F I SCAL YEARS 2 011-2012 Report of the Advisory Committee on Research on Women’s Health Office of Research on Women’s Health and NIH Support for Research on Women’s Health R A epoRt of the dvisoRy C R ommittee on eseARCh W ’ h on omen s eAlth f y isCAl eARs 2011–2012 o R ffiCe of eseARCh W ’ h on omen s eAlth And nih s R uppoRt foR eseARCh W ’ h on omen s eAlth Office of Research on Women’s Health. (2013). Report of the Advisory Committee on Research on Women’s Health, Fiscal Years 2011–2012: 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. 13-7995 Copies of this report and other publications of the Office of Research on Women’s Health are available: Office of Research on Women’s Health National Institutes of Health 6707 Democracy Blvd., Suite 400, MSC 5484 Bethesda, Maryland 20892-5484 Voice: 301-402-1770 http://orwh.od.nih.gov FFiissccaall YYeeaarrss 22001111 && 22001122 Preface The Advisory Committee on Research on Women’s Health (ACRWH), in collaboration with the Office of Research on Women’s Health (ORWH) and the National Institutes of Health (NIH) Coordinating Committee on Research on Women’s Health (CCRWH), submits to the Director of NIH this biennial report for fiscal years (FYs) 2011 and 2012, which details NIH activities car- ried out in fulfillment of the core mission of ORWH, as defined in the NIH Revitalization Act of 1993. That mission is to strengthen and enhance NIH basic, translational, and clinical research: • To increase the understanding of the diseases and conditions that affect women, includ- ing investigation and elucidation of the role of sex and gender factors in health and disease; • To build NIH programs to develop a cadre of researchers, both women and men, who are trained to conduct interdisciplinary research in these areas; • To ensure the appropriate representation of women in NIH research; and • To support the advancement of women in biomedical careers. The ACRWH has reviewed the information contained in this biennial report, and finds that it reflects the breadth and depth of research and related activities through which ORWH has achieved its mission in FY 2011 and FY 2012. The report also provides highlights from women’s health and sex/gender research supported by NIH Institutes, Centers (ICs), and Offices in the Office of the NIH Director (OD). In addition, the report presents information on NIH budget allocations for women’s health research during FY 2011 and FY 2012 using criteria supplied by the NIH Office of Financial Management and the U.S. Department of Health and Human Services (HHS) Office on Women’s Health. Finally, the report contains information document- ing the inclusion of women and minorities in NIH-funded clinical research during the same time period. The ACRWH wishes to acknowledge the work of the CCRWH representatives, whose efforts ensured the timely preparation of reports from the ICs and Offices they represent. The ACRWH also wishes to acknowledge the work of the NIH staff members who assisted in the continued implementation and analysis of the inclusion of women and minorities in NIH-funded research, and the work of staff who collected and tabulated the budgetary data presented in this report. Finally, the ACRWH wishes to acknowledge the work of ORWH staff in meeting the mandates underlying the establishment of ORWH by providing leadership, both within NIH and with the extramural research community, to accomplish the many outstanding and important advances in NIH-funded science and in career support that are described herein. iii Report of the Advisory Committee on Research on Women’s Health Advisory Committee on Research on Women’s Health, FY 2013 Janine A. Clayton, M.D., Chair Valerie Latona (2015) Associate Director for Research on Women’s Health & Fitness Writer/Editor Health New York, NY Director, Office of Research on Women’s Health Jon Levine, Ph.D. (2015) National Institutes of Health Director Wisconsin National Primate Research Center Susan E. Maier, Ph.D., Executive Secretary Deputy Director Afaf I. Meleis, Ph.D., Dr.P.S. (hon.), Office of Research on Women’s Health F.A.A.N., F.R.C.N. (2016) National Institutes of Health Margaret Bond Simon Dean of Nursing Professor of Nursing and Sociology Richard Besdine, M.D. (2015) University of Pennsylvania School of Nursing Director, Center for Gerontology and Healthcare Research Heidi D. Nelson, M.D., M.P.H. (2016) Director of the Division of Geriatrics, Research Professor, Departments of Medical Department of Medicine Informatics & Clinical Epidemiology, and Greer Professor of Geriatric Medicine Medicine Alpert Medical School Medical Director, Providence Women and Brown University Children’s Program and Research Center Co-Director, V.A. Women’s Health Fellowship John O. DeLancey, M.D. (2015) Oregon Health & Science University Norman F. Miller Professor Obstetrics and Gynecology Claire Pomeroy, M.D., M.B.A. (2014) University of Michigan Vice Chancellor, Human Health Sciences Dean, School of Medicine Francisco Garcia, M.D., M.P.H. (2014) Professor of Internal Medicine and Distinguished Outreach Professor of Obstetrics Microbiology/Immunology and Gynecology and Public Health University of California, Davis Director, Center of Excellence in Women’s Health Judith G. Regensteiner, Ph.D. (2017) The University of Arizona Professor of Medicine Division of General Internal Medicine Ronda S. Henry-Tillman, M.D. (2014) Denver School of Medicine Practice Director, Ladies’ Oncology Clinic University of Colorado Director, Cancer Control Winthrop P. Rockefeller Cancer Institute Paul F. Terranova, Ph.D. (2014) University of Arkansas for Medical Sciences Vice Chancellor for Research Senior Associate Dean for Research and Karen Kim, M.D., M.S. (2014) Graduate Education, University of Kansas Associate Professor of Medicine School of Medicine The University of Chicago The University of Kansas Medical Center Susan Kornstein, M.D. (2015) Gerson Weiss, M.D. (2016) Director and Professor of Psychiatry and Professor and Chair Obstetrics-Gynecology Department of Obstetrics, Gynecology and Institute for Women’s Health Women’s Health Virginia Commonwealth University University of Medicine & Dentistry of New Jersey—New Jersey Medical School iv Fiscal Years 2011 & 2012 Table of Contents Preface � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � iii Advisory Committee on Research on Women’s Health, FY 2013 � � � � � � � � � � � � � � � � � � � � � � � iv Table of Contents � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �v Introduction � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �1 • Organization of the FY 2011–FY 2012 Biennial Report of the ACRWH . . . . . . . . . . . . . . . .1 Report of the Office of Research on Women’s Health � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �5 A Historical Perspective: The Development of the Office of Research on Women’s Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 • References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 NIH Strategic Plan for Women’s Health Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 • Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 • Identifying the Goals for the New NIH Agenda for Women’s Health Research . . . . . . . . . .7 • Developing Success Metrics and a Toolkit to Collect and Visualize Data for the Strategic Plan Implementation Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 • Summary: Guiding Tomorrow’s Research on Women’s Health . . . . . . . . . . . . . . . . . . . . .12 I. ORWH Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 • ORWH and NIH Priorities for Women’s Health Research . . . . . . . . . . . . . . . . . . . . . . . . . .13 • Overview of ORWH-Cofunded Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 • Highlights of Long-Term ORWH-Cofunded Research Initiatives . . . . . . . . . . . . . . . . . . . .16 • Summary: ORWH Research Programs Support the Implementation of the NIH Strategic Plan for Women’s Health Research . . . . . . . . . . . . . . . . . . . . . . . . . .17 II.ORWH Interdisciplinary Research and Career Development Programs . . . . . . . . . . . 29 • Building Interdisciplinary Research Careers in Women’s Health . . . . . . . . . . . . . . . . . . . .29 • Highlights of BIRCWH Principal Investigators and Accomplishments of the Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 • Specialized Centers of Research on Sex and Gender Factors Affecting Women’s Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46 • Highlights of BIRCWH and SCOR Activities at the Annual NIH Interdisciplinary Women’s Health Research Symposium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 • Summary: ORWH Interdisciplinary Research and Career Development Programs Support the Implementation of the NIH Strategic Plan for Women’s Health Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58 v Report of the Advisory Committee on Research on Women’s Health III. ORWH Biomedical Career Development Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 • Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 • Women’s Reproductive Health Research Career Development Program . . . . . . . . . . . . . .62 • NIH Working Group on Women in Biomedical Careers . . . . . . . . . . . . . . . . . . . . . . . . . . .65 • NIH Intramural Program on Research on Women’s Health . . . . . . . . . . . . . . . . . . . . . . . .69 • Office of Intramural Training and Education Programs . . . . . . . . . . . . . . . . . . . . . . . . . . .69 • ORWH Support for Other Summer Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72 • ORWH Support for Other NIH Career Development Programs and Activities . . . . . . . . .73 • ORWH Support for Professional Society Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73 • Summary: Biomedical Career Development Program Activities Support the Implementation of the NIH Strategic Plan for Women’s Health Research . . . . . . . . . . . .74 IV. ORWH Research Dissemination and Outreach Activities . . . . . . . . . . . . . . . . . . . . . . . 75 • ORWH and the National Library of Medicine Partnership: Women’s Health Resources Web Portal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 • NIH Vulvodynia Awareness Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76 • NIH Pain Consortium Centers of Excellence in Pain Education . . . . . . . . . . . . . . . . . . . .76 • ORWH-Cofunded Research Conferences and Workshops . . . . . . . . . . . . . . . . . . . . . . . . .76 • ORWH Women’s Health Seminar Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81 • Women’s Health Scientific Interest Group Lecture Series . . . . . . . . . . . . . . . . . . . . . . . . . .83 • Anita B. Roberts Lecture Series: Distinguished Women Scientists at NIH . . . . . . . . . . . . .83 • Association of Women in Science Seminar Series—Bethesda Chapter . . . . . . . . . . . . . . . .84 • Special Events and Meetings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85 • ORWH Exhibit Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86 • National Women’s Health Week at NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86 • ORWH Pinn Point on Women’s Health Podcasts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87 • ORWH Publications and Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87 V. Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . 89 • NIH Monitoring Compliance Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89 • Summary Report of NIH Inclusion Data: Comparison of FY 2011 and FY 2012 and 5- and 10-Year Trend Data . . . . . . . . . . . . . . . .93 • Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 VI. NIH Budget for Women’s Health Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111 • NIH Budgetary Expenditures for Research on Women’s Health, FY 2011 and FY 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 vi Fiscal Years 2011 & 2012 VII. Committee Members and ORWH Staff, FY 2011–2012 . . . . . . . . . . . . . . . . . . . . . . . 123 • Advisory Committee on Research on Women’s Health, FY 2011 . . . . . . . . . . . . . . . . . . .123 • Advisory Committee on Research on Women’s Health, FY 2012 . . . . . . . . . . . . . . . . . . .124 • NIH Coordinating Committee on Research on Women’s Health, FY 2011 . . . . . . . . . . .125 • NIH Coordinating Committee on Research on Women’s Health, FY 2012 . . . . . . . . . . .129 • ORWH Staff, FY 2011. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132 • ORWH Staff, FY 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133 Report of the NIH Institutes and Centers � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �135 National Cancer Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 National Eye Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 National Heart, Lung, and Blood Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158 National Institute on Aging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 National Institute on Alcohol Abuse and Alcoholism . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 National Institute of Allergy and Infectious Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . 198 National Institute of Arthritis and Musculoskeletal and Skin Diseases . . . . . . . . . . . . . . 219 National Institute of Biomedical Imaging and Bioengineering . . . . . . . . . . . . . . . . . . . 232 Eunice Kennedy Shriver National Institute of Child Health and Human Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245 National Institute on Deafness and Other Communication Disorders . . . . . . . . . . . . . . 261 National Institute of Dental and Craniofacial Research . . . . . . . . . . . . . . . . . . . . . . . . . . 263 National Institute of Diabetes and Digestive and Kidney Diseases . . . . . . . . . . . . . . . . 275 National Institute on Drug Abuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 National Institute of Environmental Health Sciences . . . . . . . . . . . . . . . . . . . . . . . . . . . .311 National Institute of General Medical Sciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 National Institute of Mental Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327 National Institute on Minority Health and Health Disparities . . . . . . . . . . . . . . . . . . . . 343 National Institute of Neurological Disorders and Stroke . . . . . . . . . . . . . . . . . . . . . . . . 355 National Institute of Nursing Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 362 National Library of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375 Fogarty International Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381 National Center for Complementary and Alternative Medicine. . . . . . . . . . . . . . . . . . . . 385 Office of Behavioral and Social Sciences Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 390 Office of Disease Prevention—Office of Dietary Supplements . . . . . . . . . . . . . . . . . . . . 396 vii Report of the Advisory Committee on Research on Women’s Health Appendices � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �401 Appendix A: ORWH-Cofunded Research Summaries, FY 2011 . . . . . . . . . . . . . . . . . . . . . 401 Appendix B: ORWH-Cofunded Research Summaries, FY 2012 . . . . . . . . . . . . . . . . . . . . 517 Appendix C: Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Working Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 603 Appendix D: Selected BIRCWH Scholar Publications, FY 2011–FY 2012 . . . . . . . . . . . . . 605 Appendix E: Selected FY 2011–FY 2012 SCOR Publications, Including Sex and Gender Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 649 Appendix F: NIH Working Group on Women in Biomedical Careers . . . . . . . . . . . . . . . 659 Appendix G: Intramural Program on Research on Women’s Health Steering Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 661 Appendix H: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 663 Appendix I: NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 673 Appendix J: Aggregate Enrollment Tables and Trend Data . . . . . . . . . . . . . . . . . . . . . . . . 679 Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 723 Index � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �741 viii Fiscal Years 2011 & 2012 Introduction This report of the Advisory Committee on Research on Women’s Health (ACRWH) for FYs 2011 and 2012 provides a summary of the accomplishments of NIH to address women’s health over the past 2 years. The report documents the expansive growth of women’s health and sex differ- ences research, along with many other significant programs and activities across the NIH. As requested in the NIH Revitalization Act of 1993, the ACRWH, a chartered group composed of non-Federal experts, submits a report to the NIH Director every 2 years, describing its findings related to the mandates for ORWH and NIH support of women’s health research. This docu- ment fulfills that directive. In 2010, ORWH introduced a new strategic plan and research agenda for the NIH, “Moving into the Future with New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research” (NIH Publication No. 10-7606), which provided a blueprint for future NIH wom- en’s health and sex differences research and career advancement in biomedical sciences for the coming decade. This “NIH Strategic Plan for Women’s Health Research” identified six major goals for new research and other funding initiatives. In 2011 and 2012, the NIH community took steps to further these goals and to track the progress toward their achievement. These efforts are described in the ORWH section, as well as in the women’s health and sex/gender differences research initiatives reported on by NIH ICs and Program Offices, also contained in this report. Organization of the FY 2011–FY 2012 Biennial Report of the ACRWH This FY 2011–FY 2012 biennial report bears witness to the phenomenal growth in women’s health research and related programs that has occurred since the formation of the Office in 1990. It reflects major ORWH research programs, initiatives, activities, and highlights that were reported from the NIH ICs and Program Offices. This report is not a comprehensive listing of all NIH research on women’s health, which would necessarily be encyclopedic; the report does serve, however, to summarize, under a single cover, examples of the wealth of NIH advances in women’s health research. This report also provides information on and analyses of support for women’s health research and related activities. The budget figures for NIH expenditures on women’s health research and programs during FY 2011–FY 2012 are included as well. This biennial report is divided into two major parts: Part 1 presents ORWH programs, and part 2 provides individual reports on women’s health research from the NIH ICs and Program Offices in the Office of the NIH Director. Information about ORWH programs in part 1 is organized into the following seven sections: I. ORWH Research II. ORWH Interdisciplinary Research and Career Development Programs III. ORWH Biomedical Career Development Activities IV. ORWH Research Dissemination and Outreach Activities V. Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research VI. NIH Budget for Women’s Health Research VII. Committee Members, FY 2011–FY 2012 1