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.
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.
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:
- Development and implementation of strategies to improve a study’s patient engagement
- Development and implementation of strategies to ensure patient diversity and inclusion
- Incorporation of engagement strategies to enhance diversity and inclusion
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.
- Specific areas of interest for patient engagement activities include, but are not limited to:
- Developing an engagement strategy that involves participants, relevant advocacy groups, community leaders, organizations, and other stakeholders
- Environmental assessments for identifying stakeholder communities relevant to the research study. Examples of environmental assessments include assessing the demographics of the community (including race/ethnicity and primary language).
- Integrating patients into the current structure of the research program, including:
- protocol development
- recruitment and retention strategy or activities
- determining meaningful trial outcomes
- including patients in a DSMB
- Implementing community health worker initiatives or peer support programs
- Developing focus groups to better understand the needs of the relevant patient populations
- Developing community advisory boards
- Enhancing of current engagement activities to include diverse patient groups and disease states
- Ensuring that patient-engagement strategies and activities take into consideration linguistic needs, cultural backgrounds, age groups, underlying health conditions and other factors that would enable appropriate representation among possible participants
- Specific areas of interest to improve diversity and inclusion of study participants include, but are not limited to:
- Addition of culturally and/or linguistically competent patient coordinators, patient navigators, or community health educators to facilitate outreach, recruitment and retention of participants
- Cultural, linguistic and/or communication training, including translators, if needed, for study personnel to assist with building rapport with participants and helping patients fully understand and participate in the study
- Development and dissemination of outreach and study materials that are culturally, linguistically, and/or health-literacy level appropriate, including costs associated with translation of materials into multiple languages
- Development and implementation of participant retention strategies such as maintaining periodic contact with participants outside of study visits (e.g. calls, email, social media, study newsletter, other mailings, etc.)
- Provision of culturally appropriate access to the study intervention or follow-up
- Accommodation for patients with diverse scheduling, travel or dependent-care needs
- Addition of culturally and/or linguistically tailored telehealth resources
- Specific areas of interest to improve both patient engagement, or diversity and inclusion of study participants include, but are not limited to:
- Refining the stakeholder engagement and inclusion process based on previous focus groups or environmental scans of appropriate advocacy groups, community-based organizations, community leaders or other stakeholders
- Setting up telehealth infrastructure to aid in patient engagement or diverse participant inclusion
- Developing strategies or purchasing equipment to promote inclusion in studies using digital health interventions
- Other novel approaches to stakeholder or patient engagement, integration of patient engagement with diversity and inclusion efforts, or increasing clinical trial diversity and inclusion
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.
- Provide details of the parent study’s strategy for participant diversity, inclusion, and/or participant and stakeholder engagement and rationale for why additional resources are needed.
- For patient engagement proposals:
- Describe methods to monitor patient engagement, including a description of how this data will be collected within the framework of the parent grant activities; clearly justify the rationale for the stakeholder or patient engagement activities selected and describe potential outcomes and any potential adverse effects associated with the activity
- Describe the plan to analyze patient engagement activities and outcomes collected as part of the supplement activities.
- Discuss feasibility of integrating community partners into study planning and implementation
- Describe the roles of community partners and the organizational and decision-making structure for the partnerships
- For diversity and inclusion proposals:
- Describe methods to monitor efforts to improve diversity and inclusion
- Include a detailed plan that outlines recruitment and retention methods that will help achieve increased diversity and inclusion
- Describe the plan to analyze diversity and inclusion activities and outcomes collected as part of the supplement activities
- Please refer to the “Inclusion of Women and Minorities as Participants in Research Involving Human Subjects” guidance and the HHS Office of Civil Rights Limited English Proficiency guidance.
- Investigators are encouraged to capture the stakeholder and patient participant experiences and be prepared to disseminate these vignettes at future HEAL meetings; patient journeys and investigator work may be highlighted on the HEAL website.
- Applicants focusing on patient engagement initiatives should assess whether their target trial population and current enrollment are suitably diverse. If the population assessment demonstrates a need for increased diversity, then a detailed plan on recruiting diverse populations also should be included in the proposal.
- Budget requests should reflect costs that are necessary and reasonable to complete the work described in the supplement application. Applicants are expected to have readily available a participant cohort necessary to complete the proposed supplemental work.
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.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
- Application Due Date(s) – Applications will be accepted through April 30, 2021, by 5:00 PM local time of applicant organization. The NOSI expires on May 1, 2021
- For funding consideration, applicants must include “NOT-NS-21-025” (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
- All applicants must use the non-modular R&R budget
- Applicants may request up to $375,000 in direct costs for the entire project period
- The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application
- The parent award must be active when the application is submitted and must be in active status for the requested duration of the supplement. The research plan should clearly demonstrate activities planned over the duration of the parent award.
- The Research Strategy section of the application is limited to six pages.
- Applicants must have at least 18 months of active support remaining on the parent grant as of the supplement application due date. The supplement period of support cannot exceed that of the parent grant. Grant awards entering a no-cost extension within 18 months of the application date are not eligible
- Applications non-responsive to the terms of this Notice will be not be considered for this initiative.
- Administrative supplement applications to PA-20-272 must use the application form package with the Competition ID that contains “FORMS-F-ADMINSUPP”. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
- Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the appropriate Institute or Center contact listed below to discuss the proposed project in the context of the parent award. Questions specific to this NOSI should be sent to the contact listed in the NOSI.
- Award section- Funds can be used to provide travel and honoraria for stakeholders, for staff who will coordinate stakeholder engagement programs, and monitoring the progress and outcomes of engagement. Investigators will be featured at a virtual HEAL meeting to share successful strategies with the HEAL and broader scientific community.