Guide Lines and Application Forms

Institutional Review Committee for Biomedical Research

University of Veterinary and Animal Sciences
Lahore, Pakistan

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 Institutional Review Committee for Biomedical Research
University of Veterinary and Animal Sciences
Lahore, Pakistan
APPLICATION FORM

Checklist

This checklist is prepared in order to aid investigators in preparing a complete application and
to help expedite review by the Institutional Review Committee. Your cooperation in
completing it will be greatly appreciated. Do not attach unnecessary pages such as
instructions to fill the form and sample of consent form.

PRINCIPAL INVESTIGATOR/SUPERVISOR NAME:

______________________________________

TITLE OF RESEARCH: ____________________________________________________

___________________________________________________________________________

DESIGNATION: ___________________________________________________________

DEPARTMENT: ___________________________________________________________

A copy of IRC Application form with checklist.

A copy of Research Proposal/ synopsis.

A copy of Drug Brochure or any supplementary information enclosed (if applicable).

A copy of informed consent both in English and Urdu or any other local language of
the study’s population.

A copy of Questionnaire (in English or Urdu or any other local language of the
study’s population) being administered during the study (if applicable).

I have made a copy of this entire application for my files.

I have submitted the application form, research protocol and informed consent with
Urdu translation by e-mail at www.uvas.edu.pk

----------------------------------------------------------------- ----------------------
Name & Signature of student (where applicable) Date

------------------------------------------ -----------------------
Signature of Supervisor/PI: Date

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 Institutional Review Committee for Biomedical Research
University of Veterinary and Animal Sciences, Lahore

Instructions / guidelines for researchers:

1. Please answer all questions. It is the responsibility of researcher to fill the application
form appropriately. Incomplete and inappropriately filled form will not be accepted
for review and discussion in the committee. This may result in delay in approval of
the proposal.

2. In case of urgency, a strong justification should be provided for an expedited review

and approval such as meeting a deadline for funding etc. Even in case of expedited
review, it may take 7-10 days in granting approval if there is no ethical issue.

3. Application must be signed by PI. In case of student’s/ resident’s application, it

should be signed by supervisor also.

4. In response to Q.1, please give a brief background of the study indicating the need for
the study.

5. In response to Q.3, please don’t give details of laboratory or scientific procedures.

Only mention the procedures to be carried out on human subjects such as withdrawal
of blood or collection and storage of other samples, treatment to be provided to study
subjects, observations, interviews, focus group discussions etc.

6. In response to Q.8, only direct compensations should be mentioned. Travelling in

connection of studies and presentation should not be included here.

7. In response to Q.9, all possible adverse events likely to occur as a result of the study
should be included, with a plan to help the patient get appropriate treatment.

8. Consent form must be attached. Separate guidelines are given for drafting consent
form which should be strictly followed. In case of improperly drafted consent form or
its absence on preliminary scrutiny, no application will be considered for discussion
in the committee.

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 Introductory Questionnaire

Title of protocol:

Principal Investigator/Supervisor/ Student:

1. _________________________ ___________________ ________________________

NAME DESIGNATION SIGNATURE

2. _________________________ ___________________ ________________________

NAME DESIGNATION SIGNATURE

3. _________________________ ___________________ ________________________

NAME DESIGNATION SIGNATURE

Project involves the use of:

(Check all pertinent ones)

a) Experimental drug(s)/Non-approved use or non-approved dose for approved

drugs
b) Radioactive agents
c) Behavioral research/Observational studies
d) Stem cells /Cloning experiments
e) Microbial Research
f) Molecular biology and genomics research
g) Fetal research
h) Nutritional trials
i) Blood sampling
Other (please specify):

Please provide details in case of a, b, c or d if checked

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1. What is the purpose of the study? (Please give a brief background of the study)

2. Enumerate the objectives of the study

3. Brief description of methods used in protocol.

4. a) Expected duration of the study period (to completion).

b) Expected duration of study on each individual subject.

5. Please indicate source of funding.

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6. Subject information.
a) Group: Patients Public Others
b) Records:
c) Age range:

d) Sex: Male Female Both

e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it

includes foetal research, give brief explanation of need to use these particular
individuals.

7. Criteria for inclusion and exclusion of patients and controls (type separate).

8. Compensation:
a) To Research Subject:
Monetary: Yes No Amount:
Other: Yes No Specify:
Reimbursement of Yes No Type & amount:
expenses:

b) To Investigators: Yes No

If yes, then:
Monetary: Travel: Gifts: Amount:
Other Specify:

9. Adverse effects:
a) Describe adverse effects/risks expected to the subjects involved in the
investigation during the study?

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 b) What is the provision for managing these effects?

c) Who will pay for them?

10. In cases where therapeutic need of the research subject is identified during the course
of the study:

a) What is the provision for managing these cases?

b) Who will pay for them?

11. Laboratory and Radiological studies:

a) Will any tests be performed which are not routinely included as part of the work-
up for these types of patients?

b) Who or what agency will pay for these tests?

12. Location of study:

UVAS Department: ____________________________________________________

Other than UVAS (please specify the location):

13. What are the actual potential benefits, if any, to be obtained?

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 a) By participants?

b) By society as a result of this study?

c) Please specify benefit of the study to the funding agency or sponsors.

d) Please specify benefit of the study to institution where study is being conducted.

14. How will confidentiality of the subjects be ensured?

15. How will the study findings be shared with?

a) Study subjects

b) Community at large

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16. Discuss ETHICAL ISSUES involved in the study.

17. Any other information relevant to the study in context to Pakistan?

18. Has this study been conducted elsewhere earlier? If yes, where? Please give
references.

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 Guidelines for drafting an informed consent form

Although a sample of informed consent form is attached, additional guidelines are given here
in order to help and facilitate the researchers in drafting a proper, acceptable consent form.

1. All studies involving human subjects should have a properly drafted consent form. No
study should be done on human subjects without obtaining informed consent and
sufficiently before the start of the study, at an appropriate time, and not at a time when
s/he is under stress such as surgical procedure, and is unable to understand the study.
2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should
be signed by the person taking the consent and witnessed by a second person.
3. In case of children, an assent form from children and consent from guardian / parents
is needed.
4. In case of mentally or physically incapacitated subject, consent should be obtained
from immediate guardian or relative such as, wife or husband, father or mother,
brother or sister etc.
5. In case of community studies, community leaders, elders, local political leaders,
religious leaders (in certain cases), and governmental officials should be taken into
confidence, and a written consent should be obtained.
6. In case of doing a study in other locations such as other hospitals and clinics,
permission from appropriate authority or physicians should also be obtained.
7. The consent form should be in English, Urdu or other local language if needed. These
should be identical in such a way that the translation of one into other is similar. The
language should be easy which can be understood by study subjects (uneducated or
primary passed). Use of technical terms should be avoided.
8. It should be written in “second or third person” and not in “first person”. For example,
“You will be asked to give 10 cc blood” or “you will be asked few questions” etc.
9. A properly drafted consent form should contain the following important points.
a) Information sheet. There should be one paragraph or page giving information
about the nature of study, its purpose and need, possible benefits of the study, and
procedures to be carried out on the study subjects.
b) Possible risks and benefits to the study subjects
c) Availability of alternate treatment in case of therapeutic trials
d) Voluntary participation without any compulsion, moral or otherwise and without
any financial incentive or coercion. However, financial assistance or
reimbursement for time and traveling may/should be provided to study subjects;
which should commensurate with the time spent, and should not be too high.
e) Right to withdraw from the study at any time without affecting their rights and
treatment.
f) Confidentiality
g) If any specimen is to be stored, its time of storage and permission to use it in
further research.
h) Name and contact number of the investigator in case the study subject wants
further clarification or information about study.
i) Authorization from study subjects with their signature, thumb impression,
signature of witness etc.

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Important Notes

1. Studies shouldn’t be done on patient’s expenses.

2. If any new or additional tests are to be done as a requirement of study, their
cost should be supported by the study.
3. If a new treatment is compared with an existing and established one OR two
treatment modalities are being evaluated and compared, cost of treatment or
difference in cost of treatment should be borne by the study. In addition any
expected or unexpected complication arising as a result of new treatment
should also be supported by the study.
4. Studies which are unlikely to produce any significant results because of faulty
design are often considered not to be ethical as such studies cause wastage of
time and resources. These should be avoided unless there is strong
justification.

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 Sample Informed Consent

This is a generic sample form to help you address most situations. Please adapt as appropriate
for your research protocol and institution. Pending rulemaking for classified human subject
research will require additional elements of consent.

Project Information

Project Title:

Principal Investigator:

IRC Ref No: Organization:

Address: Phone:

Other Investigators: Organization:

Address: Phone:

Consent document must be clearly written and understandable to subjects. The language
must be non-technical (comparable to the language in a newspapers or general circulation
magazine), and scientific, technical or medical terms must be plainly defined.
Informed Consent, whether oral or written, may not include language that appears to waive
subjects’ legal rights or appears to release the investigators or anyone else from liability for
negligence.

It must begin with the introduction of the person seeking consent. For example: “I am Dr
[SAK] from Department of _ _ _,University of Veterinary and Animal Sciences, Lahore and
doing a research on _ _ _.”
It must also include some background information on the topic of study. For example:
“Disease X (Malaria) is a common disease in Pakistan, Asia and Africa, caused by a germ
(parasite) spread by mosquito. It causes high grade fever. Some patients may have
complications and even die. The commonly used drugs are losing their effectiveness and
germs are getting resistant to it. A new drug known as [A] is supposed to be effective in
treatment of disease (malaria) but there is not enough evidence that it is as good as other
drugs used for treatment of disease (malaria).”

It should then state the following:

1. PURPOSE OF THIS RESEARCH STUDY

o Include 3-5 sentences written in nontechnical language. “You are being asked
to participate in a research study designed to...”
2. PROCEDURES
o Describe procedures: “You will be asked to do...”
o Identify any procedures that are experimental/investigational/non-therapeutic.
o Define expected duration of subject's participation.

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 o Indicate type and frequency of monitoring during and after the study.
3. POSSIBLE RISKS OR DISCOMFORT
Note that these include not only physical injury, but also possible psychological,
social or economic harm, discomfort, or inconvenience.
o Describe known or possible risks. If unknown, state so.
o Indicate if there are special risks to women of child bearing age; if relevant,
state that study may involve risks that are currently unforeseeable, e.g., to
developing fetus
o If subject's participation will continue over time, state: “any new information
developed during the study that may affect your willingness to continue
participation will be communicated to you.”
o If applicable, state that a particular treatment or procedure may involve risks
that are currently unforeseeable (to the subject, embryo or fetus, for example.)
4. POSSIBLE BENEFITS
o Describe any benefits to the subject that may be reasonably expected. If the
research is not of direct benefit to the participant, explain possible benefits to
others.
5. FINANCIAL CONSIDERATIONS
o Explain any financial compensation involved or state: “There is no financial
compensation for your participation in this research.”
o Describe any additional costs to the subject that might result from
participation in this study.
o Please indicate any financial benefits to the subjects including therapeutic or
diagnostic costs being covered by the study.
6. AVAILABLE TREATMENT ALTERNATIVES
o If the procedure involves an experimental treatment, indicate whether other
non-experimental (conventional) treatments are available and compare the
relative risks (if known) of each.
7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES
o “This study involves (minimal risk) (greater than minimal risk).” In the event
that greater than minimal risk is involved, provide the subject with the
following information.
o If you are injured as a direct result of taking part in this research study,
emergency medical care will be provided by [name] medical staff or by
transporting you to your personal doctor or medical center. Indicate who will
pay for this treatment.
8. CONFIDENTIALITY
o Describe the extent to which confidentiality of records identifying the subject
will be maintained.
“Your identity in this study will be treated as confidential. The results of the
study, including laboratory or any other data, may be published for scientific
purposes but will not give your name or include any identifiable references to
you.”
“However, any records or data obtained as a result of your participation in this
study may be inspected by the sponsor or by AKU ERC members”.
In addition, list steps to protect confidentiality such as codes for identifying
data.
9. TERMINATION OF RESEARCH STUDY
You are free to choose whether or not to participate in this study. There will be no
penalty or loss of benefits to which you are otherwise entitled if you choose not to

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 participate. You will be provided with any significant new findings developed during
the course of this study that may relate to or influence your willingness to continue
participation. In the event you decide to discontinue your participation in the study,
o These are the potential consequences that may result: (list)
o Please notify (name, telephone no., etc.) of your decision or follow this
procedure (describe), so that your participation can be orderly terminated.
In addition, your participation in the study may be terminated by the investigator
without your consent under the following circumstances. (Describe) It may be
necessary for the sponsor of the study to terminate the study without prior notice to, or
consent of, the participants in the event that (Describe circumstances, such as loss of
funding.)
10. AVAILABLE SOURCES OF INFORMATION
o Any further questions you have about this study will be answered by the
Principal Investigator:
Name:
Phone Number:
o Any questions you may have about your rights as a research subject will be
answered by:
Name:
Phone Number:
o In case of a research-related emergency, call:
Day Emergency Number:
Night Emergency Number:
11. AUTHORIZATION
I have read and understand this consent form, and I volunteer to participate in this
research study. I understand that I will receive a copy of this form. I voluntarily
choose to participate, but I understand that my consent does not take away any legal
rights in the case of negligence or other legal fault of anyone who is involved in this
study.

Name of participant/Parents/Guardian (Printed or Typed):____________________________

Signature/Thumb Impression of participant/Parents/Guardian: ________________________

Date: _______________

Name of person obtaining consent: _____________________________________________

Signature of person obtaining consent:

Date: _______________

Signature of Principal Investigator: ______________________________________________

Date: ________________

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 Guidelines for Researcher

All research projects involving human subjects, whether as individuals or communities,

including the use of fetal material, embryos and tissues from the recently dead, supported and
undertaken by UVAS faculty, staff or students, wherever conducted, shall be reviewed by the
Ethical Review Committee (IRC) before the study begins.
Some research that involves human subjects may be exempted from the regulations requiring
IRC approval. Examples include educational research, testing and survey procedures where
no identifying information will be recorded that can link subjects to the data, and disclosure
of the data could not reasonably place the subjects at risk of civil or criminal liability or be
damaging to the subjects financial standing, employability, or reputation. Such exemption
would be conditional to:
 The informed consent is taken from the research subject.
 The information gathered being relevant/beneficial to the research subject and his/her
community.
 Proposal includes planning for sharing study findings with the research subject/s and
the relevant communities planned, as well as mechanisms for informing the research
subject.
 Also exempted are the uses of existing data, documents or specimens, where no
identifying information will be recorded that can link subjects to the data. Examples:
 Literature review; and theoretical analysis. In such cases the only ethical Concern
would be acknowledgement of sources.
 Analysis of data, documents, specimen, not linked to individual subjects.
 Evaluation studies of intervention programmes/projects, especially by those who were
partners in planning the intervention.
 All researchers must give the subject participants the option of sharing the results and
specify how this will be done.
1. Every medical research project involving human subjects should be preceded by
careful assessment of predictable risks and burdens in comparison with foreseeable
benefits to the subject or to others.
2. The human subjects in your project must participate willingly, having been informed
about the research. Please provide all information that is likely to affect the person
irrespective of age, sex, or literacy level of the subjects. If the human subjects in your
project are part of a vulnerable population, such as prisoners, children or mentally
handicapped then the researcher should clearly state why is it necessary to have such
groups as their research subjects and how do they plan to administer the informed
consent.

Essentials of informed consent are:

4.1 Comprehension
Investigator must ensure that the informed consent is clearly comprehended by the
subject / guardian

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 4.2 Purpose of research must be clearly explained.
4.3 Procedure
In simple word describe the procedure that the subjects would be expected to undergo.
Identify any procedures that are experimental/ investigational/ non-therapeutic.
Indicate type and frequency of monitoring during and after the study.
4.4 Length of time subject is expected to participate. If subject's participation is
expected to continue over a long period of time, please indicate that any new
information that develops during the study and may affect the subjects' willingness to
continue participation will be communicated to them. This would apply even when
the intervention/investigation phase of the study has ended but monitoring continues.
4.5 Benefits of the research must be shared with/communicated to:
a. Subjects
b. Other study participants
c. Society
In studies evaluating drugs or other products the subjects should be advised as to the
availability of the product after discontinuation of the study. Please indicate whether
drug would be available to the patients free of cost. If not, kindly specify expected
local cost.
4.6 Please specify financial burden to be incurred by the research subject while
participating in the study.
4.7 Explain all foreseeable risks or discomforts to the subjects. Note this not only
includes physical injury, but also possible psychological, social, or economic harm,
discomfort, or inconvenience. If risk is unknown, state so.|
4.8 Treatment for adverse experiences Explain what therapeutic measures would be
available to the subjects in case of adverse reactions or injury as a result of being a
participant in the study. All research related adverse reactions are the financial
responsibility of the researchers.
4.9 Confidentiality
Describe the extent to which confidentiality of records identifying the subject will be
maintained.
4.10 Person to contact for answers to questions, or in event of research related
injury or emergency.
4.11 Statement that participation is voluntary and that refusal to participate will not
result in any penalty or any loss of benefits that the person is otherwise entitled to
receive.
4.12 Subjects right to withdraw from the study at any time.
4.13 How sharing of results with subjects will occur.
4.14 No abbreviations will be used.

Consent document must be clearly written and/or verbally explained so as to be

understandable to subjects (local language wherever applicable). The language must
be non- technical (comparable to the language in a newspaper or general circulation
magazine), and scientific, technical or medical terms must be plainly defined. It is PI's
responsibility to ensure quality of consent procedure.
3. The researcher should submit to the committee, for review, information regarding
funding, sponsors, institutional affiliations, potential conflicts of interest and
incentives for subjects.
4. Specify the cost of management directly related to the study and indicate what portion
of the cost would be incurred by the study participants.

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5. The researcher should also declare any personal and institutional benefits (monitory
or otherwise including travel) accrued through study participation.
6. Please also specify benefits of the study to the funding agency or sponsors if any.
7. The research protocol should indicate that there is compliance with the principles of
Helsinki Declaration. In case of conflict kindly specify the particular clause, which is
being contravened.
8. a) Medical research involving human subjects should be conducted only by
scientifically qualified persons and under the supervision of a clinically competent
medical person.
b) Non-medical research should be conducted by suitably qualified persons
9. The right of research subjects to safeguard their integrity must always be respected.
Every precaution should be taken to respect the privacy and confidentiality of the
patient's information. Minimize the impact of the study on the subject's physical,
mental and social integrity.
10. In the conduct of research, the investigator must at all times respect the personality,
rights, wishes, beliefs, consent and freedom of the individual subject.
11. Volunteers and patients should be reimbursed for travel and any out of pocket
expenses e.g. any wage loss if applicable.
Application
12. The researcher responsible for the ethical and scientific conduct of the research should
submit a typed application for review of the ethics of proposed biomedical research.
The procedure is as follows:
All information and application forms are available at IRC website Institutional
Review Committee General Principles.
13. IRC meets every second Friday of the month.
14. The deadline for submission of the application is 2 weeks prior to the next meeting.
15. Applications will be acknowledged and researchers shall be informed of the review
date. The researchers shall also be communicated regarding the incompleteness of an
application. This will obviously delay the review process.
16. The outcome of review shall be communicated to the researchers within a week after
the IRC meeting.
17. In cases where the IRC requests supplementary information or changes to documents
from the applicant, such information should be provided at least a week before the
next meeting.
18. In cases where clarification is sought and researchers fail to respond within 3 months,
IRC will send a reminder and allow a further 3 months period for response. Beyond
these 6 months, the file will be closed.
19. Researcher may be asked to present the case in the meeting if required.
a) Follow-up (of the researcher).
b) At the end-report
Documents for submission

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20. Applications which are not submitted by e-mail will not be reviewed and discussed in
the meeting.
21. "Two hard copies of the IRC application form (see annexure) should be submitted in
addition to electronic submission".
22. Two copies of research protocol (clearly identified and dated), together with
supporting documents and annexes. This should always include description of the
ethical considerations involved in the research.
23. Questionnaire (if applicable) intended for research participants should be included.
24. When the research involves a study product (such as a pharmaceutical or device under
investigation), an adequate summary of all safety, pharmacological, pharmaceutical,
and toxicological data available on the study product, together with a summary of
clinical experience with the study product to date (e.g. recent investigator's brochure,
published data, a summary of the product's characteristics).
25. A description of the process to be used to obtain and document consent.
26. Informed consent form (clearly identified and dated) in the language(s) understood by
the potential research participants and, when required in other languages.
27. A statement describing any compensation for study participation (including expenses
and access to medical care) to be given to research participants.
28. CIOMS guideline "Research subjects who suffer physical injury as a result of their
participation are entitled to such financial or other assistance as would compensate
them equitably for any temporary or permanent impairment or disability. In the case
of death, their dependents are entitled to material compensation. The right to
compensation may not be waived".
29. A description of the arrangements for insurance coverage for research participants, if
applicable.
30. A statement of agreement to comply with ethical principles set out in relevant
guidelines.
31. All significant previous decisions (e.g., those leading to a negative decision or
modified protocol) by other IRCs or regulatory authorities for the proposed study
(whether in the same location or elsewhere) and an indication of modification(s) to
the protocol made on that account. The reasons for previous negative decisions should
be provided.
Approval Conditions
32. Approval is given for a specified period. If the project takes longer than the specified
period to complete, a request for an extension of the ethics clearance should be
sought.
33. Approval is given on condition that any alterations proposed to the approved protocol
are submitted to the Committee for approval prior to the alterations being affected.
34. Approval is given on condition that a copy of the research project final report is
lodged with the Ethics Committee for its information.

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 35. Approval is given subject to researchers notifying the Ethics Committee if and when a
project is curtailed, terminated or completed.
36. Approval is given for therapeutic trials subject to the principal investigator notifying
the Ethics Committee within seven (7) days of any adverse event or occurrence that
takes place during that trial.
Research could be audited by IRC during the research period to ensure compliance with
guidelines.

References:
Ethics Review Committee Guidelines for Biomedical Research Prepared by The Aga Khan
University, Karachi, Pakistan
International Ethical Guidelines for Biomedical Research Involving Human Subjects
Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in
collaboration with the World Health Organization (WHO), Geneva 1993.
Institutional Review Board Guidebook, National Institutes of Health, USA Year 2000.
Operational Guidelines for Ethics Committees that Review Biomedical Research, World
Health Organization, Geneva 2000.

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