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8/2/2019 Belmont Report_06 Dec10
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The Belmont Report
8/2/2019 Belmont Report_06 Dec10
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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
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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.
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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.”
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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
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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
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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
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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.
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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
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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
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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
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How should
weconsider
thefollowing…
12
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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?
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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)?
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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?
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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
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