Belmont Report Overview
Psychology 242, Research Methods
p. 1
The Belmont report
http://www.hhs.gov/ohrp/policy/belmont.html
A: Practice v. Research
1. If there is any element of research in an activity, that activity should undergo review for
the protection of human subjects.
2. Any procedure that involves data collection for potential generalization / publication
must be treated as research, even if it is part of normal clinical or other (e.g.,
educational) activities, or when research is designed to evaluate the safety and efficacy
of a therapy.
B: Ethical Principles
1. Respect for persons.
a. Respect and maintain peoples’ complete autonomy and self-determination.
Participant must be wholly informed about the research (informed consent)
and provided the opportunity to decline participation, ask questions, and have
concerns addressed. Cannot be coerced.
b. People with diminished autonomy are entitled to additional protection.
Due to age, medical condition, disability or circumstances (e.g., poverty)
people with diminished capacity to provide informed consent must be given
clear protection from coercion, have consent materials appropriate to their
capacity, or, in some cases, not enrolled in research.
2. Beneficence.
a. Do not harm.
Assess and minimize risks of social, psychological or physical harms and
burdens (e.g., time, effort) of research
b. Maximize possible benefits and minimize possible harms.
Design procedures around a risk – benefit analysis; potential research harms
should be evaluated against the potential individual or social benefits of the
research.
Consider both individual and social risks and benefits: “fair” research may still
be harmful if it, e.g., stigmatizes participants or contributes to a social problem.
3. Justice
“Justice” consists of the fair distribution of benefits and burdens in society.
a. Selection of research participants

Do not exploit some classes (e.g., welfare patients, racial, ethnic or sexual
minorities, people confined to institutions) simply because they are easily
available or their manipulability, rather than for reasons directly related to the
study.

Studies that provide a benefit should not exclude any social groups.
Belmont Report Overview
Psychology 242, Research Methods
p. 2
b. Distribution of research results.
When research supported by public funds leads to the development of
therapeutic devices or procedures, those benefits must be widely available
and not limited to, e.g., wealthier people or specific social groups.
C: Applications
1. Informed Consent
a. Information

People must be provided complete information about the research prior to
their decision to consent to the study. Items generally include:
o The research procedure,
o Their purposes, risks and anticipated benefits,
o Alternative procedures (where therapy is involved),
o A statement offering the subject the opportunity to ask questions and
to withdraw at any time from the research.

When full information would compromise the study design, partial disclosure
or actual deception may be appropriate, given that:
o Incomplete disclosure is truly necessary to the research
o There are no undisclosed risks that are more than minimal
o There is an plan for debriefing subjects once the study is completed
b. Comprehension

Consent and other materials must be written at a level that is easily
comprehensible (typically 8th grade reading level). Investigators should
assess whether participants actually understood the consent materials.

Special provisions are required for people whose comprehension is
compromised. In extreme cases this may require a third party to
provide consent, e.g. a parent or family member, youth representative,
clergy or clinician.
c. Voluntariness
Consent cannot be due to:

Direct threat of harm

Undue influence; an unwarranted or inappropriate reward.
Inducements that would ordinarily be acceptable may be undue
influences if the subject is especially vulnerable.

Unjustifiable pressures from people in a position of authority, often
described as a “dual role”: researchers who are also the participants
physician, teacher, employer, etc.
2. Assessment of Risks and Benefits.

“Beneficence”: Risks to participants should be outweighed by anticipated benefits to
participants as well as society, via knowledge to be gained from the research. Risks
and benefits affecting the immediate research participant carry special weight.
Belmont Report Overview
Psychology 242, Research Methods

p. 3
Risks and benefits affect individual participants, their families, specific social groups,
or society at large.
3. Selection of Subjects.
“Justice”: the moral requirement for fair procedures and outcomes in the selection of
research subjects.
a. Individual:
“fairness”: Investigators should not offer potentially beneficial research only
to some favored people, or select only "undesirable" people for risky
research.
b. Social:

Distinguish groups who ought or ought not participate in a particular study,
based on their ability to bear additional burdens of research.

Study enrollment must not reflect social, racial, sexual and cultural biases
institutionalized in society.

Groups such as racial minorities, the poor, or the institutionalized must be
protected against being recruited solely for administrative convenience, or
because they are easy to manipulate as a result of their illness or
socioeconomic condition.
Research Ethics: The Common Rule
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Minimization of risks
Reasonableness of risks
Equitable participant recruitment
Informed consent
Documentation of consent
Data monitoring for safety
Provisions to protect vulnerable participants & maintain confidential