Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select trainees and develop an enhanced program of coursework, mentored research experiences, and technical and professional skills development appropriate for the appointed trainees that provides added value to already existing programs.

The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels.

This Notice of Funding Opportunity (NOFO) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

The NIH HEAL Initiative has invested significant resources in research programs aimed at identifying effective, non-opioid approaches for pain management. To best leverage these investments, a large pool of highly-trained scientists, with diverse trainings and experiences, is needed. The NIH recognizes, however, that there is an early-stage clinical pain management workforce pipeline shortage which could affect the long-term goal of providing effective non-opioid options for the treatment of acute and chronic pain. The Interagency Pain Research Coordinating Committee (IPRCC) has identified barriers to growth in the clinical pain research workforce, noting a limited pipeline of early career clinical pain researchers, challenges entering the field, and a high departure rate of senior investigators and mentors from the field. The IPRCC also identified a need for early-stage researchers to receive structured research opportunities from experienced investigators within or outside of their home institutions to broaden mentorship foci.

HEAL has funded clinical pain workforce enhancement programs to provide time for mid-career and senior investigators to mentor early career trainees and support early career investigators who have not previously received NIH funding. There remains a need however, to establish a strong base of earlier stage postdoctoral fellows who would be eligible to apply to these programs and other HEAL grants in the future. Building system capacity among the clinical pain research workforce is crucial to future scientific advances in this area and to achieve HEAL’s programmatic goals.

To this end, the NIH HEAL Initiative in partnership with stakeholders has identified several research priority areas that represent significant knowledge gaps in pain research (e.g., advancing health equity in the field of pain, bioinformatics, chronic overlapping pain conditions, and effective interventions for pain and co-morbidities). Mentorship and training opportunities within these research priority areas will ensure that future generations of scientists are prepared to address HEAL’s programmatic goals. In addition, the pain management community has called for both broader adaptation of the biopsychosocial model in pain research and perspectives from fields that have not traditionally been involved in pain research. Broadening current training will expand scientific rigor and spark innovative solutions to clinical pain management. Examples of fields that have not traditionally been involved in pain science include engineering, social sciences, epidemiology, anthropology, biostatistics, computer sciences, demography, bioengineering, addiction medicine, public health, and mental health/behavioral health.

HEAL PAIN Cohort Program Description

This NOFO seeks applications to establish a cohort of up to four T90/R90 institutional postdoctoral training programs across various institutions as part of this NIH HEAL Partnerships to Advance INterdisciplinary Training for Clinical Pain Research (the HEAL PAIN Cohort Program). The NIH T90/R90 mechanism is a Kirschstein-NRSA institutional training program designed to support interdisciplinary research. This program is responsive to the IPRCC and needs assessment survey by providing protected research time and formal research training opportunities to clinical pain researchers at an early stage of their careers while broadening the foci of research mentorship. Since the goal is to increase the clinical pain research workforce, the T90/R90 Trainees/Participants must be in a clinical program or demonstrate an interest in clinical pain research. Investment at an early career stage aligns with the NIH HEAL Initiative’s goals by facilitating the retention of junior investigators in clinical pain research. Because limited opportunities exist for postdoctoral training in clinical pain research, the HEAL PAIN Cohort Program will play a critical role in meeting this programmatic goal.

The HEAL PAIN Cohort Program will promote retention in the clinical pain workforce by providing a cohort experience among T90/R90 program Trainees/Participants. A cohort refers here to a group of trainees/participants that enter together and remain together throughout the program’s duration. Other NIH Initiatives have used a cohort model citing evidence that it fosters a supportive group of talented peers and provides institutional support, ultimately enhancing the success of adult learners and promoting diversity and retention among candidates. The cohort model will be enhanced through the existing NOFO, RFA-NS-22-060, HEAL R24 Coordinating Center for National Pain Scientists (https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-060.html ; https://painresearchers.com/ ), which will provide high-quality training through webinars, networking opportunities, and other events tailored to the T90/R90 programs. However, each T90/R90 program will also be responsible for offering training opportunities to their Trainees/Participants locally at their institution.

HEAL PAIN Cohort Program Objective

The goal of the HEAL PAIN Cohort Program is to expand and enhance the pool of early career stage investigators (either those who have participated in a clinical program or who demonstrate an interest in clinical pain research) who are sufficiently prepared and trained to launch and maintain successful careers addressing the nation’s scientific needs in clinical pain research. In addition to providing protected research time and dedicated training, the program’s unique cohort approach aims to increase retention of these early career stage investigators in the clinical pain research workforce. The cohort experience also will provide networking opportunities to build partnerships between investigators in fields that are both traditionally and not traditionally represented in the field of pain, with the goal of leading to future scientific collaborations. Finally, the focus on broadening training foci to include fields outside of those traditionally represented in the field of pain as well as recruiting prospective Training PD/PIs, mentors, and Trainees/Participants from diverse backgrounds are expected to promote innovative solutions for pain management.

HEAL PAIN Cohort Program

Program Structure: The T90/R90 mechanism is designed to build interdisciplinary partnerships to train the next generation of clinical pain scientists. Each T90/R90 application should propose a partnership between at least two departments or colleges within an institution and describe how this partnership bridges traditional and non-traditional pain fields to advance training in clinical pain research. It is possible that one or more of the partnering departments or colleges may already be interdisciplinary in nature. However, it is still expected that there will be adequate representation of pain-focused researchers in one department and mentors from fields not traditional to pain research in the other department(s).

Institutions that do not currently have NIH funding for a pain-related institutional training program (e.g., T32) will be prioritized. Applications should identify how the within-institution T90/R90 partnership will provide training for at least two of HEAL’s clinical pain research content areas (listed below in alphabetical order):

(1) Advancing health equity in the field of pain

(2) Bioinformatics

(3) Chronic overlapping pain conditions

(4) Effective interventions for pain and co-morbidities, such as substance use disorder, sleep, and major depression

(5) Effects of social determinants of health on pain

(6) Implementation science

(7) Non-opioid pharmacological treatments for pain

(8) Nonpharmacological interventions for pain (e.g., behavioral approaches, mind and body approaches, and/or other complementary and integrative health approaches)

(9) Pain across the lifespan

(10) Prevention of the transition from acute to chronic pain

Training Scope: Each T90/R90 program is expected to provide mentorship that will prepare T90/R90 Trainees/Participants to launch and maintain productive careers in the clinical pain research workforce. Mentors are expected to provide training to T90/R90 Trainees/Participants both within the institution and across the broader HEAL PAIN Cohort Program, such as through webinars. The application should describe how:

(1) the biopsychosocial model of pain will be integrated into the training

(2) the program will use a team science approach by partnering with departments/colleges not traditionally incorporated in the pain field

(3) the program will create a culture to attract and retain a diverse pool of Trainees to expand scientific rigor and innovation

(4) training will be provided based on whole person health in a way that reduces stigma and bias

(5) Trainees/Participants will learn skills to thoughtfully engage and incorporate individuals from all backgrounds, including individuals from NIH-designated populations that experience health disparities with lived experience of pain and comorbid conditions in the research process

(6) training will be provided in advanced statistics and research methods

(7) Trainees/Participants will be taught grantspersonship skills, which should include how to write a grant and create a budget

(8) Trainees/Participants will be prepared to successfully apply to tenure-track positions in academic settings

(9) the program will help coordinate monthly webinars related to HEAL priority areas (e.g., engaging people with lived experience of pain in research, pain co-morbidities, addiction, prevention of pain chronification, pain across the lifespan, non-pharmacological pain interventions, and bioinformatics) that will be posted on the HEAL R24 Coordinating Center for National Pain Scientists website

Cohort Experience: A critical component of the HEAL PAIN Cohort Program is the creation of a cohort experience among all of the T90/R90 programs at different institutions. This cohort experience will be facilitated through the HEAL R24 Coordinating Center for National Pain Scientists (R24; RFA-NS-22-060) and coordination of all the T90/R90 Training PD/PI(s). The cohort experience will be achieved through the following efforts:

• The Training PD(s)/PI(s) and mentors will:
  • Organize a session at the HEAL R24 Annual National Pain Scientists Career Development Program Meeting (see section below) for all pain T90/R90 Trainees, mentors, and Training PD/PIs
  • Coordinate monthly webinars created by the T90/R90 programs
  • Organize cohort experiences among all of the funded T90/R90 Trainees across all of the funded T90/R90 institutions
  • Encourage the T90/R90 Trainees and mentors to participate in the HEAL R24 Coordinating Center for National Pain Scientists' networking events
  • Host events for postdoctoral Trainees to meet with faculty at external institutions to promote their job search within research settings
• The HEAL R24 Coordinating Center for National Pain Scientists will:
  • Post the monthly webinars created by T90/R90 programs on the HEAL R24 Coordinating Center’s website to make them broadly available.
  • Organize events that encourage a cohort experience and collaboration throughout the year for T90/R90 programs (in the HEAL PAIN Cohort Program) and T32 pain trainees (outside of the HEAL PAIN Cohort Program) across institutions, such as networking events
  • Connect T90/R90 Trainees and T32 postdoctoral trainees to HEAL funded mentors and grants on the HEAL R24 Coordinating Center for National Pain Scientists online platform
  • Enhance communication between basic, translational, and clinical pain trainees
  • Host events for T90/R90, T32, and non-T32 postdoctoral fellows to meet with faculty at external institutions to promote their job search within research settings

Annual National Pain Scientists Career Development Program Meeting (R24)

The HEAL R24 Coordinating Center for National Pain Scientists recipient will create a network of early-career pain scientists, pain trainees, and mentors (RFA-NS-22-060). The HEAL R24 Coordinating Center for National Pain Scientists has named their program Positively Uniting Researchers of Pain to Opine, Synthesize, and Engage (PURPOSE) https://painresearchers.com/. The HEAL R24 Coordinating Center for National Pain Scientists will work to improve the collaboration between basic, translational, and clinical researchers, who do not regularly collaborate or work together. One function of the HEAL R24 Coordinating Center for National Pain Scientists will be to organize an annual meeting for established scientists as well as early career pain investigators. This meeting will facilitate the creation of a network of pain research mentors and mentees as well as foster communication between scientists and clinicians of different disciplines, provide enhanced mentorship, leadership courses, and any additional trainings that might be helpful for early-career scientists. T90/R90 Trainees/Participants, Training PD/PIs, and mentors will be required to attend the HEAL R24 Annual National Pain Scientist Career Development Meeting. The T90/R90 awards should provide financial support for all Trainees/Participants, Training PD/PI(s), and up to 5 mentors to attend this annual meeting. T90/R90 grant applicants can propose up to $1,500 for travel costs for those people attending the annual meeting. The Training PD/PIs of all of the T90/R90 awards should schedule a workshop at the HEAL R24 Annual National Pain Scientists Career Development Program Meeting where the T90/R90 Trainees/Participants may be provided in-person trainings or mentoring experiences not already received, and/or Trainees can present the status of their research.

In addition, T90/R90 Trainees/Participants, Training PD/PIs, and mentors are strongly encouraged to participate in all other aspects of the HEAL R24 Coordinating Centers for National Pain Scientists program, including networking experiences and classes.

Additional HEAL Information

This 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 (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the NIH HEAL Initiative is available at: https://heal.nih.gov/.

In addition to broadening scientific inquiry, applicants should strive to promote diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the medical, clinical, behavioral and social sciences. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

The NIH HEAL Initiative encourages coordination and sharing between investigators. NIH HEAL Initiative recipients are expected to participate in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged. This Notice of Funding Opportunity (NOFO) does not allow appointed scholars to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

NINDS Rigor and Transparency

NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy). For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results. Each of the HEAL PAIN Cohort Programs will need to train and provide career development activities which should equip trainees with the following skills required for careers in the research workforce:

• Technical (e.g., appropriate methods, approaches, technologies, and quantitative/qualitative/mixed-methods analyses and reasoning)
• Operational (e.g., independent knowledge acquisition, appropriate data management, robust and unbiased experimental design, safe laboratory conduct, proper interpretation of data, transparent reporting of all results, and sharing of data and materials)
• Professional (e.g., leadership, management, and teamwork)
• Communication (e.g., how to communicate results to professional organizations, fellow clinicians, and the general public; how to give job talks)

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Other Award Budget Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this NOFO and must have the requisite faculty, staff, potential trainees/participants and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees/participants may gain relevant experiences consistent with their research interests and goals. This RFA is soliciting mentors and departments/colleges that might not be typically represented in the medical field. It is possible that not all fields use the same metrics of program success and quality, which is important to be mindful of when communicating how the program would meet the standards of success in review.

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Multi-PI team/Percent effort: Because the T90/R90 program is a collaborative effort, applicants are encouraged to use a team-science approach. Thus, it is permissible to propose a multiple Training PD(s)/PI(s) administrative/management model. HEAL will support up to 10% effort (1.2 calendar months of effort) for PD(s)/PI(s) which can be shared among MPIs. However, if a multi Training PD(s)/PI(s) administrative model is proposed, the Training PD(s)/PI(s) will need to split the % effort among themselves. For institutions/organizations proposing multiple Training PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide. The rationale for the percent effort is provided in the Role of Assessment and Evaluation Team portion of the NOFO

Training PD/PI Requirements: At least one Training PD(s)/PI(s) should be an established investigator(s) -- either (1) a mid-career investigator, defined as being within 10 years of receiving his/her/their first R01 equivalent award (https://nexus.od.nih.gov/all/2017/06/16/nih-next-generation-researchers-initiative/), or (2) a later stage investigator -- in the scientific area in which the application is targeted (clinical pain research) and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Other Training PD(s)/PI(s) should have pain expertise or expertise in a partnering field that is not traditionally involved in pain research to broaden training foci and provide a unique/innovative perspective. If a multiple Training PD/PI leadership plan is implemented, it should delineate the role of each Training PD/PI in achieving the training program’s goals. Training PD(s)/PI(s) should have funding (e.g., NIH funding, federal funding, or other sources of funding) throughout the duration of the T90/R90 award.

Training PD/PI Roles/Responsibilities: The Training PD(s)/PI(s) will be responsible for the selection and appointment of Trainees/Participants to the approved research training and research education program, and for the overall direction, management, administration, and evaluation of the interdisciplinary program. Creation of a cohort experience is crucial to the success of this program. To support the cohort experience of these awards, the Training PD(s)/PI(s) are required to coordinate with the HEAL R24 Coordinating Center for National Pain Scientists and the other Training PD(s)/PI(s) who are awarded a T90/R90 grant as part of the HEAL PAIN Cohort Program. The Training PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The Training PD(s)/PI(s) will be responsible for the day-to-day administration of the program and determine the appropriate allotment of funds. The Training PD/PI(s) are responsible for identifying a team of mentors at his/her/their institution that should also mentor the Trainees/Participants and should help provide educational content for the HEAL PAIN Cohort Program. For more information about mentors, please see the next section. The Training PD(s)/PI(s) can mentor Trainees/Participants and create webinar content to support the training experience. The content that is created by the T90/R90 program will be provided to the HEAL R24 Coordinating Center for National Pain Scientists in a timely manner so other postdoctoral fellows and pain researchers outside of the HEAL PAIN Cohort program can benefit from the content. The Training PD(s)/PI(s) are required to participate in organizing activities for the HEAL PAIN Cohort program at the Annual National Pain Scientist Career Development Program Meeting.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Assessment and Evaluation

Assessment and Evaluation Team: The proposed program must select either an individual or a team to complete this task. The Assessment and Evaluation team should be composed of people from the institution who are not identified as mentors or Training PD(s)/PI(s) in the application. In general, evaluators must have formal training and experience in program evaluation as demonstrated by publications, reports, or completion of previous program evaluations.

Percent Effort of Assessment and Evaluation Team: The Assessment and Evaluation Team can request up to 10% protected time (i.e., up to 1.2 calendar months) to conduct the roles and responsibilities for the T90/R90 program. . If there is more than 1 team member on the Assessment and Evaluation Team, they can split the 10% protected time. If there is more than one member of the Assessment and Evaluation Team, the team members are required to commit a minimum of 2% effort on this training grant. The percent effort for The Assessment and Evaluation Team is separate from that of the Training PD(s)/PI(s), mentors, Trainees/Participants, and administrative staff. The rationale for the percent effort is provided in the Role of Assessment and Evaluation Team portion of the NOFO.

Role of Assessment and Evaluation Team: The Assessment and Evaluation Team will help ensure that the Trainees/Participants receive high quality training and mentorship from the mentors within the program and help mediate any concerns that arise between Trainees/Participants and mentors. Responsibilities usually include preparing reports and recommendations for the Training PD(s)/PI(s) and institutional administrators; interacting with program staff; making recommendations for new administrative structures, policies and procedures; establishing and maintaining contact with institutional officials for the collection and exchange of information; gathering data and information; finding and evaluating alternative solutions; and making recommendations for program direction.

The overall evaluation plan should include the metrics to be used in evaluating the T90/R90 program such as the program activities completed, degree completion (if applicable), publications, fellowships/honors, any awards, including NIH fellowships and awards, subsequent positions including further postdoctoral or clinical training, and plans to obtain feedback from current and former Trainees/Participants to provide suggestions for program improvement. The program evaluation should include metrics for evaluating the program faculty and for monitoring and evaluating partnerships at the level of institutions, or departments/colleges.

The assessment team will be required to conduct a 360 assessment to assess both the mentors' and Trainees'/Participants' experiences and growth. The assessment team is also responsible for assessing (anonymously) the Trainees/Participants annually to assess the fellows' perceived benefits of the T90/R90 training program and assess whether there are any unmet training needs. The evaluator(s) may also provide the conceptual framework for institutional change and suggest ways of reducing any T90/R90 program member's resistance to recommended changes for the T90/R90 program. He/she/they will provide technical assistance, as necessary, to the Training PD(s)/PI(s) and mentors to ensure integrity and adequacy of data capture and reporting.

Diversity and Inclusion of Mentors and Trainees/Participants

Training PD(s)/PI(s) are encouraged to recruit a diverse group of prospective Mentors and Trainees/Participants. The program should strive to recruit prospective Mentors and Trainees/Participants from underrepresented groups such as individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis, individuals with disabilities, individuals from disadvantaged backgrounds, and women (see, e.g., NOT-OD-20-031). Similarly, there should be a diversity in the geographic location of the Mentors' and Trainees'/Participants' graduate training, terminal degree, and areas of expertise.

Mentors in the proposed T90/R90 program should be established independent researchers with externally-funded research projects, active peer-reviewed funding, and experience mentoring at the postdoctoral fellow level (i.e., a history of mentoring clinical or research postdoctoral fellows, including successful former trainees who have established productive careers). Mentors should have strong records as researchers, including recent publications, presentations, and successful competition for research support in the area of the proposed research training program. If a junior mentor is part of the mentoring team, it is recognized that he/she/they may have less experience in the above areas. Junior mentors should still have established research programs, external funding, recent publications, and experience giving presentations.

Mentoring Team: When building a mentoring team, at least half of the mentors should have research experience within the pain field. To broaden the training foci to include fields outside of those traditionally represented in pain research, up to half of the mentoring team should have research experience in a field that is not typically included in pain research. A mentor can have both experience in the pain research field as well as in a non-traditional pain research field. Mentors might come from one of the departments/colleges proposed for the T90/R90 partnership, or they may come from another department/college within the institution. It may make sense for Training PD(s)/PI(s) to leverage mentors/co-mentors from other institutional programs (e.g., Clinical and Translational Science Awards, CTSA) at their institution. Mentoring teams should be interdisciplinary in nature. Thus, the mentors should be composed of interdisciplinary pain researchers (e.g., a mix of psychologists, social workers, nurses, dentists, physical therapists, anesthesiologists, rheumatologists, neurologists, oncologists, and/or other health disciplines) and researchers who are not typically included in pain research.

Percent Effort of Mentors: Each mentor can request up to 10% protected time (i.e., up to 1.2 calendar months) for their effort within the T90/R90 training grant. However, each T90/R90 grant cannot request more than 50% protected time for all of their mentors combined. If, for example, there are 7 mentors within the T90/R90 program, they will have to split the 50% effort across all 7 mentors. Each mentor, at a minimum, are required to commit 5% effort on this training grant. The Training PD/PI(s), the Assessment and Evaluation Team, and administrative staff have a separate percent effort that should not be included in the 50% effort for mentors. The rationale for the percent effort for the Mentors is in the Role of Mentors portion of the NOFO.

Role of Mentors: Mentors will be responsible for mentoring Trainees/Participants, creating webinars, and creating training content that will broaden the research training foci and support an innovative training program. Mentors will be required to share their content with the HEAL R24 Coordinating Center for National Pain Scientists to support the cohort experience. The educational content will be made available to researchers who are part of the HEAL R24 Coordinating Center for National Pain Scientists to help further disseminate necessary information to the pain community at large. Up to five mentors (and a minimum of three mentors) from each of the funded T90/R90s will be required to attend and participate in the Annual National Pain Scientists Career Development Program Meeting.

Evaluation of Mentors: Training PD(s)/PI(s) and the Assessment and Evaluation Team should ensure that an annual 360 assessment is in place where the mentors can evaluate the Trainees/Participants and the Trainees/Participants can evaluate the mentors. Each mentor should be committed to the goals and objectives of the broad NIH HEAL PAIN Cohort Program across institutions and the proposed individual T90/R90 program within the institution.

Mentor Competencies: Previous work (Felming et al., 2013; Mickel et al., 2018; and Wiskur et al., 2020) has identified 6 core mentorship competencies. Training PD(s)/PI(s) and mentor biosketches should address how members of the T90/R90 mentoring team have a track record of providing mentorship in line with these core competencies. Further, letters of support from previous trainees (optional) can also help demonstrate the mentoring team's competencies in these areas. These competencies include:

• Address Diversity - a mentor's ability to identify inequities, take accountability for personal biases they bring into the mentoring relationship, participate in and/or lead programs designed to promote diversity in research, and work effectively with mentees whose personal backgrounds differ from their own
• Align Expectations - a mentor's ability to consider how personal and professional differences between the mentor and mentee impact their respective expectations, work with mentees to set expectations for the mentoring relationship and research goals, and help mentees develop strategies to meet goals
• Assess Understanding - a mentor's ability to accurately assess a mentee's level of ability to publish research, submit grants, and conduct research as well as guidance for strategies to enhance their mentee's scientific knowledge and skills
• Foster Independence - a mentor's ability to build mentees' confidence, motivate mentees, encourage mentees' creativity, and acknowledge mentees' professional contributions
• Maintain Effective Communication - a mentor's ability to actively listen to mentees, accommodate different communication styles, coordinate effectively with other mentors, build trust, and provide constructive feedback
• Promote Professional Development - a mentor's ability to help mentees gain resources, maintain balance with personal life goals, set career goals, and network effectively

Mentors should receive training throughout the academic year related to the mentor competencies. Mentors can either participate in existing training and/or create mentorship training that can be disseminated among the mentors at the local institution, as well as the other PAIN Cohort T90/R90 institutions.

Trainees/Participants

The proposed T90/R90 program will provide support to postdoctoral fellows -- either Trainees (T90) or Participants (R90) -- actively engaged in research-training and education activities. Trainees/Participants are postdoctoral fellows, or individuals with a doctoral degree (Ph.D., MD, DDS, or the equivalent) who are engaged in a temporary period of mentored research and/or scholarly training for the purpose of acquiring the professional skills needed to pursue their intended career path (https://www.trainin.nih.gov/resources/faqs/postodc_irp). Training PD(s)/PI(s) should limit appointments to individuals who are committed to a clinical pain research career. Training PD(s)/PI(s) should encourage and ensure that Trainees/Participants have appropriate skills so that they are prepared to apply for subsequent independent support for their training or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage.

T90 Trainees Trainees must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

Within the full-time training period, T90 Trainees who are training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience (for more information, see the Training Appointment Duration section below). Similarly, T90 Trainees may not accept NRSA support for clinical training that is part of a residency training leading to clinical certification in a health professional specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

For more information about NRSA requirements, please review the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

R90 Participants The non-NRSA component (R90) of the program supports postdoctoral research education experiences for individuals who have valid health professional degrees from an accredited domestic or foreign institution, who do not meet the T90 NRSA eligibility criteria, and are pursing independent clinical pain research careers (i.e., trainees at U.S. institutions who are not U.S. citizens or permanent residents).

The R90 Participants are expected to be recruited from the pool of non-citizen clinical scientists currently residing in the U.S. and who intend to pursue careers in clinical pain research at organizations located in the U.S.

R90 Participants who also are training as clinicians must devote their time to the proposed research education experience and must confine clinical duties to those that are an integral part of the research education experience (for more information, see the Training Appointment Duration section below). Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. R90 appointments may not be made for the purpose of satisfying state licensing board requirements for obtaining a U.S. license to practice clinically.

HEAL T90/R90 Requirements: Each HEAL T90/R90 will support up to 5 Trainees/Participants per year. The ratio of T90 Trainees to R90 Participants must be 4:1 or greater in any year of the award (budget support). Thus, a T90/R90 grant cannot support more than 1 R90 Participant annually. The institutions applying for the HEAL PAIN Cohort Program must be able to support T90 Trainees and R90 Participants. An individual who has served as a Training PD/PI on an NIH research grant (R01, R03, R21, P01, etc.), an individual career development award (K01, K02, K08, K23, K99, etc.), other non-training NIH grants (e.g., U-type or P-type grant, etc.), contract (N01) or Project Leads of program project (P01) grants may not be considered for Trainee/Participant support by the T90/R90 grant. Support for additional years will be based on satisfactory progress in the postdoctoral training program and the continued availability of funds. Potential Trainees/Participants applying to be trained at one of the T90/R90 centers will be required to submit a personal statement demonstrating their interest and promise in clinical pain research.

Additional information on postdoctoral eligibility: T90 and R90 postdoctoral Trainees/Participants are expected to be individuals who have received a doctoral degree (or equivalent) and are engaged in a temporary and defined period of mentored advanced training to enhance their professional skills and research independence needed to pursue his/her/their chosen career path. (See the NIH-NSF Definition of a Postdoctoral Scholar).

This notice of funding opportunity (NOFO) does not allow appointed T90 Trainees or R90 Participants to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

Training Appointment Duration: At least two years of training (and up to 3 years) is strongly recommended for both T90 Trainees and R90 Participants. Trainees/Participants are highly encouraged to apply for individual grants (e.g., K awards, F awards, R grants) as soon as they are ready. If the Trainee/Participant applies for and receives an individual grant, we would encourage the Trainee/Participant to exit the T90/R90 program to enable the awarded T90/R90 to support a new Trainee/Participant.

All Trainees/Participants are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no Trainee/Participant may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding NIH institute.

Academic Degree/Credentials: The interdisciplinary T90/R90 program is aimed at the postdoctoral level only, thus T90 Trainees and R90 Participants must have received, as of the beginning date of the appointment to the program, a doctoral-level degree (e.g., a Ph.D., D.D.S., D.M.D., M.D.,), or comparable doctoral degree from an accredited domestic or foreign institution Comparable doctoral degrees include, but are not limited to, the following: D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.PH., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D., as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Eligible postdoctoral Trainees/Participants include individuals with either a health professional doctoral degree (e.g., D.D.S., D.M.D., M.D.) or a Ph.D. Individuals with a Ph.D. who do not have a health professional degree must be committed to pursuing clinical pain research. Individuals in postgraduate clinical training who wish to interrupt their studies for one year or more to engage in full-time research training before completing their clinical postdoctoral training programs, also are eligible. Each T90/R90 program should include an interdisciplinary cohort. Thus, when Training PD(s)/PI(s) are selecting Trainees/Participants, they should select healthcare Trainees/Participants with differing training backgrounds (e.g., a mix of psychologists, social workers, nurses, dentists, physical therapists, anesthesiologists, rheumatologists, neurologists, oncologists, and/or other health disciplines) and interdisciplinary Trainees/Participants who do not have healthcare professional degrees.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the Training PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Laura Dover Wandner, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424 (R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training/career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of Trainees/Participants including their levels (i.e., postdoctoral) and intended Trainee/Participant outcomes.

Assessment and Evaluation Team (limit 3 pages): The Assessment and Evaluation Team will be responsible for the evaluation component that must use quantitative and qualitative methods to assess program outcomes at the Trainee/Participant and the institutional levels. Applications without an evaluation plan will not be reviewed. Describe how the evaluator(s) will function in implementing the proposed program evaluation/assessment plan and the evaluation of the overall effectiveness of the program. Please describe how the evaluator(s) will collect feedback from Trainees/Participants and mentors, how the evaluator(s) will provide feedback about the program to the Training PD(s)/PI(s), and how the program will adapt if change is necessary for the success (e.g., growth and development of the Trainees/Participants and likelihood of the Trainees/Participants receiving an independent NIH award) of the Trainees/Participants. Describe the format of the 360 assessment, wherein Trainees/Participants evaluate mentors and mentors evaluate Trainees/Participants. Please name your Assessment and Evaluation Team file Assessment_Evaluation_Team.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide.

Training and Research & Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Both the Training Budget Component and the R&R Budget Component are required for a complete application.
• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of trainees, and other factors that contribute to the overall environment of the program.

Program Plan

Program Administration

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Training PD(s)/PI(s). Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple Training PD(s)/PI(s), then the plan for Program Administration is expected to synergize with the Multiple Training PD/PI Leadership Plan section of the application, if applicable.

Describe how the level of institutional (or school/department) commitment to research and training will promote the success (e.g., growth and development of the Trainees/Participants and likelihood of the Trainees/Participants receiving an independent NIH award) of the Trainees/Participants in the T90/R90 program.

Since each T90/R90 program will be asked to collaborate with the other HEAL PAIN Cohort T90/R90 programs as well as with the HEAL R24 Coordinating Center for National Pain Scientists, please describe characteristics of the institution, Training PD(s)/PI(s), and mentors that will facilitate collaborative relationships with other institutions/organizations.

Proposed Training for the T90/R90 Program

Provide an overview of the proposed T90/R90 program and describe the immediate and long-term objectives of the proposed program.

The activities supported by the T90/R90 program will occur at the institutions with research-intensive environments using the NRSA Training guidelines. The application should demonstrate how the program will build interdisciplinary partnerships to train the next generation of scientists. The application should also demonstrate how it will build a partnership between at least two colleges or departments within an institution and describe how this partnership will bridge fields that are traditional to and not traditional to clinical pain research. Applications should identify how the within-institution T90/R90 partnership will provide training for at least two of HEAL’s clinical pain research content areas (listed below in alphabetical order):

(1) Advancing health equity in the field of pain

(2) Bioinformatics

(3) Chronic overlapping pain conditions

(4) Effective interventions for pain and co-morbidities, such as substance use disorder, sleep, and major depression

(5) Impacts of social determinants of health on pain

(6) Implementation science

(7) Non-opioid pharmacological treatments for pain

(8) Nonpharmacological interventions for pain (e.g., behavioral approaches, mind and body approaches, and/or other complementary and integrative health approaches)

(9) Pain across the lifespan

(10) Prevention of the transition from acute to chronic pain

Training Scope: The application should demonstrate how the mentoring team demonstrates the competencies described in the Mentor Competencies section to best prepare T90/R90 Trainees/Participants to succeed in the clinical pain research workforce. The application should describe how:

(1) the biopsychosocial model of pain will be integrated into training

(2) the program will use a team science approach by partnering with departments not traditionally in the pain field

(3) the program will create a culture to attract and retain a diverse pool of Trainees/Participants to expand scientific rigor and innovation

(4) training will be provided based on whole person health in a way that reduces stigma and bias

(5) Trainees/Participants will learn skills to thoughtfully engage and incorporate people from diverse backgrounds with lived experience of pain and comorbid conditions in the research process

(6) training will be provided in advanced statistics and research methods

(7) Trainees/Participants will be taught grantpersonship skills, which should include how to write a grant and create a budget

(8) Trainees/Participants will be prepared to successfully apply to tenure-track positions in academic settings

(9) the program will help coordinate monthly webinars related to HEAL priority areas (e.g., engaging people with lived experience of pain in research, pain co-morbidities, addiction, prevention of pain chronification, pain across the lifespan, non-pharmacological pain interventions, and bioinformatics) that will be posted on the HEAL R24 Coordinating Center for National Pain Scientists website

The planned training and career development activities should equip Trainees/Participants with the following skills required for careers in the clinical pain research workforce:

• Technical (e.g., appropriate methods, approaches, technologies, and quantitative/qualitative/mixed-methods analyses and reasoning)
• Operational (e.g., independent knowledge acquisition, creation of budgets, appropriate data management, robust and unbiased experimental design, safe laboratory conduct, proper interpretation of data, transparent reporting of all results, and sharing of data and materials as described at https://www.ninds.nih.gov/Funding/grant_policy
• Professional (e.g., leadership, management, teamwork/interdisciplinary, mentorship, inclusivity, and work-life balance to promote retention)
• Communication (e.g., to professional organizations, to fellow clinicians, how to communicate results to non-researchers, and how to give job talks)

These activities should include formal programmatic activities that:

• Reinforce the principles of sound experimental design and the appropriate use of statistics, such that they will foster an understanding of the critical need for the rigorous application of the concepts covered and their incorporation into the Trainees'/Participants' individual research.
• Provide Trainees/Participants with an understanding of the use and value of quantitative and/or qualitative analytic and reasoning skills that are likely to significantly enhance Trainees' data literacy and understanding of the clinical pain experience.
• Ensure that Trainees/Participants gain a thorough understanding of the principles of scientific rigor described above as well as their application to their individual research and to their written and oral research communications.

T90/R90 programs may include additional activities in any of the components that they deem appropriate to address Trainee/Participant-specific academic and research needs and that will significantly contribute to their development as successful independent investigators. In addition, applicants may include didactic and curricular development activities designed to improve the institutional capacity and Trainees'/Participants' skills in clinical research such as courses and/or certifications in integrative health clinical research. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the T90/R90 program and mentored research experiences and activities. In order for the Trainees/Participants to fully benefit from the proposed program, applicants are strongly encouraged to design and develop programs where Trainees/Participants experience activities implemented at the other T90/R90 institutions or through the HEAL R24 Coordinating Center for National Pain Scientists. Institutional program-supported activities (i.e., seminars, conferences, workshops) should not be confined to Trainees/Participants in the HEAL PAIN Cohort Program, but rather should be open to anyone interested.

The institution must have a strong and high-quality curriculum and research program in the area(s) proposed under this NOFO and must have the requisite faculty and facilities on site to conduct the proposed institutional program.

Proposed T90/R90 programs should provide detailed plans to help transition Trainees/Participants to other research and/or career opportunities by the end of their time in the HEAL PAIN Cohort Program.

Cohort Experience: The application should propose how applicants plan to create a cohort experience among Trainees/Participants within their T90/R90 program as well as describe characteristics of the institution, Training PD(s)/PI(s), and mentors that will help build collaborative relationships with other HEAL PAIN Cohort funded T90/R90 programs to facilitate a cohort experience for all HEAL PAIN Cohort Program Trainees/Participants.

Webinars/Course Content: The application should demonstrate the types of webinars and course content that the T90/R90 team could provide to Trainees/Participants within their institution as well as share with (1) the T90/R90 Trainees/Participants at other institutions and, (2) the HEAL R24 Coordinating Center for National Pain Scientists. The application also should demonstrate how an awarded T90/R90 program will work with the HEAL R24 Coordinating Center for National Pain Scientists and/or the other T90/R90 funded programs to coordinate sharing of content.

Mentors

The application must include information about the faculty who will be available to serve as T90/R90 mentors and provide guidance and expertise appropriate to the level of Trainees/Participants proposed in the application. Describe the complementary expertise, interdisciplinary nature, and experiences of the proposed program mentors, including active research and other scholarly activities in which the faculty are engaged, as well as their experience mentoring and training individuals at the postdoctoral and early stage investigator levels. If there are any junior program mentors included in the faculty, please describe a plan to ensure successful guidance for these individuals, e.g., through faculty training in mentorship, co-mentoring arrangements with an experienced mentor, or other plans to ensure high quality mentorship to all Trainees/Participants.

Provide a narrative description of the past research training record of the program mentors including the success of former trainees in establishing productive independent research or research-related careers. Evidence of success can include completion of programs and further career advancement of former trainees, such as receipt of fellowships and/or career development awards, further predoctoral, postdoctoral or other training appointments; successful competition for research science positions in industry, academia, government or other research venues and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of honors, awards or patents, high-impact peer-reviewed publications, promotion to scientific leadership positions, and other measures of success that demonstrate scientific rigor, innovation, and independence.

The application should include plans to provide training or workshops for program faculty on effective and equitable approaches to research career mentoring (at the postdoctoral/early-stage investigators) to ensure that all mentors in the training program have an opportunity to discuss mentoring challenges and solutions, and ultimately enhance the diversity and success of all Trainees/Participants in the program in their pursuit of research careers.

The application should include information about the program faculty who will serve as mentors and, if relevant, distinguish between faculty members who will serve as primary mentors and those who have other roles in the training program. It should expand on the information in the biosketches (see "Participating Faculty Biosketches") to address the following:

• How the program will ensure the involvement of participating mentors in equipping Trainees/Participants to approach their research with the utmost rigor and transparency, with attention to robust experimental design, minimization of potential experimenter biases, appropriate statistical and quantitative/qualitative/mixed methodology, proper interpretation of data, and transparent reporting of all results as described at https://www.ninds.nih.gov/Funding/grant_policy
• A plan for monitoring participating faculty to ensure their contribution to high-quality mentorship, attention to robust and unbiased experimental design, transparent reporting and sharing of data and materials, promotion of quantitative literacy, and creation of an inclusive environment that welcomes varied perspectives of both trainees and faculty
• Evidence of their ability to create a supportive and inclusive environment for Trainees/Participants across diverse backgrounds, such as trainings completed related to diversity, equity, inclusion, and accessibility; lab infrastructure to support and be inclusive of Trainees/Participants from diverse backgrounds, including individuals from underrepresented groups.

Trainees (T90) and Participants (R90)

In general terms, describe the pool of potential Trainees/Participants including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective Trainees/Participants. Describe plans to recruit and select a group of interdisciplinary Trainees/Participants and explain how these plans will be implemented (see also section on Recruitment Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of Trainees/Participants and pairing them with mentors. A required component for evaluating the Trainees/Participants will involve Trainees/Participants submitting a personal statement demonstrating their interest and promise in clinical pain research. Provide brief summaries of training plans that the program will employ for Trainees/Participants to help them become independent clinical pain researchers. The application should contain a description of how training plans will be tailored to the needs of the prospective Trainees/Participants, based on their past experiences and competences. Training Plans should include specific goals for research involvement each year, including publication submissions, research presentations, grant applications, etc. Describe program activities intended to develop the working knowledge needed for Trainees/Participants to select among and prepare for the next step in career options available in the workforce. For example, programs should provide all Trainees/Participants with instruction and training in oral and written presentation and in the skills needed to apply for individual fellowships (F), career development awards (K), or research awards (R).

Institutional Environment and Commitment to the Program

The application should describe how the level of institutional and departmental commitment to research and training will promote the success of the Trainees/Participants and T90/R90 program. Assurances of the institutional commitment should be provided in the Letters of Support section of the application.

Appropriate institutional commitment includes the provision of adequate staff, facilities, and resources that can contribute to the planned program. Institutions that propose programs must provide evidence of the institution's ability to establish or successfully implement an interdisciplinary training program. Institutions are encouraged to identify resources that would support the well-being of postdoctoral Trainees/Participants, as needed, such as a student wellness center, university ombudsman, etc.

Institutional commitment to promote diversity and an inclusive research environment should be described, i.e., describe institutional and departmental environments in which Trainees/Participants from all backgrounds are integrated into, and supported by, the institution, and how the institution plans to recruit prospective mentors from diverse backgrounds, including individuals from groups underrepresented in research (see, e.g., NOT-OD-20-031).

Applications must include a separate letter on institutional letterhead signed by a key institutional leader that describes institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices as described in NOT-OD-19-029 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-029.html).

Letters of Support

Include letters of support for all of the proposed mentors and members of the Assessment and Evaluation Team. Include letter(s) of support from the training institution department(s) and/or college(s). The Training PD(s)/PI(s) are encouraged to provide one or more letters of support from past post-doctoral fellows who can speak to the Training PD(s)/PI(s) ability to mentor early-stage researchers.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All Training PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with applications instructions by NINDS and responsiveness by components of participating organizations (NIH). Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

Webinar

In order to learn more about this RFA and to have the opportunity to ask questions, a pre-application webinar will be held on June 26th from 12:00-1:00pm EST (9:00-10:00am PST). Information on how to join the webinar is provided below.

RFA-NS-24-015: HEAL Initiative Partnerships to Advance INterdisciplinary (PAIN) Training in Clinical Pain Research: The HEAL PAIN Cohort Program (T90/R90 Independent Clinical Trial Not Allowed)

To join the web presentation:

https://nih.zoomgov.com/j/1616586014?pwd=R1hiTW1lcWJaaUdvSDJaaHFpZ0Q1QT09

Meeting ID: 161 658 6014

Passcode: 699032

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Meeting ID: 161 658 6014

Passcode: 699032

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

• Does the T90/R90 program propose to provide supportive and dedicated mentorship in accord with all of the competencies defined in the Mentor Competencies section in at least two of the 10 outlined HEAL research focus areas?
• Does the proposed training plan incorporate all nine elements of the required training scope?
• Does the application propose a partnership between at least two colleges or departments within one institution that include fields traditionally and not traditionally involved in clinical pain research? Does the application discuss how this partnership will broaden training foci and lead to innovative collaborations and areas of clinical pain research? Does the application describe how the Training PD(s)/PI(s) and mentors from different colleges/departments will work together to maintain effective and collaborative partnerships throughout the duration of the award?
• Will the level of institutional (or school/department) commitment to research and training promote the success of the Trainees/Participants in the T90/R90 program?
• Does the T90/R90 program create a research environment, a culture, and training opportunities that will attract and retain Trainees/Participants from diverse backgrounds (e.g. diverse training, experiences, scientific disciplines, etc.), including those from underrepresented groups? Does the application outline a Trainee/Participant recruitment plan?
• Does the program, planned coursework, mentored research experiences, and structured activities equip Trainees/Participants with the technical (e.g., appropriate methods, approaches, technologies, and data reasoning), operational (e.g., independent knowledge acquisition, appropriate data management, robust and unbiased experimental design, safe laboratory conduct, proper interpretation of data, transparent reporting of all results, and sharing of data and materials), and professional (e.g., leadership, communication, management, and teamwork) skills required for careers in the clinical pain research workforce? Is the training program likely to attract and appeal to a diverse group of Trainees/Participants (e.g. diverse training, experiences, scientific disciplines, etc.), including those from underrepresented groups, who will ultimately enhance the pain research workforce?
• Do formal programmatic activities reinforce the principles of sound experimental design and the appropriate use of statistics, such that they will foster an understanding of the critical need for the rigorous application of the concepts covered and their incorporation into the Trainees'/Participants' individual research? Do these activities provide Trainees/Participant with an understanding of the use and value of quantitative and/or qualitative data reasoning skills and approaches for clinical pain research that are likely to enhance their data literacy significantly and encourage them to adopt a data-driven mindset?
• Do these activities ensure that Trainees/Participants gain a thorough understanding of the principles of scientific rigor as well as their application to their individual research and to their written and oral research communications?
• Does the institution have a clear plan of how they will handle Trainees/Participants and Mentors who are not meeting the institutions definition of success based on the evaluations conducted by the Assessment and Evaluation team?

Cohort Experience

• Do the Training PD(s)/PI(s) and mentoring team have characteristics that will allow them to effectively work with investigators outside of their institution to create a cohort experience for Trainees/Participants? Does the application demonstrate a history of successful collaborative relationships among faculty within the T90/R90 program and a track record of successful collaborative relationships between T90/R90 faculty and investigators outside of the institution?
• Does the application describe the team’s approach to creating webinars, didactics, seminars, workshops, and/or curriculum content that can be used by T90/R90 Trainees/Participants as well as trainees outside of the HEAL PAIN Cohort program? How will faculty in the T90/R90 program work with the HEAL R24 Coordinating Center for National Pain Scientists to facilitate a cohort experience for Trainees/Participants?
  

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the Training PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program? Does the application demonstrate a history of clinical pain research mentorship competencies as defined in the Mentor Competencies section?
• Does the Training PD/PI plan to commit sufficient effort to ensure the program’s success?
• The Training PD/PI will have to work well with the PURPOSE network, Training PD(s)/PI(s) at other HEAL PAIN Cohort institutions, and the mentors at their institutions. Does the Training PD/PI have a track record and/or characteristics that suggest that he/she/they work well with other collaborators?
• For applications designating multiple Training PDs/PIs:
  • Is a strong justification provided that the multiple Training PD/PI leadership approach will benefit the training program and the Trainees/Participants?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the Training PDs/PIs?

Mentors

• Are sufficient numbers of experienced mentors with appropriate expertise and funding available to support the number and level of Trainees/Participants proposed in the application? Are the mentors' roles adequately described and appropriate?
• Do the mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the mentors have strong records of training individuals at the level of Trainees/Participants proposed in the program? Do they demonstrate mentorship competencies as defined in the Mentorship Competencies section? Are appropriate plans in place to ensure that mentors lacking sufficient research training experience are likely to provide strong and successful mentoring? Does the application provide evidence that mentors have a history of successful mentorship, such as evidence that they have a history of creating welcoming/supportive/inclusive training environments for trainees to flourish and that their former trainees have established independent research programs? Are at least half of the mentors experienced in clinical pain research? Are up to half of the mentors working in a field that is not traditionally involved in pain research?
• Does the application outline a yearly mentoring training plan for all mentors? Will the proposed training enhance the mentors' 6 core mentorship competencies?
• Does the mentoring team demonstrate how they will train Trainees/Participants to succeed as independent clinical pain researchers?
• Has the mentoring team demonstrated how they will broadentraining foci in a way that will lead to innovative collaborations and areas of clinical pain research?
• Do mentors have adequate training in culturally responsive mentorship that will help create a supportive and welcoming environment for Trainees/Participants from diverse backgrounds (e.g. diverse training, experiences, scientific disciplines, etc.), including those from underrepresented groups?
• If a junior mentor is part of the mentoring training team, is there an adequate plan to ensure successful mentorship from junior career-level mentors?
• Does the proposed group of mentors represent a group with complementary and diverse expertise, and experiences? Are the mentors' specialties interdisciplinary in nature?
• Does the application proposing training for mentors that will ensure all mentors can discuss mentoring challenges and solutions??
• Is there evidence of mentors' willingness and capacity to collaborate with the HEAL R24 Coordinating Center for National Pain Scientists and the other T90/R90 awardees, with the goal of supporting a cohort experience among all HEAL PAIN Cohort Program Trainees/Participants?
• Will the program ensure the involvement of participating mentors in equipping Trainees/Participants to approach their research with utmost rigor and transparency, with attention to robust experimental design, minimization of potential experimenter biases, appropriate statistical methodology, proper interpretation of data, and transparent reporting of all results?
• Does the program have a comprehensive plan for monitoring participating faculty for their contribution to high-quality mentorship, attention to robust and unbiased experimental design, transparent reporting and sharing of data and materials, promotion of data literacy, and creation of an inclusive environment that welcomes varied perspectives of both Trainees/Participants and faculty?

Trainees/Participants

• Is a recruitment plan proposed with strategies likely to attract well-qualified Trainees/Participants for the training program? The T90/R90 Trainees/Participants must be in a clinical program or demonstrate interest in clinical pain research.
• Is there a competitive applicant pool of postdoctoral fellows of sufficient size and well-qualified to ensure a successful training program?
• Does the recruitment plan implement best practices for recruiting and training a diverse and interdisciplinary group of Trainees/Participants included in the T90/R90 program?
• Is there evaluation criteria to select Trainees/Participants? A required component for evaluating potential Trainees/Participants will involve submission of a personal statement demonstrating their interest and promise in clinical pain research.
• Does the application describe how the training plan will be tailored to the Trainees'/Participants' needs? Is the training plan likely to enhance the Trainees'/Participants' ability to attain an independent research career in clinical pain science?
• Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?
• Is there evidence that the Trainees/Participants will receive appropriate training in and adhere to the highest principles of rigorous research, including robust and unbiased experimental design, proper interpretation of data, transparent reporting of all results, and sharing of data and materials?

Training Record

• HEAL is planning on prioritizing institutions who do not have, or previously had, a T32 grant related to clinical pain research. Please assess whether the institution currently has, or previously had, a T32 institutional grant related to clinical pain research.
• Does the application provide evidence that the Training PD(s)/PI(s) and mentoring team have a history of mentoring early-stage trainees to become productive independent researchers?
• Does the proposed mentoring team and institution have a history of successfully mentoring early-stage trainees? ?
• Have the former trainees of the Training PD(s)/PI(s) and proposed mentors been productive in terms of their research accomplishments, publication of research conducted during the training period, and subsequent appointments (training or independent research) and fellowship or career development awards?
• How successful are the Training PD(s)'/PI(s)' and mentors' past trainees in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
• Is there evidence that this program can augment the clinical pain research workforce by preparing Trainees/Participants for independent research positions?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former Trainees/Participants?

Assessment and Evaluation Team

• Does the application propose an individual or a team to complete the Assessment and Evaluation of the T90/R90 program?
• Does the Assessment and Evaluation Team have formal training and experience in program evaluation?
• Will the program evaluation and oversight promote a welcoming and accepting environment where Trainees/Participants, and mentors, will feel empowered to voice concerns and report unacceptable behavior and poor mentor performance? Is there a proposed approach for the 360 assessment?
• Does the Assessment and Evaluation Team have formal metrics to evaluate the success of the program, both at the institutional and Trainee/Participant level? Does the grant propose a plan in place to adapt and change based on feedback from Trainees/Participants, mentors, and Training PD(s)/PI(s)?

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

• Additionally, a completed Payback Agreement Form (PHS Form 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.

• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within five years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in clinical pain research
• Subsequent participation in research or employment in clinical pain research
• Authorship of scientific publications in clinical pain research
• Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Karen A. Kehl, PhD, RN
National Institute of Nursing Research
Telephone: 301-594-8010
Email: [email protected]

Laura D. Wandner, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Linda Porter, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-9350
E-mail: [email protected]

Anissa F Brown, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-5006
E-mail: [email protected]

Shelley Su
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-402-3869
E-mail: [email protected]

Nastaran Zahir, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6333
Email: [email protected]

Rachel Altshuler, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5873
Email: [email protected]

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Mark Egli, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: [email protected]

Helena H. Ahn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3207
Email: [email protected]

Rebecca N Lenzi, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: (301) 402-2446
E-mail: [email protected]

N/A

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Kathleen Moy
National Institute on Aging (NIA)
Phone: 301.827.2856
E-mail: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A and 45 CFR Part 75 and 2 CFR Part 200.