Wheaton College

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Wheaton College

• http//www.wheatoncollege.edu/Provost/ResearchandS
  cholarship.html

• INSTITUTIONAL REVIEW BOARD
• (IRB)

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What is an IRB?

• 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.
• Office for Human Research Protections (OHRP)

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OHRP Definitions

• 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?

• There is increasing research activity at Wheaton.
• We need to comply with federal regulations for
  the protection of human subjects and data privacy
• 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

• Twenty-six Nazi physicians are tried at
  Nuremberg, Germany, for research atrocities
  performed on prisoners of war
• Nazi War Crimes Tribunal issues first
  internationally recognized code of research
  ethics

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Nuremberg Code

• 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

• Study of natural history of untreated syphilis in
  Tuskegee, Alabama
• Poor, black males uninformed about presence of
  disease and denied a treatment discovered in 1947
• Abuses revealed in 1972

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1974 National Commission Established and Act
Passed

• National Commission for the Protection of Human
  Subjects of Biomedical and Behavioral Research
  established
• National Research Act passed by Congress
• Established IRBs and required review of federally
  funded research involving human subjects

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Autonomy

• 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

• 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

• Distribute benefits and burdens of research
  fairly and without bias
• Selection of subjects not based on
• convenience
• subject availability
• compromised position of subjects
• subject manipulability
• language barrier

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What does the IRB do?

• 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?

• 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.
• 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?

• Protection of participant rights
• 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
• Is the design minimally adequate to answer the
  research questions? Are benefits worth the risks?

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Who is on the IRB?

• At least five members
• 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 scientist-practitioners)
• 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

• Chair Dr. Grace Baron, Psychology
• Executive Secretary Dr. Frances Jeffries,
  Provosts Office
• Dr. Marcus Allen, Political Science
• Dr. Michael Berg, Psychology
• Dr. Teresa Celada, Philosophy
• Dr. Barbara Darling-Smith, Religion
• Dr. Shawn McCafferty, Biology
• Mr. Alex Vasquez, Interim Senior Associate Dean
  of Students
• Ms. Alice Polley, Sturdy Memorial Hospital
• Others as needed to assist in the review of
  issues which require specialized expertise

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Wheaton IRB Website

• Information and rights for potential research
  participants
• IRB policy and guidelines
• IRB submission instructions and forms
• IRB terms and definitions
• National Institute of Health (NIH) on-line
  training for researchers on human participants
  protection
• Contact information
• http//www.wheatoncollege.edu/Provost/ResearchandS
  cholarship.html

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For additional information contact

• Dr. Frances Jeffries, IRB Executive Secretary
• Phone [phone]
• jeffries_frances_at_wheatoncollege.edu