Transcript Office for the Protection from Research Risks (OPRR)

Office for Human Research
Protections (OHRP)
Department of Health and
Human Services
Office of Public Health and Science
Director: Greg Koski, Ph.D. M.D.
Office for Human Research
Protections (OHRP)
Dr. Jeffrey Cohen
Associate Director for Education
Phone: (301) 402-5552
Fax: (301) 402-2071
E-mail: [email protected]
OHRP Electronic Access
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E-mail: [email protected]
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Web Site: http://ohrp.osophs.dhhs.gov
Ethical Principles
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
The Belmont Report
Basic Ethical Principals:
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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
Federal Regulations
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
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.
Federal Regulations and Policy
Additional Protections Included in 45 CFR 46:
 Subpart B - Additional DHHS Protections Pertaining
to Research, Development, and Related Activities
Involving Fetuses, Pregnant Women, and Human In
Vitro Fertilization
 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
Definitions
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Research - a systematic investigation
designed to develop or contribute to
generalizable knowledge.
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Human Subject - a living individual about
whom an investigator conducting research
obtains
– data through intervention or interaction with
the individual, or
– identifiable private information
Basic Protections
The regulations contain three basic
protections for human subjects:
 Institutional Assurances
 IRB Review
 Informed Consent
Institutional
Assurances
Institutional Responsibilities
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Institutions bear full responsibility for all
research involving human subjects covered
under their Assurance
All requirements of 45 CFR 46 must be met
for all federally-sponsored research
OHRP strongly encourages institutions to
embrace the HHS regulations regardless of
sponsorship, and to commit to this standard
in their Assurance.
Institutional Responsibilities
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Designate one or more Institutional Review
Boards (IRBs) to review and approve all
nonexempt research covered by an the
Assurance
Provide sufficient space and staff to support
the IRB’s review and record-keeping duties
Establish education and oversight
mechanism
Institutional Review
Board Review
IRB Decision Matrix
BENEFICENCE
JUSTICE
Risk/Benefit Analysis
Experimental Design
Qualifications of PI
Subject selection
Inclusion/exclusion
Recruitment
RESPECT FOR PERSONS
Informed consent
Surrogate consent
Assent
J. Cooper, Albany Medical Center
Protection of subjects
(especially vulnerable
populations)
Social & Psychological Risk
Social &
Psychological risks
are real risks
Social & Psychological Risk
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Examples
– Emotional Distress
– Psychological Trauma
– Invasion of Privacy
– Embarrassment
– Loss of Social Status
– Loss of Employment
Social & Psychological Risk
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Risks are TIME and SITUATION
specific
Psychological & social risks are very
subjective
There is little or no empirical data on the
likelihood of risk in behavioral or social
research
Social & Psychological Risk
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In some cases simply participating in
the research can cause social or
psychological harm
– psychological reaction to situation
– psychological reaction to questions
Social & Psychological Risk
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Primary source of social risk results
from a breach of confidentiality.
– Confidentiality and anonymity are not the
same
– Names are not the only identifiers
– Subjects’ participation in the research may
need to be kept confidential as well as their
data
Informed Consent
Beyond the
Consent Form
The Consent Process
Informed consent is not a single event or just a form
to be signed -- rather, it is an educational process
that takes place between the investigator and the
prospective subject.
The basic elements of the consent process include:
 full disclosure of the nature of the research and
the subject's participation,
 adequate comprehension on the part of the
potential subjects, and
 the subject's voluntary choice to participate.
Consent vs. Consent Forms
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The consent form is merely the
documentation of informed consent and does
not, in and of itself, constitute informed
consent.
Informed consent is a process which is
documented by a signed consent form.
The fact that a subject signed a consent form
does not mean that he/she understood what
was being agreed to or truly gave their
voluntary consent.
Comprehension
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Informed consent is not valid unless the
consentor understands the information that
has been provided.
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It is the responsibility of the investigator to do
what he/she can to enhance each
prospective subject's comprehension of the
information.
Tampa Tribune 3/11/00
TAMPA - A lawsuit accusing USF doctors of
experimenting on pregnant women without their
consent is settled for $3.8 million…. The
experiment wasn't considered risky and no
adverse effects were documented, plaintiffs in the
suit agree. However, the failure to inform … as
many as 3,000 ... pregnant women of various
experiments conducted between 1986 and 1990
has cost Tampa General Hospital, USF and the
state $3.8 million.
Compliance Concerns
OPRR Compliance Activities:
Common Findings and
Guidance
http://ohrp.osophs.dhhs.gov/
references/findings.pdf
Does the institution support and
respect the IRB and its mission?
Is there a “culture of compliance”?
Are IRB members and investigators
knowledgeable about regulatory
requirements?
Is there adequate documentation of
IRB findings and actions?
OHRP/FDA/VA Workshops
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"Current Human Research Issues & Solutions: Regulatory
Overview & Investigator/Institutional Sponsor Partnerships ",
May 10-11, 2001, Newark, NJ.
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"Current Human Research Issues & Solutions: Regulatory
Overview & Hot Topics", June 21-22, 2001, Charleston, SC
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"Current Human Research Issues & Solutions: Regulatory
Overview & Social/Behavioral Research" July 16-17, 2001, Los
Angeles, CA.
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"Current Human Research Issues & Solutions: Regulatory
Overview & TBD", September 20-21, 2001, Minneapolis, MN.