A Message from the University of Pittsburgh Institutional Review Board
IRB Announcements
IRB Hours for Submitting Paper Protocols
The University of Pittsburgh IRB recently changed its hours for dropping off paper submissions (renewals, modifications, other non-electronic reports). Office hours for submitting paper protocols are between the hours of 8:30 am and 4:00 pm. Any submissions received after 4:00 cannot be accepted, and must be re-submitted the following day.
Clinical Trials Registration Requirements
We would like to share the following message, from Steven Reis, M.D., about recent changes in the requirement for Principal Investigators to register clinical trials with www.clinicaltrials.gov. Please note that trials may be registered prior to receiving IRB approval. However, before the first patient is randomized into the trial, IRB approval must be obtained and the ClinicalTrials.gov record for that clinical trial must be updated accordingly by the PI. In addition to including the IRB approval number in the update, the ‘approval status’ field should be set to ‘approved’, the ‘overall status’ field should be set to ‘recruiting’ and the recruiting status should be updated for each location (as applicable).
IRB approval letters must be sent by the PI to ClinicalTrials.gov. Please include the ClinicalTrials.gov specific listing number when submitting this information to the website.
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Clinical Trials.Gov
On September 27, 2007, the federal government enacted Section 801 of Public Law 110-85, which amends the Public Health Service Act to mandate registration and results reporting of all “applicable clinical trials” in ClinicalTrials.gov (http://www.clinicaltrials.gov/), and outlines penalties for noncompliance. If an “applicable clinical trial” is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, any grant or progress report shall include a certification that the responsible party has made all required submissions for the applicable trial to ClinicalTrials.gov ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html ).
Principal investigators (PIs) are responsible for making the determination of whether they are obligated to register their trials in accordance with the law.
The NIH has encouraged registration of all clinical trials, even if registration is not required by law. If PIs are unsure if a trial is an “applicable clinical trial”, they are encouraged to register the trial. Trials must be registered in full prior to enrollment of the first subject. In addition, many journals require trial registration as a condition for consideration for publication.
To Whom does this Apply?
Under the statute, “applicable clinical trials” generally include:
- Clinical trials of drugs or biologics that are clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation.
- Clinical trials of devices that are controlled clinical trials with health outcomes, other than small feasibility studies, and all pediatric post-marketing surveillance.
In addition to the registration requirement, there are requirements for publication of applicable clinical trial results.
How do I register a trial?
To initiate the clinical trial registration process, a PI must establish an account with the ClinicalTrials.gov Protocol Registration System (PRS) by sending an e-mail message to the University’s PRS administrator, Laurel Yasko, at lyasko@hs.pitt.edu. The subject line must state “Protocol Registration” and the body of the message should contain the PI’s name, telephone number, and e-mail address. After receiving notification that an account was created by the University’s PRS administrator, the PI can complete the registration process by accessing the ClinicalTrials.gov Protocol Registration System Information Website ( http://prsinfo.clinicaltrials.gov/) and following the directions for registration of any and all “applicable clinical trials.” A unique identifier, called an “NCT” number, will be generated during the registration process. This number should be used for NIH reporting purposes and for manuscript submissions.
Further information about clinical trial registration can be found on the Office of Clinical Research Website at: http://www.clinicalresearch.pitt.edu/docs/ICMJE_FAQs.pdf.
Additional questions should be addressed to Laurel Yasko at lyasko@hs.pitt.edu or 412-648-9756.