The 21st Century Cures Act

The 21st Century Cures Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring innovations and new advances to patients who need them faster and more efficiently.  The Cures Act sought to “catalyze development of new medical technologies at a unique moment in history when fundamental advances in our understanding of the genetic and protein bases of diseases and advances in medical technology have enabled us to target, arrest, and in some cases cure, these vexing conditions”.

In practice it means that the agencies that influence “our regs” (USDA, OLAWFDANIHetc) are directed to work together to reduce unnecessary regulatory burden, and try to harmonize among themselves.

In the session at the 2018 PRIM&R Conference some specifics were discussed.  OLAW and USDA are looking at options to share reporting forms and processes, while other initiatives include encouraging the use of “tools” in support of the Designated Member Review process for appropriate protocol requests.

Within our own IACUC and IRB committees, the first step to enhancing the efficiency of the services provided is to measure them.  This is an area where Elements can help.  Using protocol history grids or TOPAZ Reporter, you can analyze your cycle times for protocol review.  How long do protocols spend with the committee?  How long do they spend when returned to the PI?  Where are the rate limiting steps?  Do different types of review process impact the cycle times?

Once you know the areas of your process to target, Elements can further support your effort by enhancing the efficiency and documentation for the review processes you choose, be they DMR, primary/secondary, or other acceptable variations.

Watch for more blog posts in the near future about the specifics of tracking your IACUC, IRB and IBC Committees’ efficiency using Elements, and ways to effectively manage your review processes in the spirit of the 21st Century Cures Act!


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