Official IRB Communications
This page will be updated with official IRB communications as they are sent to the research community.
Communication from August 8, 2023
Dear Villanova Research Community,
The Institutional Review Board (IRB) announces the rollout of updated Informed Consent templates aimed at enhancing research compliance and ethical standards. The Human Research Protection Program recently underwent a review by Villanova’s Internal Audit team, and one finding was that approved and in-use consent documents included deviations from previously approved templates in meaningful ways. As such, the templates released today reflect these changes and include both editable sections (where you will include study-specific information) as well as sections that have been locked for editing (which are provided by the IRB and generally include regulatory language.) This change is expected to maximize accuracy and consistency.
Starting October 1st, these new templates are mandatory for all initial research submissions.
For existing research that remains open to enrollment at renewal, investigators will be expected to submit a modification to adopt the new templates prior to the next renewal. In certain cases, the IRB may determine that your study requires sooner adoption.
If your project requires flexibility in the regulatory language (for example if you are or expect to be approved for a waiver or alteration of the consent process to exclude required elements), please contact ORP with your request. “Unlocked” versions of the template may be approved on a study-by-study basis.
Your dedication to maintaining the highest research standards is appreciated. For questions, contact IRB@villanova.edu. Thank you for your cooperation.
Sincerely,
Emory Woodard IV PhD
Chair, Institutional Review Board
Communication from July 7, 2022
Dear Villanova Research Community,
Since Cayuse was adopted for IRB protocol submission and review in 2015, the software has aided Villanova researchers and the Institutional Review Board in collecting thorough records of human subjects research and providing a central repository for study related documentation. ORP is beginning an initiative to clean out the older Cayuse records to increase organization and efficiency and to assist researchers with keeping track of forgotten draft protocols that could be continued or protocols that should be withdrawn. Researchers may soon be sent an email detailing what protocols will be affected and what further actions are required, if applicable.
Additionally, there will be several new procedures related to record keeping for future projects:
· NHSR and Not Engaged determinations: After determinations are communicated to researchers, ORP will administratively close the protocol record. This is purely an archival process and does not affect the determination or ability to conduct the project. No new actions will be required by the PI.
· Exempt determinations: ORP will check in with researchers with exempt determinations once a year to determine if any can be closed.
· Expired protocols: When a protocol expires, all work on the study must stop immediately. Expired protocols will be archived after six months and PIs will be required to submit a new initial application if they want to continue the research.
· Protocols returned to PIs with reviewer comments: Reviewer comments will be considered “active” for six months, at which point PIs will be required to submit a new initial application.
If you have any questions about this initiative, please contact Cait St. Amour at caitlin.stamour@villanova.edu or at x94250.
Best,
Office of Research Protections
Communication from May 9, 2022
Dear Villanova Researchers,
Starting this week, the IRB will be piloting a rolling review assignment process, eliminating weekly deadlines and the practice of holding protocols for assignment on Fridays. This pilot suspension of the “Friday batch”, as the previous review cadence has come to be known, will last until Friday, August 12th, 2022, at which point the IRB looks forward to gathering your feedback. The IRB and ORP hope that this change will result in faster review periods and reduced frustration that may have resulted from missed deadlines.
Going forward, complete protocols will receive ORP pre-review within 2-3 business days of receipt and then be either assigned to an IRB reviewer or sent back to the study team to address outstanding issues. There will no longer be a need to hold completed protocols for assignment on Friday. IRB reviewers are still expected to provide feedback within two weeks.
As always, you can check the Task History on your submitted Cayuse application by navigating to the Submission Details page to learn where your protocol is in the IRB review process.
Please note that these timing estimates apply only to research submitted for Expedited review or Exempt determination and excludes administrative submissions. Full Board submission deadlines can be found on the IRB website.
Please let us know if you have any questions or concerns.
Thank you!
Office of Research Protections
IRB Newsletters