Open Mike

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The 21st Century Cures Act, and Perspectives from NIH

You may have been following news of the 21st Century Cures Act, a landmark piece of legislation with provisions for healthcare, medicine, and research. Republican and Democratic lawmakers supported this bill through its development and eventual passage, and yesterday, President Obama signed the bill into law.

The Act establishes a multitude of important changes to our nation’s approach to supporting and funding health care, medical interventions, and research. Readers of this blog may be particularly interested in the many changes directly relevant to NIH’s mission. A New England Journal of Medicine Perspective essay by NIH Director Francis Collins and NIH Deputy Director Kathy Hudson highlights those changes, and I encourage you to read it. Drs. Collins and Hudson draw attention to support for certain ongoing high-priority initiatives, enhancement of the biomedical research workforce, improved clinical research, better privacy protection for patients who participate in clinical research, greater transparency in science, and reduced red tape.

  • High-priority initiatives: The Act includes support for major ongoing NIH scientific initiatives, such as BRAIN, the Precision Medicine Initiative (“All of Us”), and the Cancer Moonshot.
  • Biomedical research workforce: A number of provisions focus on early career researchers, who continue to be the subject of much interest. Studies carried out by the National Academies committee referenced in the law will look at factors within NIH – and beyond – that impact the future workforce. Other provisions will enable NIH to develop and promote policies that will attract and sustain support for diverse groups of outstanding young and new investigators.
  • Clinical research, transparency, and privacy: The Act contains measures to assess, report, and improve inclusion of key demographic groups, groups that reflect diversity of sex, age, and minority status. NIH is encouraged to further efforts in understanding health disparities between different demographic groups. Other measures enhance the impact of “big data” through data sharing, while also protecting private information of research volunteers. For example, certificates of confidentiality – formerly provided upon request to researchers collecting sensitive information about research participants – will now be provided to all NIH-funded scientists, with strong protections against involuntary disclosure.
  • Red tape: The Act exempts NIH-supported or NIH-conducted research from the “ironically titled” Paperwork Reduction Act, making it possible to launch projects in faster time and without fulfilling paperwork requirements that have rarely yielded substantive change. The Act also strikes barriers that have made it difficult for NIH extramural staff to engage in outreach efforts to the research community through attendance at and participation in scientific conferences.

We are greatly appreciative of the hard work that went into making this bill become law. The consideration of these biomedical research topics in the scope of the 21st Century Cures Act is a huge vote of confidence in what we as a nation can accomplish, and improve, through supporting a robust and dynamic scientific enterprise.

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