IRB Application & Review Process

University policy requires institutional review and approval of ALL activities that involve using human participants in research. The University's Institutional Review Board (IRB) is composed of two committees (Biomedical Committee and Social Sciences Committee) appointed by the IO. The Institutional Official at Penn State is the Senior Vice President for Research and the Dean of the Graduate School.

A "human participant" is defined as an individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

The role of the IRB is to ensure compliance with all governmental regulations with the use of human participants. Applicable Federal regulations are detailed in Title 45 of the Code of Federal Regulations, Part 46.

Approval of the IRB must be obtained PRIOR to the involvement of participants. Failure to have human participants research reviewed by the IRB is a violation of University Policy RA-14, "The Use of Human Participants in Research."

If a funding source has been identified for the proposed research project, one complete copy of the grant application must be submitted to the IRB for their review.

Biomedical Research Versus Social Science Research:

Many biomedical research issues are not applicable to social science. However, many social science research issues involve biomedical elements. When social science research crosses the line into biomedical territory, the Application for the Use of Human Participants for Biomedical Research must be submitted and reviewed by the Biomedical IRB since the members will have more knowledge of the side effects and/or other possible risks.

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 of 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.

Procedures for Submitting a Research Project for Review:

1. Review all submission instructions.
2. Complete the Application for the Use of Human Participants; attach the proposed Informed Consent Form, as applicable; and append copies of any surveys or written instruments to be used in the investigation. [All information must be presented in a complete, typewritten format.]
3. Signatures must be obtained from department heads (and advisors, if applicable) on the Application for the Use of Human Participants.
4. Make the required number of copies of all materials. Investigators should determine the appropriate type of review for their study.
5. Send the completed application and appropriate number of copies to the Office for Research Protections, The 330 Building, Suite 205.
6. One complete copy of the grant application (if applicable) must be provided.

Please click here for further information on the procedures for submission.

View the monthly IRB meeting schedule.

Next Topic