Washington, DC - Yesterday, United States Senators Susan Collins ( R-Maine ), Elizabeth Warren ( D-Mass. ), Mark Kirk ( R-Ill. ), Tammy Baldwin ( D-Wis. ), Chairman Lamar Alexander ( R-Tenn. ), and Ranking Member Patty Murray ( D-Wash. ) introduced the Advancing NIH Strategic Planning and Representation in Medical Research Act.
The legislation will advance a number of policies to improve planning, collaboration, and representation in research conducted and funded by the National Institutes of Health ( NIH ). Today, the bill was favorably reported out of the Health, Education, Labor & Pensions ( HELP ) Committee.
"Biomedical research holds tremendous promise for treating many of the most costly and devastating diseases we face," said Senator Collins. "It is encouraging that Congress is already working in a collaborative and bipartisan manner to increase these investments, as evidenced by the $2 billion increase to NIH funding secured last year. By encouraging long-term planning and enhancing demographic representation in clinical studies, this bipartisan legislation will help improve the critical research conducted by the NIH."
"Although we've made progress in recent years, research on how diseases and new treatments impact women still lags far behind research on men," Senator Warren said. "We need to do a better job including meaningful numbers of women and minorities in clinical trials so that we can understand known sex differences and uncover differences we haven't looked for before. This bipartisan bill takes a number of steps to improve the inclusiveness of research funded by the NIH, and I'm glad to join Senator Collins and my colleagues on the HELP Committee in moving it forward."
"By diversifying research and clinical trial groups, the doctors and researchers at NIH will have more accurate, real-life data to utilize when developing the newest treatments to save lives," Senator Kirk said. "In the spirit of my predecessor in the House, Rep. John Porter, I have always championed more funding for NIH and will continue to do so with the help of my bipartisan Senate colleagues."
"Our knowledge of the health of the LGBT community is drastically insufficient. Although we have ample anecdotal evidence of LGBT health disparities, only valid research data will allow us to make progress toward improving the health of LGBT Americans and their families," said Senator Baldwin. "I am proud to help lead this bipartisan reform supporting greater inclusion of more Americans to maximize the value of biomedical research. This bill will take the critical first steps to enhance research at NIH and ensure we have the necessary tools to accelerate participation of LGBT individuals, as well as women, minorities and expecting mothers, in biomedical research."
"There has never been a more exciting time in science, and I commend the leadership of Sens. Collins and Warren on this legislation to bring those benefits to patients by requiring the NIH to set clear priorities, improve researchers' ability to work together across the agency's 27 institutes and centers, and ensure that NIH research addresses the health needs of all Americans. I look forward to including this important bipartisan contribution in our committee's effort to form companion legislation to the House-passed 21st Century Cures Act to improve the health of nearly every single American," Chairman Alexander said.
"As medical treatments become increasingly tailored to patients' unique needs, it is more important than ever that clinical trials account for all our communities and all stages of life, and I'm glad that our bill takes strong steps toward this critical goal," said Ranking Member Murray. "By reassessing research priorities so that NIH-supported clinical trials and other research better incorporate women and members of minority groups, including the LGBT community, we can significantly improve public health and biomedical research and make meaningful progress toward reducing health disparities. I am very proud of the work done to bring this bill to the table, and I look forward to working with my committee colleagues to move it forward."
The Advancing NIH Strategic Planning and Representation in Medical Research Act:
-Requires the Director of the NIH to Develop a Six-Year Strategic Plan to Outline the Direction of Biomedical Research Investments Made by the NIH.
-Fosters Collaboration to Accelerate Research on Public Health Burdens and Health Disparities.
-Promotes Inclusion of Women and Minorities in Research.
The Act requires the directors of the National Institutes and National Centers to consult annually with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Office of Research on Women's Health regarding their objectives to ensure that future activities take into account women and minorities.
The Act requires the NIH to report information to Congress on the number of women and members of minority groups included in clinical research projects and the number of completed clinical research projects that included women and members of minority groups that have complied with reporting requirements.
The Act helps ensure that subgroup analyses that examine whether women and minorities are impacted differently by interventions or diseases being examined in clinical trials are reported publically.
-Improves Research for Sexual and Gender Minorities.
The Act directs the NIH to continue to encourage and support research efforts related to the health of sexual and gender minority populations and directs the Department of Health and Human Services ( HHS ) and the NIH to develop and disseminate measures related to reporting health information about sexual and gender minority populations.
-Encourages Coordination Between Institutes and Centers within the NIH to Improve Research Related to Minority Health and Health Disparities.
-Establishes a Working Group to Examine Policy Options to Enhance the Rigor and Reproducibility of Scientific Research.
-Establishes a Task Force on Research Regarding Pregnant Women and Lactating Women.
The Task Force on Research Specific to Pregnant Women and Lactating Women, will help address gaps in knowledge about which therapies are safe and effective for use by pregnant women and lactating women.
The Task Force will examine and make recommendations on ethical issues in research involving pregnant women and lactating women, ways to better communicate to health care providers and the public, and improving the development of safe and effective therapies for pregnant women and lactating women.
-Promotes Consideration of Sex as a Biological Variable in Scientific Research.
The Act encourages research results and analyses be disaggregated by sex when reported or published.
The Act requires the NIH to develop policies for basic research, in consultation with stakeholders, for better assessment and analysis of sex as a biological variable.
The Act requires the NIH to update relevant clinical research guidelines to enhance compliance with current law requiring that NIH-funded clinical research projects include women and minorities and clarify when studies should be designed to analyze significant differences.