Institutional Review Board for Human Subject Research: Does Your Research Need One?

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Institutional Review Board for Human Subject
Research Does Your Research Need One?

• Merle Rosenzweigoriley_at_umich.edu
• Michael Unsworth
• unsworth_at_msu.edu

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OUTLINE

• IRB Background
• ?Definitions Concepts
• ?History matter of ethics
• ?IRB process
• Case Studies

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Definitions Concepts
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Institutional Review Board (IRB)

• A group that reviews and approves any type of
  research to protect the people who take part in
  it.
• IRBs check to see that the research is well
  designed, legal, ethical, does not involve
  unneccesary risks, and includes safeguards for
  people taking part.

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AS DEFINED BY FEDERAL REGULATIONS
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• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
• Studies that involve interviews, follow-up
  contact to determine the effectiveness of a
  program.
• Marketing surveys and surveys to assess user
  satisfaction often do not require IRB review and
  approval because contracts with member groups
  specifically allow members to be contacted
  without such approval and because these surveys
  do not contribute to generalizable knowledge.
• If information from a project will be published
  in a scientific journal or presented at a
  scientific meeting, the project is considered
  research by the federal definition and requires
  IRB review and approval. Publication or
  presentation implies an intention to contribute
  to generalizable knowledge. Additionally, many
  medical journals require documentation of review
  by a human subjects committee as a condition of
  publication.

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Human Subjects Research Involves

• Wide variety of biomedical and clinical research
• Behavioral research
• Survey research

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• A fundamental ethical requirement in connection
  with research involving human subjects
• A basic principle of respect for persons
• Respect for persons requires that subjects, to
  the degree they are capable, be given the
  opportunity to choose what shall or shall not
  happen to them

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Most Research Receiving Federal Funding Must
Follow The Common Rule.(45 CFR 46)

• Elements
• ? requirements for assuring compliance by
  research institutions
• ? requirements for researchers obtaining and
  documenting informed consent
• ? requirements for Institutional Review Board
  (IRB) membership, function, operations, review of
  research, and record keeping.
• ? additional protections for certain vulnerable
  research subjects-- pregnant women, prisoners,
  and children

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IRBs Are the Result of 20th Century Research
Misconduct or Dilemmas
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The IRB Process
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• Title of the Study
• Principle Investigator ,Study Team Members
  (Roles,Conflict of Interest information,
  Credentials)
• Project Summary
• Estimated start and end dates
• Performance Site(s) and Details
• Research Design Objective, Specific
  Aim(s)/Hypothesis, Background Information,
  Interactions (e.g., information gathering,
  survey, interview, focus groups), Statistical
  Design
• Benefits and Risks
• Subject participation (number and age)
• Recruitment (may include screening)
• Informed Consent
• Confidentiality/Security
• Retention of Data

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An IRB then reviews the application to insure
that

• Risks to subjects are minimized.
• Risks to subjects are reasonable in relation to
  anticipated benefits, if any.
• Selection of subjects is equitable.
• Informed consent will be sought from each
  prospective subject.
• The possibility of coercion or undue influence is
  minimized.
• Require that additional information be given to
  subjects when in the IRB's judgment the
  information would meaningfully add to protection
  of the rights and welfare of subjects.

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IRBs are also responsible for ensuring that
members who review research have no conflicting
interest.
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Research that meets the categories set forth by
the federal regulations (45 CFR 46) that expose
participants to no more than minimal risk.
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Research limited to the following activities may
qualify for an exemption determination by an IRB

• Studying educational methods
• Interviewing public figures
• Use of publicly available data sets
• Use of existing data and/or specimens stripped of
  identifiers

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HOW AN IRB DETERMINES AN EXEMPTION
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TO GET AN IRB EXEMPTION, ONE MUST STILL DO A LOT
OF PAPERWORK!
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CONCLUSIONACCEPT THE IRP PROCEDURESAS PART OF
THE RESEARCH PROCESSAND FOLLOW THEM
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CASE STUDIES