The Institutional Review Board has updated several existing forms and has launched two new forms: the Report Form and the Study Inactivation Request Form. The revisions and new forms were developed during a program review in anticipation of AAHRPP (Association for the Accreditation of Human Research Protection Programs) reaccreditation and incorporate feedback from users.
New and updated forms will be required starting Oct. 6, 2014. Until then, the IRB will accept either the new or the recently retired versions.
While the changes to the forms are generally small, they are significant, but will not likely contribute to administrative burden associated with completion. Provided below is a summary of the forms that have changed and the nature of those changes.
The new Report Form replaces the UPIRTSO Form. This form significantly clarifies what must be promptly reported and allows the IRB to collect relevant information related to the issue to ensure appropriate review. Of significant note, the timeline for reporting these events is now five business days. This aligns with peer institution expectations and communicates the urgency with which these events must be reported to the IRB. See the Post-approval forms section on the IRB Forms page to download the form. Additional guidance about the Report Form is available on the IRB website.
In addition to the new Report Form, there is a new template for reporting, at continuing review, events that do not require more prompt reporting. Researchers may use this form or a similar spreadsheet format to notify the IRB of those events that do not meet the criteria for prompt reporting. Please see the Templates section of the IRB Forms webpage for more information.
The new Study Inactivation Request Form provides relevant information about when a study is ready to be inactivated and confirmation that all study related activities have ceased and the study is eligible for inactivation. It also allows the IRB to collect final enrollment details and any events that did not require more prompt reporting that may have occurred since the last continuing review. See the Post-approval forms section on the IRB Forms page for more information.
The following forms have been updated:
- Add/Remove Personnel – Expanded details and questions for Conflict of Interest
- Add/Remove Funding – Moved and expanded details and questions for Conflict of Interest; added statement that if research activities associated with the new funding source do not match the current IRB application/documentation, then a Change in Protocol must be submitted
- Medical Application – Note reflecting that researchers must take CITI training refresher if it has been more than three years since completion of the basic or last refresher course; Section 4.9 revised to clarify inclusion/targeting of subjects with diminished or fluctuating capacity to consent–change reflected in Appendix I
- Social Application – Note reflecting that researchers must take CITI training refresher if it has been more than three years since completion of the basic or last refresher course; Section 4.4 revised to clarify inclusion/targeting of subjects with diminished or fluctuating capacity to consent–change reflected in Appendix I
- Exempt Applications – Revised to new format with additional clarification questions
Appendix A – Additional wording to reflect PI responsibilities and requirements for federally funded research; question added regarding sponsor requirement of compliance with full ICH-GCP E6
- Appendix I – Updates and additional questions that clarify review on inclusion/targeting of subjects with diminished or fluctuating capacity to consent
- Appendix T – Physical location of existing samples; volume of sample to be taken prospectively; specify what other group may collect samples for the research (e.g. BioNet); details on sharing/sending samples outside UMN–where, how much and purpose for doing so
All of the updated and new forms are available on the IRB Forms page.
In addition, the following webpages have been updated with new or clarified guidance:
- PI Investigator Responsibilities – Updated guidance for when research is funded by federal agencies or when the sponsor requires compliance ICH-GCP E6
- Adults Lacking Capacity or with Diminished Capacity to Consent
- Reporting Problems and Events
Two drop-in sessions are available for researchers to meet with IRB staff to discuss any of the new forms or updates. These sessions will be held on the following days in the HRPP conference room (D528 Mayo):
Sept. 16 1:00 – 2:00 p.m.
Sept. 26 8:00 – 9:00 a.m.
If you are not able to attend one of the sessions, feel free to contact the IRB at firstname.lastname@example.org.