The director and former deputy director of the National Institutes of Health applauded the 21st Century Cures Act for reducing red tape and allowing the organization to better share scientific data.
NIH Director Francis Collins, M.D., and former Deputy Director Kathy Hudson, Ph.D., wrote in an opinion piece published in The New England Journal of Medicine, that the law’s provisions eliminate barriers for data-sharing at the agency. Under the Cures Act, Collins is now able to require that researchers share scientific data to allow for faster biomedical research.
The pair also lauds the act’s data privacy measures, which they consider “the most significant advances in research privacy protections in two decades.” Under the law, all NIH-funded scientists will be issued certificates of confidentiality, which were previously available upon request, according to the piece. The certificates allow for better protections against the release of study participants’ names or other identifying data. The law also allows NIH to withhold identifying biomedical data from requests under the Freedom of Information Act.
“It is essential that biomedical research reflect, and provide a benefit to, the entire U.S. population,” the pair write. “The Cures Act encourages diversity by setting out a path for the NIH to continue and expand its efforts to allow Americans of all stripes to participate in and benefit from NIH-funded biomedical research.”
The law also includes two major steps to eliminate unneeded regulation that hampered NIH, according to the editorial. The Cures Act reduces restrictions on scientific meetings that previously hampered the flow of research data, according to Collins and Hudson, and also reduces extra paperwork that can delay the start of research by months.
President Barack Obama signed the bipartisan legislation into law in mid-December. But it is not without its critics. Sens. Bernie Sanders, I-Vt., and Elizabeth Warren, D-Mass., have been critical of the potential for the act’s concessions to the pharmaceutical industry, and analysts have noted that drug and biomedical device manufacturers are major “winners” in the law’s passage.