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The IRB


The formal title of the IRB is The Institutional Review Board for the Protection of Human Subjects in Non-medical Research.

The IRB's function is to protect the rights and welfare of human subjects involved in research at Duke. To do so the IRB provides ongoing peer and community review of research with human subjects. (Not all research with human subjects needs review by the full IRB. See Types of Review.)

Membership

The composition of the IRB is dictated by federal reguulations and includes:

  • Faculty from the academic disciplines submitting protocols to the IRB
  • A member whose primary expertise is in a non-scientific area
  • A community representative
  • An advocate for children
  • An advocate for prisoners

Submissions to the IRB

  • Requests to approve protocols
  • Request to modify approved protocols
  • Requests to renewal protocols
  • Reports of unactipated risks or adverse events

IRB Authorities

  • Approve requests
  • Disapprove requests
  • Request modifications
  • Suspend or terminate previously approved research that is not being conducted in accordance with the approved protocol or in which there is unanticipated harm to subjects
  • Monitor the consent process and the research

Reporting Findings to Investigators

The IRB will notify investigators, in writing, of the decision of the board.

Institutional Review

Research that has been approved by the IRB is subject to review and disapproval by institutional officials, but those officials may NOT approve research which has been disapproved by the IRB.