The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are: Respect for Persons: The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected. Beneficence: The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits. Justice: The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others. These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.

1. Welcome
The Belmont Report
(Three Benchmark Rules)
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2. 00
THE BELMONT REPORT
A. Boundaries Between
Practice and Research
THE BELMONT PRINCIPLES
B. Basic Ethical Principles
APPLICATIONS
C. ICF, Risk and Benefit Assessment,
Selection of Subject
01
02
03
Journey of
Presentation

3. The Belmont Report
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Ethical Principles and Guidelines for the
Protection of Human Subjects of Research
On July 12, 1974, National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research created Belmont Report to identify
the basic ethical principles that should underlie the conduct of biomedical
and behavioral research involving human subjects and to develop guidelines
which should be followed in accordance with those principles.
The Commission was directed to consider:
I. The boundaries between biomedical and behavioral research and the accepted and routine
practice of medicine,
II. The role of assessment of risk-benefit criteria in the determination of the appropriateness of
research involving human subjects,
III. Appropriate guidelines for the selection of human subjects for participation in such
research and
IV. The nature and definition of informed consent in various research settings.

4. Part A. Boundaries between Practice and Research
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The Belmont Report necessitates the separation and
differentiation of the definitions of practice and research.
• Practice-Refers to a practitioner adjusting or
slightly deviating from the standard protocol of
treatment to help an individual client or patient.
• Research-Refers to a rigidly designed protocol
that needs to be tested or is being tested. The
goal is to develop a hypothesis and to contribute
to the body of knowledge in field.
• The distinction between practice and research is blurred;
often because they occur together.
• The IRB must ensure that the researcher (and the
participant) distinguishes practice from research in both
social science and biomedical research
• Minimize the potential for therapeutic misconception
when one believes the purpose of clinical research is to
treat rather then to gain knowledge.

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The Belmont Principles
Principles of
Belmont Report
Respect for Persons
Justice Beneficence

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Who ought to receive
the benefits of research
and bear its burdens?
This is a question of
justice, in the sense of
"fairness in distribution"
or "what is deserved”.
An injustice occurs when
some benefit to which a
person is entitled is
denied without good
reason or when some
burden is imposed
unduly.
Justice
Persons are treated in an
ethical manner not only
by respecting their
decisions and protecting
them from harm, but
also by making efforts to
secure their well-being.
In this document,
beneficence is
understood in a stronger
sense, as an obligation.
Two general rules have
been formulated as
complementary
expressions of
beneficent actions in this
sense: (1) do not harm
and (2) maximize
possible benefits and
minimize possible
harms.
Beneficence
Respect forPersons
incorporates at least two
ethical convictions:
first, that individuals
should be treated as
autonomous agents, and
second, that persons
with diminished
autonomy are entitled to
protection.
Respect for Persons
Part B. Basic Ethical Principles

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Part C. Applications
Respect for Persons principle directly pertains to Informed
Consent (IC) and explains why IC must encompass 3 components:
Information, Comprehension, and Voluntariness.
➢ Information: Most codes of research establish specific
items for disclosure intended to assure that subjects are
given sufficient information.
These items generally include:
a) the research procedure,
b) their purposes,
c) risks and anticipated benefits,
d) alternative procedures (where therapy is involved),
e) a statement offering the subject the opportunity to ask
questions and to withdraw at any time from the research.
➢ Comprehension: The manner and context in which
information is conveyed is as important as the
information itself.
For example, presenting information in a disorganized and
rapid fashion, allowing too little time for consideration or
curtailing opportunities for questioning, all may adversely
affect a subject's ability to make an informed choice. Because
the subject's ability to understand is a function of intelligence,
rationality, maturity and language, it is necessary to adapt the
presentation of the information to the subject's capacities.
Voluntariness: An agreement to participate in research
constitutes a valid consent only if voluntarily given.
This element of informed consent requires conditions free of
coercion and undue influence.
➢ Coercion occurs when an overt threat of harm is intentionally
presented by one person to another in order to obtain compliance.
➢ Undue influence, by contrast, occurs through an offer of an
excessive, unwarranted, inappropriate or improper reward or other
overture in order to induce the potential volunteer to put
themselves at a risk that they would otherwise not do.
➢ Unjustifiable pressures usually occur when persons in positions of
authority or commanding influence -- especially where possible
sanctions are involved -- urge a course of action for a subject.

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Assessment of Risk and Benefit
Beneficence - Persons are treated in an ethical manner not only by respecting their decisions and
protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls
under the principle of beneficence. The term "beneficence" is often understood to cover acts of
kindness or charity. In this document, beneficence is understood in a stronger sense, as an obligation.
Two general rules have been formulated as complementary expressions of beneficent actions in this
sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
What kinds of harms are there?
Economical
Privacy
vs
Confidentiality
Psychological
Social
Legal
Physical
How is Harm Minimized and Benefit Maximized?
Likelihood
of
benefit
Magnitude of benefit
0%
100%
Likelihood
of
harm
Magnitude of harm
0%
100%

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Selection of Subject
Belmont relies on the principle of Justice (equality of treatment) to focus on
injustice in two senses:
(a) The injustice of keeping persons from receiving what they deserve and
(b) Imposing undue burdens on emotionally, socially, and economically
disadvantaged persons.
Justice is relevant to the selection of subjects of research
at two levels: the social and the individual.
➢ Social justice requires that distinction be drawn
between classes of subjects that ought, and ought not,
to participate in any particular kind of research.
➢ Individual justice in the selection of subjects would
require that researchers exhibit fairness: thus, they
should not offer potentially beneficial research only to
some patients who are in their favor or select only
"undesirable" persons for risky research.

10. 1. Risks to subjects are minimized
2. Risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the
importance of the knowledge that may reasonably
be expected to result.
3. Selection of subjects is equitable.
4. Informed consent will be sought from each
prospective subject or the subject's legally
authorized representative, in accordance with,
and to the extent required by §46.116.
5. Informed consent will be appropriately documented,
in accordance with, and to the extent required by
§46.117.
6. When appropriate, the research plan makes
adequate provision for monitoring the data
collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to
protect the privacy of subjects and to maintain
the confidentiality of data.
8. When some or all of the subjects are likely to be
vulnerable to coercion or undue influence, such as
children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally
disadvantaged persons, additional safeguards
have been included.
1. Respect
for Persons
2. Beneficence
3. Justice
Three Benchmark Rules

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References
I. http://www.ucdmc.ucdavis.edu/clinicaltrials/tools.html
II. https://www.law.cornell.edu/cfr/text/45/46.117
III. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-
report/index.html
IV.https://www.sciencedirect.com/topics/medicine-and-dentistry/belmont-
report

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Mohd Noman
B. Pharm
CSRPL_INT_OFL_WKD_140/0822
drx.mohdnoman@gmail.com

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