A Message from the University of Pittsburgh Institutional Review Board

IRB APPROVAL/EXPIRATION DATE POLICY REVISED

Effective March 1, 2007, the IRB will change the way that approval and expiration dates are calculated. This change is in response to a recent Guidance from OHRP, as well as continuing confusion related to the method by which the IRB currently assigns approval and expiration dates

Federal regulations at 45 CFR 46.109 and 21 CFR 56.109 give IRBs the authority to approve, require modifications in (to secure approval) or disapprove all research activities covered under the regulations. In addition, the regulations require that an IRB conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once a year.

As of March 1, 2007, approval dates and expiration dates will be determined in the following manner.

Full Board Studies:

  1. When the research study receives full approval at a convened meeting, the date of IRB approval will be the date of the convened meeting. The IRB expiration date will be one year (minus 1 day) from the date of the convened meeting.

    2. For example, if the committee meeting date is 10/17/06, then the IRB approval date is 10/17/06, and the IRB expiration date is 10/16/07 (for an annual approval).

  2. When the research study is approved subject to modifications at a convened meeting, the date of IRB approval will be the date that the requested changes are verified by the Chair, Vice Chair, or his/her designee. The date of expiration, however, will continue to be one year from the date of the convened meeting (minus one day).

    3. For example, if, during the 10/17/06 meeting, the committee approves a research study subject to modifications, the investigator subsequently responds on 10/25/06, and the Chair, Vice Chair, or his/her designee verifies that response on 10/26/06, then the date of IRB approval is 10/26/06. The IRB expiration date is 10/16/07 (one year from the date of the convened meeting minus one day) for annual approval or 4/16/07 for a six month approval.

Expedited Studies:

  1. When research is reviewed and approved through an expedited review process, the date that approval is granted by the Chair, Vice Chair, or his/her designee will be the date of IRB approval. The expiration date will be one year from that date (minus one day).

Maintaining an IRB Approval Period:

  1. The Office for Human Research Protections, as well as the IRB, recognizes the logistical advantages of keeping the IRB approval period constant from year to year throughout the life of a project. When continuing review occurs annually and the IRB performs continuing review within 30 days before the IRB approval period expires, the IRB may retain the anniversary date as the date by which the continuing review must occur.

What does this mean for the research community?

The IRB has always recommended that renewals be submitted at least five weeks prior to the expiration date of the research project. For protocols that qualify for expedited review, that timeframe should be sufficient. However, for protocols that require full board review, earlier submission is recommended. This is particularly important for studies that are reviewed at either the pediatric committee or one of the cluster committees for oncology or pregnant women because those committees meet less often.

If you have any questions related to this policy, please contact Jean Barone, Assistant Director for Regulatory Affairs at baronej2@upmc.edu.