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The Belmont Report



Unethical Research Events2

Catalyst Event

Sulfanilamide Tragedy

Nazi Physicians Trial

Thalidomide Tragedy

Syphilis Study

Regulatory Milestone

Food, Drug, and Cosmetic Act

Nuremberg Code

Kefauver-Harris Amendments

National Research Act



National Research Act (1974)3

Due to the publicity from the Syphilis Study, theNational Research Act of 1974 was passed.

The National Research Act created the National

Commission for the Protection of Human Subjectsof Biomedical and Behavioral Research.

The Commission charge was to identify the basicethical principles that should underlie the conductof biomedical and behavioral research involvinghuman participants and to develop guidelines whichshould be followed to assure that such research is

conducted in accordance with those principles.



National Commission for the Protection of Human Subjects of Biomedical and Behavioral

Research

4

Carrying out its charge, the Commission prepared

the Belmont Report in 1979.

The Belmont Report is a statement of basic

ethical principles and guidelines that provide “ananalytical framework to guide the resolution of

the ethical problems arising from research with

human subjects.”



National Commission for the Protection of Human Subjects of Biomedical and Behavioral

Research

5

The framework of the Belmont Report is

presented in three discussion topics:

Boundaries between practice and research

Basic ethical principles

Applications



Boundaries betweenPractice and Research6

The distinction between practice and research is

blurred; often because they occur together.

The IRB must ensure that the researcher (and theparticipant) 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



Basic Ethical Principles7

Respect for Persons

– Individuals should be treated as autonomous agents

– Individuals with diminished autonomy are entitled to

protections Beneficence

Do not harm

Maximum possible benefits, and minimize potential

harms

Justice

Fair distribution of burdens and benefits of research



Respect for Persons8

Treat individuals as autonomous persons; allowindividuals to choose for themselves

Persons with limited autonomy need additionalprotection, even to the point of excluding themfrom activities that may harm them. The extentof protection should depend upon the risk of harm, and the likelihood of benefit.

The judgment that any individual lacks autonomyshould be periodically re-evaluated, and will vary

across situations.



Beneficence9

The IRB should determine whether the risks to subjectsare reasonable in relation to anticipated benefits

Obligations of beneficence affect both the researcher

and society–

investigators are required to give forethought on

maximization of benefits and reduction of risk thatmay be involved in the research

society should recognize the longer term benefits andrisk that may result from the improvement of knowledge, and from the development of novelmedical, psychological, and social processes andprocedures



Justice10

Treat people fairly

Do not exploit those who are readily availableor malleable

Fair distribution of the risks and the benefits of research based upon the problem/issue underinvestigation

Equal opportunity and risk irrespective of gender, skin colour, economic status or anyother such basis



Applications of theGeneral Principles11

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



How should

weconsider

thefollowing…

12



Application of Respect for Persons13

Informed Consent Process Information - Does the consent form provide all the

information necessary for the individual to make areasoned decision?

Comprehension - Is the consent form crafted in languageunderstandable to the potential participant?

Voluntariness - Does the consent form clearly indicatethat participation in the research is voluntary?

What additional protections can be in place to protectthose with limited autonomy?

How to determine whether one lacks the autonomy tomake a reasoned decision?



Applications of Beneficence14

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 envisioned harm; while the term, benefit refers tosomething that promotes health, well-being, or welfare.

What are the risks of harm to the participants (considerphysical, psychological, social, and economic harms)? Are therisk justified? Can they be minimized?

Can the research design be improved to minimize risk andmaximize benefit?

What are the benefits (to the participant; to society)?



Applications of Justice15

Selection of Subjects

Is the potential subject pool appropriate for theresearch?

Is it appropriate to involve vulnerable populations (e.g.,economically disadvantaged; limited cognitive capacity)in the research or are they being enrolled because it isconvenient or because they are easily manipulated as aresult of their situation?

Are the recruitment procedures fair and impartial?

Are the inclusion and exclusion criteria fair andappropriate?



The Belmont Report16

Although never officially adopted or endorsed by Congress

or DHEW (now DHHS), the Belmont Report has served as

an ethical framework for protecting human subjects for

over 25 years. Many of it recommendations have been

incorporated into DHHS Title 45 CFR Part 46 and FDA Title21 CFR Part 50.

To obtain a full appreciation of the Belmont Report, IRB

Members are strongly encouraged to read it in its entirety.The report can be found @

http://www.fda.gov/oc/ohrt/IRBS/belmont.html





Questions?

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