Determine your timeline
Investigators should plan to submit their Request for Review at least two months prior to beginning low risk studies. Researchers planning studies with highly vulnerable populations, involving FDA regulations, involving HIPAA or PHI, or other high-risk research should plan to submit their Request for Review at least six months prior to beginning the study.
Factors that influence the speed with which a protocol can be reviewed include the following:
- High risk versus low risk. Low risk studies can be read by one or two reviewers while higher risk studies require more reviewers or a full-panel review.
- Complete information. Requests for Review that include all of the information indicated do not require requests for additional information, which slows the review process.
- Attention to detail. Information presented in more than one place, in the RfR and in the consent form for example, should match. When they don't, the reviewer may have to re-read the document several times to determine the investigator's intention.
It is important to remember that many protocols are not approved on the first review. After being reviewed, the Principal Investigator will receive a Determination Letter. Determination Letters are not the same as approval letters. Investigators may receive a Determination Letter indicating that their protocol is approved and they may begin collecting data. Alternatively, investigators may receive a Determination Letter requesting modifications that must be re-reviewed before the protocol can be approved.
The IRB will meet the following dates in the 2012-13 school year:
- August 24, 2012
- September 28, 2012
- October 26, 2012
- November 30, 2012
- January 25, 2013
- February 22, 2013
- March 22, 2013
- April 26, 2012
Because of privacy requirements dictated by 45 CFR 46, IRB meetings are not open to the public.