:

Displays the articles in a format suited for printing.

Advantages of SCOPUS:
• Helps to spread the word about the research
outcomes
• Gain a reputation in the scientific community
• Paves the way for collaborative opportunities
• Bolstering the integrity of firm
• Helps in acquiring financing / funding

WEB OF SCIENCE
Web of Science is a database providing access to billions of
cited references, dating back to 1900 in the areas of life
sciences, social sciences, arts, and humanities. Reference
materials include journals, books, reports, and conference
papers. The Web of Science is published by Thomson Reuters
and is an interdisciplinary database with records from
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several bibliographic databases, among them Science Citation

Index Expanded (SCI-EXPANDED) and Social Sciences
Citation Index (SSCI). It is used for searching of a subject and
cited references. It retrieves the articles that are cited by a
reference article. It helps in viewing of the references that are
already cited in a relevant article. It shows 10–15 results per
page, with details like name of authors and source. The
articles can be searched by using entries like author name,
country, title, and source. This can retrieve number of articles
from various disciplines and hence saves time.
BASIC SEARCH:
1.Choose a search option
➢ Basic search
➢ Author search
➢ Cited reference search
➢ Advanced search
➢ Structure Search
2.Limit your search
➢ Change your timespan limit in your search.
➢ Click “More settings” to see the list of all indexes in the
Web of science core subscription
3.Tools

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➢ Use Tools and searches and alerts to move to your

saved searches
4.Search
➢ Combine words and phrases to search across the source
records in Web of Science collection
5.Select a database
➢ Use a dropdown to select another content set
6.Add another search field
➢ In case of necessity, we can add another field to search
7.Select the search field
➢ Use a dropdown to select search field

SEARCH OPERATORS:
➢ Use AND to find records containing all search items
➢ Use OR to find records containing any of the search
items
➢ Use NOT to exclude records containing certain words of
the search items
➢ Use NEAR to find records containing all terms within
certain number of words
➢ Use SAME to find terms in same line

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Phrase Searching:
➢ It is used to search exact phrases in topic or title
searches.
➢ The phrase should be included in quotation marks.
Author Searching:
➢ Enter the last name first, followed by space and upto five
initials.
➢ Use truncation and search alternative spelling to find
name variants.
SCIENCE DIRECT

Science Direct is an authoritative, full-text scientific, technical

and health publications with intuitive functionality.

With high-quality books and reference content and journals,

the Science Direct platform uniquely supports an
uninterrupted workflow.

It helps the researchers

in academia, government and corporate organizations to make
smarter and faster decisions.

The users can work more effectively and efficiently.

Steps Involved:

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1. Go to library home page at www.esc.edu/library

2. Click Article databases
3. Scroll down the alphabetical list
4. Click on Science direct
5. Enter the login and password
6. Science Direct main page appears
7. Now search by keywords or browse by topic.

In case of first login into Science Direct,

• Basic search box will appear at the top of the screen

• Type your search into the box.
• Click the search button.

While searching:

1. Put quotation marks around the search keywords

➢ Use AND between any two keywords

➢ Use OR between keywords to search for articles

2. Browse publications by subject area using the

expandable list right below the search box, on the left
side.

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3. If the title of journal is known, use browse publications

by title menu, which is below the search boxes, on the
right.

Advanced Search:

Click Advanced Search Link for advanced search.

First decide the type of search

➢ All sources, journals, books, reference works or images,

using the tabs up at the top of the search box.

➢ Books, reference works or images – Choose journal tab

1. Each search box has pull- down menu to the right of

it. Some fields are:

➢ All Fields – keyword search

➢ Authors – the author of the article
➢ Source title – title of the article
➢ Keywords – important words
➢ Full text – words in text

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2. A pull down menus between the two search boxes

are added with AND, OR or NOT.
3. Select a particular subject area to search in.

Search Result List:

1. The search results page will display 25 search results per

page.
2. If more than 1 page of search results are there, page
numbers will be seen at the top and bottom right.
3. The title of the article is a link to the Article Information
Page.
4. Beneath each search result the PDF icon and related
articles are seen.
5. On the left side of search results page is the search within
results menu. Use it to narrow the search.
6. Below that, on the left side of search results page is the
Refine results menu.

Article Information:
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1. Click on the title of the article to get the article

information page. It shows:
2. Authors, journal name, volume, issue, page numbers,
publication date.
3. Abstract, is the summary of articles content.
4. An outline, use to click HTML full text.
5. Download PDF and Export citation
6. Related Articles – the way to find articles on the same
topic.

Finding full article:

Science Direct always has the full text. Articles are available
in HTML full text. They are also available as downloadable
PDF files.

UGC – CARE

UGC Approved Journals are the medium for publishing the

research articles. University Grant Commission will consider
the research article as valid only when we submit it in the
UGC Approved Journals.The UGC-CARE List of Quality

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journal is now divided into 2 groups. These are not hierarchic

or ranked groups.

• UGC-CARE List Group I: Journals found qualified

through UGC-CARE protocols
• UGC-CARE List Group II: Journals indexed in
globally recognised databases
• UGC-CARE List is updated quarterly i.e. on first of
January, April, July, and October every year.
• Journals found to be involved in unethical practices are
immediately removed.

Essential Features of UGC-CARE list:

➢ To promote quality research, academic integrity, and

publication.
➢ To prevent publications in dubious/predatory/sub-
standard journals.
➢ To maintain the Reference UGC CARE List of Quality
Journals.
➢ To develop a methodology and approach for good quality
journal identification.

Steps Involved:

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• The site
is https://ugccare.unipune.ac.in/apps1/home/index
• Click the website link

• If there is no account with UGC Care, click on top right

Login.

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• Click on “ Register Here” at the bottom of the page .

• Use the form to register.

• Submit the form.

• After registration, go back to login page and login
now.

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• A new page appears.

• Now search by title, ISSN, Publisher, subject etc.
using drop down menu.

• Example by title: Choose the Title from drop down

menu, Select Title and Enter Your Subject.

• See results carefully on last right column for the

current and complete indexing and other details.
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• We can view many pages…….1,2,3…..

REFERENCES
Arthur M. Lesk, Introduction To Bioinformatics, 2002,
Oxford University Press.
Jin Xiong, ssential Bioinformatics, 2006,Cambridge
University Press.
Supratim Choudhuri, Bioinformatics for Beginners, Genes,
Genomes, Molecular Evolution, Databases, and Analytical
Tools, 2014,Elsevier Inc.

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CHAPTER-IV

Laboratory animals used for Life science research.

Ethics in animal experimentation. CPCSEA
guidelines−Animal care and technical personnel
environment, animal husbandry, feed, bedding, water,
sanitation and cleanliness, waste disposal, anaesthesia and
euthanasia.

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INTRTODUCTION

Choosing the correct animal model is an essential component

to the success of biomedical research. Each species used in
biomedical research must be provided with adequate housing
and care to ensure the well-being of the animals. Because
good science and good animal care go hand in hand, it is
important to understand and address the biological and
behavioural needs of the animals being studied.

MICE
Mice and rats make up approximately 95% of all
laboratory animals, with mice the most commonly used
animal in biomedical research. Mice (Fig.1) are a commonly
selected animal model for a variety of reasons, including
small size (facilitating housing and maintenance); short
reproductive cycle and lifespan; generally mild-tempered
and docile; wealth of information regarding their anatomy,
genetics, biology, and physiology; and the possibility for
breeding genetically manipulated mice and it have
spontaneous mutations. They are used to model human
diseases for the purpose of finding treatments or cures. Some
of the diseases they model include: hypertension, diabetes,

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cataracts, obesity, seizures, respiratory problems, deafness,

Parkinson's disease, Alzheimer's disease, various cancers,
cystic fibrosis, and acquired immunodeficiency syndrome
(AIDS), heart disease, muscular dystrophy, and spinal cord
injuries. Mice are also used in behavioural, sensory, aging,
nutrition, and genetic studies. This list is in no way complete
as geneticists, biologists, and other scientists are rapidly
finding new uses for the domestic mouse in research.

Mice are mammals and their organ systems are very

similar to organ systems in humans in terms of shape,
structure, and physiology. Mice have only two types of teeth,
incisors and molars. The incisors are open-rooted and erupt
(i.e., grow) continuously throughout their lives. This
predisposes mice to malocclusion if not given feeds or objects
such as nylon bones to help wear down the teeth during
mastication. The molars are rooted and, thus, do not
continuously erupt. The stomach has two compartments with
the proximal portion completely keratinized and the distal
portion entirely glandular. Their intestines are simple, but the
rectum is very short (1–2 mm) and hence is prone to prolapse,
especially if the animal has colitis. The gastrointestinal flora

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consists of more than 100 species of bacteria that form a

complex ecosystem that aids digestion and health of the
mouse.

Mice have no sweat glands but have a relatively large

surface area per gram of body weight. In addition to the lack
of sweat glands, they cannot pant or produce large amounts of
saliva to aid in cooling their body temperature. The thermo
neutral zone, the range of ambient temperatures at which the
mouse does not have to perform regulatory changes in
metabolic heat production or evaporative heat loss to maintain
its core temperature, is about 29.6°C–30.5°C. The female
reproductive system is comprised of paired ovaries and
oviducts, uterus, cervix, vagina, clitoris, and paired clitoral
glands. Pregnant female mice have hemochorial placentation,
similar to humans. The female mouse also has five pairs of
mammary glands. The male reproductive system consists of
paired testes, penis, and associated sexual ducts and glands.
Both sexes have well-developed preputial glands, which can
become infected. Mice breed continuously throughout the
year unless conditions are very unfavourable to them (e.g.,
lack of food). Their reproductive potential can be affected by

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a number of external influences such as noise, diet, light

cycles, population density, or cage environment.

RATS

Rats (Fig.2) and humans have a long history of

coexistence. The origins of the laboratory rat, also known as
the Norway rat, stretch back centuries to the areas of modern
day China and Mongolia. The dispersal of the Norway rat has
occurred across the centuries and its natural habitat stretches
from the Mediterranean across Southeast Asia and down into
Australia and New Guinea. Over the centuries, rats have also
been used for food (e.g., in Imperial China), companionship,
and sport. Ratting, a vicious blood sport where people laid
bets on the dog that could kill the most rats in a given period
of time was especially popular in both the Victorian England
and American Underworld.

The first recorded use of rats as research subjects

occurred in 1828, and the first known rat breeding
experiments occurred in the late 1800s. The first major effort
to perform research in the United States using laboratory rats
occurred at the Wistar Institute of Philadelphia, the oldest

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independent research institute in the United States, in 1894.

Rattus norvegicus constitutes one of the most commonly used
laboratory species, second only to the laboratory mouse.
RABBIT
The ancestral home of the European rabbit (Fig 3)
(Oryctolagus cuniculus) is the Iberian Peninsula. European
rabbits have been used in research since the middle of the
19th century. Early work with the species was concentrated on
the comparative anatomy of the rabbit with other species, such
as the frog, and the unique features of the rabbit's heart and
circulatory system. Louis Pasteur used rabbits in a series of
experiments that led to the development of the world's first
rabies vaccine.

While there are numerous so-called “fancy” breeds of

rabbits available in the pet trade, the list of breeds routinely
used in research is much shorter. The New Zealand White
(NZW) rabbit is the most frequent breed of used in research.
The California and Dutch-belted rabbit breeds are also
occasionally used. Researchers have developed genetically
inbred rabbit strains for particular research applications. For
example, the Watanabe heritable hyperlipidemic (WHHL) and
the myocardial infarction-prone WHHL rabbit (WHHLMI),
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both developed by researchers in Japan, are used to explore

diseases associated with dyslipidemia such as atherosclerosis.
ZEBRAFISH
The zebrafish (Fig 4), Danio rerio of the Cyprinidae
family, is a small, dark blue and yellow striped, shoaling,
teleost fish, popular among aquarium enthusiasts, and
increasingly among the research community. The adult fish
are 4–5 cm in length, with an incomplete lateral line and two
pairs of barbels. Males have larger anal fins and more yellow
coloration; females have a small genital papilla just rostral to
the anal fin.

Zebrafish are hardy, fresh water fish originating from a

tropical region with an annual monsoon season. The fish are
generally found among slow moving waters of rivers, streams,
and wetlands, across the South Asia region of India,
Bangladesh, and Nepal. The waters tend to be shallow,
relatively clear with substrates of clay, silt, or stone of varying
size. The fish feed mostly on insects and plankton, with
evidence of feeding along the water column as well as water
surface. The small size of zebrafish, the ease of keeping large
numbers, frequent spawning, large egg clutches, translucent
nonadherent eggs, rapid development and complex
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sequencing of the zebrafish genome are all key components

that make the zebrafish an attractive research model.
Interestingly, approximately 70% of zebrafish genes have at
least one orthologous human gene. Developmental biology
was the initial focus of zebrafish research use. However, in
recent years, use of the zebrafish in research related to
biochemistry and molecular biology, cell biology,
neurological sciences, and genetics has been rapidly
increasing.
GUINEA PIGS
Guinea pigs (Fig 5) (Cavia porcellus) are rodents, related
to porcupines and chinchillas in the suborder Hystricomorpha.
They originate from the mountain and grassland regions along
the mid-range of the Andes Mountains in South America.
They are small, stocky, non burrowing, crepuscular herbivores
with short legs and little to no tail, ranging from 700 to
1200 g, females being smaller than males. Guinea pigs have a
long-standing historical role in research stretching as far back
as the 1600s, when they were first used in anatomical studies.
Further, they were used by Louis Pasteur and Robert Koch in
their investigations of infectious disease, and have contributed
to the work of several Nobel Prize worthy studies.

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Specifically, the guinea pig has been used as a model for

infectious diseases such as tuberculosis, Legionnaires disease,
sexually transmitted diseases such as chlamydia and syphilis,
and one of the more common causes of nosocomial infections
in people, Staphylococcus aureus . Guinea pigs have also
been useful tools in researching cholesterol metabolism,
asthma, fetus and placental development and aspects of
childbirth, as well as Alzheimer's disease.

Guinea pigs have many similarities to humans

hormonally, immunologically, and physiologically. Unlike
other rodents, and more like primates (including people),
guinea pigs are prone to scurvy if they do not receive
adequate vitamin C, typically in their diet. Guinea pigs are
housed similarly to other rodents, although they require more
room than the smaller rodents.

HAMSTERS

Hamsters (Fig6)are of the Rodentia order, suborder Myo

morpha along with the mouse and the rat. There are over 24
species of hamsters described in the literature, with the most
common hamster used in research being the Golden or Syrian

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hamster, Mesocricetus auratus . Originating from the

northwest region of Syria, Golden hamsters are thought to be
descendants of only three or four littermates collected from
Syria in 1930. As their name implies, the typical wild-type
coat is reddish gold along their dorsum, with a gray underside.
They are granivores and insectivores, weighing 85–150 g,
females weighing more than males, with short legs and short
tail, and large cheek pouches.
ETHICS AND EXPERIMENTS ON ANIMALS

The ethical assessments related to the use of animals in

research are wide-ranging. It is generally thought that it may
be necessary to use laboratory animals in some cases in order
to create improvements for people, animals or the
environment. At the same time, the general opinion is that
animals have a moral status, and that our treatment of them
should be subject to ethical considerations. Such views are
reflected in the following positions: (i) Animals have an
intrinsic value which must be respected, (ii) Animals are
sentient creatures with the capacity to feel pain, and the
interests of animals must therefore be taken into
consideration, (iii) Our treatment of animals, including the use

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of animals in research, is an expression of our attitudes and

influences us as moral actors.

The guidelines reflect all these positions, and stipulate

principles and considerations that can be used as tools when
balancing between harm and benefit. The three Rs (Replace,
Reduce, and Refine) are established principles that are also
enshrined in legislation. These principles can establish
absolute limits for experiments on animals, even when there
are great benefits. These principles also state what can
reasonably be considered harm and benefit, and the principles
thus facilitate good assessments. Assessments of harm and
benefit associated with experiments on animals are
particularly demanding, because experiments may result in
researchers intentionally causing actual harm to animals,
while the future benefits are often uncertain.

The guidelines are dynamic and must be reviewed in line

with technological developments and the appearance of new
ethical issues. New gene technology methods create new
opportunities for the use of genetically modified animals
in research, which is a growing trend. Genetically modifying
laboratory animals, i.e. changing the genetic material of

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laboratory animals using gene technology, gives rise to a

special responsibility in that this method entails a double
intervention: first, intervention in the animal's genetic material
and second, use of the animal as a research object. This
practice has the potential to change our view of humans
and our attitudes towards generating or eliminating genetic
characteristics in ourselves.

RESPECT FOR ANIMALS' DIGNITY

Researchers must have respect for animals' worth,

regardless of their utility value, and for animals' interests as
living, sentient creatures. Researchers must be respectful
when choosing their topic and methods, and when
disseminating their research. Researchers must provide care
that is adapted to the needs of each laboratory animal.

RESPONSIBILITY FOR CONSIDERING OPTIONS

(REPLACE)

Researchers are responsible for studying whether there

are alternatives to experiments on animals. Alternative options
must be prioritised if the same knowledge can be acquired
without using laboratory animals. If no good options are
available, researchers should consider whether the research
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can be postponed until alternative methods have been

developed. When justifying experiments on animals,
researchers therefore must be able to account for the absence
of options and the need to acquire knowledge immediately.

THE PRINCIPLE OF PROPORTIONALITY:

RESPONSIBILITY FOR CONSIDERING AND
BALANCING SUFFERING AND BENEFIT

Researchers must consider the risk that laboratory

animals experience pain and other suffering (see guideline 5)
and assess them in relation to the value of the research for
animals, people or the environment. Researchers are
responsible for considering whether the experiment may result
in improvements for animals, people or the environment. The
possible benefits of the study must be considered,
substantiated and specified in both the short and the long
term. The responsibility also entails an obligation to consider
the scientific quality of the experiments and whether the
experiments will have relevant scientific benefits. Suffering
can only be caused to animals if this is counterbalanced by a
substantial and probable benefit for animals, people or the
environment. There are many different methods for analysing

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harm and benefit. Research institutions should provide

training on suitable models, and researchers are
responsible for using such methods of analysis when planning
experiments on animals.

RESPONSIBILITY FOR CONSIDERING REDUCING

THE NUMBER OF ANIMALS (REDUCE)

Researchers are responsible for considering whether it is

possible to reduce the number of animals the experiment plans
to use and must only include the number necessary
to maintain the scientific quality of the experiments and the
relevance of the results. This means, among other things, that
researchers must conduct literature studies, consider
alternative experiment designs and perform design
calculations before beginning experiments.

RESPONSIBILITY FOR MINIMISING THE RISK OF

SUFFERING AND IMPROVING ANIMAL WELFARE
(REFINE)

Researchers are responsible for assessing the expected

effect on laboratory animals. Researchers must minimise the
risk of suffering and provide good animal welfare. Suffering
includes pain, hunger, thirst, malnutrition, abnormal cold or
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heat, fear, stress, injury, illness and restrictions on the ability

to behave normally/naturally. A researcher's assessment of
what is considered acceptable suffering should
be based on the animals that suffer the most. If there are any
doubts regarding perceived suffering, consideration of the
animals must be the deciding factor. Researchers must not
only consider the direct suffering that may be endured during
the experiment itself, but also the risk of suffering before and
after the experiment, including trapping, labelling,
anaesthetising, breeding, transportation, stabling and
euthanising. This means that researchers must also
take account of the need for periods of adaptation before and
after the experiment.

RESPONSIBILITY FOR MAINTAINING

BIOLOGICAL DIVERSITY

Researchers are responsible for ensuring that the use of

laboratory animals does not endanger biological diversity.
This means that researchers must consider the consequences
to the stock and to the ecosystem as a whole. The use of
endangered and vulnerable species must be reduced to an
absolute minimum. When there is credible, but uncertain,

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knowledge that the inclusion of animals in research or the use

of certain methods may have ethically unacceptable
consequences for the stock and the ecosystem as a whole,
researchers must observe the precautionary principle.

RESPONSIBILITY WHEN INTERVENING IN A

HABITAT

Researchers are responsible for reducing disruption and

any impact on the natural behaviour of individual animals,
including those that are not direct subjects of research, as well
as of populations and their surroundings. Certain research
and technology-related projects, like those regarding
environmental technology and environmental surveillance,
may impact on animals and their living conditions, for
example as a result of installing radar masts, antennas or other
measurement instruments. In such cases, researchers must
seek to observe the principle of proportionality (see guideline
3) and minimise the possible negative impact.

RESPONSIBILITY FOR OPENNESS AND SHARING

OF DATA AND MATERIAL

Researchers are responsible for ensuring that there is

transparency about research findings and facilitating the
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sharing of data and material from experiments on

animals. Such transparency and sharing are important in order
to avoid unnecessary repetition of experiments. Transparency
is also important in order to ensure that the public are
informed and is part of researchers' responsibility for
dissemination. In general, the negative results of experiments
on animals should be public knowledge. Disclosing negative
results may give other researchers information about which
experiments are not worth pursuing, shine a light on
unfortunate research design, and help reduce the use of
animals in research.

REQUIREMENT OF EXPERTISE ON ANIMALS

Researchers and other parties who handle live animals

must have adequately updated and documented expertise on
animals. This includes specific knowledge about the biology
of the animal species in question, and a willingness and
ability to take care of animals properly.

REQUIREMENT OF DUE CARE

There are national laws and rules and international

conventions and agreements regarding the use of laboratory
animals, and both researchers and research managers must
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comply with these. Any person who plans to use animals in

experiments must familiarise themselves with the current
rules.

COMMITTEE FOR THE PURPOSE OF CONTROL

AND SUPERVISION ON EXPERIMENTS ON
ANIMALS (CPCSEA): GUIDELINES
Committee for the Purpose of Control and Supervision of
Experiments on Animals (CPCSEA) it Includes various
guidelines and sub committeesHead quarters at Chennai
Revived in 1998, under the committed chairpersonship of
Meneka Gandhi Formed in 1964 Statutory body formed by
the Act of the Indian Parliament under the Prevention of
Cruelty to Animals Act, 1960. In 2004 CPCSEA officially
accepts the concept of the 4th R “investigators have a moral
responsibility to take care of laboratory animals after use”
Introduced the credo of 3R principles Introduced a national
“Good Laboratory Practice” document National level expert
committee to scrutinize and approve the research projects
conducted using animals. The committee has 10 experts and
3 official membersAnimal activists. Regulatory authority’s
members of the scientific community this committee is

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composed of Ministry of Environment and Forests (Animal

welfare). For large animals- make its recommendation to
SCLA (Sub-Committee on Large Animals) for small animals-
give the final approval IAEC scrutinize all project proposals
for experimentation on animals. CPCSEA Nominee
important link between CPCSEA and IAEC is to monitor
animal experiments through ethics committees set up in
institutions IAEC. The validity of IAEC is for 3 years. other
members: Main nominee, Link Nominee, scientist from
outside and socially aware nominee. The Chairman
(preferably Head of the Institution / Department) and Member
Secretary need to be nominated from the above five members.
Scientist in-Charge of animal house facility. a veterinarian
involved in care of animals. Two scientists from different
biological disciplines, Effective functioning of Institutional
animal ethical committee to provide specifications that will
enhance animals well being and quality of research.
Permission of Committee for Conducting Experiments
approval of animal house facilities for breeding of animals for
experiments on animals, registration of establishments main
activities Physical separation of animals by species to prevent
anxiety and behavioural change Physiologic, psychological

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and nutritional stabilization required Quarantine period for

small lab animals: one week to one month, large lab animals :
up to 6 weeks daily observation of animals adopted
quarantine, stabilization and separation: Provided by a
veterinarian Permissible number of animals accommodated
in each container use of transport containers (cages or crates)
of appropriate size during transport, stress avoided by:
procurement of animals done from established commercial
animal vendors.
Good Laboratory Practices (GLP) for animal facilities is
intended to assure quality maintenance and safety of animals
used in laboratory studies while conducting biomedical and
behavioural research and testing of products. The goal of
these Guidelines is to promote the humane care of animals
used in biomedical and behavioural research and testing with
the basic objective of providing specifications that will
enhance animal well being, quality in the pursuit of
advancement of biological knowledge that is relevant to
humans and animals.
Adequate veterinary care must be provided and is the
responsibility of a veterinarian or a person who has training or
experience in laboratory animal sciences and medicine. Daily

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observation of animals can be accomplished by someone other

than a veterinarian; however, a mechanism of direct and
frequent communication should be adopted so that timely and
accurate information on problems in animal health, behaviour,
and well being is conveyed to the attending veterinarian. The
veterinarian can also contribute to the establishment of
appropriate policies and procedures for ancillary aspects of
veterinary care, such as reviewing protocols and proposals,
animal husbandry and animal welfare; monitoring
occupational health hazards containment, and zoonosis
control programs; and supervising animal nutrition and
sanitation. Institutional requirements will determine the need
for full-time or part-time or consultative veterinary services.
All animals must be acquired lawfully as per the CPCSEA
guidelines. A health surveillance program for screening
incoming animals should be carried out to assess animal
quality. Methods of transportation should also be taken into
account (Annexure 4). Each consignment of animals should
be inspected for compliance with procurement specifications,
and the animals should be quarantined and stabilized
according to procedures appropriate for the species and
circumstances.

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Quarantine is the separation of newly received animals

from those already in the facility until the health and possibly
the microbial status of the newly received animals have been
determined. An effective quarantine minimizes the chance for
introduction of pathogens into an established colony. A
minimum duration of quarantine for small lab animals is one
week and larger animals are 6 weeks (cat, dog, monkey, etc.)
Effective quarantine procedures should be used for non-
human primates to help limit exposure of humans to zoonotic
infections. Regardless of the duration of quarantine, newly
received animals should be given a period for physiologic,
psychologic and nutritional stabilization before their use. The
length of time stabilization will depend on the type and
duration of animal transportation, the species involved and the
intended use of the animals. Physical separation of animals by
species is recommended to prevent interspecies disease
transmission and to eliminate anxiety and possible
physiological and behavioural changes due to interspecies
conflict. Such separation is usually accomplished by housing
different species in separate rooms; however, cubicles,
laminar-flow units, cages that have filtered air or separate
ventilation, and isolators shall be suitable alternatives. In

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some instances, it shall be acceptable to house different

species in the same room, for example, if two species have a
similar pathogen status and are behaviourally compatible.
SURVEILLANCE, DIAGNOSIS, TREATMENT AND
CONTROL OF DISEASE
All animals should be observed for signs of illness,
injury, or abnormal behaviour by animal house staff. As a
rule, this should occur daily, but more-frequent observations
might be warranted, such as during postoperative recovery or
when animals are ill or have a physical deficit. It is imperative
that appropriate methods be in place for disease surveillance
and diagnosis (Annexure 1 & 2). Unexpected deaths and signs
of illness, distress, or other deviations from normal health
condition in animals should be reported promptly to ensure
appropriate and timely delivery of veterinary medical care.
Animals that show signs of a contagious disease should be
isolated from healthy animals in the colony. If an entire room
of animals is known or believed to be exposed to an infectious
agent (e.g. Mycobacterium tuberculosis in non-human
primates), the group should be kept intact and isolated during
the process of diagnosis, treatment, and control. Diagnostic
clinical laboratory may be made available.

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ANIMAL CARE AND TECHNICAL PERSONNEL

ENVIRONMENT
Animal care programs require technical and husbandry
support. Institutions should employ people trained in
laboratory animal science or provide for both formal and on-
the-job training to ensure effective implementation of the
program.
Personal Hygiene is essential that the animal care staff
maintain a high standard of personal cleanliness. Facilities
and supplies for meeting this obligation should be provided
e.g. showers, change of uniforms, footwear etc. Clothing
suitable for use in the animal facility should be supplied and
laundered by the institution. A commercial laundering service
is acceptable in many situations; however, institutional
facilities should be used to decontaminate clothing exposed to
potentially hazardous microbial agents or toxic substances. In
some circumstances, it is acceptable to use disposable gear
such as gloves, masks, head covers, coats, coveralls and shoe
covers. Personal should change clothing as often as is
necessary to maintain personal hygiene. Outer garments worn
in the animal rooms should not be worn outside the animal

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facility. Washing and showering facilities appropriate to the

program should be available. Personnel should not be
permitted to eat, drink, smoke or apply cosmetics in animal
rooms. A separate area or room should be made available for
these purposes.
Institutions should have policies governing
experimentation with hazardous agents. Institutional Biosafety
Committee whose members are knowledgeable about
hazardous agents are in place in most of the higher-level
education, research institutes and in many pharmaceutical
industries for safety issues. Since the use of animals in such
studies requires special consideration, the procedures and the
facilities to be used must be reviewed by both the Institutional
Biosafety committee and Institutional Animal Ethics
Committee (IAEC).
ANIMAL HUSBANDRY
Building materials should be selected to facilitate
efficient and hygienic operation of animal facilities. Durable,
moisture-proof, fire-resistant, seamless materials are most
desirable for interior surfaces including vermin and pest
resistance. Corridor(s) should be wide enough to facilitate the
movement of personnel as well as equipments and should be

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kept clean. Utilities such as water lines drain pipes, and

electrical connections should preferably be accessible through
service panels or shafts in corridors outside the animal rooms.
Animal room doors should be rust, vermin and dust proof.
They should fit properly within their frames and provided
with an observation window. Door closures may also be
provided. Rodent barriers can be provided in the doors of the
small animal facilities. Exterior windows are not
recommended for small animal facilities. However, where
power failures are frequent and backup power is not available,
they may be necessary to provide alternate source of light and
ventilation. In primate rooms, windows can be provided.
Floors should be smooth, moisture proof, non-absorbent, skid-
proof, resistant to wear, acid, solvents, adverse effects of
detergents and disinfectants. They should be capable of
supporting racks, equipment, and stored items without
becoming gouged, cracked, or pitted, with minimum number
of joints. A continuous moisture-proof membrane might be
needed. If sills are installed at the entrance to a room, they
should be designed to allow for convenient passage of
equipment.

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Floor drains are not essential in all rooms used

exclusively for housing rodents. Floor in such rooms can be
maintained satisfactorily by wet vacuuming or mopping with
appropriate disinfectants or cleaning compounds. Where floor
drains are used, the floors should be sloped and drain taps
kept filled with water or corrosion free mesh. To prevent high
humidity, drainage must be adequate to allow rapid removal
of water and drying of surfaces.
Walls should be free of cracks, unsealed utility
penetrations, or imperfect junctions with doors, ceilings,
floors and corners. Surface materials should be capable of
withstanding scrubbing with detergents ad disinfectants and
the impact of water under high pressure. Separate storage
areas should be designed for feed, bedding, cages and
materials not in use. Refrigerated storage, separated from
other cold storage, is essential for storage of dead animals and
animal tissue waste.
An area for sanitizing cages and ancillary equipment is
essential with adequate water supply Experimental procedures
in small animals should be carried out in a separate area away
from the place where animals are housed. For larger animal
functional areas for aseptic surgery should include a separate

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surgical support area, a preparation area, the operating room

or rooms, and an area for intensive care and supportive
treatment of animals.
ENVIRONMENT
Air conditioning is an effective means of regulating these
environmental parameters for laboratory animals.
Temperature and humidity control prevents variations due to
changing climatic conditions or differences in the number and
kind of room occupants. Ideally, capability should be
provided to allow variations within the range of
approximately 18 to 29°C (64.4 to 84.2øF), which includes
the temperature ranges usually recommended for common
laboratory animals. The relative humidity should be
controllable within the range of 30% to 70% throughout the
year. For larger animals a comfortable zone (18 to 37°C)
should be maintained during extreme summer by appropriate
methods for cooling. In renovating existing or in building new
animal facilities, consideration should be given to the
ventilation of the animals' primary enclosures.

Heating, ventilating, and air-conditioning systems should

be designed so that operation can be continued with a standby

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system. The animal facility and human occupancy areas

should be ventilated separately. The electrical system should
be safe and provide appropriate lighting and a sufficient
number of power outlets. It suggested that a lighting system
be installed that provides adequate illumination while people
are working in the animal rooms and a lowered intensity of
light for the animals. Fluorescent lights are efficient and
available in a variety of acceptable fixtures. A time-controlled
lighting system should be used to ensure a regular diurnal
lighting cycle wherever required. Emergency power should be
available in the event of power failure. The facility should be
provided with noise free environment. Noise control is an
important consideration in designing an animal facility.
Concrete walls are more effective than metal or plaster walls
containing noise because their density reduces sound
transmission. The caging or housing system is one of the most
important elements in the physical and social environment of
research animals. It should be designed carefully to facilitate
animal well being, meet research requirements, and minimize
experimental variables. The housing system should: Provide
space that is adequate, permit freedom of movement and
normal postural adjustments, and have a resting place

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appropriate to the species; (Annexure 3) Provide a

comfortable environment Provide an escape proof enclosure
that confines animal safety Provide easy access to food and
water; Provide adequate ventilation Meet the biological
needs of the animals, e.g., maintenance of body temperature,
urination, defecation, and reproduction; Keep the animals dry
and clean, consistent with species requirements ; Facilitate
research while maintaining good health of the animals.
They should be constructed of sturdy, durable materials
and designed to minimize cross-infection between adjoining
units. Polypropylene, polycarbonate and stainless steel cages
should be used to house small lab animals, Monkeys should
be housed in cages made of steel or painted mild steel and for
other animals such as sheep, horses, the details can be seen in
Annexure 3.
To simplify servicing and sanitation, cages should have
smooth, impervious surfaces that neither attract nor retain dirt
and a minimum number of ledges, angles, and corners in
which dirt or water can accumulate. The design should allow
inspection of cage occupants without disturbing them.
Feeding and watering devices should be easily accessible for
filling, changing, cleaning and servicing. Cages, runs and pens

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must be kept in good condition to prevent injuries to animals,

promote physical comfort, and facilitate sanitation and
servicing. Particular attention must be given to eliminate
sharp edges and broken wires, keeping cage floors in good
condition. When animals are maintained in outdoor runs,
pens, or other large enclosures, there must be protection from
extremes in temperature or other harsh whether conditions and
adequate protective and escape mechanism for submissive
animals, as in case of monkeys by way of an indoor portion of
a run, should be provided. Shelter should be accessible to all
animals, have sufficient ventilation, and be designed to
prevent build up of waste materials and excessive moisture.
Houses, dens, boxes, shelves, perches, and other furnishings
should be constructed in a manner and made of materials that
allow cleaning or replacement in accordance with generally
accepted husbandry practices when the furnishings are soiled
or worn-out. Ground-level surfaces of outdoor housing
facilities can be covered with absorbent bedding, sand, gravel,
grass, or similar material that can be removed or replaced
when that is needed to ensure appropriate sanitation. Build up
of animal waste and stagnant water should be avoided by, for
example, using contoured or drained surface. Other surfaces

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should be able to withstand the elements and be easily

maintained. The social environment includes all interactions
among individuals of a group or among those able to
communicate. The effects of social environment on caged
animals vary with the species and experience of the animals.
In selecting a suitable social environment, attention should be
given to whether the animals are naturally territorial or
communal and whether they will be housed singly or in
groups.
When appropriate, group housing should be considered
for communal animals. In grouping animals, it is important to
take into account population density and ability to disperse;
initial familiarity among animals; and age, sex, and social
rank. Population density can affect reproduction, metabolism,
immune responses, and behaviour. Group composition should
be held as stable as possible, particularly for canine, non-
human primates, and other highly social mammals, because
mixing of groups or introducing new members can alter
behavioural and physiological functions. Non-human primates
should have a run for free ranging activities:
Activity provision should be made for animals with
specialized locomotors pattern to express these patterns,

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especially when the animals are held for long periods. For
e.g., ropes, bars, and perches are appropriate for branching
non-human primates. Cages are often used for short-term (up
to 3 months) housing of dogs and may be necessary for
postsurgical care, isolation of sick dogs, and metabolic
studies. Pens, runs, or other out-of-cage space provide more
opportunity for exercise, and their use is encouraged when
holding dogs for long periods.

FOOD
Animals should be fed palatable, non-contaminated, and
nutritionally adequate food daily unless the experimental
protocol requires otherwise. Feeders should allow easy access
to food, while avoiding contamination by urine and faeces.
Food should be available in a mounts sufficient to ensure
normal growth in immature animals and maintenance of
normal body weight, reproduction, and lactation in adults.
Food should contain adequate nutrition, including formulation
and preparation; freedom from chemical and microbial
contaminants; bio-availability of nutrients should be at par
with the nutritional requirement of the animal. Laboratory
animal diets should not be manufactured or stored in facilities

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used for farm feeds or any products containing additives such

as rodenticides, insecticides, hormones, antibiotics, fumigants,
or other potential toxicants. Areas in which diets are
processed or stored should be kept clean and enclosed to
prevent entry of insects or other animals. Precautions should
be taken if perishable items such as meats, fruits, and
vegetables are fed, because these are potential sources of
biological and
Chemical contamination and can also lead to variation in
the amount of nutrients consumed. Diet should be free from
heavy metals (e.g., lead, arsenic, cadmium, nickel, mercury),
naturally occurring toxins and other contaminants. Exposure
to extremes in relative humidity, unsanitary conditions, light,
oxygen, and insects hasten the deterioration of food. Meats,
fruits, vegetables, and other perishable items should be
refrigerated if required to be stored. Unused, open food should
be stored in vermin – proof condition to minimize
contamination and to avoid potential spread of disease agents.
Food hoppers should not be transferred from room to room
unless cleaned and sanitized. The animal feed should contain
moisture, crude fibre, crude protein, essential vitamins,

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minerals crude fat and carbohydrate for providing appropriate

nutrition.
BEDDING
Bedding should be absorbent, free of toxic chemicals or
other substances that could injure animals or personnel, and of
a type not readily eaten by animals. Bedding should be used in
amounts sufficient to keep animals dry between cage changes
without coming into contact with watering tubes. Bedding
should be removed and replaced with fresh materials as often
as necessary to keep the animals clean and dry. The frequency
is a matter of professional judgement of the animal care
personnel in consultation with the investigation depending on
the number of animals and size of cages. The desirable criteria
for rodent contact bedding is ammonia binding, sterillizable,
deleterious products not formed as a result of sterilization,
easily stored, non – desiccating to the animal,
uncontaminated, unlikely to be chewed or mouthed, non –
toxic, non – malodorous, nestable, disposable by incineration,
readily available, remains chemically stable during use,
manifests batch uniformity, optimizes normal animal
behaviour, non – deleterious to cage – washers, non –
injurious and non – hazardous to personnel, non – nutritious

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and non – palatable. Nesting materials for newly delivered

pups wherever can be provided (e.g. Paper, tissue paper,
cotton etc.).
WATER
Ordinarily animals should have continuous access to
fresh, potable, uncontaminated drinking water, according to
their particular requirements. Periodic monitoring of
microbial contamination in water is necessary. 14 Watering
devices, such as drinking tubes and automatic waterers if used
should be examined routinely to ensure their proper operation.
Sometimes it is necessary to train animals to use automatic
watering devices. It is better to replace water bottles than to
refill them, however, if bottles are refilled, care should be
taken that each bottle is replaced on the cage which it was
removed.
SANITATION AND CLEANLINESS
Sanitation is essential in an animal facility. Animal
rooms, corridors, storage spaces, and other areas should be
cleaned with appropriate detergents and disinfectants as often
as necessary to keep them free of dirt, debris , and harmful
contamination. Cleaning utensils, such as mops, pails, and
brooms, should not be transported between animal rooms.

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Where animal waste is removed by hosting or flushing, this

should be done at least twice a day. Animals should be kept
dry during such procedures. For larger animals, such as dogs,
cats, and non – human primates, soiled litter material should
be removed twice daily. Cages should be sanitized before
animals are placed in them. Animal cages, racks, and
accessory equipments, such as feeders and watering devices,
should be washed and sanitized frequently to keep them clean
and contamination free. Ordinarily this can be achieved by
washing solid bottom rodent cages and accessories once or
twice a week and cages, racks at least monthly. Wire – bottom
rodent cages for all other animals should be washed at least
every 2 weeks. It is good practice to have extra cages
available at all times so that a systematic cage-washing
schedule can be maintained. Cages can be disinfected by
rinsing at a temperature of 82.2C (180 F) or higher for a
period long enough to ensure the destruction of vegetative
pathogenic organisms. Disinfection can also be accomplished
with appropriate chemicals; equipments should be rinsed free
of chemicals prior to use. Periodic microbiologic monitoring
is useful to determine the efficacy of disinfection or
sterilization procedures. Rabbits and some rodents, such as

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guinea pigs and hamsters, produce urine with high

concentration of proteins and minerals. Minerals and organic
compounds in the urine from these animals often adhere to
cage surfaces and necessitate treatment with acid solutions
before washing. Water bottles, sipper tubes, stoppers, and
other watering equipment should be washed and then
sanitized by rinsing with water of at least 82.2C (180F) or
appropriated chemicals agents (e.g. hyperchlorite) to destroy
pathogenic organisms, if bottles are washed by hand, powered
rotating brushes at the washing sink are useful, and provision
should be made for dipping or soaking the water bottles in
detergents and disinfectant solutions. A two – compartment
sink or tub is adequate for this purpose. Some means for
sterilizing equipments and supplies, such as an autoclave or
gas sterilizer, is essential when pathogenic organisms are
present. Routine sterilization of cages, food and bedding is not
considered essential if care is taken to use clean materials
from reliable sources. Where hazardous biological, chemical,
or physical agents are used, a system of equipment monitoring
might be appropriate. Deodorizers or chemical agents other
than germicidal should not be used to mask animal odors.
Such products are not a substitute for good sanitation.

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ASSESSING THE EFFECTIVENESS OF SANITATION

Monitoring of sanitation practices should be appropriate
to the process and materials being cleaned; it can include
visual inspection of the materials, monitoring of water
temperatures, or microbiologic monitoring. The intensity of
animal odors, particularly that of ammonia, should not be
used as the sole means of assessing the effectiveness of the
sanitation program. A decision to alter the frequency of cage –
bedding changes or cage – washing should be based on such
factors as the concentration of ammonia, the appearance of the
cage, the condition of the bedding and the number and size of
animals housed in the cage.
WASTE DISPOSAL
Wastes should be removed regularly and frequently. All
waste should be collected and disposed of in a safe and
sanitary manner. The most preferred method of waste disposal
is incineration. Incinerators should be in compliance with all
central, state, and local regulations. Waste cans containing
animal tissues, carcasses, and hazardous wastes should be
lined with leak – proof, disposable liners. If wastes must be
stored before removal, the waste storage area should be
separated from other storage facilities and free of flies,

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cockroaches, rodents, and other vermin. Cold storage might

be necessary to prevent decomposition of biological wastes.
Hazardous wastes should be rendered safe by sterilization,
contamination, or other appropriate means before they are
removed from an animal facility for disposal.
PEST CONTROL
Programs designed to prevent, control, or eliminate the
presence of or infestations by pests are essential in an animal
environment. Animals should be cared for by qualified
personnel every day, including weekends and holidays, to
safeguards their well – being including emergency veterinary
care. In the event of an emergency, institutional security
personnel and fire or police officials should be able to reach
people responsible for the animals. That can be enhanced by
prominently posting emergency procedures, names, or
telephone numbers in animals facilities or by placing them in
the security department or telephone center. A disaster plan
that takes into account both personnel and animals should be
prepared as part of the overall safety plan for the animal
facility.
RECORD KEEPING

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The Animal House should maintain following records:

Animal House plans, which includes typical floor plan, all
fixtures etc. Animal House staff record – both technical and
non – technical Health record of staff/ animals All SOPs
relevant to the animals Breeding, stock, purchase and sales
records Minutes of institute Animals Ethics Committee
Meetings Records of experiments conducted with the number
of animals used. Death Record Clinical record of sick
animals, training record of staff involved in animal activities,
water analysis report Standard Operating Procedures (SOPs) /
Guidelines the institute shall maintain SOPs describing
procedures / methods adapted with regard to Animal
Husbandry, maintenance, breeding, animal house microbial
analysis and experimentation records.
PERSONNEL AND TRAINING
The selection of animal facility staff, particularly the
staff working in animal rooms or involved in transportation, is
a critical component in the management of an animal facility.
The staff must be provided with all required protective
clothing (masks, aprons, gloves, gumboots, other footwears
etc.) while working in animal rooms. Facilities should be
provided for change over with lockers, wash basin, toilets and

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bathrooms to maintain personal hygiene. It is also important a

regular medical check-up is arranged for the workers to
ensure that they have not picked up any zoonotic infection and
also that they are not acting as a source of transmission of
infection to the animals. The animal house in-charge should
ensure that persons working in animal house don’t eat, drink,
smoke in animal room and have all required vaccination,
particularly against tetanus and other zoonotic diseases. Initial
in-house training of staff at all levels is essential. A few weeks
must be spent on the training of the newly recruited staff,
teaching them the animal handling techniques, cleaning of
cages and importance of hygiene, disinfection and
sterilization. They should also be made familiar with the
activities of normal healthy and sick animals so that they are
able to spot the sick animal during their daily routine check up
for cages .
TRANSPORT OF LABORATORY ANIMALS
The transport of animals from one place to another is
very important and must be undertaken with care. The main
considerations for transport of animals are, the mode of
transport, the containers, the animal density in cages, food and
water during transit, protection from transit infections, injuries

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and stress. The mode of transport of animals depends on the

distance, seasonal and climatic conditions and the species of
animals. Animals can be transported by road, rail or air taking
into consideration of above factors. In any case the transport
stress should be avoided and the containers should be of an
appropriate size so as to enable these animals to have a
comfortable, free movement and protection from possible
injuries. The food and water should be provided in suitable
containers or in suitable form so as to ensure that they get
adequate food and more particularly water during transit. The
transport containers (cages or crates) should be of appropriate
size and only a permissible number of animals should only be
accommodated in each container to avoid overcrowding and
infighting (Annexure 4) .
TRANSGENIC ANIMALS
Transgenic animals are those animals, into whose germ
line foreign gene(s) have been engineered, whereas knockout
animals are those whose specific gene(s) have been disrupted
leading to loss of function. These animals can be bred to
establish transgenic animal strains. Transgenic animals are
used to study the biological functions of specific genes, to
develop animal models for diseases of humans or animals, to

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produce therapeutic products, vaccines and for biological

screening, etc. These can be either developed in the laboratory
or produced for R&D purpose from registered
scientific/academic institutions or commercial firms, and
generally from abroad with approval from appropriate
authorities.
MAINTENANCE
Housing, feeding, ventilation, lighting, sanitation and
routine management practices for such animals are similar to
those for the other animals of the species as given in
guidelines. However, special care has to be taken with
transgenic/gene knockout animals where the animals can
become susceptible to diseases where special conditions of
maintenance are required due to the altered metabolic
activities. The transgenic and knockout animals carry
additional genes or lack genes compared to the wild
population. To avoid the spread of the genes in wild
population care should be taken to ensure that these are not
inadvertently released in the wild to prevent cross breeding
with other animals. The transgenic and knockout animals
should be maintained in clean room environment or in animal
isolators. DISPOSAL The transgenic and knockout animals

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should be first enthanized and then disposed off as prescribed

elsewhere in the guidelines. A record of disposal and the
manner of disposal should be kept as a matter of routine.

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ANAESTHESIA AND EUTHANASIA

A fundamental responsibility of individuals that use
animals in research, teaching or testing is to anticipate and
eliminate or minimize any potential that procedures may
cause animal pain, distress, or discomfort. Although animals
that are in pain may not behave like humans, (e.g., pain in
animals may be accompanied by immobility and silence, in
contrast to the groans and cries of human patients), it is
assumed that procedures that cause pain in humans cause pain
in animals. The presence of pain in animals can be recognized
by alterations in animal behavior (e.g., reduced activity,

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reduced grooming, hunched- up posture, altered gait, changes

in temperament, vocalizations, reduced food and water intake,
reduced urinary and fecal output), and in physiological
variables, (e.g., reduced depth of respiration, increased heart
rate, and reduced hydration status). Animal pain, distress, and
discomfort can produce a range of undesirable physiological
changes, which may radically alter measured responses to
experimental stimuli, as well as the rate of recovery from
surgical procedures; hence, its avoidance and alleviation are
in the best interest of both the animal and researcher.
Reducing post-procedural/post-operative pain, distress,
and discomfort is accomplished by good nursing care, (e.g.,
keeping the animal warm, clean, dry and well padded), and by
the administration of analgesic drugs. In addition to the
avoidance and alleviation of pain and discomfort, adequate
post-procedural /postoperative animal care also includes
efforts to prevent and/or treat post-anaesthetic complications,
(e.g., aspiration, hypostatic pneumonia, cardiovascular and
respiratory depression, dehydration, and infection). The
prevention or minimization of animal pain, distress, or
discomfort by the proper use of tranquilizers, anaesthetics,
and analgesics is scientifically and ethically essential to the

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humane care, use, and treatment of research animals. The use

of these classes of drugs must effectively prevent or minimize
suffering and discomfort of animals during potentially painful
procedures. The use of these three classes of drugs must be in
accordance with currently accepted veterinary medical
practice and produce in the subject animal an appropriate
level of tranquilization, anaesthesia, or analgesia consistent
with the protocol or design of the experiment.

ANAESTHESIA
The word anaesthesia has been derived from Greek word
that means “without perception of insensibility”, is the act of
providing sensation-free relief from pain or pain-producing
procedures. It must be performed by a person with knowledge
of and familiarity with the drugs to be used in the animal
species under consideration. The following factors are
affecting the activity of anaesthetics Many factors can affect
the activity of anaesthetics. The species, strain, sex, age,
nutritional and disease status, relative body size,
disposition/demeanour, presence of concurrent pain or
distress, or medication are known to cause a variation in the

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amount of drug needed to produce a desired effect in an

individual animal.
A suitable, effective and free of complications anesthetic
protocol is very important in experimental studies on animal
models since it could bias the outcome of a trial. To date there
is no universally accepted protocol for induction, maintenance
and recovery from anaesthesia. The endotracheal intubation
with the use of inhalation anaesthesia is used very especially
in the form of large size laboratory animals, because it is a
secure and easy control mode. However, it is not common for
small laboratory animals because of the high technical skills
required. Laboratory animals are sometimes used in
experimental clinical studies such as pre-marketing of a drug
or a medical-surgical device or in regenerative medicine and
surgery. The anaesthesia protocols influence the survival of
laboratory animals and can also greatly affect the
experimental data results.
Anaesthetic agents which are most frequently used
(Annexure 5) (ketamine, propofol, isoflurane/halothane) to
induce and maintain anaesthesia in laboratory animals
influence the carbon dioxide tension in arterial blood (PaCO2)
or exhaled (as ETCO2 ) and can cause respiratory acidosis.

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They must therefore be carefully monitored all the vital

parameters of the animal and restoring fluid and electrolyte
balance in the event that it were altered.
CLASSIFICATION OF ANESTHETICS
Injectables – Effects of these agents cannot be reversed
quickly. The drug must be metabolized, excreted, or
counteracted by another drug to terminate anaesthetic
action. Examples include sodium pentobarbital,
ketamine/xylazine cocktail. Some are controlled
substances. Logs must be kept of usage and are subject to
audit by the DEA (Drug Enforcement Agency).
Inhalants – Effects of these agents can be reversed
quickly. The agent is eliminated when the administration is
discontinued as the animal exhales. The most common
inhalant is isoflurane.
Dissociatives – Agents that depress the central nervous
system and produce a state of catalepsy (ketamine). These
are most effective when combined with tranquilizers and
sedatives (e.g., xylazine, diazepam).
EUTHANASIA
The term euthanasia is derived from the Greek terms eu
meaning good and than atos meaning death. A “good death”

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would be one that occurs with minimal pain and distress. In

the context. Euthanasia is the act of inducing humane death in
an animal. “Sacrificing the experimental animal after use by
gentle procedure causing minimum of physical and mental
suffering is called euthanasia (Painless killing). The primary
criteria for euthanasia in terms of animal welfare are that the
method be painless, achieve rapid unconsciousness and death,
require minimum restraint, avoid excitement, is appropriate
for the age, species, and health of the animal, must minimize
fear and psychological stress in the animal, be reliable,
reproducible, irreversible, simple to administer (in small doses
if possible) and safe for the operator, and, so far as possible,
be aesthetically acceptable for the operator.
METHODS OF EUTHANASIA
Barbiturate overdose, CO2 asphyxiation Must always be
followed by a physical means to ensure death, such as cervical
dislocation or pneumothorax. Use CO2 from tanks, not from
dry ice, Cervical dislocation Must be preceded by anaesthesia
or CO2 asphyxiation unless scientifically justified in the
protocol. If cervical dislocation alone is done, it must be
performed by well‐ trained personnel and Decapitation Must
be preceded by anesthesia or CO2 asphyxiation unless

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scientifically justified in the protocol (Annexure 6). If at any

stage during the experiment the investigator feels that he has
to abandon the experiment or he has inflicted irrepairable
injury, the animal should be sacrificed. Neuromuscular
blocking agents must not be used without adequate general
anaesthesia (Annexure 5). In the event of a decision to
sacrifice an animal on termination of an experiment or
otherwise an approved method of euthanasia should be
adopted (Annexure 6) and the investigator must ensure that
the animal is clinically dead before it is sent for disposal. The
data about large animals, which have been euthanised, should
be maintained. Anaesthesia Unless contrary to the
achievement of the results of study, sedatives, analgesics and
anaesthetics should be used to control pain or distress under
experiment. Anaesthetic agents generally affect
cardiovascular, respiratory and thermoregulatory mechanism
in addition to central nervous system. Before using actual
anaesthetics the animals is prepared for anaesthesia by over
night fasting and using pre-anaesthetics, which block
parasympathetic stimulation of cardio-pulmonary system and
reduce salivary secretion. Atropine is most commonly used
anti-cholinergic agent. Local or general anaesthesia may be

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used, depending on the type of surgical procedure. Local

anaesthetics are used to block the nerve supply to a limited
area and are used only for minor and rapid procedures. This
should be carried out under expert supervision for regional
infiltration of surgical site, nerve blocks and for epidural and
spinal anaesthesia. A number of general anaesthetic agents are
used in the form of inhalants. General anaesthetics are also
used in the form of intravenous or intra-muscular injections
such as barbiturates. Species characteristics and variation
must be kept in mind while using an anaesthetic. Side-effects
such as excessive salivation, convulsions, excitement and
disorientation should be suitably prevented and controlled.
The animal should remain under veterinary care till it
completely recovers from anaesthesia and postoperative
stress. Euthanasia is resorted to events where an animal is
required to be sacrificed on termination of an experiment or
otherwise for ethical reasons. The procedure should be carried
out quickly and painlessly in an atmosphere free from fear or
anxiety. For accepting a euthanasia method as humane it
should have an initial depressive action on the central nervous
system for immediate insensitivity to pain. The choice of a

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method will depend on the nature of study, the species of

animal to be killed (Annexure 6).
The method should in all cases meet the following
requirements: Death, without causing anxiety, pain or distress
with minimum time lag phase. (b) Minimum physiological
and psychological disturbances. (c) Compatibility with the
purpose of study and minimum emotional effect on the
operator. (d) Location should be separate from animal rooms
and free from environmental contaminants. Tranquilizers have
to be administered to larger species such as monkeys, dogs
and cats before a euthanasia procedure.

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REFERENCES
1. AVMA Guidelines on Euthanasia (Formerly Report of the
AVMA Panel on Euthanasia) June 2007.
2. Caridad Suárez* and Carmen Amarylis Guevara 2003
CPCSEA Guidelines for laboratory animal facility. Vet Med
Health 2022, Vol 6(2): 143 : 257-274 DOI:
10.4172/Jvmh.1000143
3. Cicero L, Fazzotta S, Palumbo VD, Cassata G, Lo Monte AI.
Anesthesia protocols in laboratory animals used for scientific
purposes. Acta Biomed. 2018 Oct 8;89(3):337-342. doi:
10.23750/abm.v89i3.5824. PMID: 30333456; PMCID:
PMC6502126
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4. Essentials of medical pharmacology by KD Tripathi, 6th

edition, jaypee brothers medical publishers (p ) ltd, page no –
351, 365.
5. Euthanasia of animals used for scientific purposes by
J.S.Reilly, Second edition.
6. Guidelines on anesthesia and analgesia in laboratory animals,
University of South Florida provides the following guidelines
for use by IACUC- certified faculty and staff.
7. Hickman DL, Johnson J, Vemulapalli TH, Crisler JR,
Shepherd R. Commonly Used Animal Models. Principles of
Animal Research for Graduate and Undergraduate Students.
2017:117–75. doi: 10.1016/B978-0-12-802151-4.00007-4.
Epub 2016 Nov 25. PMCID: PMC7150119.
8. Laboratory animals: Rodent Anesthesia & Analgesia by
Kathleen A. Murray.
9. Modern pharmacology with clinical applications Charles R.
Craig, fifth edition, Page no-291.
10. Practical pharmacology and clinical pharmacy by
S.K.Kulkarni, Vallabh publications, Page no- 21.

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CHAPTER–V

Composition of institutional Ethical Committee (IEC),

General ethical issues. Specific principles for chemical
evaluation of drugs and human genetics research, Ethics in
food and drug safety. Environmental release of
microorganisms and genetically engineered organisms.
Ethical issues in human gene therapy and human cloning.

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COMPOSITION OF INSTITUTIONAL ETHICAL

COMMITTEE (IEC):

➢ INTRODUCTION
Institutional Ethics Committee (IEC), also referred to as,
Institutional Review Board (IRB), Ethics Review Board
(ERB) and Research Ethics Board (REB) in many countries
and situations, serves as an independent representative and
competent body to review, evaluate and decide on the
scientific and ethical merits of research proposals. The
primary purpose of this committee is to protect the rights,
safety and wellbeing of human subjects who participate in a
research project. The Ethics Committees are entrusted with
the initial review of the proposed research protocols prior to
initiation of the projects and also have a continuing
responsibility of regular monitoring of the approved
programmers till the same are completed. Such an ongoing
review is in accordance with the Declaration of Helsinki and
all the international guidelines for biomedical research.

BASIC RESPONSIBILITIES

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The basic responsibility of an Institutional Ethics

Committee (IEC) is to ensure a competent review of all
ethical aspects of the project proposals received by it in an
objective manner. IECs should provide advice to the
researchers on all aspects of the welfare and safety of the
research participants after ensuring the scientific soundness of
the proposed research through appropriate
Scientific Review Committee.
Small institutions could form alliance with other IECs or
approach registered IEC. Large institutions/Universities with
large number of proposals can have more than one suitably
constituted IECs for different research areas for which large
number of research proposals are submitted. The main IEC
may review proposals submitted by undergraduate or post-
graduate students or if necessary, a committee may be
separately constituted for the purpose, which will review
proposals in the same manner as described above.

The responsibilities of an IEC can be defined as follows:-

• To protect the dignity, rights and wellbeing of the potential
research participants.

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• To ensure that universal ethical values and international

scientific standards are expressed in terms of local community
values and customs.
• To assist in the development and the education of a research
community responsive to local health care requirements.

➢ COMPOSITION
The IECs should be multidisciplinary and multi-sectorial in
composition. Independence and competence are the two
hallmarks of an IEC. The number of persons in an ethics
committee should be kept fairly small (8 - 12 members). It is
generally accepted that a minimum of five persons is required
to form the quorum without which a decision regarding the
research should not be taken. The members should be a mix of
medical/ non-medical, scientific and non-scientific persons
including lay persons to represent the differed points of view.
The composition may be as follows: -
1. Chairperson
2. One - two persons from basic medical science area
3. One - two clinicians from various Institutes
4. One legal expert or retired judge

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5. One social scientist / representative of non-governmental

voluntary agency
6. One philosopher / ethicist /theologian
7. One lay person from the community
8. Member Secretary
As per revised Schedule Y of Drugs & Cosmetics Act,
1940, amended in 2005, the ethics committee approving drug
trials should have in the quorum at least one representative
from the following groups:
1. One basic medical scientist (preferably one
pharmacologist).
2. One clinician
3. One legal expert or retired judge
4. One social scientist/ representative of non-governmental
organization / philosopher / ethicist / theologian or a similar
person
5. One lay person from the community.
The Ethics Committee (EC) can have as its members,
individuals from other institutions or communities with
adequate representation of age and gender to safeguard the
interests and welfare of all sections of the community/society.

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GENERAL ETHICAL ISSUES

Research is the pillar of knowledge, and it constitutes an
integral part of progress. In the fast-expanding field of
research, this has improved the quality and quantity of life.
Historically, researchers have been in the privileged position
to carry out research, they were able to control “life and
death” and have free access to their confidential information.
This has resulted in some researchers conducting unethical
researches. In the light of these ethical controversies few
ethical issues to be studied are as follows:
1) Study design and ethics approval
2) Data analysis
3) Authorship
4) Conflicts of interest
5) Redundant publication and plagiarism

1. Study design and ethics approval: “Good research should

be well adjusted, well-planned, appropriately designed, and
ethically approved”. It is essential to obtain approval from the
Institutional Ethics Committee (IEC), of the respective
organisations for studies involving people, medical records,
and anonymised human tissues. The research proposal should

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discuss potential ethical issues pertaining to the research and

pay special attention to vulnerable subjects to avoid breech of
ethical codes.
2. Data analysis: It is the responsibility of the researcher to
collect and analyze the data appropriately. Although
inappropriate analysis does not necessarily amount to
misconduct, intentional omission of result may cause
misinterpretation and mislead the readers. Fabrication and
falsification of data do constitute misconduct. To ensure
appropriate data analysis, all sources and methods used to
obtain and analyze data should be fully disclosed. Failure to
do so may lead the readers to misinterpret the results without
considering possibility of the study being underpowered
3. Authorship: There is no universally agreed definition of
authorship and is generally agreed that an author should have
made substantial contribution to the intellectual content,
including conceptualizing and designing the study, acquiring,
analyzing and interpreting the data. The author should also
take responsibility to certify that the manuscript represents
valid work and take public responsibility for the work.
Finally, an author is usually involved in drafting or revising

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the manuscript, as well as approving the submitted

manuscript.
4. Conflicts of interest: This happens when researchers have
interests that are not fully apparent and that may influence
their judgments on what is published. These conflicts include
personal, commercial, political, academic or financial interest.
Financial interests may include employment, research
funding, stock or share ownership, payment for lecture or
travel, consultancies and company support for staff. This issue
is especially pertinent in biomedical research where a
substantial number of clinical trials are funded by
pharmaceutical company. The researchers need to take extra
effort to ensure that their conflicts of interest do not influence
the methodology and outcome of the research. It would be
useful to consult an independent researcher, or Ethics
Committee, on this issue if in doubt.

5. Redundant publication and plagiarism: Redundant

publication occurs when two or more papers, without full
cross reference, share the same hypothesis, data, discussion
points, or conclusions. However, previous publication of an
abstract during the proceedings of meetings does not preclude
subsequent submission for publication, but full disclosure
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should be made at the time of submission. This is also known

as self-plagiarism. On the other hand, plagiarism ranges from
unreferenced use of others’ published and unpublished ideas,
including research grant applications to submission under
“new” authorship of a complete paper, sometimes in different
language. Therefore, it is important to disclose all sources of
information, and if large amount of other people’s written or
illustrative materials is to be used, permission must be sought.

SPECIFIC PRINCIPLES FOR CHEMICAL

EVALUATION OF DRUGS AND HUMAN GENETICS
RESEARCH

Evaluation of a drug ensure the identity of a drug and

determines the quality and purity of drugs. The main reasons
behind the need for evaluation of crude drugs are biochemical
variation in the drug, effect of treatment and storage of drugs,
and the adulterations and substitutions.
1) Organoleptic Evaluation
2) Microscopic Evaluation
3) Chemical Evaluation
4) Physical Evaluation

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5) Biological Evaluation

➢ Chemical Evaluation of Drugs:

The chemical evaluation includes qualitative chemical
tests, quantitative chemical tests, chemical assays and
instrumental analysis. The isolation, purification and
identification of active constituents are chemical methods of
evaluation.
Qualitative chemical tests include identification tests for
various phyto constituents like alkaloids, glycosides, tannins
etc. and Quantitative chemical tests such as acid value(resins,
balsams), saponification value(balsams), ester value (balsams,
volatile oils), acetyl value (volatile oils), etc. are also useful in
evaluation of a drug by means of chemical treatment.
Chemical assay include assays for alkaloid, resin, volatile oils,
glycoside, vitamins or other constituent. Instrumental analyses
are used to analyze the chemical groups of phyto-constituents
using chromatographic spectroscopic methods.

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Principles of Human Genetics research

Ever since the discovery of Mendel's laws of inheritance
and subsequently the double helical structure of DNA by
Watson and Crick, genomic research has made great strides to
an extent that genomic era is a real possibility in the near
future. Genomic research is an upcoming field which is fast
emerging after the results of human genome project were
made publicly accessible. Human genetics refers to the study
of individual genes, their role and function in disease, and
their mode of inheritance. Genomics refers to an organism’s
entire genetic information, the genome, and the function and
interaction of DNA within the genome, as well as with
environmental or non-genetic factors, such as a person’s
lifestyle. With the characterization of the human genome,
genomics not only complements traditional genetics in our
efforts to elucidate the etiology and pathogenesis of disease,
but it plays an increasingly prominent role in diagnostics,
prevention, and therapy. These transformative developments,
emerging from the Human Genome Project, have been
variably designated genomic medicine, personalized
medicine, or precision medicine. Precision medicine aims at
customizing medical decisions to an individual patient. For

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example, a patient’s genetic characteristics (genotype) can be

used to optimize drug therapy and predict efficacy, adverse
events, and drug dosing of selected medications
(pharmacogenomics). The characterization of the mutational
profile of a malignancy allows to identify driver mutations or
overexpressed signaling molecules, which then facilitates the
selection of targeted therapies. Genomic risk prediction
models for common diseases are also beginning to emerge. It
involves the study of genes which code for a protein, enzyme,
or a transporter in a particular individual, and to find out if
there is any mutation, single nucleotide polymorphism, or
copy number variations which may determine the
susceptibility of the individual to a disease or the response to
drugs. Advances in technology and ample funding
opportunities, both national and international, increase in
commercial interest, more public awareness on personalized
medicine (yet to evolve in a big way in India), and media
coverage have increased genetic research as well as whole
genome research. These developments have raised many
ethical issues associated with genetic research. The two main
tools which ensure protection of the participants of any
clinical research in general are written informed consent and

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ethics committee (EC) review. The ECs have a major role in

ensuring that the rights of the subjects involved in clinical
trials are preserved. This is a major concern in India given the
fact that very few ECs in India are properly constituted and
functioning and there is no legal requirement for the members
of the ECs to declare conflict of interest.
➢ Existing Guidelines and Recommendations
ICMR has provided comprehensive guidelines for Indian
researchers working in genomic area, and a separate chapter
has been included in the 2006 issue of “Ethical guidelines for
biomedical research on human subjects.” In India, the
Guidelines for Good Clinical Practice (2001) emphasizes
upon the principles which govern the ethical code of conduct,
namely, non-maleficence, beneficence, institutional
arrangement, risk minimization, ethical review, voluntariness,
and compliance. It states that the staff engaged in biomedical
sciences or research should be aware of their ethical
responsibilities and comply with the ethical principles
mentioned below:
• Informed consent: Informed consent involves explaining
to the research participant about the research activity, the
expected results of the research, the beneficiaries of the

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result, the risk and benefits of participation. This can

enable the participant to make a voluntary decision about
participating in the research. However, the
implementation of the "real" informed process is difficult
to achieve unless the investigator takes extra effort to
clearly explain in simple language about the benefits and
risks of participating in the research.
• Withdrawal from research: A subject must be allowed to
withdraw from research at any time of the study. This
information needs to be mentioned during informed
consent process. When a subject decides to withdraw
from the study, it is implied that he/she wants all the
samples to be destroyed and all results if obtained to be
destroyed both in the electronic and print form.
• Addressing incidental findings in genomic research: Lots
of information can be gathered during whole genome
analysis about the subject's genetic profile. This
information could either relate to the phenotype under
study when it is pertinent information or it could be
additional data relating to a new health problem, an
incidental finding. The subject has the right to know the
results of genetic testing – both the pertinent and the

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incidental findings. In India, the researcher has the

additional responsibility of putting across the results in a
simple and understandable language taking into
consideration the moral, religious, and cultural beliefs of
the population to which the research subject belongs.
• Role of Ethical Committees (ECs): The role of ECs in
genetic or genome-related studies is no different from
that of other clinical research. ECs should ensure
protection of research participants in general. They
should ensure that all the information pertaining to future
use of sample and data sharing has been provided to the
subject before obtaining blanket consent. With
expanding research in the field of genetics, the only way
to ensure good-quality conduct of ECs is mandatory
registration and an accreditation process.
• Biobanks and data abuse: Biobanks are private or public
structured resources that contain long-term collection of
human tissue and/or other medically relevant data and
information connected to the collected tissue. The
utilization of this data for forensic purposes by
governmental sources can lead to its abuse for political
purposes to control and punish citizens or distinct

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segments of the population. Biobanks are also essential

for genetic and genomic research because it is possible to
study rare genetic variants or those with modest
association with phenotypic traits or the effect of
combination of genetic traits from the large size of data
available in these banks.
• Compensation for participants: According to ICMR
guidelines on genomic research, it state that “undue
inducement through compensation for individual
participants, families and populations should be
prohibited. This prohibition, however, does not include
agreements with individuals, families, groups,
communities or populations that foresee technology
transfer, local training, joint ventures, and provision of
health care or of information infrastructure,
reimbursement costs of travel and loss of wages and the
possible use of a percentage of any royalties for
humanitarian purposes”.
• Sharing the benefits of human genetic research:
Biological Diversity Convention text states that benefits
of genomic research can be thought of as those arising
from the use, whether commercial or not, of genetic

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resources, and may include both monetary and non-

monetary returns to the individual or the society.
Schroeder[17] states that there are essentially four
different justification models that cover the main
possibilities with regards to benefit sharing in genomic
research:
✓ The outcomes of human genetic research are
sufficient benefits for both cooperators and the
public at large.
✓ Cooperators who cannot benefit directly from
genetic research, qualify for some form of
additional benefits, whereas cooperators who can
benefit directly are not eligible.
✓ All cooperators qualify for additional benefits
(owing to the risks involved or because their
property is being used).
✓ Altruism should be the guiding principle for
contributors to human genetic research
With all the above discussions, we can say that, there is a
real need to provide more clarity and build upon the
specific principles and regulations with regards to ethical
issues surrounding genomic research

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