A new program from the Office of Research on Women’s Health (ORWH) at the National Institutes of Health (NIH) aims to improve sex- and gender-specific training in science, medicine, and other health professions by supporting curricula and courses that address the intentional integration of gender and gender considerations into NIH research. Specifically, as breakthroughs in women’s health research continue to occur at every stage of the biomedical research continuum, a paradigm shift from including women to intentionally integrating gender and gender differences and information requires the development of new skills and innovative methodologies.
The program, called Galvanizing Health Equity Through Novel and Diverse Educational Resources (GENDER)R25, will fund courses and curricula for health professionals at every career stage to help address questions related to how health is affected by gender such as biological variable and/or gender as an identity, social, cultural or structural variable. NIH staff will also host a technical assistance webinar on Wednesday, September 21, for all healthcare professionals who want to learn more; funded projects will lead to the development of curricula, courses and methods that can be used across disciplines and will be accessible through the ORWH e-learning webpage.
Specifically, Dr. Elizabeth Barr, Administrator of Social and Behavioral Scientist at ORWH, explained further in an interview with Pharmacy Times that ORWH welcomes applications from pharmacy professionals as well as other biomedical communities, as pharmacists are critical members of patient healthcare teams with a direct impact on adverse effect (AE) management, dosing, and polypharmacy—all of which may affect women more than men due to the limited nature of data on these topics in relation to gender and gender-related differences.
“Despite concerted efforts, sex and gender remain understudied in curricula within biomedical education programs, including pharmacy programs,” Barr said. “Because each health profession has its own discipline-specific language and accreditation standards, pharmacists are ideally positioned to develop curricula to fill the gap in their field; we hope that pharmaceutical professionals will consider submitting applications for POL R25.”
With an understanding of the distinct impact of sex and gender on health, the use of clear gender and gender terminology is essential to facilitate more accurate study of human health and the delivery of health care by professionals in the field. Sex classification—which is a multidimensional construct based on clusters of anatomical and physiological traits—can include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones. However, gender is often misunderstood as an extension or synonym of gender; instead, gender is a social and cultural variable that encompasses a variety of domains, including gender identity and expression, gender roles and norms, gender relations, structural sexism, power, and justice.
“Understanding the impact of gender on health … can facilitate the delivery of equitable care by all biomedical professionals,” Barr said. “Pharmaceutical professionals can benefit from an enriched understanding of the gender and gender domains [in their practices].”
By understanding the differences in terminology and the impact of both sex and gender on patient health, pharmacy professionals can better provide more effective individualized patient-centered services. For example, at the individual level, health care professionals themselves can influence patient health care outcomes based on the results of 1-to-1 communication with patients about patients’ symptom experiences.
In addition, gender can affect patient health at both a relational and structural level. At the relational level, gender may influence whether a patient may experience intimate partner violence in their home environment, while the structural effects of gender may include different levels of access to health care based on geographic location for certain women conditions.
Federal law and NIH policy require NIH-funded clinical research to include women, minorities, and individuals across the lifespan. Importantly, however, this does not just involve the inclusion of women in studies, but should also require consideration of research design. Studies should be designed to detect the influence of gender on efficacy and safety. If women are included but sex-specific outcomes are not collected and reported, women and health professionals lack important knowledge that can impact patient health.
Furthermore, gender differences may also have an impact on treatment outcomes, such as through different rates of drug absorption, metabolism, and excretion. For example, women typically have different amounts of adipose tissue, a different hormonal environment, and may have different kidney and liver functions compared to men, all of which can affect dosages and side effects. Despite these known effects, women are often underrepresented in clinical trials, resulting in results that may not be sex-disaggregated, leaving potential differences in drug distribution unidentified.
Gender may also influence whether and how patients report side effects, as well as how these effects are perceived by healthcare professionals. Women often report experiencing rejection of their reported symptoms in health care settings, and this experience has been confirmed in research published in professional journals. This rejection of the symptom experience can lead to delayed dose adjustments, accumulation of side effects, and even discontinuation of effective therapies.
Gender and gender issues also remain understudied in biomedical education programs, including those in schools of pharmacy. By working with multiple specialists and health experts in patient care teams, pharmacists are ideally positioned to play a critical role in influencing discussions about gender and gender differences and the use of appropriate terminology for patients, bridging the gaps during communication with these professionals. POL R25 can assist pharmacists in these efforts by improving their education on these issues in pharmacy programs, which can then be disseminated and used in other disciplines.
For pharmacists interested in learning more, the technical assistance webinar on Wednesday, September 21 will provide an opportunity for potential applicants to learn about the scope, purpose and requirements for the GENDER R25 program. Members of the ORWH staff, participating NIH Institutes and Centers, and members of the NIH Center for Scientific Review will also participate in the discussion to provide additional details about the program and answer applicants’ questions. For those interested in applying for funding, non-AIDS-related applications must be submitted by 5:00 p.m. EDT on October 27, 2022 and June 27, 2023, while HIV-related applications /AIDS, must be submitted by January 7, 2023 and September 7, 2023.
“Gender and sex-specific training, such as that which will be supported through GENDER R25, provides pharmaceutical professionals with the opportunity to advance pharmaceutical education, research and practice – and therefore improve human health,” said Barr. “The benefits of improved inclusion in clinical trials and improved gender and gender integration in all aspects of pharmacy training and care are impressive and achievable.”
In addition, ORWH will offer other career development and interprofessional education resources and programs, including:
Developed in partnership with the FDA’s Office of Women’s Health, the course explores sex- and gender-related disparities in key disease areas. The 6 modules included provide biomedical researchers, clinicians and students in the healthcare professions with knowledge they can use when designing and conducting research and/or interpreting evidence for clinical practice.
Developed with funding support from the National Institute of General Medical Sciences, the course helps researchers understand and apply the NIH policy on gender as a biological variable (SABV) in research design, analysis, and reporting. The four modules of the course deal with basic, preclinical, clinical and population health research.
The 6-module course is designed for the biomedical research community to account for and appropriately teach the SABV policy.
An introductory self-paced training aimed at researchers, clinicians and policy makers, the downloadable slides and accompanying facilitator’s guide can be used by individuals or teams to start a dialogue about how and why it might be useful to include gender- and -a gender lens in research and clinical care.