The New Common Rule

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When working with our Human Protocols module users (aka “IRB”) we often encounter questions about the “new common rule” and how the rule changes are supported within Elements.  As you probably know, implementation of the rule has been delayed by the DHHS until (at least) July 19th, but many institutions are wisely gearing up to adopt these practices, and the NIH implementation of the sIRB policy did come into effect in January 2018.

The main changes impact consent forms, exemption categories, annual re-reviews and the sIRB requirements.  The impact of these changes will vary considerably between institutions based on the nature of their research programs.

Within TOPAZ Elements, the flexibility of the protocol form structures, the ability for the IRB to easily manage their own form templates, along with the flexibility of the review processes mean that there are no “code changes” needed from TOPAZ to support these new rules.  It is advisable, however, for customers to review their form templates well in advance to ensure that they understand the changes that need to be made.  In particular, for institutions with NIH funding it may make sense to consider having separate forms for cases where your institution is the IRB of record and those cases when it is not.

The TOPAZ support team is here (in Austin) to help with any questions you may have!

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