Native Collective Research Effort to Enhance Wellness (N CREW) Program - Questions and Answers (Q&A)

 

N CREW Program

1. How is the N CREW Program funded?

The N CREW Program is funded through NIH’s Helping to End Addition Long-term® Initiative, or NIH HEAL Initiative®. This Initiative bolsters research across NIH to improve (1) prevention and treatment for opioid misuse and addiction, and (2) pain management, including understanding and treating pain. Learn more about the HEAL Initiative.

2. What are the goals of N CREW?

The N CREW Program focuses on three main goals that reflect priorities for addressing the opioid/drug overdose crisis identified in Tribal Consultations (in 2018 and 2022) and through community input:

  • Support T/NASOs to lead community prioritized research projects, including research elevating and integrating Indigenous Knowledge and culture.
  • Enhance capacity within T/NASOs to conduct locally prioritized HEAL related research, accomplished through the development and provision of novel, accessible, culturally grounded technical assistance and training, resources, and tools.
  • Improve access to and the quality of data on substance use, pain, and related health and wellbeing factors to maximize their potential for use in local decision-making.

3. The work we are doing in our community aligns with the goals of the N CREW Program, but we are not sure about pursuing these current research opportunities. How can we share the work we are doing?

Currently there are two active research opportunity announcements: OTA-23-007 and OTA-23-008. Even if you are not sure about applying for either of the two active research opportunity announcements, please email us at [email protected] to let us know about your work! NIH is interested in learning about the different ways communities are addressing overdose, substance use, pain, and related factors.

4. What are the NIH’s desired outcomes and lessons learned across the N CREW Program?

N CREW embodies and recognizes that Tribes and Native American Serving Organizations (T/NASOs) are best positioned to identify and respond to community needs through culturally grounded knowledge and strategies. Therefore, we expect that the Program will lead to more sustainable community solutions stemming directly from the development of culturally-relevant research and data projects and increased capacity for research that is driven by Tribes and Native community priorities. NIH’s desired outcomes for the N CREW Program include the following and understand the outcomes and lessons learned will be community driven:

5. N CREW is described on the website as “multi-component” and in the ROAs as a “two-phase” program. What does that mean?

In short, N CREW is both multi-component in its structure and two-phase in terms of the timing of activities.

Let’s break that down:

N CREW is multi-component in structure.

Throughout the duration of the N CREW program, NIH will fund projects from two kinds of applications, each engaged in different kinds of activities. Specifically, NIH is currently inviting applications from:

1) Tribes and Native American Serving Organizations (T/NASO) who want to plan for or conduct research or data projects in their community.

And, separately

2) T/NASOs and Ally Organizations with demonstrated cultural expertise and experience to provide comprehensive training and resources to support T/NASOs awarded through the application type noted above.

NIH may also introduce other components of the N CREW Program to support achieving the broad N CREW Program goals.

N CREW is two-phased in its timing of activities.

Because the aim of the program is to build capacity of T/NASOs for engagement in research, NIH has designed the program in two phases.

Years 1 and 2 (FY24-FY25) constitute Phase I, otherwise known as the planning phase of the program. Phase I is currently open for applications. The two ROAs that are currently active (i.e., OTA-23-007 and OTA-23-008) describe Phase I activities and N CREW Program goals.

Years 3 – 7 (anticipated FY26 start) constitute Phase II of the N CREW Program. This phase is intended to support the implementation of research, projects, and activities developed by participants in each component (I.e., application type) of Phase I. Although Phase II intends to build from the learning and achievements from Phase I, the receipt of an award in Phase I does not guarantee recipients’ continuation to Phase II. NIH will release more information about Phase II at a later date.

The following table summarizes the program components and timeline:

N CREW program phase 1 at about 25 million dollars phase 2 at about 240 million dollars.

6. How are ROAs OTA-23-007 and OTA-23-008 connected with one another?

There are two ROAs that are active:

  • ROA OTA-23-007. This opportunity invites Tribes and Native American Serving Organizations (T/NASO) who want to engage in the planning, development, piloting and/or implementation of research and/or data improvement projects. As noted in this ROA, N CREW seeks to support T/NASOs to conduct community-led research and/or improve data while increasing research capacity.
  • ROA OTA-23-008. T/NASOs and Ally Organizations awarded through the OTA-23-008 will form a Native Research Resource Network. The Native Research Resource Network will provide comprehensive training and resources to support T/NASOs awarded through OTA-23-007 in real-time as they develop plans to lead research and data improvement projects. Components of the Native Research Resource Network will also provide coordination of resources, reporting, and cross-site activities.

T/NASOs awarded through OTA-23-007 and Native Research Resource Network members awarded through OTA-23-008 will collaborate to meet program objectives. Note that final activities to be performed under OTA-23-008 will be determined by the needs identified in the T/NASO research applications (via ROA OT-23-007) and in real-time over the life of the N CREW Program, in collaboration with NIH. NIH intends to fund approximately 20 awards – approximately 15 awards under OTA-23-007 and 5 awards under ROA OTA-23-008.

It is important to note that The N CREW Program is designed as agile, flexible, and innovative to reflect the complexity and diversity across communities in responding to the opioid public health crisis, also reflecting an openness to authentic collaboration with Native communities.

Given the significant diversity across T/NASOs’ existing research capacity and expansion goals, no single organization is likely to meet the needs of all T/NASOs funded through OTA-23-007. Partnership structures are also expected to require flexibility as new needs emerge and the levels and types of resources needed change. For example, T/NASOs might need to change who they partner with from the NNRN, for how long they partner with each organization, and the degree to which they need to engage with each partner. Moreover, the N CREW program aims to develop a set of resources that are accessible and relevant to all T/NASOs across the nation, not just those funded through N CREW, requiring a broad range of expertise that no single organization can provide and that cannot be fully predicted in advance.

The use of Other Transactions Authority (OTA) allows the N CREW program to provide a broad range of research support to award recipients that cannot be fully predicted in advance, meaning that new ideas or needs that arise can be addressed quickly. Additionally, OTA allows the N CREW program and participants to quickly pivot. That is, there is agility and flexibility in the ability to modify activities, partners, or formal partnership structures in response to new or evolving needs. This flexibility allows N CREW to support the discovery and creation of the best infrastructure and capacity building strategies possible.

The use of Other Transactions Authority (OTA) offers the N CREW program the unique opportunity to develop a custom program to support attaining Program goals. OTA allows NIH to provide a broad range of research support to award recipients that cannot be fully predicted in advance, meaning that new ideas or needs that arise can be addressed quickly. Additionally, OTA allows the N CREW program and participants to quickly pivot. That is, there is agility and flexibility in the ability to modify activities, partners, or formal partnership structures in response to new or evolving needs. This flexibility allows N CREW to support the discovery and creation of the best infrastructure and capacity building strategies possible through, for example, testing novel research infrastructures, bringing in new partners, etc.

7. What kinds of research and data projects are anticipated to be funded under the N CREW Program?

Topically the project must include a focus on overdose, substance use (including opioids or stimulants), or pain management. Projects may also include related factors (e.g., well-being, mental health, alcohol misuse), to support positive health outcomes in Native American communities. Within these topical areas, the specific research and data projects are expected to be diverse since they are applicant-driven and based on their community’s priorities but could broadly be classified into three areas: Projects to (1) plan for or conduct research; (2) to improve data (e.g., access, quality, availability), or: (3) to enhance capacity of your community/organization to engage in (NIH supported) research.

Projects may include, for example, planning and development of research (e.g., needs assessments, research/data project planning, expanding research capacity), pilot and feasibility assessments, and/or conducting research. This includes technology needed to collect data or conduct research. It could also include research training and development for scholars working on the proposed research. All types of research, for example epidemiology, prevention, treatment, and services studies, as well as qualitative (including oral traditions) and quantitative data collection will be considered. Applications who are proposing a new way of implementing research will also be considered. The research may or may not involve human participants (e.g., administrative data analysis, artificial intelligence/machine learning approaches). Data availability and access are also critical for research; therefore, projects that include a focus on data sovereignty and strategy development for improved data and knowledge sharing among T/NASOs, or possibly with others, also align with the priorities of the N CREW Program.

Examples of relevant projects that were highlighted during Tribal Consultations include:

  • Determining and addressing the modifiable individual or structural factors that will address health disparities in substance use and/or pain management outcomes.
  • Considering the role of holistic conceptions of health, strength-based perspectives, traditional medicine, ceremony and spirituality (where research is desired and allowed) and other approaches important within Native American communities for addressing substance misuse or improving pain management, and addressing related factors including improving mental health.
  • Increasing data relevance, accuracy, and timeliness to support local decision-making, and serve as a foundation for impactful research, and underpin the design of effective interventions.

8. Can you provide more detail about what are considered HEAL related factors?

The N CREW Program is part of the NIH’s Helping to End Addiction Long-term® (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative® bolsters research across NIH to improve (1) prevention and treatment for opioid misuse and addiction, and (2) pain management. The HEAL Initiative emphasizes a whole-person approach in which individuals and communities are understood as unique, as are risk (e.g., alcohol use) and resilience (e.g., connection to culture) factors related to substance misuse and addiction, mental health, and pain. Further, risk and resilience are understood as intersecting with individual and community-level factors and circumstances. Please keep in mind that applications must include a focus on overdose, substance use (including opioids or stimulants), or pain management and may also include related factors (e.g., mental health, wellness, alcohol use). Learn more about the HEAL Initiative.

9. The ROAs say that the N CREW Program seeks to promote wellness among Native Americans by advancing research addressing overdose, substance use, pain, and related factors. How is wellness defined?

The N CREW Program does not specify a definition of wellness. Tribes and Native American Serving Organizations (T/NASOs) that apply to conduct research or enhance data as part of the N CREW Program can define wellness based on community priorities.

Note that wellness cannot be the only outcome measured. As we just talked about, the ROA states: Projects must explicitly include a focus on overdose, substance use (including opioids or stimulants), or pain management. They may also include related factors such as mental health or wellness, among others, to support positive health outcomes in Native American communities.

10. What is research?

In the most general terms, research can be understood as a methodological approach used to answer a question; it is typically based on or meant to test or extend an existing theory or to create a new theory. The research question is important because it will drive the research project/process. The research approach should utilize methods that are well suited to answering the research question to obtain results that one can have confidence in. Additionally, the approach should be tracked from beginning to end, from the formation of the research question(s) through the reporting of results, to transparently document and demonstrate quality and reliability of the process and results.

The research process starts with an idea. This could be a local observation, or it could stem from previous research findings or frameworks. Taking this idea and turning it into a research question is the second step. From there, if you are testing or extending an existing theory, you would want to incorporate that into or let it guide your planning for the project. Then you design the research project, collect your data, analyze it, and report out your findings. If you are using research to create a new theory, you might move from your idea to your question, then move into designing your research project, data collection, data analysis and reporting of findings to ultimately lead up to being able to articulate your new theory.

There are many existing research traditions and methods – including Indigenous research methods – each with their own standards for rigor (i.e., parameters for judging quality and reliability of the research process and results). Research traditions and methods may also require the creation or refinement of standards for rigor. Further, the research processes may not always move forward in a linear fashion, meaning that sometimes steps in the process are revisited for a variety of reasons (e.g., researchers become aware of new information or theories during the process). All these factors support the use of a systematic process that is well-documented throughout the project. The NIH is committed to promoting rigorous and transparent research in all areas of science. ROA (OTA-23-007) solicits applications for T/NASOs to lead the planning, development and piloting of research and data improvement projects.

Applicants are strongly encouraged to review the companion ROA (OTA-23-008), which will support T/NASOs and Ally Organizations to provide comprehensive, real-time training and resources, and Program coordination to recipients of this current ROA. T/NASOs and the Native Research Resource Network will collaborate to meet program objectives.

It may be useful to see responses to two other questions listed in this Q&A: “What kinds of research and data projects will be funded under the N CREW Program?" and “Once projects are funded through OTA-23-007, what support and resources will be available for planning and developing our research/data project?"

11. What does it mean that the N CREW Program is a trans-NIH Program?

This means that many Institutes, Offices, and Centers within the National Institutes of Health are in support of ROAs OTA-23-007 and OTA-23-008.

Issuing Institutes and Centers include:

The following Institutes, Centers, and Offices are participating:

12. Do participating Institutes and Centers have research focuses areas for the N CREW Program?

As the ROAs state, the N CREW Program will support research that is community prioritized to improve outcomes related to the opioid public health emergency, including research and data enhancements related to addiction and/or pain. Within these broad parameters, different NIH institutes each have a different focus. Some examples of what Institutes concentrate on are provided here, but these are examples and are not meant to be limiting.

For example, there are many NIH Institutes, Centers, and Offices focused on pain research and examples of topics of interest include:

  • Understanding the biopsychosocial mechanisms of pain with a goal towards therapy development for complex human pain conditions with high unmet needs
  • Developing safe, effective, pain therapies and pain management strategies
  • Evaluating safety and effectiveness of pharmacological and non-pharmacological approaches, and models of care to improve acute and chronic pain management
  • Addressing cross-cutting research areas across multiple ICOs (pain inequities in populations experiencing health disparities; diversity and inclusion in clinical studies; pain comorbidities and under-studied pain conditions)
  • Implementing and disseminating evidence-based integrated pain management models of care into clinical practice

As another example, the National Institute on Drug Abuse (NIDA) supports culturally appropriate etiology, prevention, treatment, implementation, and dissemination research focused on opioid or methamphetamine use, alone or in combination with other drugs, among Native adolescents and adults. Specific areas of interest include, but are not limited to:

  • Research pertaining to increasing the availability of naloxone
  • Intervening to improve the uptake of medication assisted treatment (MAT) to treat opioid use disorder (OUD) or to prevent OUD
  • Etiologic or intervention research that addresses substance use (as related to opioid and stimulant overdose) and incorporates comorbid conditions, including alcohol use, suicidal ideation and other mental health conditions
  • Research that includes trauma (current and historical), either as an etiological factor or considered in the intervention, including development, implementation, or analysis of trauma-informed interventions to address SUD

While specific areas of focus are not listed for other Institutes, you can find their mission by following the hyperlinks in the previous question.

13. How is the N CREW Program funded?

The N CREW Program is funded through NIH’s Helping to End Addition Long-term® Initiative, or NIH HEAL Initiative®. This Initiative bolsters research across NIH to improve (1) prevention and treatment for opioid misuse and addiction, and (2) pain management. Learn more about the HEAL Initiative.

14. What is Other Transactions Authority?

Other Transactions Authority (OTA) is a unique type of authority that allows an agency to enter a legal agreement with a recipient organization that is not a contract, grant, or cooperative agreement. Policies and terms for individual OTs may vary between awards. Each award is therefore issued with a specific governing agreement, which is negotiated with the recipient and may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape, performance and/or availability of funds (Learn more about OTAs on the NIH website).

15. What is different about Other Transactions Authority (OTA) for the N CREW Program?

OTA offers the N CREW program the unique opportunity to develop a custom program to support attaining Program goals. This includes supporting the development of individualized solutions in real time. It is a type of funding that allows N CREW to respond to the evolving and unique needs of the T/NASOs that participate in the program.

More specifically, OTA allows NIH to provide a broad range of research support to award recipients that cannot be fully predicted in advance, meaning that new ideas or needs that arise can be addressed quickly. Because N CREW will connect T/NASOs with partnering organizations to provide the needed support to build T/NASOs research capacity, OTA is ideal for providing flexibility in the partnership selection, development and construct.

Additionally, OTA allows the N CREW program and participants to quickly pivot. That is, there is agility and flexibility in the ability to modify activities, partners, or formal partnership structures in response to new or evolving needs. This flexibility allows N CREW to support the discovery and creation of the best infrastructure and capacity building strategies possible through, for example, testing novel research infrastructures, bringing in new partners, etc.

ROA OTA-23-007 – Tribes and Native American Service Organizations N CREW Research and Data Projects

16. Can single research projects, or one-off projects, be funded under ROA OTA-23-007?

Yes. However, applicants should note that enhancing research capacity is one of the three primary goals of the N CREW Program and consider how a single project will work to enhance research capacity within the T/NASO.

17. What kinds of research and data projects will not be funded under ROA OTA-23-007?

  • Direct services in the absence of a research or research capacity component.
  • Capacity building that is not focused on HEAL related research/data projects (HEAL Website).
  • Projects that do not include a focus on topics or outcomes related to the HEAL Initiative.

18. Is the award for ROA 007 open to applications that identify a list of potential interventions to research in the proposal, with the idea that the actual intervention may be selected after the completion of a preliminary research/planning phase?

Yes, this would be an acceptable approach.

19. Would a pilot project be acceptable for this research opportunity announcement (ROA OTA-23-007)?

Yes. Phase I supports planning and development activities. Pilot projects can be included in the planning and development work.

20. ROA OTA-23-007 says 1 milestone will be to: "register study with the HEAL platform within 1 year of award." What does this entail?

Registration will occur on the NIH HEAL Initiative’s website: heal.github.io/platform-documentation. This website provides more information about how to register your study and what type of information will be collected about your study. Registration involves submitting metadata (e.g., information about the type of study or study design, type of subject such as human participants or animals, variable information, etc.) that will allow your study to be findable within the HEAL platform. Program staff and the HEAL data ecosystem developers are flexible and can work one-on-one with Investigators to make sure their study and the expected data/outcomes are represented accurately in the Platform.

Please note that registration of your study does not mean submission of the actual data. Registering your study increases transparency for collaborators and others in the research community to reach the Principal Investigators directly if they know a dataset exists. Registration can be performed by the Principal Investigator or another member of the research team.

21. Once projects are funded through OTA-23-007, what support and resources will be available for planning and developing our research/data project?

Given the significant diversity across T/NASOs’ existing research capacity and the individuated nature of community prioritized projects, the N CREW Program aims to develop supports that are comprehensive, accessible, relevant, flexible, and culturally responsive through the creation of the Native Research Resource Network (NRRN). This network can assist T/NASOs with creating or disseminating resources; identifying effective strategies and approaches to support research capacity building; identifying and/or implementing activities (including coordination) to help facilitate long-term change; finding opportunities to scale effective strategies to other communities; among many other examples. NRRN is designed to be flexible to allow for modifying supports, activities, partners, and formal partnerships structures throughout the funded project period to meet the real time needs of T/NASO awardees.

22. Does a Phase I award guarantee transition to Phase II?

No. The receipt of an award in Phase I does not guarantee recipients’ continuation to Phase II.

23. Who is eligible for this research opportunity?

T/NASOs are eligible to apply to ROA OTA-23-007. For the purposes of ROA OTA-23-007, T/NASOs are defined as federally or state recognized Tribes and/or organizations with core missions to serve and/or a track record in serving Native Americans and that are poised to reach this population. These could include, for example, community or faith-based organizations, local businesses, neighborhood authority or association, patient or consumer advocacy groups, regional/local and public healthcare systems, schools, law enforcement or criminal/juvenile justice agencies, or social service agencies.

The following T/NASO entities that are located in the United States are eligible to apply under this ROA:

Non-profits

  • Non-profits with 501(c)(3) IRS Status
  • Non-profits without 501(c)(3) IRS Status including but not limited to:
    • Faith-based or community-based organizations
    • Patient or consumer advocacy groups
    • Social service organizations
    • Healthcare systems and providers (including Federally Qualified Health Centers)
    • Schools
    • Law enforcement and criminal/juvenile justice agencies
    • Neighborhood associations

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • Tribal District Governments (with any Tribally required approvals as required by the Tribe)
  • American Indian/Alaska Native Tribal Governments
  • American Indian/Alaska Native Tribal Governments (Other than Federally Recognized)
  • business regularly employed by a T/NASO to provide fiscal management services.

Non-federal Tribal governments are eligible and their respective departments of public health, commerce, labor, transportation, housing and recreation or other departments within a Tribe.

Academic research centers, academic healthcare organizations, private healthcare organizations, and research organizations are eligible only if they are a Tribe or organization with a core mission to serve Native Americans, can demonstrate a track record of successfully meeting this mission, are poised to reach this population, and can obtain a Tribal Resolution, executive order, or letter of commitment from the Tribal authorized representative, if appropriate, before the time of award. Academic research centers that do not meet the above eligibility specifications may be identified partners in the application through an MoU, contract, subaward, etc.

If applying as a NASO, the applicant will need to document they have a core mission to serve Native Americans and are poised to lead community-prioritized research.

If applying as a business or Financial Management company, the applicant will need to demonstrate a legally binding relationship with the T/NASOs in financial matters, meet other eligibility criteria, and obtain a Tribal Resolution, executive order, or letter of commitment from the Tribal authorized representative before the time of award.

24. Who is not eligible for this research opportunity?

Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components are allowed if they maintain a legally documentable relationship to a US Tribe.

Individuals not affiliated with an organization, or who want to submit an application independent of their current organization, may not apply.

25. What are examples of Tribes/Native American Serving Organizations (NASOs)?

For the purposes of OTA-23-007 (and OTA-23-008), Tribes/NASOs are defined as federally or state recognized Tribes and organizations with a core mission to serve and/or track record in serving Native Americans and that are poised to reach this population. In OTA-23-007, examples of NASOs are provided, including for example, community organizations, local businesses, neighborhood authority or association, patient or consumer advocacy groups, regional/local and public healthcare systems, schools, law enforcement or criminal/juvenile justice agencies, or social service agencies.

NASOs must provide justification that demonstrates a core mission to serve Native Americans and that they are poised to lead Native American community prioritized research work. For example, this may be by submitting a copy of their organization’s mission statement articulating their core mission to serve Native Americans, information about its track record of partnering with Native American communities and individuals, and/or through means they deem appropriate of demonstrating their historical commitment to serving Native Americans.

26. How do I determine if my organization is a Native American Serving Organization (NASO) and eligible to apply to ROA OTA-23-007?

Tribes: All federally or state recognized Tribes are eligible to apply to OTA-23-007. Non-federal Tribal governments are eligible and their respective departments of public health, commerce, labor, transportation, housing and recreation or other departments within a Tribe.

Native American Serving Organizations (NASOs) that are not Tribes:

To determine whether your organization is a NASO and eligible to apply to OTA-23-007:

  1. Consider what entity will be the applicant organization. The applicant organization is the organization that is registered or will be registered in eRA Commons for application submission.
  2. The applicant organization must meet all eligibility requirements specified in OTA-23-007 for their type of organization:
    • If the applicant organization is an academic research center, academic healthcare organization, private healthcare organization, research organization, your entity must meet all of the following criteria to be eligible to apply as a NASO:
      • be a Tribe or organization with a core mission to serve Native Americans,
      • document a track record of successfully meeting this mission,
      • are poised to reach Native Americans, and
      • can obtain a Tribal Resolution, executive order, or letter of commitment from the Tribal authorized representative, if appropriate, before the time of award.
  3. If your entity is a business or financial management company, your entity will need to:
    • Demonstrate a legally binding relationship with T/NASOs in financial matters
    • Meet other eligibility criteria, i.e., located in the United States
    • Obtain a Tribal Resolution, executive order, or letter of commitment from the Tribal authorized representative, if appropriate, before the time of award.
  4. For all other applicant organizations, including non-profit organizations, for-profit organizations, and governments, etc., to apply as a NASO your entity must demonstrate:
    • A core mission to serve Native Americans OR a track record in serving Native Americans and
    • Are poised to reach Native Americans.

27. Can my Tribe/organization apply to this ROA (OTA-23-007) and ROA (OTA-23-008)?

Yes. T/NASOs are eligible to apply to this ROA (OTA-23-007) and the companion ROA (OTA-23-008).

28. Are ROA OTA-23-007 applicants encouraged to have experience managing federal awards?

Applicants are not required to have experience managing federal awards. They are required to have the organizational capacity and fiscal experience and/or expertise available to manage a program greater than $200,000. This expertise could be based on prior experience, partnerships (or planned partnerships) or a proposed plan to successfully manage the federal award. The purpose of the N CREW Program is to support T/NASOs as they enhance their capacity to do research; thus, it is not expected applicants will have demonstrated expertise. But all applicants should have a plan.

29. What should be included in our application ROA OTA-23-007?

Applications for both ROAs require multiple sections (see below). In general, please keep in mind that the content of your application needs to thoroughly describe your project. The application should include everything the reviewer needs to know in order to understand and assess the project.

All ROA OTA-23-007 applications should include the following sections: (1) title page; (2) abstract; (3) specific aims; (4) planned activities and approach, including a discussion of key personnel experience, a management/staffing plan, and milestones; (5) data sharing plan; (6) budget; and (7) fiscal management information. If applicable, applications should also include the following sections: (8) justification for identifying as a Native American Serving Organization, and (9) letters of support.

Details about each of these sections, including page limits, are included in the ROA.

30. What are “Specific Aims”?

Applications for ROA OTA-023-007 require that applications include a Specific Aims section (limited to 3 pages). The specific aims should discuss the broad overarching goals of the proposed project, detailing a high-level focus of the proposed work and its significance for the community and/or Native American populations. It should include a discussion of solutions or approaches that are novel or innovative for the community and culturally appropriate, also addressing how the proposed activities and/or methods can advance knowledge to address drug overdose, substance use, or pain management and other related factors such as mental health in the local communities.

31. What criteria will be used to determine what OTA-23-007 applications are non-responsive?

Applicants will be considered non-responsive if:

  • Activities include direct services in the absence of a research or research capacity component
  • Research topics are not HEAL-related
  • NASOs do not include a justification that clearly demonstrates a core mission to serve Native American populations and that they are poised to lead Native American community prioritized research work.

Applications that are non-responsive will not be reviewed.

32. How will applications be reviewed?

Responsive applications to this ROA will be reviewed by subject matter experts using a process referred to as Objective Review. The subject matter experts will include NIH and other federal staff, and external expertise as needed. The Objective Review process will use review criteria (described below) to guide the subject matter reviewers on the assessment of applications.

Each of the Objective Review Criteria listed below will be rated by reviewers using a rating scale of a) highly likely, b) moderately likely, or c) unlikely (for more details about each, see ROA OTA-23-007):

  1. Likelihood of contributing to advances in addressing substance use (including opioid and/or stimulants) and/or pain disparities for Native Americans
  2. Likelihood of accomplishing proposed activities
  3. Likelihood of forming effective collaborations and partnerships

Assessment of Overall Impact: Reviewers will provide an assessment of whether the overall proposed activities are likely to have a high, medium, or low potential impact on advancing research/data or research capacity building to address overdose, substance use, and/or pain management, also possibly including related factors such as mental health and wellness within Native American communities.

Additionally, reviewers will be asked to identify key aspects of applications that merit additional interest:

  1. Components: Laudable activities within applications that independently have potential to significantly advance the N CREW Program goals.
  2. Areas for Improvement: How applications or independent activities proposed might be improved.

Review outcomes are likely to include recommendations that could facilitate dialogue or site visits between applicants and federal staff, leading to modifications of the milestones submitted to NIH. Components of the applications may be accepted into the final plan in whole, in part, or may be omitted. The modified tasks and milestones, as shaped by the objective review process, will serve as a framework for the final negotiated terms for the resulting awards.

33. How many total awards will be made for OTA 23-007?

For OTA-23-007, NIH intends to fund approximately 15 awards. Annual budgets, per award, are anticipated to range from $200,000 to $500,000. Note that there is not a cap on the budget you may submit. Number and award levels are subject to change based on programmatic needs, funding ability, and recipient performance.

ROA OTA-23-008 The Native Research Resource Network

34. Will the NRRN be responsible for collecting or managing data?

It is possible the NRRN members will collect and/or manage data but this will be developed in real time as the Program is built out. T/NASO sites will advise on what is allowable and activities will be developed within the acceptable parameters. NRRN example activities around data collection and management include:

  • Coordinating and gathering information across T/NASOs and sites, possibly generating summary data
  • Initiating data collection activities at the request of T/NASOs or NIH
  • Providing data management and sharing support to T/NASOs
  • Coordinating any NIH/HEAL reporting requests and working with the HEAL Data Ecosystem (where appropriate and with permission from T/NASO sites)
  • Supporting dissemination of information learned throughout the program
  • Managing the coordination of comprehensive, real-time resources
  • Developing and/or selecting and maintaining collaborative infrastructure and technology to share materials, communicate updates or other information, etc.

35. Do the resources created by the Native Research Resource Network need to be Tribe specific?

No. Resources created by the NRRN do not need to be Tribe specific. NIH will prioritize resources with the broadest utility – including resources generalizable to multiple Tribes or resources developed or designated for one Tribe but adapted for others. NIH expects all Tribe specific resources to be developed in partnership with the Tribe.

36. Does a Phase I award guarantee transition to Phase II?

No. The receipt of an award in Phase I does not guarantee recipients’ continuation to Phase II.

37. Who is eligible for this research opportunity?

T/NASOs and Ally Organizations are eligible for OTA-23-008. The T/NASOs and Ally Organizations funded under this ROA are expected to be diverse in their mission and entity type, but all must document significant experience working with T/NASOs.

T/NASOs are eligible to apply to OTA-23-007 (companion ROA) and OTA-23-008.

The following entities are eligible to apply under this ROA:

Higher Education Institutions

  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • American Indian/Native American Tribal Governments (Federally Recognized)
  • American Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

  • Independent School Districts
  • Public Housing Authorities/American Indian Housing Authorities
  • Native American Tribal Organizations (Other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

38. Who is not eligible for this research opportunity?

Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components are allowed if they maintain a legally documentable relationship to a US Tribe.

Individuals not affiliated with an organization, or who want to submit an application independent of their current organization, may not apply.

39. Can my Tribe/organization submit more than one application for this ROA (OTA-23-008)?

No. Applicant organizations may not submit more than one application.

40. What are examples of Ally Organizations for ROA OTA-23-008?

For ROA OTA-23-008, Ally Organizations are defined as organizations that can document a track record of partnering successfully with Native American communities. To be eligible for OTA-23-008, Applicants must demonstrate significant experience working with T/NASOs. Applicants do not need to be a federally or state recognized Tribe or a Native American Serving Organization.

Examples of Ally Organizations include:

  • A research technical assistance organization that is not affiliated with a federally or state recognized Tribe or organization but has experience contracting with Tribes or researchers for the purpose of coordinating data collection, analysis and reporting on projects focused on Native American populations or communities.
  • A faith-based or community-based organization that is not affiliated with a federally or state recognized Tribe or organization that serves a significant number (in terms of their total community/clients) of Native Americans.
  • A Center within a University with deep experience working authentically with Tribes and Native communities.

41. What should be included in our application for ROA OTA-23-008?

Applications require multiple sections (see below). In general, please keep in mind that the content of your application needs to thoroughly describe your project. The application should include everything the reviewer needs to know in order to understand and assess the project.

All ROA OTA-23-008 applications should include the following sections: (1) title page; (2) abstract; (3) specific aims; (4) planned activities and approach, including a discussion of key personnel experience, a management/staffing plan, and milestones; (5) data sharing plan, (6) budget, and (7) fiscal management information. If applicable, include (8) letters of support.

Details about each of these sections, including page limits, are included in the ROA.

42. What are “Specific Aims”?

Applications for ROA OTA-23-008 require that applications include a Specific Aims section (limited to 3 pages). The specific aims should summarize, at a high level, the scientific, training, operational, coordination, institutional and other strategies proposed to support T/NASOs as they build research capacity and develop research projects over approximately 2 years. Describe why the proposed work is likely to yield benefits for Native communities. Describe how the proposed strategies are innovative and will advance strategies for partnering and providing research training and resources.

43. What criteria will be used to determine what OTA-23-008 applications are non-responsive?

Applicants will be considered non-responsive if they do not document strong Native American cultural expertise and experience working with Native populations.

Applications that are non-responsive will not be reviewed.

44. How will applications be reviewed?

Responsive applications to this ROA will be reviewed by subject matter experts using a process referred to as Objective Review. The subject matter experts will include NIH and other federal staff, and external expertise as needed. The Objective Review process will use review criteria (described below) to guide the subject matter reviewers on the assessment of applications.

Each of the Objective Review Criteria listed below will be rated by reviewers using a rating scale of a) highly likely, b) moderately likely, or c) unlikely (for more details about each, see ROA OTA-23-008):

  1. Likelihood of meeting N CREW Program needs
  2. Likelihood of contributing to research and/or data expertise to support t/NASOs to make advances in addressing substance use (including opioids and/or stimulants) and/or pain disparities?
  3. Likelihood of forming effective collaborations and partnerships

Assessment of Overall Impact: Reviewers will provide an assessment of whether the overall proposed activities are likely to have a high, medium, or low potential impact on advancing T/NASO led research/data to address overdose, substance use, and/or pain management, also possibly including related factors such as mental health and wellness within Native American communities.

Additionally, reviewers will be asked to identify key aspects of applications that merit additional interest:

  1. Components: Laudable activities within applications that independently have potential to significantly advance the N CREW Program goals.
  2. Areas for Improvement: How applications or independent activities proposed might be improved.

Review outcomes are likely to include recommendations that could facilitate dialogue or site visits between applicants and federal staff, leading to modifications of the milestones submitted to NIH. Components of the applications may be accepted into the final plan in whole, in part, or may be omitted. The modified tasks and milestones, as shaped by the objective review process, will serve as a framework for the final negotiated terms for the resulting awards.

45. How many total awards will be made for OTA-23-008?

For OTA-23-008, NIH intends to fund approximately 5 awards. Annual budgets, per award, are anticipated to range from $500,000 to $1,300,000. Note that there is no annual budget limit, the budget must reflect the needs of the proposed activities. The number and award levels are subject to change based on programmatic needs, funding ability, and recipient performance.

46. Are ROA OTA-23-008 applicants encouraged to have experience managing federal awards?

Applicants are not required to have experience managing federal awards. They are required to describe their organizational capacity and fiscal experience and/or expertise available, particularly with managing program costs over $200,000.

Common Questions for ROA OTA-23-007 and ROA OTA-23-008

47. If a project for either ROA includes multiple tribes delivered under the auspices of a Tribal Consortium, do we need a resolution from each Tribal Nation or will a resolution from the Consortium Board suffice? 

A resolution from each tribe will be required at the time of award.

48. Projects that include multiple PIs must submit an “MPI Plan” (also called a “leadership plan”). Does the MPI plan require its own section of the proposal or is it part of another section (and if so, which section), and does it count toward the page limit of that section and/or the application? 

For the purposes of this program, the MPI Plan and Leadership Plan are the same document and does not count toward any page limit for the application. The MPI leadership plan can either be submitted as an appendix within the single pdf application document or as a pdf attachment in ASSIST in the Leadership Plan field denoted after selecting Add Additional PD/PI. 

49. Who should attend the Teaming Meetings and how many days should we budget for this annual meeting?

Applicants should budget for a Principal Investigator and at least one other team member (or as many are anticipated as needed) to attend the Teaming Meetings. Applicants may choose different individuals and partners, but budgeting for at least two attendees for up to three days (two nights) would be a reasonable estimate (per year).

50. Are indirect costs (or F&A/Facilities and Administrative) required?

No. Indirect costs or F&A (Facilities and Administrative) are not required for this opportunity. Any indirect costs are included in the total budget and in the total award amount.

51. Can you provide guidance on indirect costs?

Applicants with an indirect/F&A (Facilities and Administrative) cost rate agreement with the Federal Government should include that amount in the total budget and in the total award amount.

If an applicant has an approved facilities and administrative costs rate agreement with the federal government, the approved rate should be reflected in the budget request. If the applicant does not have an approved facilities and administrative costs rate agreement, they may propose a rate for NIH review and consideration.

52. Which federally negotiated indirect cost (F&A) rate should a university-based research partner for our project use in calculating their budget? Should it be the approved “research,” “Other sponsored programs,” or some other rate?

The N CREW Program is a research and data capacity building project. Applicants and partners should follow their internal organizational policies for determination of which type of rate should be applied.  If a partner has an approved facilities and administrative costs rate agreement with the federal government, the approved rate should be reflected in the budget request.  If a partner does not have an approved facilities and administrative costs rate agreement, they may negotiate a rate with the applicant organization that will be subject to NIH review.

53. Is the anticipated budget range based on direct or total costs?

The anticipated budget range is meant to be a gauge for the level of funding that NIH may provide for the applicable ROAs. The final award will be based on pre-award negotiations and the final dollar amount may be more or less than the range provided. Applicants should provide a reasonable budget request based on the activity described in the application.

54. When will my application be reviewed and by whom?

We anticipate the review of responsive applications will begin in January 2024. Applications will be reviewed by subject matter experts using a process referred to as Objective Review. The subject matter experts will include NIH and other federal staff, and external expertise as needed.

55. How will awards be selected for funding?

Based on the objective review and programmatic priorities, NIH will select a subset of applicants and/or subsections of applications to negotiate award terms. Funding decisions will be based on the outcome of the objective review, programmatic priority and negotiations between the selected recipients and NIH. Agreements for all awards will be negotiated via video conference, site visit, and/or teleconferences. Final funding decisions will be based on the objective review and negotiations between selected recipients and NIH.

NIH reserves the right to:

  • Accept applications in their entirety or to select only portions of applications for award.
  • Fund projects by combining applications as part of a reorganized, consolidated consortium operating under an article of collaboration, teaming arrangement, or other means acceptable to NIH.
  • Remove applicants from award consideration should the parties fail to reach a finalized, fully executed agreement, or the applicant fails to provide requested additional information in a timely manner.

If a limited number of responsive applications are received and/or there are significant gaps in the research areas proposed, NIH may determine a need to invite additional organizations to submit an application for consideration after the posted due date. Invited applications will undergo an internal review process based on the criteria specified above.

56. Will applicants receive written feedback on their applications for ROAs OTA-23-007 and OTA-23-008?

No. Applicants will not receive written feedback on their application. However, if resources allow, NIH may provide feedback in a post review discussion call if requested by the applicant.

57. Can I appeal the outcome of the objective review?

No. Appeals of the objective review will not be accepted for applications submitted in response to this funding opportunity.

58. What are milestones?

A milestone is a finding or set of findings that signal the achievement of a specific aim in your research plan or project that can be objectively measured. An example of a poorly defined milestone is "collaborate with partners” whereas a well-defined milestone would be "Attend 4 Teaming Meetings with other N CREW Program recipients within the first 12 months of the project”

59. Where can I find a sample milestone document?

See below for a sample milestone chart. You may use this format, or any format of your choosing, in developing proposed milestones.

Milestone Task(s) Start Date (months after award) Due Date (months after award) Milestone Definition Payment
1. Develop a Research Agenda 1.1. Develop a planning committee to meet bi-weekly 0 3

Milestone name/description:

  • Determine committee members
  • Meet bi-weekly
 $7,000
1. Develop a Research Agenda 1.2. Create an initial draft research agenda 15 17

Milestone name/description:

  • Determine format of agenda
  • Create timeline for drafting agenda
 $2,000
1. Develop a Research Agenda 1.3. Share research agenda with the community for input 17 21

Milestone name/description:

  • Schedule community meetings to present agenda and collect feedback
  • Revise research agenda based on community input
 $4,000

60. Are there meetings I am required to attend?

Given that partnerships are critical to the success of the N CREW Program, NIH anticipates dedicating funding to the development and implementation of innovative strategies for fostering and sustaining partnerships. Although final plans will be determined in collaboration with N CREW funded entities, NIH anticipates recipients will support:

  • Approximately 4 teaming meetings or events (2 in-person and 2 virtual) to foster partnership building in the first year of funding
  • 2-3 ongoing special interest or cross-site workgroups
  • N CREW governance meetings (minimum of one per month)
  • Native Research Resource Network members selected to conduct cross-site coordination will also engage in routine (e.g., weekly or bi-weekly, to be negotiated) meetings with NIH

In addition, we expect that T/NASOs and the NRRN will actively participate in regular N CREW meetings and engage in regular meetings with partnering T/NASOs throughout the duration of the program.

61. What are HEAL PI Meetings?

There is a high level of coordination and sharing among NIH Health Initiative award recipients. To facilitate collaboration, N CREW award recipients will be invited to attend an annual HEAL Investigators meeting. This annual two-day meeting brings together HEAL-funded researchers across the career spectrum, federal officials, community partners, and others who are taking on pain and opioid crises from all angles, studying a broad range of topics. Applicants interested in attending this annual meeting should budget accordingly for their Principal Investigators.

62. Do I need to submit progress reports?

Yes. The frequency and types of technical and financial reports (e.g., Federal Financial Reports) required will be specified in the Agreement document, and will include, at minimum, financial status reports that will establish the burn rate for the project and a bi-annual progress report.

63. What are the data sharing requirements?

NIH updated its Data Management and Sharing Policy (DMS Policy), effective January 25, 2023. It reinforces NIH's longstanding commitment to making the results and outputs of NIH-funded research available to the public through effective and efficient data management and data sharing practices. Under the DMS Policy, NIH requires researchers to prospectively plan for how scientific data will be preserved and shared. Thus a data sharing and management plan will be required before the time of award. NIH also honors Tribal Sovereignty, and so justified exceptions to the DMS Policy requirements are allowed, as noted in the policy. A data sharing plan should provide a justification for exemptions to the DMS Policy. Please also review supplemental material to the DSM Policy for Tribes (Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data) for additional detail.

64. Since the N CREW Program is funded through HEAL, will research or data projects on pain management require the normally required Common Data Elements (CDEs)?

The NIH HEAL Initiative® supports a HEAL Data Ecosystem, which aims to accelerate sharing HEAL-generated data and results among the broad community of researchers, health care providers, community leaders, policy makers, and other HEAL stakeholders who can benefit from learning the results of initiative research. Core HEAL-defined CDEs can be found in the HEAL CDE repository. The supplemental CDEs will be added soon, in the meantime they can be accessed by contacting [email protected].

The N CREW Program, in partnership with T/NASOs, may develop common data elements that are appropriate and meaningful for Tribes and Native American Serving Organizations. While not required, we encourage applicants to consider and use the HEAL-defined CDEs for pain projects and as relevant for addiction projects. The final project requirements for all research and data projects, including clinical pain research studies, will be negotiated prior to an award.

65. What are study requirements for projects involving Human Participants?

For research involving human participants, NIH has specific requirements for research staff, and policies regarding research conduct, safety monitoring, and reporting of information about research progress. If funded, all human subjects research must be approved by an Institutional Review Board (IRB) and be conducted under a Federal Wide Assurance (FWA). Before engaging in any human subjects research, recipients must obtain Federal Wide Assurance (FWA) from the DHHS Office for Human Research Protections (OHRP), and comply with 45 CFR 46, and, as applicable, any relevant FDA regulations (e.g., 21 CFR 11, 50, 54, 56, 312, and 812) governing the protection of human subjects and the conduct, management, and oversight of clinical trials.

Recipients will need to provide to the NIH Agreement Officer/Specialist (the NIH staff person who is authorized to award Other Transactions) evidence of an active FWA prior to the commencement of any human subject research activities contemplated under this Agreement. Further, recipients must comply with all applicable laws and regulations relating to the privacy and confidentiality of human subjects.

In addition, for research involving human participants, recipients will be required to provide the number of participants they plan to recruit, and NIH will monitor progress made towards recruiting that number.

Submission Information and Process (OTA-23-007 and OTA-23-008)