National Policies And Guidelines

Federal Policies And Guidelines

• Food and Drug Administration (FDA)
• National Institutes of Health (NIH)
• Professional Societies
• Institute Of Medicine (IOM) International Reports
• Health Disparities and Special Populations
• Health Issues
• Journals
• Federal Policies and Guidelines

Food and Drug Administration (FDA)

• Understanding Sex Differences at FDA
• Evaluation of Sex-Specific Data in Medical Device Clinical Studies: Guidance for Industry and FDA Staff 
• FDA Research, Policy, and Workshops on Women in Clinical Trials
• Regulations, Guidance and Reports Related to Women’s Health
• Women’s Health and the FDA

October 20, 2005
Women’s health and the FDA. By Wood, S. F.  Susan Wood’s discussion of why she resigned from the FDA and how FDA policies harmed women in a number of areas. Resignation Prompted by Decisions Disregarding Science by Susan Wood, MD, adjunct associate professor at the School of Public Affairs at American University, Washington, D.C. Formerly,assistant commissioner for women’s health and director of the Office of Women’s Health at the Food and Drug Administration.

National Institutes of Health (NIH)

• NIH Sex and Gender Resources
• NIH Policy on Sex as a Biological Variable
• Consideration of Sex as a Biological Variable in NIH Funded Research
• Sex Specific Reporting of Scientific Research
• Methods and Techniques to Integrate Sex into Research
• NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
• NIH Policy on the Inclusion of Both Sexes in Cell and Animal Studies

Professional Societies

AMA Resolution: An Expanded Definition of Women’s Health

June 2016
The AMA passed a resolution in June 2016 indicating that the definition of women’s health should be expanded beyond reproductive health to include all conditions for which risk, prevalence or treatment differed between women and men. The document includes a discussion of how sex and gender affect health and identifies a set of illnesses in which there is an evidence base of difference between women and men (CVD, autoimmune, Alzheimer’s, mental illness, alcohol addiction, osteoarthritis, etc.). Sex differences between women and men can lead to different recommendations for care and treatment, and consideration of gender identity, cultural identity, socioeconomic status, and other factors can lead to better outcomes for all patients.

AMWA’s Position on Sex and Gender Specific Medicine

2012
The AMWA board approved a position statement supporting Sex and Gender Specific Medicine.

The North American Menopause Society

The North American Menopause Society (NAMS) has various Position Statements surrounding evaluation and treatment of various health conditions of postmenopausal women.  Hormone Replacement Therapy, Non-Hormonal Management of Menopause, Osteoporosis Prevention, Screening and Treatment, The Role of Calcium in Peri- and Post- Menopausal Women, and Vulvovaginal Atrophy.

Prescription for Change: Teaching New Physicians that Women Are Not Men

May/June 2011
Teaching new physicians that women are not men …. how you can help. Massion, CT, Fugh-Berman, A. The terms “gender-specific medicine and “sex-specific medicine” refer to the biological and physiological differences between the sexes, and the fact that these differences affect individuals’ experiences of health and disease. Despite widespread recognition that women are not men, coverage of women’s health issues is lacking in medical education. In fact, most educators seem to believe that reproductive health courses are sufficient to fully teach about women’s health. American College of Women’s Health Physicians.

Institute of Medicine Reports

Exploring the Biological Contribution to Human Health: Does Sex Matter?

April 4, 2001
Institute of Medicine Report. It’s obvious why only men develop prostate cancer and why only women get ovarian cancer. But it is not obvious why women are more likely to recover language ability after a stroke than men or why women are more apt to develop autoimmune diseases such as lupus. Sex differences in health throughout the lifespan have been documented. Exploring the Biological Contributions to Human Health begins to snap the pieces of the puzzle into place so that this knowledge can be used to improve health for both sexes. From behavior and cognition to metabolism and response to chemicals and infectious organisms, this book explores the health impact of sex (being male or female, according to reproductive organs and chromosomes) and gender (one’s sense of self as male or female in society).

Exploring the Biological Contributions to Human Health discusses basic biochemical differences in the cells of males and females and health variability between the sexes from conception throughout life. The book identifies key research needs and opportunities and addresses barriers to research.

Women’s Health Research: Progress, Pitfalls and Promise

September 23, 2010
Institute of Medicine Report. Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women’s health research–in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women.

Clinical Preventive Services for Women: Closing the Gaps

July 19, 2011
Institute of Medicine Report. As a centerpiece of the Patient Protection and Affordable Care Act (ACA) of 2010, the focus on preventive services is a profound shift from a reactive system that primarily responds to acute problems and urgent needs to one that helps foster optimal health and well-being. The ACA addresses preventive services for both men and women of all ages, and women in particular stand to benefit from additional preventive health services. The inclusion of evidence-based screenings, counseling and procedures that address women’s greater need for services over the course of a lifetime may have a profound impact for individuals and the nation as a whole.

International Reports

The Gender Handbook for Humanitarian Action

2017
Published by the Inter-Agency Standing Committee, 2nd edition.  Includes a discussion of gender equality across specific sectors: education, food security, health, nutrition, protection, shelter, water, sanitation and hygiene, etc.

The Global Strategy for Women’s, Children’s and Adolescent’s Health (2016-2030)

Report by the World Health Organization (WHO) Published 2015? The WHO site offers this and similar resources.

Health Disparities and Special Populations

Healthcare Quality and Disparities in Women

2011
Selected findings from the 2010 National Healthcare Quality Report that are specific to women. Includes findings about many women’s health conditions and topics.

Literature Review on Effective Sex and Gender Based Systems/Models of Care

January 30, 2007
The U.S. Department of Health and Human Services, Office on Women’s Health (OWH), commissioned this literature review to provide an up-to-date review of effective sex- and gender based systems/models of healthcare. The review investigated seven main research questions. The review considers topics such as: quality improvement, systems level changes, the role of provider behavior, insurance patterns, etc. The needs of both women and men are examined.

Research and Reports on Women Veterans

U.S. Department of Veterans Affairs, Center for Women Veterans. Resources for researchers conducting research on women veterans.

Health Issues

10Q Report: Advancing Women’s Heart Health through Improved Research, Diagnosis and Treatment 

June 2011
The 2011 10 Q Report presents a consensus by leading experts on the top ten questions in cardiovascular care for women. The report provides a road map for future research concerning women’s cardiovascular health. Answers to the questions should improve early detection, accurate diagnosis and treatment for women living with or at risk of heart disease.

Cardiovascular Disease in Women: Update on the 2011 American Heart Association Guidelines

Evidence-based guidelines for the prevention of cardiovascular disease in women developed in 2004, updated in 2007, and updated again in 2011. For the original 2004 guidelines, over 1,270 articles were screened by the panel, and 400 articles were included for evidence tables. The summary evidence used by the expert panel in 2011 can be obtained online as a Data Supplement at http://circ.ahajournals.org.

Understanding the Impact of Sex and Gender on Alzheimer’s Disease: A Call to Action

June 12, 2018
Precision medicine methodologies and approaches have advanced our understanding of the clinical presentation, development, progression, and management of Alzheimer’s disease (AD) dementia. However, sex and gender have not yet been adequately integrated into many of these approaches.

Management of Osteoporosis in Post-Menopausal Women

2010
Position statement by the North American Menopause Society

Opioide Use, Misuse and Overdose in Women

July 19, 2017
This report was developed as part of an initiative of the U.S. Department of Health and Human Services
(HHS) Office on Women’s Health (OWH) to examine prevention, treatment, and recovery issues for
women who misuse opioids, have opioid use disorders (OUDs), and/or overdose on opioids.

Journals

Sex and Gender Differences

Biology of Sex Differences

Biology of Sex Differences considers manuscripts on all aspects of the effects of sex on biology and disease. Sex has profound effects on physiology and the susceptibility to disease. The function of cells and organs depends on their sex, determined by the interplay among the genome and biological and social environments. The study of sex differences is a discipline in itself, with its own concepts and methods that apply across tissues. Biology of Sex Differences is the official journal of the Organization for the Study of Sex Differences, and a publication of the Society for Women’s Health Research.

Gender and the Genome

Gender and the Genome is a peer reviewed, open access journal that provides evidence-based original research, reviews, perspectives, and commentaries that illuminate the impact of biological sex on technology and its effects on human life. The journal is the official journal of the Foundation for Gender-Specific Medicine, the International Society for Gender-Specific Medicine, and the Israeli Society for Gender-and Sex Conscious Medicine. The Journal’s international editorial board is comprised of the most forward-thinking leaders in gender-specific medicine to engage the community of molecular biologists, engineers, ethicists, anthropologists, and legal experts in a dialogue about the nature and implications of 21st century technology.

Women’s Health with Gender Included

Journal of Women’s Health

The Journal of Women’s Health is the primary source of information for meeting the challenges of providing optimal health care for women throughout their lifespan. The Journal delivers cutting-edge advancements in diagnostic procedures, therapeutic protocols for the management of diseases, and innovative research in gender-based biology that impacts patient care and treatment.

Women’s Health Issues

Women’s Health Issues (WHI) is a peer-reviewed, bimonthly, multidisciplinary journal that publishes research and review manuscripts related to women’s health care and policy. As the official journal of the Jacobs Institute of Women’s Health, it is dedicated to improving the health and health care of all women throughout the lifespan and in diverse communities. The journal seeks to inform health services researchers, health care and public health professionals, social scientists, policymakers, and others concerned with women’s health.

Endocrinology

Animals have a sex. so should titles and methods sections  

June 1, 2012
“Beginning with papers submitted as of July 1, 2012, the methods sections of manuscripts submitted to Endocrinology must indicate the sex of animals used, or in the case of primary cells or cultures, the sex of animal from which they were derived.” Endocrinology, Volume 153, Issue 6, 1 June 2012, Pages 2539–2540.

Immune cells have a sex and so should journal articles

June 1, 2012
“Establishing journal policies that require authors to report the sex of their cells, animals, and subjects will improve our understanding of the pathogenesis of diseases, with the long-term goal of personalizing treatments for immune-mediated diseases differently for males and females in an effort to protect us equally.”

Journal of the National Cancer Institute

Sex Specific Reporting of Scientific Research: A Workshop Summary

2012
Barnett Kramer, editor-in-chief of the Journal of the National Cancer Institute (JNCI), noted that JNCI was the first journal to include instructions for addressing the effects of sex as part of its manuscript-preparation policy. Specifically, the JNCI instructions for authors state that “where appropriate, clinical and epidemiologic studies should be analyzed to see if there is an effect of sex or any of the major ethnic groups. If there is no effect, it should be so stated in Results.”