After completing various metrics reporting activities in late 2016 and early 2017 regarding research volume and turnaround times (you can see our results posted here) we began to look at the IRB administrative processes to identify areas where we could potentially reduce the amount of time it takes for a study team to receive approval.
OHRP and FDA regulations do not require that IRB determination letters include a list of considered documents. However, over time, the Penn IRB developed very precise and stringent naming conventions for listing documents submitted by study teams for review. These lists have always been fully generated by the IRB staff and included in IRB determination letters. After assessing the utility of this practice we have decided to implement a procedural change regarding document lists.
In June 2016 the IRB released new submission forms which included the requirement for study teams to supply a list of all documents being submitted with modifications and continuing reviews. This policy is now being extended to all submission types and will fully be the responsibility of the study team. As document listing is not an official IRB Policy, these changes will not be noted in the updated version of IRB SOPs being released this year. The new requirement will be noted in an official IRB memo that can be shared with study sponsors when required, upcoming revised versions of all submission forms and instructional documentation on the IRB website.
The new procedural requirements which go into effect on May 1, 2017 are as follows:
For Greater Than Minimal Risk Research:
As the IRB is most concerned with review and tracking of Greater Than Minimal Risk research, where the most up to date information is crucial to participants, these studies will require document listing. The IRB staff will no longer generate a document list based on our interpretation of the attachments in HSERA. Every submission for Greater Than Minimal Risk protocols (Initial, Modification, Continuing Review, Deviation, Exception, and Reportable Event) must include a full list of documents being submitted for review. This list must reflect the Document Name, Version #, and Date for every document as it should appear in the determination letter. The IRB staff will copy the list provided by the study team into the determination letter.
If upon receipt of a submission a document list appears to be incorrect (i.e. number or description of attachments does not match the number or description of documents listed) the study team will be asked via email to provide a corrected list.
If any documents are submitted via email, the email from the study team should include the text to add this document to the existing list.
The IRB staff will continue to list the HSERA application with appropriate confirmation code and date of receipt as usual. The IRB staff will also list any email correspondence that includes information pertinent to the determination being made. These correspondences will be listed as “IRB Email Correspondence RE: (a brief description of the main issue raised), Dated (the most recent date on the email thread)”
For Minimal Risk Research:
The IRB will no longer include document listings for any actions reviewed for Minimal Risk research. As such, study teams who submit this type of research do not have to include a list in any of their submissions. Instead the IRB staff will continue to list only the HSERA application with appropriate confirmation code and date of receipt and the IRB letter will make reference to “the submitted documents” included with the associated confirmation code. Any study team submitting minimal risk research who requires a specific document listing in a letter for whatever reason must clearly state so in a cover letter and provide the list of documents for that submission in alignment with the procedures noted above for greater than minimal risk research.
If you need revisions to a recently received letter as a result of this change, please email an IRB administrator with a copy of the letter you received and the full document list in the email so that we may quickly send you a revised letter.