EXPIRED
March 5, 2021
NOT-NS-22-066 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PA-20-272 - HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Sexual and Gender Minority Research Office (SGMRO)
National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
This Notice of Special Interest (NOSI) provides an opportunity for clinical trials and studies funded by the Helping to End Addiction Long-Term (HEAL) initiative to address challenges of recruitment, retention and engagement of populations suffering from pain and opioid use disorder.
NIH will support supplements to current HEAL awards that would either 1) enhance their patient, community, and other stakeholder engagement efforts or 2) improve recruitment, retention and inclusion of participants from U.S. racial and ethnic minority populations; or 3) both, as appropriate for a particular study.
This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity and inclusion in HEAL clinical studies. Activities proposed must be within the scope of the approved aims of the parent award.
Background
The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose.
Developing strategies to engage study participants and ensure a diverse and inclusive clinical trial are distinct goals but they can have common elements and both are likely to result in stronger studies.
Patient and stakeholder engagement
Patient and stakeholder engagement in the clinical trial context is the act of soliciting and incorporating the perspective of participants and their communities throughout the lifespan of a study, from early conception of a research question through study design and implementation and bringing an intervention into real-world settings.
Engaging patients in research contributes to successful study implementation and helps translate study results into practice, potentially improving health outcomes. Patients can share their experiences to ensure that endpoints, protocols and outcomes are relevant to their needs. Continued engagement can improve patient retention and adherence to the study protocol.
Seeking patient input throughout the course of clinical research is increasingly seen as essential, and patient engagement strategies and protocols built into studies may be particularly important for research on pain and opioid use disorder. Engagement can help build trust in patient communities that may be fearful of participating in clinical research because of stigmas around addiction. As the pain and opioid use disorder’s field explores new treatment options, input from patients, caregivers, and family members can provide valuable perspectives about whether novel interventions would be beneficial.
Clinical Study Participant Diversity and inclusion
The NIH is mandated by the Public Health Service Act, sec. 492B, 42 U.S.C. sec. 289a-2, to ensure inclusion of women and minority groups in all NIH-funded clinical research in a manner that is appropriate to the scientific question under study. More information can be found at https://grants.nih.gov/policy/inclusion/women-and-minorities.htm. Yet racial and ethnic minorities remain underrepresented in scientific research.
Given that clinical trials and studies supported by the HEAL Initiative are occurring across clinical trials and studies spanning nearly every state, there is an unprecedented opportunity to recruit a diverse group of participants that mirrors the United States population, and bolster health equity in pain management and opioid use disorder. Clinical studies are an essential tool for translating research findings into effective treatments and for supporting improvements in the day-to-day lives of patients. However, the limited representation of underserved racial/ethnic minority populations that experience health disparities in scientific research despite increasing diversity in the United States jeopardizes the generalizability of study findings, increases the risk of perpetuating and exacerbating health disparities and decreases the quality of health care for all. This long-recognized disproportional representation is attributable to complex factors of social determinants of health such as access to healthcare, distrust of the healthcare system, racism/discrimination, stigma, demographic and socioeconomic factors, as well as bias from health care providers in enrolling racial/ethnic minorities in clinical trials. Disparate recruitment strategies, perception of research, and barriers to cross-cultural communication are also contributing factors.
An inclusive clinical study takes into account factors that facilitate or deter participation of underrepresented groups by ensuring that the research team possess appropriate linguistic and cultural competence to enable recruitment and retention of racial/ethnic minority populations. Logistical concerns such as accommodating work schedules, transportation, and dependent-care needs are important factors that when considered throughout the research process can promote a more inclusive study.
Research Objectives
HEAL has allocated substantial funding to establish and follow different cohorts of patients with acute and chronic pain and opioid use disorder. The administrative supplement mechanism will support the ability of ongoing studies to develop appropriate stakeholder and patient engagement programs, and to improve diversity and inclusion within the cohorts as appropriate for the study.
Areas eligible for funding under this administrative supplement request include, but are not limited to:
The supplemental funding will cover costs that are not requested in the parent award. Appropriate costs should be associated with achieving the supplemental research objectives described above.
Note: Applications that propose an additional clinical trial or any other study designed to test and administer an additional intervention are not appropriate for this administrative supplement.
Requirements
This supplement is not meant to offset costs incurred due to the COVID-19 pandemic.
Application and Submission Information
Applications for this supplement must be submitted through eRA Commons using the following opportunity.
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
Please direct general inquiries to:
Danielle Haney, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
[email protected]
Cheryse Sankar, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
[email protected]
Please direct program specific questions to:
Alexis Bakos, PhD, MPH, RN
National Cancer Institute (NCI)
[email protected]
Melissa Ghim, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-7853
Email: [email protected]
Marcyi Fitz-Randolph, DO, MPH
National Institute on Drug Abuse
[email protected]
Maurice Davis, DHA, MPA-MHSA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6887
Email: [email protected]