The Review Process

PRAMS eSubmission applications for studies involving human participants are received by the Human Research Participant Program (HRPP) in the Office for Research Protections (ORP). Some HRPP staff members serve on the Institutional Review Board (IRB).

Studies that are exempt from IRB review are reviewed by HRPP coordinators. Coordinators review the study to ensure that it is indeed exempt from IRB review. Studies that qualify for expedited review will be reviewed by at least one IRB member. Since HRPP coordinators are also IRB members, expedited studies may be reviewed by one of them, by another IRB member external to the Office for Research Protections, or both. Studies requiring review by the full IRB will be reviewed during a convened meeting of one of Penn State's two IRBs.

All submissions are pre-screened by HRPP staff members to ensure that all personnel have completed the required trainings and that all necessary documents are received for review. Once all pre-screening requirements have been fulfilled, the submission will be forwarded to the appropriate IRB/HRPP staff member for review. The reviewer may request additional information from the investigator, which may include requests for revisions to documents, such as consent forms, recruitment materials, and/or instruments used in the study. Resolution of reviewer's questions and requests may extend the review the process beyond the estimated time line.

For Full Review studies, investigators are typically invited to attend IRB meetings to answer questions posed by the IRB. Following the meeting, additional information requests and notice of approvals will be coordinated by an HRPP staff member.

 Please see the  IRB Full Meeting Dates to see the schedule of IRB meetings.

Next: Once your human participant research study has been approved, please see Ongoing Actions Post Approval to learn more about what will be required post approval as you conduct your study.

Getting Started → Preparing a New eSubmission Application → The Review Process → Ongoing Actions Post Approval → Closing the Study