Office for Research Protections | Institutional Review Board (IRB)
November 3, 2022
NIH Data Management and Sharing Policy
Effective January 25, 2023, any new NIH-funded research that generates scientific data must submit a Data Management & Sharing Plan (DMSP) with their grant proposal, this includes new research projects. This policy requires a plan for maximizing the sharing of scientific data while acknowledging factors (legal, ethical, or technical) that may affect the extent to which it can be shared. The policy allows researchers to request funding for personnel costs or other fees related to data management and sharing activities, but the money must be spent during the grant’s award period. Learn more.
Toolkit and Other Updates
- A number of documents in the CATS IRB Library have been updated, including the Investigator's Manual (HRP-103) and the protocol templates. The Research Data Plan Review Form (HRP-598) for College of Medicine/Penn State Health, has been updated with new acceptable methods for data storage and transfer. Use of new templates will be enforced effective January 3, 2023.
- There is a new document in the CATS IRB Library: the Ancillary Review Matrix (HRP-309) outlines all ancillary reviews, when such reviews are required, and office contacts for each ancillary review.
- Penn State charges fees to serve as the reviewing IRB for multi-center and cooperative projects that designate Penn State as the reviewing IRB. Researchers should consult with the HRPP before identifying Penn State as the reviewing IRB in a grant application. Learn more about Single IRB reviews.
- For College of Medicine researchers working with information from medical records through Enterprise Information Management (EIM), a watermarked form from the IRB must be submitted to EIM to release the data. This watermarked EIM form can be in a study workspace under the Documents tab > Site Related Documents.
- Did you know you can create a single PDF of all the documents associated with a submission in CATS IRB? Use the "Print Materials" function from the lefthand menu in a study's workspace.
Make an Appointment to Speak with Your IRB Analyst
Beginning November 14, IRB Analysts will be available through the Bookings app to meet to discuss clarification requests and upcoming studies. While this does not replace calling or scheduling a meeting outside of Bookings, the HRPP hopes that this will make scheduling time with your analyst more convenient. The Bookings app link will be found on the IRB Analysts page beginning November 14, as well as in clarifications requested and analyst emails.
Reminders
- Per Penn State Policy RP03 and the Investigator Manual (HRP-103), the Principal Investigator bears the ultimate responsibility for assuring the conduct of the study complies with all PSU HRPP policies & procedures for the protection of human subjects.
- Continuing Review and Administrative Reviews must be submitted to the IRB for review in a timely manner. Studies not submitted by the end of the appoval date will lapse and no human subjects research can occur. A study that is lapsed for more than 45 days will be administratively closed.
- For sponsored trials, the use of sponsor’s consent template is encouraged but should include Penn State's consent template language.
- If your study is under review, reach out to your IRB Analyst before withdrawing a submission; withdrawing the study without notification may increase review time.
- The HRPP will be closed for the University's December break starting December 23, reopening January 3, 2023. See here for the holiday review schedule.