Key Dates

Related Announcements

PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

PA-20-195 - NIH Exploratory/Developmental Research Grant (Parent R21 Clinical Trial Not Allowed)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-20-146 - NIDA Small Research Grant Program (R03 Clinical Trial Required)

Issued by

National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Purpose

The purpose of this Notice is to inform potential applicants of the National Institute on Drug Abuse (NIDA) special interest in grant applications to conduct rigorous basic, translational and/or clinical research to: (1) advance identification of sex and/or gender differences in risk for substance use disorders or the response or medical consequences of alcohol or substance misuse to uncover the mechanisms of those differences, and to conduct translational research on those differences, and (2) advance research specific to women or highly relevant to women.  Both preclinical and clinical studies are sought across all areas of drug and alcohol research.

Commitment to Improving Research to Eliminate Health Disparities and Advance Health Equity

The National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism are committed to improving the quality and quantity of drug and alcohol research focused on underrepresented populations. Groups shown to suffer health disparities, or differences in incidence, morbidity, and mortality associated with alcohol and other substance misuse,as well as different medical, interpersonal and social consequences, include but are not limited to:

• Racial and ethnic minorities
• Rural populations
• Groups with low socioeconomic status
• Persons with disabilities
• Sexual and gender minority populations

Specifically, NIDA and NIAAA encourage research that will:

• Increase the evidence base related to harmful substance use, including enhancing epidemiologic and etiologic knowledge;
• Understand the biological, social, and cultural contexts of harmful substance use in minority and health disparities populations;
• Develop improved prevention and treatment interventions for these groups;
• Decrease alcohol and other substance-related health inequities. 
• Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the applicants to this FOA will include diverse teams of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIDA and NIAAA are especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators. Any individuals referenced in NOT OD 20-031 (Notice of NIH's Interest in Diversity) are expected to serve as key contributors to the biomedical research along with investigators who have a strong track record of funding. In addition, research teams should include investigators from various disciplines/departments and specialties.

Background

On September 10, 1990, the NIH Office of Research on Women’s Health was the first Public Health Service office dedicated specifically to women’s health. The Office was reaffirmed by statute in congressional legislation by the NIH Revitalization Act of 1993 to serve as the focal point for women’s health research.

On June 9, 2015, NIH issued NOT-OD-15-102, Consideration of Sex as a Biological Variable in NIH-funded Research requiring that grant applications submitted to the NIH must address sex as a biological variable (SABV) in both human and vertebrate animal grant applications.  This SABV policy extended NIH’s 1994 policy requiring inclusion of women in clinical research to requiring the inclusion of females in preclinical research.  Further, SABV policy moves beyond inclusion by requiring that SABV must be factored in the design, analysis and reporting of NIH clinical and preclinical research and that strong justification must be provided for proposing single sex research. 

To advance the field beyond changes in policy and practice relevant to the 1993 NIH Revitalization Act and NOT-OD-15-102, there is a need for research that not only includes women and sexual and gender minorities, but examines issues specific to, or highly relevant to these populations, including research that addresses health disparities among women and sexual and genderminorities. There is a similar need for research in which sex is a primary variable and/or that test interactions between biological sex and other biological variables and manipulations designed to model risk factors or manifestations of substance use disorder (SUD), including alcohol use disorder (AUD).

Research Objectives

A growing body of drug and alcohol research has been reporting outcomes that vary by sex across all domains of research, including basic, translational and clinical, resulting in a growing number of literature reviews.  This research has been encouraged by past issuances of women & sex/gender differences in drug abuse and alcohol abuse/dependence funding announcements women & sex/gender differences in alcohol and other substance use disorders (PA-14-038, PA-18-601, PA-18-602, PA-18-603).  This Notice seeks to build on those past women and sex/gender differences initiatives to advance research considering sex and gender as primary and interacting factors in alcohol and substance use disorder research by encouraging the following research approaches:

• Research that moves beyond SABV policy by seeking applications that have statistical power to detect sex/gender differences in outcomes. The research must be designed from a sex/gender-based perspective and sex/gender hypotheses must be grounded in existing sex/gender-based literature which may be within or outside the fields of drug and alcohol use disorders.

• Research that assess gender as more than a binary construct. This will make research more comprehensive in terms of representing the people in the study as well as address inequalities in substance use research and practice. Investigators are encouraged to examine the challenges faced by people who identify outside of the gender binary as well as their resilience, strengths and contributions to substance use research.
• Research that develop or adapt instruments or resources (e.g., surveys, administrative data, national data sets) to expand sexual orientation and gender identity data collection and analyses of substance and alcohol use disorders in health care and related settings.
• Research that develop robust linked data sources to examine the dyadic health of women and their infant(s) and the integration of programs that span the perinatal continuum into early childhood to improve linkages to health care, relapse prevention and recovery management services among women with substance use disorder.
• Mechanistic and bi-directional translational research that investigates mechanisms underlying well-established sex/gender differences in drug and alcohol outcomes. Underlying mechanisms span the continuum from chromosomal complement (i.e., omics, epigenetic factors, metabolism, neuroactive steroids, neural circuits, and glia cells) to a wide range of behavioral, cognitive, emotional, environmental and sociocultural factors.
• Research focused on multidirectional interactions of risk factors and co-occurring morbidities that contribute to risk-outcome processes that disproportionally or uniquely impact the health of women and/or sexual minorities with substance use disorder across the lifespan, including the reproductive life cycle (premenarche, reproductive, premenopausal, early menopausal, late menopausal and menopause).
• Research that presents opportunities for precision medicine tailored for women with substance use disorder and/or alcohol use disorder. Female-focused research is subject to the NIH SABV policy regarding justification for single sex studies.
• Research that examines the scalability and sustainability of small sets of evidence-based practices (EBPs) implemented to improve outcomes across the women's health continuum including obstetric care for women with SUD.
• Basic research in which inclusion of sex as a biological variable, and/or sex or gender as a behavioral or social variable, creates the potential to transform our understanding of the neurobehavioral and social mechanisms contributing to risk for, or resilience against, SUD/AUD, consequences of substance use or SUD/AUD, or recovery from, SUD/AUD.

Premise Considerations

As appropriate, research should be premised not only on the drug and alcohol literature base, but also on established knowledge bases of relevant broader scientific fields such as on lifespan development, gender-related sociocultural factors, sexual dimorphisms in the nervous system and other relevant biological systems such as the HPA and HPG axes. 

Analyses of Existing Data Sets

Under this Notice, investigators may request funds to perform secondary data analyses of either their own data sets or other data sets that are publicly available.  For example, NIDA's Clinical Trials Network Data Share website (https://datashare.nida.nih.gov/) currently includes HIPAA-de-identified raw data from 51 NIDA funded studies.  No approval is needed to download the data.  

Application and Submission Information

This notice applies to due dates on or after June 5, 2021 and subsequent receipt dates through September 8, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-195 - NIH Exploratory/Developmental Research Grant (Parent R21 Clinical Trial Not Allowed)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-146 - NIDA Small Research Grant Program (R03 Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DA-21-012 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Epidemiology, Prevention and Health Services Research

Keisher Highsmith, DrPH
National Institute on Drug Abuse (NIDA)
Email: highsmithks@nih.gov

Basic and Translational Neuroscience Research

Holly Moore, PhD
National Institute on Drug Abuse (NIDA)
Email: holly.moore@nih.gov

Deidra Roach, MD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Email: droach@nih.gov