The Belmont Report is a foundational document in the field of ethics and research involving human subjects. It was issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The report outlines ethical principles and guidelines for conducting research involving human participants, with a focus on protecting their rights, welfare, and dignity.

1. Welcome
Belmont Report
(The Three Benchmark Rules)
Manas Gumtya
B. Pharm
Student ID:
157/082023
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2. Table of Contents
A. History
• Why Belmont report is created?
B. The Belmont report
• Boundaries between practice and research
C. The Belmont principles
• Basic Ethical principles
D. Application of general principles
• ICF, risk assessmentof risk and benefits,selectionof subject
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3. A. History
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Why Was the Belmont ReportCreated?
Another event in history that led to the development of the
Belmont Report was the Tuskegee Syphilis Study, which
was conducted in Alabama to study the effects and
conditions of syphilis. The study included 600 African men
who were recruited with incentives such as free medical
exams, treatments, and medications. During the study, the
treatment for syphilis was discovered; however, researchers
did not provide the male participants with the medications,
resulting in the death of many men. The study ended in 1972
when the public was notified of the unethical treatment of
participants in the Tuskegee Syphilis Study.
• The Belmont Report was created in response to several
events that occurred in history. Forexample,
the Nuremberg Trials were held after World War II to
prosecute the Nazi scientists who conducted inhumane
experiments on Jewish women and children in
concentration camps. The Nuremberg Trials led to the
development of the Nuremberg Code, which was one of the
first documents to establish ethical standards and guidelines
in research. One of the main ethical standards to come from
the Nuremberg Trials was that research subjects must give
voluntary consent before research can be conducted.
Informed consent protects the participant's rightto
withdraw from the studyat any time.
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4. B. The Belmont Report
TheBelmont Report isa
federal documentthat
provides the ethical
principles and guidelinesthat
must be followed inresearch
involving humanparticipants.
Themain purpose of the
report isto protecttherights,
well-being, and safetyof the
participants involved in a
research study. Themost
important aspectof the
BelmontReport are the
ethicalprinciplesit
establishes,which
include respect for
persons, beneficence,
andjustice.
The Commission considers:
(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. The Belmont Report attempts to summarize the basic ethical
principles discussed by the commission.
Expertsin the field of human research ethicswere assembled at
the Smithsonian Institute Belmont House in Elkridge, MD in July,
1974.
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EthicalPrinciples& Guidelinesfor Research
Involving HumanSubjects

5. • The distinction between practice and
researchis blurred; often because they
occur together.
• The IRB must ensure that the researcher (and
the participant) distinguishes practice from
researchin 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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Boundaries between Practice and Research

6. C. The Belmont Principles
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7. Basic Ethical Principles
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. In this
document, beneficence is understood in a
stronger sense, as an obligation. Two general
rules have been formulated as complementary
expressions of beneficent actionsin
this sense: (1) do not harm and (2) maximize
possible benefits and minimize possibleharms.
1. RESPECT FOR PERSONS
Respect for persons
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.
2. BENIFICIENCE JUSTICE
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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

8. D. Applications of the
General
Principles
Consideration of the three general principles in the
conduct of research lead to the consideration of:
• Informed Consent process
• Risk/Benefits assessment
• Selection of research participants
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9. Application of Respect for Persons
Informed Consent Process
• Information - Does the consent form provide all the information necessary
for the individual to make a reasoned decision?
• Comprehension - Is the consent form crafted in language understandable
to the potential participant?
• Voluntariness -Does the consent form and clearly indicate that
participation in the research is voluntary?
Informed
Consent
Information
Voluntariness
Comprehension
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10. Applications of Beneficence
Assessment of Risks and Benefits
• Risk refers to the probability of harm; when considering
risk, one should consider both the probability and the
severity of the projected harm; while the term, benefit
refers to
something that promotes health, well-being, or welfare.
• What are the risks of harm to the participants (consider
physical, psychological, social, and economic harms)?
Are the
risks justified? Can they be minimized?
• Can the research design be improved to minimize risk
and
maximize benefit?
• What are the benefits (to the participant; to society)?
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11. Applications ofJustice
Selection of Subjects
• Is the potential subject pool appropriate for the research?
• Is it appropriate to involve vulnerable populations (e.g., economically disadvantaged;
limited intellectual capacity) in the research or are they being enrolled because it is
convenient or because they are easily manipulated as a result of their situation?
• Are the recruitment procedures fair and impartial?
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12. Reference
1. https://sites.lib.jmu.edu/elsi-
biotech/genomics- justice/historical-context-
and-economic-issues/
2. https://www.hhs.gov/ohrp/regulations-and-
policy/belmont-
report/read-the-belmont-report/index.html
3. https://academic-
accelerator.com/encyclopedia/belmont- report
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13. Thank You!
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