Notice Number: NOT-OD-17-108

Key Dates
Release Date: September 12, 2017
Response Date: November 10, 2017

Issued by
Office of Research on Women’s Health (ORWH)

Purpose

The Office of Research on Women’s Health (ORWH) is updating the trans-NIH Strategic Plan for Women’s Health Research. NIH is publishing this Notice to solicit input from the basic, clinical and translational scientists as well as advocacy and patient communities on topics under consideration for the next strategic plan.

Background

ORWH was established in the Office of the NIH Director by the Public Health Service Act to (a) identify projects and multidisciplinary research related to women’s health; (b) encourage research on sex differences and promote coordination among research entities; (c) assist NIH efforts to include women as subjects in clinical research; and (d) develop opportunities and support for women in biomedical careers. These efforts will continue to be part of the office's core mission. ORWH is tasked with the development of a trans-NIH strategic plan for women’s health research that promotes allocation of NIH resources for conducting and supporting these research efforts across NIH Institutes and Centers.

Please see https://orwh.od.nih.gov/about/mission/ for more on the ORWH mission.

Information Requested

This Request for Information (RFI) seeks feedback on 3 cross-cutting themes and goals under consideration for the next trans-NIH strategic plan for women’s health research. These themes will stimulate new research areas, priorities, and approaches to help put science to work for the health of women.

Specifically, the ORWH seeks your comments on the following:

• What are some ways that the scope of each theme might be expanded or more narrowly focused to address the most important areas in research on women’s health?

• What topics would you recommend adding to the list of cross-cutting themes for research on women’s health?

• What big idea or audacious goal to improve women's health should be pursued by the NIH?

Cross-Cutting Theme 1: Expand the Exploration of Sex as a Biological Variable (SABV) in NIH Research

To gain a better understanding of the diseases and conditions affecting the health of women, NIH introduced the NIH Policy on Consideration of Sex as a Biological Variable in NIH-funded Research (NOT-OD-15-102) in 2015. The policy requires that investigators consider the role of sex (male and female) as a biological variable in research designs, analyses, and reporting in vertebrate animal and human studies; that is, how differences between males and females might influence the outcome of research studies. However, the SABV policy does not require investigators to test for sex-differences in their research findings or report such findings. The following objectives take the SABV policy to the next level.

Proposed Goals:
1.1 Support training of researchers on the design and conduct studies that explore sex-differences in pre-clinical and clinical research, promote efforts to test for sex-differences where appropriate, and encourage reporting of any sex-differences found in NIH supported research.

1.2 Help disseminate research findings from NIH supported research on sex-differences to key stakeholders including researchers, clinicians, patients, advocacy groups, industry, and media. Strengthen women’s health research through support for data sharing from studies that explore sex differences

1.3 Continue to support for basic, clinical and translational science; this includes genetic and epigenetic studies; systems biology approaches; neuroscience; and studies of the structure and function of male and female cells (including stem cells), tissues, organs, and physiological systems.

Cross-Cutting Theme 2: A Multi-Dimensional Approach to the Science of Women's Health

Research has revealed complex interactions among biological systems and processes that affect health status, disease presentations, and treatment responses. Also of interest are the ways in which female biology, including hormonal and reproductive phases, interacts with psychosocial factors. To capture the multidimensional interplay of these influences on women's health, novel cross disciplinary approaches and perspectives are needed. The following objectives support this aim.

2.1 Promote collaboration and sharing of ideas and methodologies across disciplines to stimulate new approaches to research on female biology as it relates to women’s health and well-being.

2.2 Convene cross-disciplinary experts to discuss strategies for capturing contextual factors that contribute to the understanding of the health of women, between demographic groups and geographic regions; and among social, economic and cultural groups.

2.3 Encourage study of the interaction of social roles on sex-specific biology, including, but not limited to reproductive phase and status.

Cross-Cutting Theme 3: Quality of Life and Disease Burden over the Life-Course

Biological functions and unique life experiences at various stages of life have an impact on both men and women's health. Just like there are clear differences in the biological condition and needs of children versus adults, there are also important variations in health stages and challenges unique to women from early to older adulthood. Research has shown that early life experiences and physical conditions can result in cumulative health advantages and disadvantages for subsequent years. The following objectives are proposed to expand our understanding of quality of life and disease burden and across and during transitions between life stages.

3.1 Promote a life-course perspective in research on women's health promotion, disease prevention, and treatment. Support the consideration of age, life phase, and reproductive/hormonal status in research on women's health.

3.2 Encourage exploration of resilience and well-being, quality of life, and social functioning in addition to disease-specific outcomes; and encourage the exploration of common stressors that affect the health of women, such as caregiver burden and trauma.

3.3 Explore early health challenges, life experiences and physical conditions that may contribute to cumulative health advantages and disadvantages for women across the life span, between demographic groups and geographic regions; and among social, economic and cultural groups.

How to Submit a Response:

Responses no longer than 300 words should be submitted at https://orwh.od.nih.gov/RFI/ by 11:59:59 pm (ET) on November 10, 2017. You will see an electronic confirmation acknowledging receipt of your response. All submissions will be considered and will not be considered confidential.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Paris Watson, Legislative Policy Analyst
Office of Research on Women’s Health
Telephone: 301-451-7082
Email: [email protected]