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Basic Code of Ethics when dealing with people.
The goal of The BelmontReport “is to deliver a reasoned framework that will escort the
resolution of ethical glitches arising from research involving human subjects.”The framework of
The Belmont Report presents three discussion topics: boundaries between practice and research,
basic ethical principles, and applications. The Belmont Report identifies three fundamental
principles that underlie all research involving human subjects:respect for other people,
beneficence, and justice.
Firstly, respect for other persons includes two ethical presumptions. The first is that
persons should be treated autonomous individuals, capable of own decisions.Autonomous
individuals possess the capacity for self-determination.(pg. 126)Someoneshows respect for
persons when they encourage and accept an individual’s opinions and choices.We show a lack of
respect for persons when we with-hold information and deny individuals the freedom to make an
informed decision. The second presumption is that not every person is able of self willpower.
The capability for self grit develops during a person’slife. Therefore, the exact young have
diminished autonomy. Additionally,some individuals may lose the capacity for self-
determination because of physical illness, mental disabilities, or situations that restrict personal
freedom, such as prisons and the military.Respect for persons who are immature,incapacitated, or
restricted requires that we provide them protection as human subjects.
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The second basic ethical principleis beneficence. Beneficence is the practice of doing
good, making all efforts to improve an individual’s well being. The principle of beneficence
incorporates the ethical tradition of medicine as defined by Hippocrates: “As to illnesses, make a
tradition of two things — to aid, or at least to do no harm.” (pg. 128)However, inorder to help
and avoid harm, we must first learn what is harmful.For research that will benefit society,
subjects may be exposed to a risk of harm with no personal benefit. In research, an ethical
dilemma occurs indeciding when it is proper to pursue certain gains despite the perils
constituted, and when the gains should be foregone because of known or potential risks to the
subject.
Justice is the third basic principle identified in The Belmont Report.While conducting
research, this is another element you shuld put into consideratin. Justice requires that each person
gets treated fairly, equitably, and given what heor she is due. There is an equal distribution of
benefits as well as burdens.(pg. 129)An injustice occurs when a benefit to someone who is
eligible gets deprived of without good cause or when an excessive burden gets imposed on
them.In clinical research, we should always be mindful that certain classes of persons, e.g.,
indigent, ethnic groups, or the institutionalized may be selected because of their
availability,dependence, or because they are easy to manipulate rather than for reasons related to
the problem under study.These classes are frequently referred to as “vulnerable populations”
andrequire protection as human subjects activities: informed consent, evaluation of risks and
gains, and assortment of research subjects.
We can gain an understanding of the Belmont principles by applying them to some of the
procedures in the scientific study course. The Belmont Report mainly highlights on the
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following activities: informed approvvval(consent), evaluation of risks and benefits, and
selection of research subjects.
The first Belmont principle, respect for persons, requires that research subjects be given
the opportunity to decide what will or might not happen to them. This opportunity occurs during
the informed consent process, which contains three components: information, comprehension,
and voluntariness.
When presenting information, it is essential for subjects to understand the research is
neither necessary for their well being nor are the effects of the research fully known
or understood. Understanding this subjects can decide if they wish to participate in the research
for the purpose of contributing to general knowledge. If a direct benefit to subjects is
expected, they should clearly understand the range of risks.
Another component of informed consent is comprehension. Comprehension is the
capacity to understand. The information provided to a subject must be in a language and at a
level that he or she can comprehend. Informed consent is invalid if the consentor does not
understand the information upon which the consent was based. Investigators are responsible for
determining that a subject has comprehension of the information.
Voluntariness is the third component of informed consent. The informed consent process
must be free of coercion, undue influence, and unjustifiable pressures. Coercion is the threat or
intention of harm by one person to another in order to gain compliance. For example, the subject
may be denied medical care unless the subject enrolls in the study. Undue influence is an offer of
an excessive or unwarranted reward in order to gain compliance. An example of this may be the
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sum of cash offered to healthy subjects who participate in Phase 1 trials, or making
compensation contingent upon the subject completing the study. Unjustifiable pressure occurs
when someooone in a place of influence urges a course of action for the subject. This may occur
with the investigator as well as with any member of the investigator’s team, when presenting the
informed consent to the subject. The dilemma is to recognize when objective discussion of the
research study becomes unjustifiable pressure to participate.
The second Belmont principle, beneficence, is applied in the assessment of risks and
benefits. Risk refers to the likelihood that damage may occur. Benefit refers to something of
positive value related to well being. Assessment of risks and benefits deals with the possibity of
there being harm and probable benefits. In general, risks to the subject should be outweighed by
the sum of anticipated benefits to the subject being interviewed and to people in the structure of
new information. It is commonly stated that risks and benefits should be
“balanced.”Unfortunately, there are few quantitative measures available to provide this kind of
objective assessment for investigators or IRBs.
The third Belmont principle is justice and this is applied during the selection of subjects.
Justice in the selection of subjects occurs at two levels: individual justice and social justice.
Individual justice requires the investigator to consistently demonstrate fair procedures in
selectingsubjects. For example, investigators should not offer potentially beneficial research to
their favored patients while offering riskier studies to less favored patients.
Societal justice is based on a fair and equitable selection of subjects across economic, ethnic,
and gender classes. No class of subjects should bear the burdens of research particularly if
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disabilities, restrictions, or a hostile social environment already burdens them. All the above
mentioned principle elequently aid in the conduction of research.
Information consent form example for the research I will carry out.
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Informed Consent Form
The following is a consent form for a investigation project. It is a research project on Campus
Institution life, approved by the researcher (PI)______(insert name)__________ of this project
from the _____[name]________Varsity. The interviewer should have the interviewee read this
form cautiously and ask any questions the subject candidate may have. Before the interview can
begin, the researcher and the examinee should sign two copies of this form. The examinee will
be provided with one duplicate of the signed form.
Consent for Involvement in Interview Research
I volunteer to take part in a research project conducted by Mr./Dr./Mrs./Miss __[Name of the
PI]___ from ____[name]___ University . I understand that the project is designed to gather
information about work research of people on campus. I will be one of about 30 people being
interviewed for this research.
1. My contribution in this project is charitable. I recognize that I will not be paid for my input. I
may withdraw and stop participation at any time with no penalty. If I refuse to participate or
leave from the study, no one on my college grounds will be told.
2. I am aware of that most interviewees in will find the debate exciting and stimulating. If,
however, I feel uncomfortable in any means through the interview session, I have the right to
decline to act in response to any question or stop the interview.
3. Participation comprises being interviewed by researchers from __[name of]__ University. The
interview will last around 30-45 minutes. Comments will be written and documented during the
interview. An audio tape of the interview and following dialogue will be made. If I do not want
to be taped, I will not be able to partake in the study.
4. I am aware the researcher will not mark me by name in any reports using data gotten from this
interview, and that my privacy as a partaker in this research will stay secure. Ensuing uses of
reports and information will be subject to normal data use rules which guard the secrecy of
people and institutions.
5. Working staff and administrators from my institution will neither be in attendance at the
questioning nor have right to use to raw notes or transcripts. This safety measure will prevent my
personal comments from having any unconstructive repercussions.
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6. I recognize that this study has been reviewed and permitted by the College Review Board
(IRB) for Studies concerning people: Behavioral Sciences Committee at the ___[name of]___
Varsity. For study problems or queries concerning subjects, the Institutional Review Board may
be contacted through [information of the contact person at IRB office of ___[name of]___
Varsity.
7. I have read and comprehended the clarification provided to me. I have had all my queries
answered to my fulfillment, and I willingly consent to partake in this research.
8. I have been availed a copy of this consent form.
____________________________ ________________________
My Signature Date
____________________________ ________________________
My Printed Name Signature of the Researcher
For further information, please contact:
Mr./Dr./Mrs./Miss. __[Name of Principle Researcher]___
[Contact Information of P