The IRB application form has been updated to facilitate compliance with current policies, regulations, and procedures, and to provide improved guidance to study teams.
What are the changes?
The new application version includes new questions and ‘advisements’ (these are the instructions that appear in bold red font when certain application boxes are checked) on the following topics:
- HIV testing for eligibility screening and/or study procedures
- Consistency between the grant application and IRB application (Federally funded studies only)
- Collection of GI specimens
- General Data Protection Regulation (GDPR) applicability
- San Francisco VA Health Care Systems (SFVAHCS) research policies
- Participant reimbursement for expenses related to study participation (please note that this is separate from the existing question about participant payment)
Additionally:
- Questions that are required to support regulatory determinations or are necessary for IRB review may no longer be left unansered
- Several application questions and advisements have also been revised for clarity
Also of note, the Principal Investigator’s Certification section has been updated to include a new attestation: “If federally funded, I certify that the research activities described in this application are consistent with those described in the grant application(s), or that I have fully described any inconsistencies in the Funding section of the Study Application.”
Please be sure to read the application questions and advisements closely, as they contain information that is crucial to your study team’s compliance with applicable policies and regulations.
What studies are affected?
New studies that are submitted to the IRB on or after October 1st, 2022, must use the new version of the application form. New studies submitted on or after October 1st will be retracted by the IRB and returned to the study team in draft form if they are not on the new version.
If you have not started your new application yet, iRIS will automatically generate the correct form for you. If you have already started the application but haven’t completed or submitted it yet, iRIS will prompt you to convert to the new version. When you get the following pop-up window, click ‘Convert to New Form Version.’
Do approved studies need to convert to the new application version?
Approved studies do NOT need to convert to the new version unless the study meets the criteria listed in the pop-up window. The window will appear if you open an editable version of your IRB application. If your study does not meet the criteria described in the window, click ‘Cancel Conversion- Retain Current Version.’ Note: If you click ‘Convert to New Form Version,’ you will be prompted to answer the newly added application questions, and there is no option to reverse this action once you have chosen it.
What about new studies submitted before October 1st?
New studies that have already been submitted to the IRB but are not yet approved do not need to convert to the new application version. New studies submitted between today and October 1st are encouraged but not required to convert to the new application.
How do I find the application version number?
If you want to know which version of the application you are using, go to Section 4 of the application, ‘Initial Screening Questions.’ The section header indicates the version date and number. This screenshot is from the new application version, which shows a September 2022 update and a version number of 98 (‘v98’).
If you have questions about this bulletin, please contact the IRB office by submitting an Ask Andy form.