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Report of the Advisory Committee on Research on Women's Health NATIONAL INSTITUTES OF HEALTH Report of the Advisory Committee on Research on Women’s Health: Fiscal Years 2017–2018 Office of Research on Women’s Health and NIH Support for Research on Women’s Health Office of Research on Women’s Health Office of Research on Women’s Health. (2019). Report of the Advisory Committee on Research on Women’s Health, Fiscal Years 2017–2018: Office of Research on Women’s Health and NIH Support for Research on Women’s Health. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. NIH Publication No. 19-OD-7995 Copies of this report and other publications of the Office of Research on Women’s Health are available from: Office of Research on Women’s Health National Institutes of Health ii Report of the NIH Advisory Committee on Research on Women’s Health | Fiscal Years 2017–2018 NATIONAL INSTITUTES OF HEALTH Report of the Advisory Committee on Research on Women’s Health: Fiscal Years 2017–2018 Office of Research on Women’s Health and NIH Support for Research on Women’s Health Office of Research on Women’s Health Report of the NIH Advisory Committee on Research on Women’s Health | Fiscal Years 2017–2018 iii Table of Contents Letter from the ORWH Director ..............................................................................................vii Preface .....................................................................................................................................viii Advisory Committee on Research on Women’s Health, Fiscal Years 2017–2018 ..............xii Organization of the Fiscal Years 2017–2018 Report of the Advisory Committee on Research on Women’s Health ..........................................................................................xiv I. ORWH Background ........................................................................................................1 II. ORWH Research .............................................................................................................5 III. ORWH Biomedical Career Development Activities ...................................................26 IV. Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research .......................................................38 V. NIH Budget for Women’s Health Research ................................................................54 Report of the NIH Institutes and Centers ..............................................................................62 National Cancer Institute ......................................................................................................63 National Eye Institute ............................................................................................................78 National Heart, Lung, and Blood Institute .............................................................................91 National Institute on Aging ..................................................................................................105 National Institute on Alcohol Abuse and Alcoholism .......................................................... 117 National Institute of Allergy and Infectious Diseases ..........................................................129 National Institute of Arthritis and Musculoskeletal and Skin Diseases ................................144 National Institute of Biomedical Imaging and Bioengineering .............................................158 Eunice Kennedy Shriver National Institute of Child Health and Human Development ........168 National Institute on Deafness and Other Communication Disorders ................................183 National Institute of Dental and Craniofacial Research ......................................................193 National Institute of Diabetes and Digestive and Kidney Diseases .....................................209 National Institute on Drug Abuse ........................................................................................227 National Institute of Environmental Health Sciences ..........................................................246 iv Report of the NIH Advisory Committee on Research on Women’s Health | Fiscal Years 2017–2018 Table of Contents National Institute of General Medical Sciences ..................................................................261 National Institute of Mental Health ......................................................................................267 National Institute on Minority Health and Health Disparities ...............................................281 National Institute of Neurological Disorders and Stroke .....................................................296 National Institute of Nursing Research ...............................................................................304 Fogarty International Center ............................................................................................... 312 National Center for Advancing Translational Sciences .......................................................323 National Center for Complementary and Integrative Health ...............................................327 National Human Genome Research Institute .....................................................................334 National Library of Medicine ...............................................................................................344 Office of AIDS Research ....................................................................................................358 Office of Behavioral and Social Sciences Research ..........................................................364 Office of Disease Prevention ..............................................................................................368 Office of Disease Prevention—Office of Dietary Supplements ..........................................369 Office of Research Infrastructure Programs .......................................................................377 Sexual & Gender Minority Research Office .......................................................................396 Appendices Appendix A. Coordinating Committee on Research on Women’s Health (CCRWH) Roster ................................................................................400 Appendix B. ORWH-Co-funded Research Summaries ......................................................402 Appendix C. Members of the NIH Working Group on Women in Biomedical Careers .......................................................................................................433 Appendix D. Aggregate Enrollment Data and Tables .........................................................434 Appendix E. 2019 Biennial Advisory Council Reports Certifying Compliance With NIH Policy on Inclusion Guidelines.........................................................455 Index ......................................................................................................................................483 Report of the NIH Advisory Committee on Research on Women’s Health | Fiscal Years 2017–2018 v Letter from the ORWH Director I am honored to share with you the accomplishments related to the health of women achieved by the National Institutes of Health (NIH) for fiscal years (FY) 2017 and 2018. This biennial report is issued by the NIH Advisory Committee on Research on Women’s Health (ACRWH). It summarizes NIH research investments and scientific advances in women’s health research and related programs during the reporting period. Within these pages, you will find updates on the programs, initiatives, and activities of the NIH Office of Research on Women’s Health (ORWH), as well as research highlights on the health of women from each NIH Institute, Center, and Office (ICO). Additional reporting addresses adherence to NIH policies on the inclusion of women and minorities in clinical research and FY 2017–2018 NIH budgetary expenditures for research on women’s health. The 21st Century Cures Act (Public Law 114–255), signed into law on December 13, 2016, introduced significant changes that are facilitating the efforts of ORWH as a focal point to promote the health of women across NIH. Its provisions stand on the shoulders of the groundbreaking sex as a biological variable (SABV) policy by increasing trans-NIH collaboration, accelerating the promise of personalized medicine, and requiring that certain Phase III clinical trials report their results in ClinicalTrials.gov by sex and gender and by race and ethnicity. The 21st Century Cures Act requires that members of the advisory body known as the Coordinating Committee on Research on Women’s Health (CCRWH), who serve as liaisons between ORWH and the ICOs, be either directors or their senior-level staff designees. The Institute and Center (IC) directors must consult annually with the ORWH Director about their objectives to ensure that they are taking women into account and are focused on reducing women’s health disparities. The strategic plans issued by the individual ICs, required at least every 6 years, must document the same priorities. The inclusion of women and minorities in NIH-supported clinical research has been law since the enactment of the NIH Revitalization Act of 1993. The Inclusion Across the Lifespan policy (related to section 2038 of the 21st Century Cures Act) builds on the 1993 legislation and subsequent NIH commitments to inclusion. It applies to grant applications and contract solicitations submitted after January 25, 2019, expanding current
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