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Role and Composition

Role of the IRB

The National Research Act, Public Law 93-348, mandates that an institutional review board, or human subjects committee, must be established by any university that receives federal funding for biomedical or behavioral research. The administration and monitoring of IRBs is conducted by the DHHS Office for Protection from Research Risks (OHRP). Institutions found to be in non-compliance with regulations can lose federal funding of both its research and student programs. In its broadest sense the purpose of the IRB is to protect the rights and safety of human subjects. In fulfilling its task the IRB must carefully examine research proposals to arrive at an independent determination that the research will meet the following ethical criteria:

  • Risks to subjects are minimized.
  • Risks to subjects are reasonable in relation to anticipated benefits.
  • Selection of subjects is equitable.
  • Informed consent is sought from each prospective subject or the subject's legally authorized representative.
  • Informed consent is appropriately documented.
  • When appropriate, the research plan makes adequate provision for monitoring the data collected, to ensure the safety of subjects.
  • When appropriate, there are adequate provisions to protect the privacy of subjects, and to maintain the confidentiality of data.

Additional safeguards are included to insure that members of vulnerable populations (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons) are not the subject of coercion or undue influence.

Composition of the IRB

Each IRB is required to have at least 5 members with sufficient diversity with respect to gender, race, cultural background, and professional expertise. Each IRB must include members whose primary concerns are in scientific areas and in nonscientific areas and at least one member not affiliated with the institution. The diversity of IRB membership should enable it to assess the ethical acceptability of a research proposal with respect to its:

  • Scientific merit
  • Sensitivity to community attitudes
  • Safeguarding of participant rights and welfare
  • Institutional commitments and regulations
  • Applicable law
  • Standards of professional conduct and practice