OHSU

IRB (Institutional Review Board)

Updated Consent Templates and Liability Language (3.28.2014)

The IRB has posted revised consent form templates and consent form liability language to the IRB Forms website. The changes were mostly minor corrections and revisions for clarity. In addition, we have consolidated the various former liability language options down to two.In adding liability language to your consent form, please read the options carefully and make sure to supply/select the appropriate information in [bracketed bold italics].

Studies submitted on or after April 15, 2014 must use the new templates and the new liability language. Consent forms for currently approved studies do not need to be revised. If you need an exception to the April 15 cut-off date because you have already negotiated consent form language with your sponsor, let us know that when you submit your study.

Always start new consent forms by taking your template directly from the IRB Forms website to ensure you are working with the most current version! If you have questions, feel free to call our help desk at 503-494-7887, option 1.

 

The Shorter IRQ & You

You may have heard over the past couple months that the IRB has been working on streamlining the electronic Initial Review Questionnaire (IRQ). We are removing pages and questions that provide information that is either unnecessary for our review or duplicative with what should be in your study documents.

A shorter 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

See the Minimal Risk Protocol Template and the Security and Confidentiality Protocol Checklist for additional guidance.

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

For existing studies: 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)." Call our office if you have trouble finding anything! 503-494-7887, option 1.

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!

What is Human Subject Research?

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The Code of Federal regulations defines Research as:

"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]

and defines Human Subjects as:

"...living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual , or (2) identifiable private information." [45 CFR 46.102(f)(1-2)]


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