Office of Research Assurances

Institutional Review Board (IRB)

Washington State University Institutional Review Board (IRB)

Determination of Human Subject Research Checklist, Flowchart, and When is IRB Review Required Table Summary


Introduction:

WSU IRB and IRB staff, in conjunction with the IRB Scope Committee, have been evaluating the current IRB policies and procedures in response to nationwide debate about the scope and oversight of IRBs. Some faculty and researchers at WSU also have questioned the need for and appropriateness of WSU IRB review of some projects. The review of the scope of WSU IRB oversight also was undertaken to ensure that WSU IRB resources are utilized efficiently and effectively.

Current WSU IRB Policies and Procedures:

Current WSU policy and procedures require that all "projects" involving human subjects must be reviewed by the WSU IRB. In addition, all "projects" submitted to the WSU IRB are evaluated using the federal regulations that apply research. This could result in unwarranted and excessive review in certain situations.

Proposed WSU IRB Policies and Procedures:

WSU IRB, WSU IRB staff, and IRB Scope Committee proposed to develop policies and procedures that more closely follow the federal regulations that apply to review of research involving human subjects. Some projects and activities would be determined to be outside the scope and authority of the WSU IRB and require no review (such as many classroom activities, masters in teaching, and nursing practicum etc…)

The Determination of Human Subject Research Checklist, Determination of Human Subject Research Flowchart and Table 1, prepared by WSU IRB staff, provides guidance to WSU investigators who may be uncertain if their activity meets the definition of human subjects research stated in the federal regulations (45CFR46.102) and if it requires WSU IRB review (exempt determination, non-exempt, or ORA). These decision tools offer investigators an explanation of the review process, relevant definitions, and examples of studies that do or do not qualify as human subject's research.

The following statement from Belmont Report1 (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, (1979) reiterates the importance of reviewing the protocols based on broad ethical principles:

"The codes consist of rules, some general, others specific that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted".

WSU IRB recognizes the importance of reviewing the activities based on broader ethical principles and added a separate section on the flow chart for activities conducted by WSU investigators that involve vulnerable target populations as participants in non research projects and activities.


1National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979, April 18). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Available from www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Version: January 2008
Office of Research Assurances, P.O. Box 643143, Neil Room 427, Washington State University, Pullman WA 99164-3143
Human Subjects Protection Manager : Malathi Jandhyala, irb@wsu.edu, Phone: 509-335-3668, Fax: 509-335-6410