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Do I Need to Submit?
Frequently asked questions about when a submission to the Institutional Review Board (IRB) is required
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- When am I required to submit a human participants proposal?
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All proposed studies involving the use of human participants being conducted under the auspices of The Pennsylvania State University are to be submitted for review prior to the beginning of the study. This includes proposed research involving secondary data and previously collected human fluid and tissue samples.
- I am just doing a simple survey, do I need to submit to the IRB?
- Yes. The Assurance Penn State has with the Department of Health and Human Services states that all research being conducted under the auspices of this institution will be submitted to the Office for Research Protections which oversees the review and approval process for the IRBs.
- I am not collecting any identifying information, do I need to submit for approval?
- Yes. Federal regulations and Penn State regulations require that ALL research (a systematic investigation) involving human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
- I am not collecting any identifying information, do I still need an Informed Consent Form?
- Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, drivers license numbers, etc.), an implied Informed Consent Form may be used. That is, all of the elements of consent must be documented for the participant, but the signature line is replaced with a statement informing the participant that completion and return of the survey is considered implied consent. If however, the procedures involve risk or biological sample collections, written consent may be required.
- I am only working with previously collected data, do I need to submit for approval?
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Yes. Federal regulations require that the study of existing data, documents, records, pathological specimens, or diagnostic specimens are to be submitted for review and approval.
- I will be collaborating with another institution, do I need to submit to PSU and the other institution?
- Investigators should contact the Office for Research Protections whenever collaborative research is occurring. Separate applications may be necessary, or an IRB Authorization Agreement may be reached with the other institution.
