Information for IRB Members

Welcome to the Institutional Review Board (IRB)!

This page will provide you with some background information on IRBs as well as links to government information, university forms, and helpful information from other institutions.

Background on the federal system

IRBs came about after the abuses of Nazi medical experimentation and a period of behavioral and medical research in the U.S. in which human subjects were placed at high risk of adverse effects. In response to these excesses, the U.S. government set standards for protection of human subjects as conditions of federal research funding. An IRB is the committee that oversees the application of these standards. By law, an IRB must comprise at least five members, including one non-scientist (neither behavioral nor biomedical) and one community representative who is not affiliated with the institution; research protocols may not be approved without the non-scientist present at the meeting.

An IRB reviews protocols in order to protect human research subjects. The protocol must have IRB approval before the research begins. American IRBs are guided by principles articulated in the 1979 report "Ethical Principles and Guidelines for the Protection of Human Subjects Research," authored by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and commonly referred to as the Belmont Report.

Not every type of investigation involving humans falls under the federal definition of "human subjects research." You can find the federal definitions of "research," "human subjects," and "informed consent" in Title 45 Section 46 of the Code of Federal Regulations (45 CFR 46). These regulations were created for federally-funded research. However, the customary practice across American universities and other research institutions is to apply the federal standards to all human subjects research, regardless of how the research is funded. Any researcher who wishes to use Puget Sound students, faculty or staff as subjects, or who will be conducting research using university resources or facilities, must go through the Puget Sound IRB process. This includes researchers who are not affiliated with the university and projects that have already been approved by IRBs at other institutions.

University of Puget Sound approval process

When researchers submit their protocols for approval by the Puget Sound IRB, they will use this cover sheet and follow this general outline to propose their project. There is a separate form for requesting renewed IRB approval and requesting permission to modify previously approved protocols.

The IRB will determine which of the following categories best describes the nature of the project:

  1. Exempt (not further subject to federal regulations)
  2. Expedited (subject to all federal regulations, but may be approved by a single reviewer.) Alverno College has a useful set of guidelines for thinking about what qualifies for expedited review. However, expedited reviewers are expected to use their judgment rather than a checklist alone.
  3. Full Board (subject to all federal regulations, must be approved by the full IRB) You may find these criteria from the University of Kentucky helpful as you review protocols that come before the full Board. However, the Puget Sound IRB determines approval based on discussion rather than simple application of a checklist.

Approval processes vary slightly by category.

In deciding whether to approve a protocol, IRBs consider such factors as whether the project's potential benefits outweigh potential risks to subjects, risk levels are acceptable in an absolute sense, subjects fully understand nature of their participation, and subjects freely consent to participate. 45 CFR 46.111 lays out the federal criteria for IRB approval of research protocols.