Transcript irb.uindy.edu

Ethics & Regulation of
Human Subjects
Research
Jeffrey M. Cohen, Ph.D., CIP
President, HRP Associates, Inc.
© HRP Associates, Inc.
The Belmont Report
Ethical Principles and Guidelines for the Protection
of Human Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979
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The Belmont Report
Three Basic Ethical Principles:
• Respect for Persons
– Individual autonomy
– Protection of individuals with reduced autonomy
• Beneficence
– Maximize benefits and minimize harms
• Justice
– Equitable distribution of research costs and
benefits
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Public Trust
• The conduct of research is a privilege granted
by society, not an inalienable right
• The granting of the privilege is based on the
public’s trust that research will be conducted
responsibly
• Erosion of that trust can result in the public’s
withdrawal of the privilege
• Public trust is maintained through accountability
– Documentation
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Federal Regulations and Policy
• 45 CFR 46 - Basic DHHS Policy for Protection of
Human Research Subjects
Originally adopted May, 1974, Revised January
13, 1981, Revised June 18, 1991
– Additional protections for vulnerable populations
in Subparts B-D
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Federal Regulations and Policy
• Federal Policy for the Protection of Human
Subjects - “The Common Rule” June 18, 1991
– Departments of Agriculture, Energy, Commerce, HUD,
Justice, Defense, Education, Veterans Affairs,
Transportation, and HHS. NSF, NASA, EPA, AID,
Social Security Administration, CIA, and the
Consumer Product Safety Commission.
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Federal Regulations and Policy
Additional Protections Included in
45 CFR 46:
• Subpart B - Additional Protections for Pregnant Women,
Human Fetuses and Neonates Involved in Research
(revised December 13, 2001)
• Subpart C - Additional DHHS Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners
as Subjects
• Subpart D - Additional DHHS Protections for Children
Involved as Subjects in Research
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Definitions
46.102(d) & (f)
• Research - a systematic investigation
designed to develop or contribute to
generalizable knowledge.
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Definitions
46.102(d) & (f)
• Human Subject - a living individual
about whom an investigator conducting
research obtains
– data through intervention or interaction with
the individual, or
– identifiable private information
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Ethical Challenges in CrossCultural Research
• Conflicting values and beliefs regarding
appropriate conduct
• Potential for coercion of vulnerable
populations
• Political/scientific agendas to achieve
results
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Challenges for IRBs
• Inexperience of IRB members with crosscultural studies
• Unavailability of experienced reviewers for
cross-cultural studies
• Difficulties meeting U. S. criteria for ethical
approval of studies
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Informed Consent in
Cross-Cultural Context
• Requirements for informed consent
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Communication of study goals
Comprehension of information
Voluntary participation
Risks and benefits
Culturally appropriate
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Authority to Provide Consent
• Western Assumptions
– Centered on individual person and rights
– Emphasis on personal control, individual
agency
• Non-Western Assumptions
– Emphasis on person as a member of family
and community
– Emphasis on social agency
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Language Differences
• Problems with translation of research
instruments
– Language
– Concepts
• The Use of Interpreters in Obtaining
Consent
– Communication of information
– Relationship of translator to research
participant
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Socioeconomic Influences
on Informed Consent
• Status differences between researcher
and participant
– age, gender, education, income, religion,
ethnicity
• Implications for Expressions of Power
– vulnerability of subjects
– potential for coercion
– importance of trust and integrity
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Ethical Challenges in
Cross-Cultural Research
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Privacy/Confidentiality
Reimbursement
Individual vs. Group
Community Involvement
Lack of Infrastructure & Experience
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General Principles
• Respect cultural context
• Identify points of value conflict
• Educate researchers on need to respect
persons, respect human rights
• Act with integrity
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Summary
• There are ethical principles underlying
research involving human participants
• The Federal regulations are designed to:
– assure that research is conducted according
to the ethical principle
– preserve the public trust
• There are special concerns with crosscultural research
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