The 40th Anniversary of the
Belmont Report
Le quarantième anniversaire
du Belmont Report
Ivor Pritchard
Office for Human Research Protections
April 25, 2014
Why do REBs make questionable or
varying decisions about research
projects?
1. The local circumstances are peculiar.
2. The REB members don’t know the facts.
3. The REB members don’t understand and apply the
rules.
4. REB members exhibit psychological behavior.
5. REB members are influenced by each other in the
group’s decision-making processes.
6. The REB members hold different ethical
perspectives.
Oops!
2014
-1979
35
National Research Act (1974)
“The Commission shall … conduct a
comprehensive investigation and study to
identify the basic ethical principles which
should underlie the conduct of biomedical
and behavioral research involving human
subjects…”
National Research Act (1974)
“…the Commission shall consider at least the
following:
(i) The boundaries between biomedical or
behavioral research involving human subjects
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…”
National Research Act (1974)
“(iii) Appropriate guidelines for the selection
of human subjects for participation in
biomedical and behavioral research.
(iv) The nature and definition of informed
consent in various research settings…”
The Belmont Report
Ethical Principles and Guidelines for the
Protection of Human Subjects in Research
(National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research (1979))
Respect for Persons/Le Respect
Principle: Respect for
Applications:
Persons
• Informed Consent
• Subjects as
as Informed,
Autonomous
Competent, and
Beings
Voluntary
• Protection of
• Subjects’ Assent
Subjects with
and Third Party
Limited Autonomy
Consent
Beneficence/La Bienfaisance
Principle:
Beneficence
• Do No Harm
• Maximize Benefits
and Minimize
Possible Harms
Applications:
• Favorable
Risk/Benefit
Assessment
• Systematic
Analysis and
Minimization of
Acceptable Risks of
Harm
Justice/La Justice Distributive
Principle: Justice
• Distribute Burdens
and Benefits
Equitably
• Don’t Exploit
Vulnerable
Populations
Applications:
• Select Individuals
and Classes of
Subjects Equitably
• Link Burdens to
Benefits
How Old are the Belmont
Report’s Ethical Principles?
And Where Did They
Come From?
Respect for Persons (1785)
Immanuel Kant,
leading philosopher of
Deontology and the
categorical imperative of
treating every rational
being (person) as a end.
Beneficence (1789)
Jeremy Bentham,
leading philosopher of
Utilitarianism and the
Principle of Utility of the
Greatest Happiness of
the Greatest Number
Justice (350 BCE)
Aristotle,
leading philosopher of
Aristotelian Philosophy
and of the principle of
distributive justice
according to what people
deserve.
Conflict Between Principles
Beneficence vs. Justice
(E.g. Rare Disease Research)
Respect for Persons vs. Beneficence
(E.g. Deception Research)
Justice vs. Respect for Persons
(E.g. Culturally Stigmatizing Research)
An Ethical Dilemma
A Second Ethical Dilemma:
Take Me Out to the Ballgame?
Practice/Research
La Pratique/La Recherche
“Research and practice may be carried on
together when research is designed to evaluate
the safety and efficacy of a therapy. This need
not cause any confusion regarding whether or
not the activity requires review; the general rule
is that if there is any element of research in an
activity, that activity should undergo review for
the protection of human subjects.” (Belmont
Report)
Learning Health Care Systems
“The Research-Treatment Distinction: A
Problematic Approach for Determining Which
Activities Should Have Ethical Oversight” (Kass
et. al., 2013)
“An Ethics Framework for a Learning Health
Care System: A Departure from Traditional
Research Ethics and Clinical Ethics” (Faden et.
al., 2013)
A Third Ethical Dilemma