Transcript ND Department of Human Services

Wheaton College
INSTITUTIONAL REVIEW BOARD
(IRB)
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What is an IRB?
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The Institutional Review Board (IRB) is a
committee established to protect the rights
and welfare of human research subjects
recruited to participate in research activities
conducted under the auspices of the
institution with which it is affiliated.
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Office for Human Research Protections (OHRP)
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OHRP Definitions
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RESEARCH: A systematic investigation
designed to develop or contribute to
generalizable knowledge
HUMAN SUBJECT: An individual about
whom an investigator conducting research
obtains data through intervention or interaction
with the individual, or identifiable private
information
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Why does Wheaton have an IRB?
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There is increasing research activity at Wheaton.
We need to comply with federal regulations for
the protection of human subjects and data privacy
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e.g., 45 CFR 46 and 42 CFR; HIPAA
We need to comply with standards of professional
conduct and practice.
Not all research proposals are pre-approved by
another IRB; and even if they are, the other IRB
may not apply all standards relevant to Wheaton.
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Historical Significance
1947: Nuremberg Trials
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Twenty-six Nazi physicians are tried at Nuremberg,
Germany, for research atrocities performed on prisoners
of war
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Nazi War Crimes Tribunal issues first internationally
recognized code of research ethics
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Nuremberg Code
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Basic principles of voluntary consent
Capacity of subjects to consent
 Freedom of subjects from coercion
 Comprehensive analysis of risks and benefits
 Minimization of risk and harm to subjects
 Favorable risk/benefit ratio
 Qualified investigators
 Appropriate research design
 Freedom of subjects to withdraw at any time
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Tuskegee Studies: 1932-1972
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Study of natural history of untreated syphilis in Tuskegee,
Alabama
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Poor, black males uninformed about presence of disease and
denied a treatment discovered in 1947
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Abuses revealed in 1972
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1974: National Commission
Established and Act Passed
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National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
established
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National Research Act passed by Congress
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Established IRBs and required review of federally funded research
involving human subjects
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Autonomy
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Give respect, time, and opportunity to subjects to make own
decisions
No pressure to participate
Protection for potentially vulnerable populations such as
 Children
 Elderly
 Cognitive or emotionally impaired
 Prisoners
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Beneficence
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Obligation to secure well-being of research participants
Protection of subjects from harm
Maximization of benefits
Careful balancing of risks and benefits
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Justice
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Distribute benefits and burdens of research fairly and
without bias
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Selection of subjects not based on
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convenience
subject availability
compromised position of subjects
subject manipulability
language barrier
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What does the IRB do?
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Reviews research proposals involving direct contact with
Wheaton students, or release of Wheaton staff or student
data to researcher(s) outside of Wheaton; Reviews research
proposals
 Approves, suggests specific revisions, or disapproves
these proposals
Provides Continuing Review of approved research
projects (at least annually)
Provides in-service training about human participant
protection in research to Wheaton students and staff
Responds to participant inquiries or concerns about their
participation in Wheaton research
Provides technical assistance to researchers
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When does research need IRB review?
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All prospective projects that pertain to research and
human subjects as defined earlier, that involve
Wheaton students, staff, or data, must be reviewed
by the Wheaton IRB.
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Internal data analysis undertaken by Wheaton staff
exclusively for purposes of Wheaton needs
assessment, program planning, program evaluation,
or other administrative requirements is exempt from
need for DHS IRB review.
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What does the IRB look for?
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Protection of participant rights
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Adequate Informed Consent to participate
Procedures which are not harmful – psychologically or
physically
Procedures which assure maintenance of confidentiality of
sensitive data
Right to refuse to participate without adverse consequence
such as denial of services
Scientific merit of the proposed study
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Is the design minimally adequate to answer the research
questions? Are benefits worth the risks?
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Who is on the IRB?
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At least five members
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At least one nonscientific member and one not otherwise
affiliated with the institution
Must include member “primarily concerned” with the
welfare of vulnerable subjects, e.g., children, prisoners,
pregnant women, or mentally ill
Professional competence necessary to review specific
research activities, and knowledge of standards of
professional conduct and practice (1+ scientistpractitioners)
Know what is acceptable research in terms of
institutional commitments and regulations (a senior
management representative)
Know legal requirements
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Current Membership
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Chair: Michael Berg (2012-15) Dept. of Psychology
Teresa Celada (2010-13) Dept. of Philosophy
Karen McCormack (2012-15) Dept. of Sociology
Shawn McCafferty (2012-15) Dept. of Biology
Charles (Chuck) Kennedy (2010-13)(Outside Member)
M. Gabriela Torres (2012-15) Dept. of Anthropology
Executive Secretary: Joel Relihan (2010-14) Associate
Provost
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Wheaton IRB Website
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Information and rights for potential research
participants
IRB policy and guidelines
IRB submission instructions and forms
IRB terms and definitions
Contact information
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For additional information
contact
Joel C. Relihan, Associate Provost
IRB Executive Secretary
Human Protections Administrator
Phone: 508.286.3497
[email protected]
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