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Background
The Ofce o Research on Women’s Health (ORWH), estab-lished in September 1990 within the Ofce o the Director,NIH,
()
advises the NIH Director and sta on matters re-lating to research on women’s health;
(b)
strengthens andenhances research related to diseases, disorders, and condi-tions that aect women;
()
ensures that research conductedand supported by NIH adequately addresses issues regardingwomen’s health;
()
ensures that women are appropriatelyrepresented in biomedical and biobehavioral research stud-ies supported by NIH;
()
develops opportunities or andsupports recruitment, retention, re-entry, and advancemento women in biomedical careers; and
()
supports researchon women’s health issues. ORWH works in partnershipwith the NIH institutes and centers to ensure that women’shealth research is part o the scientifc ramework at NIH andthroughout the scientifc community.ORWH benefts rom two important committees: the
ai-s ci  rsh  W’s Hh (acrWH)
and the
 cii ci  rsh  W’sHh (ccrWH)
. ACRWH provides leadership to ORWH byadvising the ORWH Director on appropriate research activi-ties on women’s health. ACRWH members are chosen romamong physicians, practitioners, scientists, and other healthproessionals who are not ederal employees. Committeemembers are actively involved in reviewing research priori-ties, the women’s health research portolio or NIH, careerdevelopment, and the inclusion o women and minorities inclinical research. The CCRWH is composed o NIH instituteand center (IC) directors or their designees as a direct liaisonor ORWH with the NIH ICs. Both ACRWH and CCRWH areinvolved in the activities o the ORWH and women’s healthresearch and careers at the NIH.
Vivian W. Pinn, M.D.,
Associate Director or Research on Women’s HealthDirector, Ofce o Research on Women’s Health
Lisa Begg, Dr. P.H., R.N.,
Director, Research Programs
Joyce E. Rudick,
Director, Programs and Management
Advisory Committee onResearch on Women’s HealthMembership RosterFebruary 2007-2008
Vivian W. Pinn, M.D.,
Chairperson
 
Bethesda, MD
 Joyce Rudick,
Executive Secretary
 
Bethesda, MD
 Joanna M. Cain, M.D.
 Portland, OR 
Luther T. Clark, M.D.,F.A.C.C., F.A.C.P.
North Wales, PA
PonJola Coney, M.D., F.A.C.O.G.
Richmond, VA
Andrea Dunaif, M.D.
Chicago, IL
Ronald S. Gibbs, M.D.
Denver, CO
Margaret M. Heitkemper, Ph.D.,R.N., F.A.A.N.
Seattle, WA
Constance A. Howes, J.D.
Providence, RI
Scott J. Hultgren, Ph.D.
St. Louis, MO
Linda M. Kaste, D.D.S., M.S., Ph.D.
Chicago, IL
Nancy Norton
Milwaukee, WI
Mary Beth O’Connell, Pharm.D,B.C.P.S., F.A.S.H.P., F.C.C.P.
 Detroit, MI
Mary I. O’Connor, M.D.
 Jacksonville, FL
Eugene P. Orringer, M.D.
Chapel Hill, NC
Sally Rosen, M.D., M.F.S.
Philadelphia, PA
Susan P. Sloan, M.D.
 Johnson City, TN
Phyllis M. Wise, Ph.D.
Seattle, WA
Barbara Yee, Ph.D.
Honolulu, HI
Carmen D. Zorrilla, M.D.
 San Juan, PR 
Coordinating Committee onResearch on Women’s HealthMembership RosterFebruary 2007-2008
Vivian W. Pinn, M.D.,
Chairperson
 
Bethesda, MD
 Joyce Rudick,
Executive Secretary
 
Bethesda, MDYvonne Bryan, Ph.D., NINR  John Burklow, ODMaría Teresa Canto,
D.D.S., M.S., M.P.H., NIDCR 
Vicki Cargill, M.D., M.S.C.E., OAR Deborah Dozier-Hall, M.S.W., CCGale Dutcher, M.L.S., NLMValery Gordon, M.P.H., Ph.D., NIBIBMarcella Haynes, OEODMEleanor Ho, Ph.D., NIDDKKaren Homan, M.D., FICM.K. Holohan Quattrocchi, J.D., NHGRIAnne Houser, OLPABonnie Kalberer, M.P.H., OSE
Tamara Lewis-Johnson, M.B.A., M.P.H., NIAID
Anna Levy, M.S., NCIEllen S. Liberman, Ph.D., NEIBarbara Liu, S.M., NHLBIPatty Mabry, Ph.D., OBSSR Vicki Malick, OITEPamela Marino, Ph.D., NIGMSSheila McClure, Ph.D., NCRR Kate Nagy, NIASheila Newton, Ph.D., NIEHSMary Frances Picciano, Ph.D., ODSCarol Pontzer, Ph.D., NCCAMLinda Porter, Ph.D., NINDSSvetlana Radaeva, Ph.D., NIAAACatherine Roca, M.D., NIMHMona Rowe, M.C.P., NICHD John Run, Ph.D., NCMHDLana Shekim, Ph.D., NIDCDEsther Sternberg, M.D., OIR Kate Stoney, Ph.D., NCCAMMadeline Turkeltaub, R.N., Ph.D., C.R.N.P.,F.A.A.N., NIAMSCora Lee Wetherington, Ph.D., NIDADenise Wiesch, Ph.D., M.P.H., CSR 
of  rsh  W’s Hh | ni Isis  Hh | u.S. dp Hh & H Sis | Ph (301) 402 –1770 | hp://wh..ih.
 
reSearcH on Women’S HealtH or tHe 21St century
ORWH, in collaboration with the NIH and the extramural sci-entic and public advocacy communities, published a report,
 Agenda for Research on Women‘s Health for the 21st Century,
which provides a basic strategic plan or the ORWH. ORWHcontinues to enhance, stimulate, und and co-und meritoriousresearch, sponsor research conerences on women’s health, anddevelop new research initiatives through partnerships with theNIH ICs. The strategic plan is available on our Web site at
http://orwh.od.nih.gov/.
overarcHIng tHemeS ImPortant oraddreSSIng nIH PrIorItIeS or Women’S HealtH
Lifespan:
Developmental, physiological, and psychologicalage aect the health o women and girls across the liespan,rom intrauterine lie to the elderly years. Other actors,such as work, caring or children and the elderly, marital andreproductive status, and chronic illness, also contribute tothe health o women. These variables need to be consideredwhen designing women’s health studies.
Sex/Gender Determinants:
Women are characterized by bothsex and gender as highlighted in the
 Agenda for Research inWomen’s Health for the 21st Century
and the Institute o Medicinereport,
 Exploring the Biological Contributions to Human Health: Does Sex Matter?
In these contexts, “sex” reers to being male oremale according to reproductive organs and unctions assignedby chromosomal complement; and “gender” reers to sociallydeined and derived expectations and roles rooted in biologyand shaped by environment and experience. Considerationo these variables is critical to the accurate interpretation and validation o research aecting women’s health.
Health Disparities/Differences and Diversity:
Many condi-tions and diseases disproportionately aect women in termso incidence, diagnosis, course, and response to treatment.Further, actors such as biology, genes, culture, education,income, access to and quality o care, and access to oppor-tunities or inclusion in clinical trials and studies can con-tribute to adverse health outcomes or many populations owomen. In order to better document, describe, prevent, andtreat disease in women and girls, research should take intoaccount this diversity o experience and population-speciiccharacteristics.
Interdisciplinary Research:
As the inter-relatedness and com-plexity o human health and disease is better understood, sci-ence is shiting to an interdisciplinary approach. Such practicecan integrate knowledge across specialties and disciplines andimprove the ability to deine complementary and synergisticpathologies underlying disease conditions. Women’s healthresearch, an already multi-disciplinary ield, is uniquely suitedto promote and advance such an approach.The current research priorities listed below are not comprehensive,but refect selected areas identied or new or expanded investiga-tive eorts. 
(http://orwh.od.nih.gov/research/priorities.html)
current nIH PrIorItIeS or Women’S HealtH reSearcH
 Areas o Research Interest—Basic, clinical, and translational research that address priority areas, including:
disss  ciis h a W
Investigate the pathogenesis and develop preventive and therapeutic inter-ventions or acute and chronic diseases and disorders that aect women.
mhi as
Develop clinical trials methodology, such as novel recruitmentstrategies and statistical analysis, that addresses ethical and studydesign issues specifc to studies o women, and detects sex and gender dierences.
ei  c dp  W i Si
Identiy and explore actors aecting the selection and advancemento women’s careers in biomedical sciences; implement novel educa-tion programs directed at girls and women; and promote uniqueprograms or addressing impediments to the advancement and eec-tive mentoring o women to senior positions in science.
Qi  li
Elucidate the unique sex and gender actors aecting women’s qualityo lie, and develop disease and wellness management approaches.
rsh cbi  Pships
Foster public-private partnerships and collaborations in all areas o research and career development related to women’s health.
Special Emphasis Areas
Pi  t
Research to identiy and validate biomarkers and their applicationsto disease prevention, early detection and treatment, including thedevelopment o novel tools.Studies o the impact o biological, behavioral, cultural, social, eco-nomic, and environmental actors on susceptibility to or protection rom disease and response to treatment.
Bii  Bhi Bsis  Sx  g dis
While there has been much research to identiy the unction o cel-lular pathways and genes, research on the eects o sex as a modifer o cellular and gene unction is under-investigated. Systemic andcellular modeling o the inluence o sex dierences in biologicalpathways and systems is needed. For example, greater research willclariy the mechanism o sex eects on gene expression and cellular signaling pathways, including the impact o puberty, the menstrualcycle, pregnancy, and menopause.
 
advancIng novel ScIence In Women’S HealtHreSearcH (anSWHr)
ORWH has just published two program announcements (or an
R 
21
and an
R 
03
) to stimulate new research in women’s healthand/or the study o sex/gender actors. For more details:
th r21
hp://s.ih./s/i/p-fs/PaS-07-381.h
th r03
hp://s.ih./s/i/p-fs/PaS-07-382.h
orWH InterdIScIPlInary InItIatIveS
ORWH develops, implements and unds innovative interdisci-plinary research centers and interdisciplinary research trainingprograms. These programs benet both women’s and men’s healththrough sex and gender research, interdisciplinary scientic col-laboration, and support or young investigators in a mentoredenvironment. Each Fall, scholars, investigators and studentsparticipate in the Annual Interdisciplinary Women’s Health Re-search Symposium and as a result several collaborations betweenindependent centers have developed to promote independentresearch. These interdisciplinary programs are:
• Specialized Centers o Research on Sex and Gender Factors Aecting Women’s Health (SCORs)
ORWH led the development and implementation o elevenSCORs with co-unding rom six NIH institutes. The interdisci-plinary nature o these centers provides innovative approachesto advancing research on the infuence o sex and gender as itrelates to health and disease. Primary research areas currentlyunder study include pain, pregnancy, substance abuse, and uro-logic health. A second round o SCOR applications was undedin 2007.
• Building Interdisciplinary Research Careersin Women’s Health (BIRCWH)
ORWH developed and implemented an innovative K12 pro-gram to support the training o junior aculty researchers inan interdisciplinary mentored environment in women’s healthresearch by pairing junior researchers with senior investigators.This program bridges advanced training with research inde-pendence, in addition to combining scientic disciplines in aninterdisciplinary nature. ORWH leads the BIRCWH initiativewith several cosponsors, including NIH Institutes, the NIHOce o Dietary Supplements, and the Agency or HealthcareResearch and Quality. Ater three rounds o awards, a total o29 BIRCWH Centers have been established. A ourth round oBIRCWH applications was unded in 2007.
• Intramural Programs
ORWH developed a trans-NIH interdisciplinary collaboration onwomen’s health and sex/gender research through the establish-ment o the Intramural Program on Research on Women’s Health(IPRWH). In 2006, ORWH and IPRWH announced the selectiono the rst recipients o the NIH Women’s Health Fellowships inIntramural Women’s Health Research. Both ellowships are sup-ported by ORWH and the Oce o Intramural Research (OIR)and are unded by the Foundation or the NIH, with donationsrom Batelle (Shared Postdoctoral Fellowship) and AstraZeneca(Clinical/Translational Fellowship).
• Chronic Fatigue Syndrome
ORWH serves as the ocal point or NIH research on ChronicFatigue Syndrome (CFS). CFS initiatives or the NIH are co-ordinated by the ORWH in partnership with NIH ICs andother Federal agencies. In 2006, ORWH sponsored, throughthe NIH Working Group or Research on Chronic FatigueSyndrome, unding or seven awards to investigators whoseresearch projects will help understand the central mechanismsunderlying the neuro-immune interactions in CFS.
nIH mandate or tHe IncluSIon o Women andmInorItIeS In clInIcal reSearcH
ORWH leads NIH eorts in monitoring adherence to the NIHpolicy on the inclusion o women and minorities in clinical re-search studies. The NIH policy or inclusion (Federal Register,March 1994) was strengthened in response to the NIH Revital-ization Act o 1993 (Public Law 103-43) to ensure that women,and minorities and their subpopulations, are included in researchinvolving human subjects in suicient numbers to allow orsubset analysis by sex (or race). ORWH convenes a trans-NIHcommittee that ensures that the implementation o the inclusionpolicy is uniorm across NIH. Working in collaboration with thiscommittee, ORWH coordinates data collection and reportingmethodologies to track numbers o women, men, minorities andnon-minority men in NIH-supported research studies. These dataare generated electronically and detail the number o subjectsincluded in all clinical research studies as well as those enrolledin Phase III clinical trials. The aggregate data are used to helpdocument investigator compliance with the NIH Inclusion Policy.NIH has updated guidelines to clariy and strengthen the require-ment that Phase III clinical studies be designed and carried outto allow or the valid analysis o dierences between women andmen
(http://grants.nih.gov/grants/funding/women_min/guide-lines_update.htm).
Analyses o NIH-wide demographic data onsubjects enrolled in clinical research studies show that substantialnumbers o women and minorities have been included as researchsubjects. For complete inclusion data, see:
http://orwh.od.nih.gov/inclusion.html.
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