All levels of committee review use the same PSU IRB human subjects research application form. The same criteria for approval are used for each of the three levels of review. The major difference between the three levels of review is the potential level of risk for human subjects. Subsequently the internal processes used by the IRB to review applications is reflective of that difference.
Exempt/Expedited Review Applications
Federal guidelines allow for some research to be exempt (45 CFR 46.104) from full IRB review or eligible for expedited (45 CFR 46.110) review by the committee. These reviews should normally take about 2 weeks if all required information and documents are provided, and there are no revisions or additional information required.
Full Board Review
Per PSU IRB Guidelines and Procedures, this type of review is conducted by a fully convened IRB committee, which discusses the study and makes an approval decision. The convened meeting must have a quorum of IRB members present. For the research to be approved, it must receive the approval of a majority of those members present. This type of review is carried out for studies with greater than minimal risk to human subjects or at the request of researchers.
Applications reviewed through full-board review often involve special/vulnerable population(s) and can involve some level of physical, psychological, social, legal, and/or economic harm to the subject(s) and/or the researcher(s).
Common examples of research reviewed at the Full Board level at PSU are studies that include:
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Maximal exercise by healthy volunteers
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Institutionalized persons (e.g., prisoners, patients in long term care facilities)
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Persons who lack capacity to consent (e.g., persons with severe mental disabilities or developmental delays, children less than 18 years of age) or
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Sensitive topics (e.g., criminal behavior, sexuality, abuse, drug use)
Applications/proposals that require full board review may take up to two months to be reviewed depending on when the application is received, availability of board members, and the complexity of the proposal.
