ORP Review Process
Q: I dropped off a new "Application for the Use of Human Participants" to the Office for Research Protections (ORP) and didn't hear anything back about approval until nearly 3 weeks later. I thought my study was a simple one involving little to no risk to participants/subjects and I was just performing simple tasks. Why does it take so long?
A: As a rule of thumb, a new "Application for the Use of Human Participants" generally takes 3 weeks for review. The 3-week review time applies to those studies that are designated as "exempt" or "expedited". Studies determined to be full reviews are evaluated by the full Institutional Review Board at their monthly meeting and require a longer review. For further guidelines on Full Review Submission for human participants, please visit http://www.research.psu.edu/orp/areas/humans/irbmeetings.asp (for submission deadlines) and http://www.research.psu.edu/orp/areas/humans/reviewtypes.asp (for an explanation of the criteria for the different levels of reviews).
The Review Process
In the beginning...
- The process involves a step-by-step review starting with prescreening at the ORP to check for complete applications, proper signatures, correct number of copies and an initial determination of the type of review.
- Once these criteria have been met, a reviewer is assigned to the protocol.
Exempt Reviews...
- Human Participant Protocols that fall under the "exempt" level of review are exempt from 45CFR46, the federal regulations governing human participant research. However, these regulations indicate that a researcher cannot determine for him/herself that their research is exempt. A third party not involved in the research must determine the protocol exempt. At PSU, that determination is made by the ORP. Therefore, researchers must still submit an Application for the Use of Human Participants. The review time for an exempt protocol is three weeks.
Who are these "reviewers"?
- Reviewers are members of the two Institutional Review Boards (IRB) that are administratively supported by the ORP. Committees consist of a minimum of 5 members comprised of at least one scientist, at least one non-scientist and at least one person not affi liated with the Institution (e.g., a community member). The membership of these committees is comprised of Colleges and Units throughout the University. This allows the committees to have expertise in many areas.
What do these "reviewers" do with my protocol?
- Each reviewer is granted 2 weeks to review a protocol and is given a copy of the protocol along with a reviewer sheet. Upon completion of the review, the reviewer then sends their comments back to the ORP. Depending on the committee, this is done in various ways (i.e. email, fax, US Mail or Campus Mail).
Then what...?
- Once the review sheet has been returned to the ORP, the IRB Administrator composes a list of necessary revisions as a result of the review. This list is compiled in an email, which is sent to the Principal Investigator (PI) and copied to other personnel as applicable.
Back to the investigator...
- Upon receipt of this email, the PI has the opportunity to respond to the revisions requested and reply with any items necessary for approval.
Back to the ORP...or..."The Final Lap to Approval"
- When the ORP receives correspondence from the investigator and assuming all the necessary information is contained therein, approval is granted. The ORP sends an email to the investigator indicating that they may begin their research. Occasionally, the reviewer may ask to see the response from the investigator, in which case the review period may be extended.
At last!
- Shortly after the approval email is sent, a hard copy of the formal approval letter and any pertinent accompanying documents (e.g., the approved informed consent form, etc.) are sent to the investigator and copied to other personnel as applicable.
Further information regarding the review timeline
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