About the Institutional Review Board (IRB)

Penn State has established two IRBs: the Social Science IRB and the Biomedical IRB. The Social Science IRB reviews human participant research that involves questionnaires, surveys, interviews, focus groups, etc. The biomedical IRB reviews human participant research (e.g., saliva, tissue, urine, or blood samples, dietary manipulation, exercise studies, etc.) that involves the scientific study of normal or abnormal physiology and development, studies that evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and studies that involve any invasive procedures.

What are some examples of biomedical research?

Examples include (but are not limited to...)

• Feeding participants
• Injecting participants with various substances
• Having participants exercise in various ways
• Attaching electrodes to participants
• Performing X-rays, CT-scans, MRIs, sonograms, blood pressure readings, EMGs, EEGs, EKGs, etc. on participants
• Having participants perform tasks that involve physical manipulations or actions (such as having the participant place their hand in cold water or walk up and down steps, etc.)
• Having participants use experimental drugs or medical devices
• Having participants wear devices (such as helmets used to hold tiny cameras that measure eye movements) or vests that measure body temperature (or perhaps change the temperature of the body), etc.
• The researcher may be taking hair and nail clippings, collecting spit, blood, dental plaque, bodily excretions (e.g., urine or feces), human tissues, etc.

The IRBs consist of faculty, staff, and community members appointed by the Senior Vice President for Research. Each IRB must have at least one community member serving on the board who is not employed or affiliated with the University or has an immediate family member employed or affiliated with the University. All IRB activities are coordinated through the Office for Research Protections (ORP) located at 201 Kern Graduate Building.

The IRB is responsible to review and approve, require modifications in, or withhold approval of research involving human participants. Approval is only granted for one year or less; therefore, the IRB is also responsible for reviewing ongoing activities on a continuing basis. To assist in the ongoing reviews, ORP sends a Continuing Progress Report and Review (CR) form to the principal investigator approximately four to eight weeks prior to the expiration of the approval. This form must be completed and returned to ORP before the approved expiration date. Once approval has expired, the project will be inactivated and the file will be sent to University archives and subsequently destroyed. Once a project's approval has expired, a new application will need to be completed for review and approval before human participants research can resume. It is very important for investigators to follow their approved protocols. If a protocol is not followed as approved, the IRB may suspend those activities.

PLEASE NOTE: Approval for expedited and full review studies is granted for a maximum of one year. ORP attempts to reach all investigators prior to the expiration date of their protocol, however, the principal investigators are responsible for ensuring their approval does not lapse.