You may have heard over the past couple of months that the OHSU Institutional Review Board has been working to streamline the electronic Initial Review Questionnaire (IRQ). We are removing pages and questions that are unnecessary or duplicative.
A short IRQ means less work for you, but it also means that it’s important to make sure your study documents contain all of the information the IRB needs to review your study. Your study protocol should address the protection of human subjects by describing:
- Recruitment, including identification of subjects and payments to subjects;
- The informed consent process and documentation of consent;
- Potential risks to subjects and benefits, if any;
- Mechanisms for protecting subjects’ privacy and the confidentiality of study data;
- Protections for vulnerable populations and procedures for compliance with state/local laws (such as the Oregon Genetic Privacy Law), if applicable.
For multi-site studies we may need more specific information on the above points than your multi-site protocol provides, but we realize that you may not be able to revise your protocol if it was written by industry or by another institution. Therefore, a Local Context Supplement is now REQUIRED for all multi-site studies in which OHSU investigators cannot edit the protocol. This will help the IRB understand how subjects will be protected at OHSU. The Local Context Supplement is available on the IRB Forms page.
We will still be able to access information about recruitment, consent, and payments that you previously entered into the IRQ, so you do not need to complete a Local Context Supplement. You can also access this information by using the “jump to” menu in the blue bar at the top of the IRQ and choosing the page entitled “Subject Information for Prospective Studies (Legacy).”
New IRB Memos and Other Changes
IRB approval memos and other communications will look a little different. Most notably, you will no longer see study-specific information about what you need to do to comply with HIPAA. Instead, we have revised the Waiver of Authorization, Prep to Research, and Decedents Representation forms to describe the HIPAA requirements and limitations specific to those types of permission. You can find the revised forms on the IRB Forms page.
Other eIRB changes include fixing broken links, moving and rephrasing some IRQ questions, changing some yes/no questions to check boxes, and other minor tweaks. Please don’t hesitate to contact us if you have questions or encounter a problem! 503 494-7887, option 1.