3. What is the Institutional Review Board (IRB) and how does it oversee human subjects research?

The Institutional Review Board (IRB) is a federally required committee that reviews human subjects research to ensure that it is both ethical and conducted in compliance with federal regulations, state regulations, and institutional policies and procedures. The IRB must approve human subjects research prior to its initiation and oversees the progress of approved research via annual renewals and check-ins.

Before a researcher can begin work with human subjects, the researcher must submit a protocol outlining the intended procedures. Protocols submitted to the IRB receive a robust review focusing on the rights and welfare of those individuals who voluntarily agree to take part as research participants. The protocol must include necessary materials for the IRB to conduct the review including:

  • a detailed description of the project procedures, copies of items participants will be asked to complete (e.g., surveys, questionnaires, description of actions they will be asked to take, etc.);
  • a description of how participants will be recruited;
  • a description of how participants will provide consent to participate; and,
  • a description of how the subjects' privacy and confidentiality will be safeguarded, etc.

The IRB or representatives examine these materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social, or economic. Benefits include both those to the individual research participant and to society as a whole. As part of that review, the IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

For more information on the review process, view Getting Started – IRB Process Overview.

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