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The Time to Read Up on New Policies is Now

Two agencies recently rolled out new policies that affect many researchers working in biomedical fields. As always, the best time to acquaint yourself with the policies is now, not when you are scrambling to assemble your proposal and get it uploaded before the deadline.
One is NIH’s new Data Management and Sharing Policy, which went into effect January 25th 2023. As with most NIH policies, there is a lot of jargon and clutter on the pages explaining it. I suggest starting with the FAQ page, which should answer most of your questions. For example, if multiple sites apply for one grant do they each need to submit a DMS section? (Short answer: No. Phew). The FAQs also explain what types of grants are exempted (e.g., training grants, whose focus is not “new knowledge” per se). This page has several add-on notices with useful information about, e.g., allowable costs for data sharing, sharing genomic data, and other issues.  I did chuckle when I read that PIs are supposed to ask their librarians for help managing these requirements. While I absolutely revere librarians, this seems like a lot to ask. And, ultimately, as PIs, the responsibility for compliance falls on you, so the more you acquaint yourself the better! If you still have questions after perusing the site, you can email them here: [email protected].

The second is from the FDA. Back in April 2022, the FDA released their draft guidance on diversity in clinical trials. Now, however, as part of the omnibus bill just passed by Congress, that draft has become law. The FDA will now have to clarify their draft guidance and add details. So be on the lookout for those. This page has documents outlining guidance about specific issues such as what this means for EMR studies, or for biologics.

While the FDA draft document focused on race and ethnicity, the Depict Act  passed by Congress also calls for better representation in research on the basis of age, sex, geographic location, and socioeconomic status. Considering that most Americans live more than 2 hours from an academic medical center, and 70% of trials are conducted at, you guessed it, academic medical centers, this is actually a thorny problem to solve.

While these requirements may make researchers’ lives a bit harder in the short term, they are important and will benefit everyone in the long term. This report from the National Academies of Sciences, Engineering, and Medicine 2022, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups states that lack of representation in research is costing the U.S. hundreds of billions of dollars per year in health expenditures and perpetuating serious health disparities among groups that are underrepresented in trials. The report has 17 recommendations for how researchers, funding agencies, and health systems can lower barriers for entering research and incentivize researchers and health systems to diversify the questions they are asking and the populations of those participating. Better representation will also result in more rigorous research, so it really is a win-win.

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