Key Dates

Related Announcements

PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute on Drug Abuse (NIDA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Center for Complementary and Integrative Health (NCCIH)

Purpose

Purpose

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 explore the role of criminal legal system involvement in on-going studies.For the purposes of this opportunity, criminolegal (justice) involvement includes, but is not limited to: incarceration in a jail, prison or other detention facility; arrest (with or without charges; participation in problem solving courts, including but not limited to drug courts, mental health courts, veterans courts, tribal courts, family courts; child welfare involvement; juvenile justice; and community supervision, including probation, parole, and electronic monitoring.

NIH will support supplements to current HEAL awards that do the following: 1) add measures of criminal legal system involvement to existing studies; 2) conduct in-depth qualitative research that examines the role of criminal legal system -involvement in the context of the parent study; or 3) make adaptations to study design to better understand the influence of criminal legal system involvement on the parent study outcomes of interest.

This supplement program is not intended to enhance exploration of criminal legal system -involvement in studies that already have a criminal legal (justice) system component, but rather to add a criminal legal (justice) system component to studies that have not directly measured or considered the role of criminal legal system involvement in the original design.

Background

As the severity of opioid use increases, so does the likelihood of involvement in the criminal legal (justice) system. Often criminolegal system involvement is viewed as something that takes individuals out of community-based systems of care; however, typically this is not the case. For many forms of criminolegal system involvement, individuals remain in the community—for example, participants in drug courts or other problem solving courts are not incarcerated. For those who are incarcerated in prisons or jails, the vast majority (95%) of people are detained in these facilities only briefly and return to the community and engage with community services. People who are engaged with the criminolegal system represent a very high need population. People with recent criminal legal system involvement tend to have more health needs and more complex needs than the rest of the population: they have higher rates of mental health problems, infectious disease comorbidities, disabilities and physical disorders, chronic physical health conditions, cardiovascular diseases, suicide attempts, substance use disorders including opioid use disorders, and dependence on pain medications.

The Helping to End Addiction Long-Term® (HEAL) initiative was begun in 2019 to address rising overdose deaths in the United States, with specific attention to the roles of both pain and addiction. To date, the NIH HEAL Initiative® has funded hundreds of studies. One initiative, the Justice Community Opioid Innovation Network (JCOIN) focuses specifically on interventions targeting criminal legal (justice) system-involved populations. Outside of the JCOIN initiative, however, criminolegal system involvement (both lifetime and current) is rarely measured in HEAL studies. This is not unique to HEAL—in many national data collections and clinical trials people who are currently involved in the criminal legal system are excluded from data collection. Given the increased prevalence of comorbidities among suchpopulations, it is likely that criminal legal system involvement (historical or current) may exercise an important, yet unexplored, effects on outcomes of interest across a wide variety of HEAL studies. This is of importance both scientifically and practically, as criminal legal system involvement could have important implications for clinical care across a variety of conditions.

Research Objectives

The proposed initiative seeks to use targeted supplements to better understand the impact of criminal legal system involvement on outcomes of interest in HEAL studies. Applicants may propose to add brief measures or do more in-depth qualitative work, as is appropriate to their study design.

Current HEAL awardees may request supplements to their parent grants to address the impact of criminal legal system involvement in the following ways: 1) add measures of criminal legal system involvement to the parent study; 2) conduct in-depth qualitative research that examines the role of criminal legalsystem involvement in the context of the parent study; or 3) make adaptations to the parent study design to better understand the influence of criminal legalsystem involvement on the parent study outcomes of interest.

Examples of research questions include, but are not limited to:

• Do care providers express prejudice or hold stigma toward criminal legal (justice) system-involved patients? How do these attitudes affect the intervention being studied or outcomes of interest?
• Does a current or historical experience with the criminolegal system mediate or moderate the effects of the intervention being studied?
• Are adaptations to studied interventions necessary to address issues unique to patients with current or lifetime experiences with the criminolegal system?
• Does involvement with the criminolegal system affect adherence to study interventions?
• What are the relationships between criminal legalsystem involvement and factors such as social determinants of health (e.g., housing, family structure, healthcare coverage) or biological factors (e.g., sleep disruptions) and outcomes of interest in the parent study?

Special Considerations:

• The project team should include an investigator who has expertise in criminal legal (justice) system research. If the team does not currently include someone with this expertise, a collaborator with relevant expertise should be included in the supplement application.
• 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.
• Rather than the creation of new measurement tools to measure criminal legal system involvement, applicants are strongly encouraged to use existing psychometrically validated measures where possible. Possible sources of measures include, but are not limited to:

• Social Determinants of Health Measures in the PhenX toolkit: https://www.phenxtoolkit.org/sub-collections/view/31
• Arrest and Incarceration measures used in the NSDUH: https://www.phenxtoolkit.org/protocols/view/662402
• Core measures used in JCOIN: https://www.jcoinctc.org/resources/core-measures/

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – November 1, 2022, May 15, 2023, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-DA-23-011” (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.
• Requests may be for one year of support only.
• Budgets are limited to $100,000 in direct costs.
• All applicants must use the non-modular R&R budget.
• Eligible applications must currently be receiving funding through the HEAL initiative.
• The parent award must be active when the application is submitted. The project and budget periods must be within the currently approved project period for the existing parent award.
• Applications non-responsive to the terms of this Notice will be not be considered for this initiative.
• The Research Strategy section of the application is limited to 6 pages.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Carrie Mulford
National Institute on Drug Abuse (NIDA) (IC)
Telephone: 301-827-6473
Email: [email protected]

Tisha Wiley
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-4381
Email: [email protected]