Consent requirements and tools
While implementation of the majority of changes to the federal human subjects regulations (45 CFR 46, AKA: the “Common Rule”) has been delayed, there is one element of the forthcoming revised regulations that we elected to implement now because it does not conflict with the current regulations.
Brown has elected to implement the forthcoming requirement for consent documents to “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject … in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
Why implement this now?
First, this change is consistent with our ongoing efforts to ensure that participants enter into research with a full understanding of a project’s scope, including all potential risks and benefits.
Secondly, we are requiring the new consent format for all NEW protocol submissions to ensure that we don’t have to ask investigators to revise consent documents when the revised Common Rule becomes effective as planned on July 19, 2018. Consistent with this approach, for EXISTING studies, we request that investigators make the formatting change to their consent document(s) when submitting an amendment that already requires a consent change, or at the time of their next continuing review, whichever comes first.
Is there any guidance to help researchers implement these changes to consent documents?
The HRPP has templates and tools available on the Forms page of our website to assist investigators with developing consent documents that conform to this new requirement. These include a "Standard Consent Template," "Additional Consent Language," and a new “Bulleted Format” template for studies that are not so complex that they require a lengthy consent document headed with a separate section for key information. HRPP staff are also offering the course "What's New in Human Subjects Consent Documents" to assist investigators with the changes and present the templates and tools.(see LearningPoint for more information and to register or contact the HRPP at 863-3050 to set up a training with your department).
NIH CLINICAL TRIAL SUPPORT
Effective January 25, 2018, NIH requires that all applications involving one or more “clinical trials” be submitted through a Funding Opportunity Announcement (FOA) or request for proposal (RFP) specifically designed for clinical trials. The Brown HRPP is available to support you in determining whether your proposed research meets the definition of an NIH Clinical Trial. Learn more about the NIH Clinical Trial definition, the available NIH resources, the support the Brown HRPP is able to provide, and access a list of FAQs here.
NIH Single IRB Mandate
The NIH single IRB (sIRB) mandate is now in effect. The Brown HRPP is available to work with investigators on application of this mandate, and has created a new page with information about interpretation and implementation of this NIH requirement. Please contact HRPP staff early in the process to discuss plans for establishing an sIRB.