[PDF] NATIONAL INSTITUTES OF HEALTH - Report of the Advisory

View - Download NATIONAL INSTITUTES OF HEALTH - Report of the Advisory

Previous PDF

Next PDF

NATIONAL INSTITUTES OF HEALTH

Report of the Advisory Committee

on Research on Women's Health:

Fiscal Years 2017-2018

Of?ce 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

Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018ii

NATIONAL INSTITUTES OF HEALTH

Report of the Advisory Committee

on Research on Women's Health:

Fiscal Years 2017-2018

Of?ce of Research on

Women's Health

Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018iii

Table of Contents

Letter from the ORWH Director

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

I. OR WH Background ........................................................................................................1

II. OR WH Research

III. ORW H Biomedical Career Development Activities ...................................................26

IV. Mo nitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

V. N IH Budget for Women"s Health Research

Report of the NIH Institutes and Centers

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

Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018iv

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

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

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 ........................................................................ Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018v

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 21
st 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 21 st 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 21 st 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

policies for the inclusion of women, minorities, and children in clinical research to include individuals of all

ages. It clarifies that justifications for exclusion based on age must be because of valid ethical or scientific

reasons and requires that participant age at enrollment be provided in progress reports. Implementation of

these requirements will serve as a major milestone in achieving the goals of ORWH, as it will ensure that

women, people of all ages, and racial and ethnic minorities are appropriately represented in clinical research

and will shed light on whether the treatments studied would work for these populations. NIH has been

preparing to implement this policy during the reporting period by revising policies and research guidelines

and preparing to collect data on the age of participants.

The progress made by NIH in the past 2 fiscal years on behalf of women's health is impressive. However,

we have more work to do as we continue to implement the SABV policy and the requirements of the 21
st Century Cures Act. The NIH vision is that sex and gender influences are integrated throughout the biomedical research enterprise; that every woman receives evidence-based disease prevention and

treatment tailored to her circumstances, needs, and goals; and that women in science careers reach their

full potential. We are continuing to work toward these aims by building on our past successes and forging an

increasingly transdisciplinary path for the next generation of women's health and sex/gender research.

Janine A. Clayton, M.D.

Associate Director for Research on Women's Health

Director, Office of Research on Women's Health

National Institutes of Health

October 23, 2019

Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018vii

Preface

This

Report of the Advisory Committee on

Research on Women's Health (ACRWH) for

Fiscal Years (FY) 2017 and 2018

describes the programs and initiatives undertaken across the

National Institutes of Health (NIH) in service of

the core mission of the NIH Office of Research on

Women's Health (ORWH), which was established

in 1990. The mission, outlined in the NIH

Revitalization Act of 1993 (Public Law 103-43,

Section 141), is:

• To advise the NIH Director on matters relating to research on women"s health

• To strengthen and enhance research related to diseases, disorders, and conditions that affect women

• To ensure that research conducted and supported by NIH adequately addresses issues regarding women"s health

• To ensure that women are appropriately represented in biomedical and biobehavioral research studies supported by NIH

• To develop opportunities for and support recruitment, retention, reentry, and advancement of women in biomedical careers

• To support research on women"s health issues.

The members of the ACRWH are pleased to

submit this report to the NIH Director through the Associate Director for Research on Women"s

Health. They have reviewed the report and find

that it provides essential information about the research, programs, and other activities of ORWH and all NIH Institutes, Centers, and Offices (ICOs). It describes the breadth and depth of the work undertaken by NIH to achieve its mission in

FY 2017 and 2018, including:• NIH-supported research on women"s health and the influence of sex and gender on health and disease. This research was supported by the Institutes and Centers (ICs) across NIH, as well as by program offices within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the NIH Office of the Director (OD).

• NIH budget allocations for women"s health research, submitted by the U.S. Department of Health and Human Services" Office of the Assistant Secretary for Financial Resources.

• Continuing implementation of the sex as a biological variable (SABV) policy, including revised business practices.

• The continued focus on increased inclusion of women, minorities, and children in NIH-funded clinical research and efforts to lay the groundwork for grants/contracts submitted on or after January 25, 2019, when new requirements became effective based on the Inclusion Across the Lifespan policy.

• Creation of the Specialized Centers of Research Excellence (SCORE) on Sex Differences cooperative agreement program, based on its predecessor, the Specialized Center of Research (SCOR) on Sex Differences.

• Addition of a new administrative supplement program for populations of women that are understudied, underreported, or underrepresented (U3) in biomedical research. The first 2 years of the program took place in FY 17 and FY 18.

Over the past 2 fiscal years, the Trans-NIH SABV

Working Group has continued collaborative

efforts across the ICOs to improve rigor and transparency in NIH-funded research. In April Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018viii

2017, the Trans-NIH SABV Working Group was

charged with implementing the SABV policy into

NIH business practices. With ORWH support,

tools and resources were developed. SABV- related information has been disseminated to the

ICOs through road shows across NIH, website

resources, and grant review guidance. New and updated FAQs were developed for NIH and grant applicants. ORWH is continuing to provide support for consideration of SABV across the research continuum.

ORWH has made significant progress in another

key element of the mission: to promote career advancement for women in biomedical careers.

ORWH provided resources on mentoring,

retention, and career advancement; leadership development; and work-life integration. The

ORWH Director co-chairs the NIH Working Group

on Women in Biomedical Careers with the NIH

Director. This working group led the request for

applications (RFA) titled “Research on Causal

Factors and

Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering," with support from 11 institutes and centers and 4 OD offices.

ORWH has supported supplements to assist

women and men as they reenter research careers after interruptions for family or other responsibilities with participating ICOs. Resources for women in biomedical careers are regularly made available on the ORWH website at nih.gov/ women and womeninscience.nih.gov. ORWH also hosts the Women of Color Research Network an online members forum that aims to facilitate the research careers of women of color.

ORWH sponsored a workshop titled “Raising the

Bar," which shed light on important issues about

the relative disadvantages concerning the health of women in the U.S. in comparison with women in 16 other economically advanced nations.

The workshop identified key research areas for

Report of the NIH Advisory Committee on Research on Women's Health | Fiscal Years 2017-2018ix decreasing mortality and morbidity, in both the short term and the long term. It also identified areas in which small, relatively inexpensive interventions could have large effects. In 2017, insights from a “Raising the Bar" data analysis were presented at the 44 th meeting of the

ACRWH. The challenge now is to communicate

and educate the research community and the public, in part by disseminating information to journal editors and colleagues and getting the word out to additional women. The report based on this workshop has been downloaded more than 5,000 times. It is available at orwh.od.nih. health-women-united-states.

Outreach

NIH is continuing integration of sex and gender

considerations throughout the entire research continuum, from basic and preclinical studies to clinical trials and implementation science.

ORWH created the Sex and Gender in Health and

Disease (SGHD) Scientific Interest Group (SIG) to

align with these efforts, exploring the influences of sex as a biological variable and gender as a social construct as they relate to health and disease. This SIG fosters interdisciplinary collaboration among NIH scientists who work on or are interested in sex differences research at various points in the research continuum. It also aims to leverage the scientific expertise of neighboring research institutions. During the reporting period, three SGHD meetings were held that featured presentations from representatives of various disciplines who had relevant information to add to the discussion of sex and gender in research.

Policy

The 21
st

Century Cures Act, signed into law in

2016, introduced several significant changes

in the way ORWH operates and how research is conducted. It has increased interaction and collaboration between the ORWH Director and the directors of all the NIH Institutes and Centers (ICs). The 21 st

Century Cures Act ensures that

the ICs' strategic plans have objectives that take women into account and focus on reducing women's health disparities. The act's Inclusion

Across the Lifespan section applies to grant

applications and contract solicitations submitted after January 25, 2019. It also ensures that women, racial/ethnic minorities, and people of all ages are appropriately represented in clinical research. Participant age at enrollment must now be provided in progress reports, and certain Phase III clinical trials must report their results in

ClinicalTrials.gov by sex and gender and by race

and ethnicity, which reinforces the SABV policy.

The 21

st

Century Cures Act also calls for

the NIH Director to encourage efforts to: (1) improve research related to the health of sexual and gender minority populations through increased participation in NIH clinical researchquotesdbs_dbs33.pdfusesText_39

[PDF] Document médical À remplir par un professionnel de la santé. Le règlement oblige que tous les champs soient remplis sauf lorsqu indiqué autrement.

[PDF] Document N 11 Document de travail, n engage pas le Conseil Les observatoires des situations de fragilité

[PDF] Document réalisé avec le soutien de

[PDF] Document sur la qualité des données, Base de données sur la morbidité hospitalière

[PDF] Documentation Technique de Référence d ERDF

[PDF] Dompter l affichage et l impression

[PDF] DONNER AUX TPE-PME LA PLACE QU ELLES MÉRITENT. «Notre valeur ajoutée, c est l Homme»

[PDF] Donner les clés pour éviter les risques et situations d autorévision

[PDF] DONNEZ DE LA DIMENSION A VOTRE TALENT. Cabinet conseil en stratégie de communication & accompagnement de dirigeants

[PDF] DOSSIER : LES ARNAQUES SUR INTERNET

[PDF] Dossier à compléter et à apporter le jour de votre entretien de positionnement avec les pièces à fournir. FILIÈRE ESTHETIQUE

[PDF] DOSSIER CLOTURE Cahier des charges pour une Préparation Opérationnelle à l Emploi collective N 2

[PDF] DOSSIER D ADMISSION «PASSERELLE EQUILIBRE» Nom de naissance : Prénom : Nom d usage / d époux (se) : Adresse du lieu de vie de la personne :

[PDF] Dossier d autorisation loi sur l eau et DIG du programme d entretien et de restauration des cours d eau et du bassin Hâvre, Grée, Donneau» -COMPA

[PDF] DOSSIER D INFORMATION ET D INSCRIPTION