National Institutes of Health (NIH)

PAR-23-151: Emergency Medicine Research Career Development Program in the Neurological Sciences (EMRCDP-NS) (K12 – No Independent Clinical Trial Allowed)

Slots: 1

Deadlines

Internal Deadline: Friday, June 9, 2023, 5pm PT

LOI: July 9, 2023

External Deadline: August 9, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: 1

Anticipated Award Amount: $2,300,000

Who May Serve as PI:

The PD/PI(s) of the EMRCDP-NS should possess the scientific expertise, demonstrated leadership capabilities, stature and administrative capabilities required to implement, coordinate and supervise a national, multidisciplinary research career development program for EM clinicians. The PD/PI(s), together with the NAC and, if applicable, co-directors, will be responsible for the selection and appointment of scholars to the EMRCDP-NS, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day-to-day administration of the program and is responsible for appointing members of the NAC and using their recommendations to determine the appropriate allocation of funds. The PD/PI(s) are also responsible for informing all scholars, mentors and chairs of the goals of the program, and ensuring that policies designed to achieve these goals are followed. Any co-PD/PIs and co-directors should also have the qualifications necessary to guide an institutional training program for emergency medicine. It is highly recommended, although not required, that the program be led by a multi-PD/PI leadership arrangement, with individual PD/PIs responsible for critical roles required to achieve the comprehensive goals of the program. If the program does employ multiple PIs, applicants are strongly encouraged to recruit leadership team members from a variety of backgrounds, who represent a wide range of perspectives, and who, as a group, must have expertise that reflects the range of interests of the discipline as a whole. In addition, if a multi-PI leadership team is used, it is recommended that at least one member of this team have expertise with the pediatric EM patient population.

Any PD/PI who has overseen an NIH institutional training program in the past (e.g., T32, K12, etc.) should have a strong outcome record from that program, which would include trainees and scholars achieving individual NIH funding, subsequent placement into positions that provide strong research support and the launching of a research program that includes rigorous experimental approaches to address a significant scientific question.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-151.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

Purpose and Background Information

The purpose of this notice of funding opportunity (NOFO) is to invite applications for an Emergency Medicine Research Career Development Program in Neurological Sciences (EMRCDP-NS). The EMRCDP-NS will support a national effort for mentored career development and training of junior emergency medicine (EM) faculty at institutions nationwide that support EM research. The goal of this program is to increase the cadre of EM investigators trained to lead and conduct research into neurological disorders, making use of their EM training and clinical experience. This research career development program should promote high quality, novel, creative research and innovative investigation by this cohort of individuals who possess unique clinical and research skills. As a result of training in this program, highly skilled EM physician-scientists should be prepared to develop a successful, independent, well-funded research program, which they will combine with their clinical career to advance the understanding and treatment of neurological disorders commonly treated in the Emergency Department (ED) setting. This NOFO will fund the administration and infrastructure of one, national EMRCDP-NS for 5 years. It uses the K12 Career Development mechanism, to be overseen by one or more PD/PIs and a national cohort of renowned basic and clinical investigators, to support the career development of EM-researchers at institutions around the country.

The involvement of EM physicians in cutting edge scientific research is critical, due to their unique access to, and experience with, patients entering the ED setting with a wide variety of neurological disorders. Research into, for example, seizures, head trauma, acute cognitive dysfunction, acute stroke, sensory loss, loss of consciousness, spinal cord injury, meningitis, addiction and many other neurological disorders can benefit greatly from the leadership and involvement of EM physicians. Moreover, treatments and cures for diseases across the age range, from pediatrics to neurological disorders associated with aging, will be more quickly discovered with the involvement of EM physicians. However, the cohort of EM physicians conducting NIH-funded research is small relative to the need. The dearth of EM clinician-scientists largely reflects the relative youth of emergency medicine as a field positioned to lead research programs. Moreover, junior EM faculty are often not equipped to make use of individual NIH research career development mechanisms, which require a level of research experience and skills that most EM residencies and fellowships don’t provide. Even with additional fellowship training, it is often difficult for an EM physician to have sufficient research training to obtain individual support from NIH career development awards, which are used to prepare clinician-scientists to launch an independently funded research program. The purpose of the EMRCDP-NS program is to support an immersive period of mentored research and career development following residency or fellowship, to provide a venue for networking, collaboration and support of junior EM researchers, and to facilitate the transition of EM physicians from mentored to independent research positions. Scholars must start support by the EMRCDP-NS in either their first or second faculty year.EM physicians may apply to the EMRCDP-NS program within the first two years of their first independent faculty position subsequent to completion of residency or fellowship. The selected scholars may receive up to 3 years of financial support, during which the EMRCDP-NS will provide them with the mentorship, career development guidance, research experience, and protected time for research necessary to initiate a vigorous, sustainable research program. In addition, the EMRCDP-NS will create a support and mentoring network whereby scholars will have the opportunity to interact with both junior and senior EM researchers, as well as clinician-scientists from other subspecialties. A successful outcome of the program will be that all EMRCDP-NS scholars obtain subsequent, individual major awards, such as an NIH K or R01-equivalent, to continue to grow their research project and career. The primary metric by which this program will be evaluated will be the transition of supported scholars to subsequent funding equivalent to an NIH K or R01 award. Because of the critical mentorship and community building component incorporated into the annual meeting and program activities, a secondary metric by which the EMRCDP-NS program will be evaluated will be the number of candidates to the program who do not receive scholar support but nonetheless go on to obtain NIH research funding to continue towards a robust dual career as clinician-scientists.

The EMRCDP-NS Program

The EMRCDP-NS K12 award provides five years of funding to the applicant organization to support a national research career development program. Although this K12 award is housed at the contact PD/PI’s institution, it is not intended to support scholars solely at that institution. The PD/PIs will solicit applications to the EMRCDP-NS program from eligible candidates at institutions from across the country, and selected scholars will proceed with their career development and research plan at their home institution, with a local mentor. The institution that houses this K12 is just one of these institutions from which a scholar might be selected. The leadership of the EMRCDP-NS consists of one or more PD/PIs and a committee of advisors (the National Advisory Committee, or NAC) selected by the PD/PIs to help guide the program. The PD/PIs may also choose to appoint program co-directors to help accomplish the goals of the program. The PD/PIs, together with the NAC and, if applicable, co-directors, will define the specifics of the application process, advise potential applicants, review candidate applications, provide feedback to the candidates on their applications, select candidates for appointment, monitor progress of each scholar, and ensure that program policies and requirements are followed. It is also expected that program leaders (i.e. PD/PIs or NAC members) will serve as secondary mentors for each scholar, working with the scholar, primary mentor and Chair to ensure success of the scholar’s development into an independently funded research investigator.

Annual EMRCDP-NS Meeting

The PD/PI(s) will organize an annual meeting for applicants, scholars, the NAC, and appropriate additional faculty. This meeting will serve as the venue for candidate interviews and selection, and also provide a forum for mentoring, career development activities, monitoring of scholar progress, and development of scientific networks among scholars, applicants and other researchers as well as other related purposes. As the primary goal of the EMRCDP-NS is to prepare scholars to transition to competitive, individual funding (such as an NIH K award), this meeting should include organized sessions to help scholars formulate and refine their projects, write a strong specific aims page intended to be used for their next grant submission, and otherwise help with creation of a clear, well-organized grant application. It is expected that, each year, all scholars will orally present their research projects to the entire cohort of attendees and will receive feedback to hone both their communication skills and project approach. This meeting should also include junior EM researchers not affiliated with the EMRCDP-NS program to broaden the scope of career development, mentorship and networking within the EM research community.

Although not required, there are many benefits to organizing this meeting at a small venue as a stand-alone event where participants will be immersed in the activities and social structure of this meeting without distraction. Funding provided by this award is designed to support a stand-alone meeting, which is strongly recommended.

Preceptors/Mentors

Although the identity of future mentors will not be known at the time of application, the mentors of successful scholar applicants to the EMRCDP-NS should fulfill some general requirements. Primary mentors must be tenure-track faculty (or equivalent) who have an established record of research productivity, competitive grant support and successful training of clinician scientists. A primary mentor should have a strong research program in a neuroscientific area directly relevant to the NINDS, NIDA or NIA mission. Just as in any mentored award, scholars should have a team of mentors when needed to cover the variety of expertise needed, such as technical, analytical and subject matter expertise. Mentors should have research expertise and experience relevant to the proposed research project and must be committed to providing strong mentorship to the scholar throughout the duration of the award and efforts to obtain subsequent funding. The primary mentor need not be an EM clinician or even a clinician-scientist. However, in such cases, all scholars should have a secondary mentor who is an accomplished EM researcher who has experience navigating a dual career as EM clinician and researcher. Members of the NAC may serve as secondary mentors that provide career guidance to scholars when an appropriate, local EM-researcher is not available.

Linkages of scholars to other departments, potentially through choice of mentors, should be encouraged, as they enhance career development and facilitate collaborative efforts. It is particularly encouraged that scholars develop interactions with neurologists, neurosurgeons, neuropathologists, neuroradiologists and/or other non-EM clinicians, as this can foster multidisciplinary research and the development of novel ideas and approaches. In addition, working with Ph.D. scientists can expand the scholar’s knowledge of specialized fields and technologies, as well as providing the perspective of a full-time research scientist. Although mentors must demonstrate a strong commitment to the EMRCDP-NS program and scholars, they cannot receive salary, fringe benefits or research support for this role on the K12 grant.

Candidates should be strongly encouraged to include researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women as mentors, as this provides a diverse perspective on their research approach and scientific thinking. Scholars should be encouraged to create a mentoring team that fulfills a wide variety of useful purposes, with thought as to the roles, commitment, and availability of each mentor.

Program Scholars

Scholars funded by the EMRCDP-NS K12 must be conducting research that falls within the NINDS, NIDA or NIA mission. All types of research, including basic, clinical and translational, are equally appropriate. Regardless of research type, it should be directly relevant to diseases or disorders of the nervous system and be potentially applicable to clinical practice. It is expected that this research will integrate with the scholar’s clinical activities and that their clinical and research activities will inform each other. The program should strive to support individuals whose research might have a significant impact on patients who enter the ED environment with neurological diseases or disorders.

As part of the recruitment effort, the EMRCDP-NS program should make every effort to broadly advertise the program. The program must actively recruit prospective individuals from diverse backgrounds, including individuals from groups underrepresented in Emergency Medicine.. The candidate selection process must include a written application (the format of an NIH K award is recommended) and interviews by the PD/PI and multiple members of the NAC. It is expected that, unless impossible due to an individual’s circumstance or in the interest of the health and safety of all involved, all applicant interviews will take place in-person at the annual meeting.

The EMRCDP-NS K12 will have funds committed to support up to three new scholars per year, in each of 5 years (15 different individuals for 3 years each). For each scholar, a five-year career development program consists of two phases.

Phase I

In Phase I, the scholar receives up to three years of financial support directly from the K12 award. During this phase, the scholar will embark on a focused career development program that will include research, skills development and educational activities, under the auspices of a mentor who has a strong record of research productivity and training. In conjunction with the mentor, the scholar will develop a research and career development plan suitable to launch an independent research career to investigate a clinically significant research topic. This plan, and scholar progress, will be reviewed annually by the EMRCDP-NS PD/PI and NAC. Provided they make appropriate progress during the first year, as judged by the PD/PI and NAC, scholars are renewed for a second year of EMRCDP-NS support. With appropriate progress made in year 2, scholars may be supported for a 3^rd year. It is strongly encouraged that scholars apply for an NIH individual mentored K award no later than halfway through the 3^rd year of K12 support. This will accomplish two purposes. First, it will encourage scholars, together with their mentors, to create a focused research and training plan that will result in the progress needed to submit a competitive NIH K application on a specific timeline. Second, it will help scholars obtain individual funding before or shortly after phase I funding expires. Scholars are also encouraged to seek funding from non-NIH sources during and after phase I of the program.

During each year of Phase I, in addition to conducting research and pursuing their research career development at their home institution, scholars will submit an annual progress report to the EMRCDP-NS PD/PI, will attend the EMRCDP-NS annual meeting, and will present their research in a public forum at the meeting. Scholars may engage in brief research activities at another institution if they are directly related to the purpose of the award. For research activities outside of their home institution that last longer than one month, scholars must obtain prior written approval from the K12 PD/PI. In addition, periods of leave from the program for greater than three months, for either professional or personal reasons, require prior written approval from the K12 PD/PI and the NINDS Director of Training and Workforce Development.

Phase II

In Phase II of the EMRCDP-NS program, the scholar begins to transition to independence. The scholar is expected to remain associated with the EMRCDP-NS program, but must be supported by funds not derived from the K12. As such, scholar selection should consider 1) the likelihood that the candidate will be competitive for individual funding by the end of the third year of the program and 2) the strength of the commitment by the applicant’s chair to support the candidate’s research success subsequent to EMRCDP-NS support. It is intended that the scholar will secure funds from an individual, mentored career development award, such as an NIH K08, K23 or equivalent. However, some scholars may be ready to obtain support under a large independent research grant, such as an NIH R01 or equivalent, or an independent career development award such as an NINDS K02. To this end, it is important that the scholar receive strong guidance and support from their local mentor, the EMRCDP-NS PD/PI, the NAC and the Chair of the scholar’s department, to provide the best possible opportunity for success. Because scholars might not receive competitive funding by the end of phase I, it is critical that the scholar’s Chair is committed to continuing to support the scholar towards their goal of successfully developing a funded research program (see below).

Scholars should continue to attend the annual EMRCDP-NS meeting and are encouraged to provide progress updates to, and present their research findings at, the EMRCDP-NS meetings during each year of the phase II period. This attendance at EMRCDP-NS meetings during phase II will help them with their own careers, will serve to facilitate their role as mentors to those who come behind them, and will serve to strengthen the network of EM researchers, ranging from those in the career development phase of their careers to more established faculty.

Phase I and II effort expectations

The EMRCDP-NS program requires that scholars commit 75% of full-time professional effort to research when funded by the K12 program (phase I). In phase II of the EMRCDP-NS program (years 4-5, when K12 funds are not used to support the scholars), candidates should be expected to devote a minimum of 50% of full-time professional effort, and ideally up to 75% of full-time professional effort, to research, towards the goal of achieving individual K or R01 funding. In the event that the candidate is making good progress during Phase I, makes appropriate efforts to obtain individual funding for the start of Phase II, but fails to do so by the end of phase I, an ability to continue to devote at least 50% effort to research is critical to the scholar’s continued progress towards success. Thus, it is expected that the Chair of the scholar’s home department will commit, in the initial application to the EMRCDP-NS program, to continuing to provide at least 50% protected time to the scholar during the entire Phase II period, even in the absence of external research funding. Because protected time for research is critical for a candidate’s success, the EMRCDP-NS is expected to obtain a description of the home department’s 5-year financial and non-financial commitment to the candidate’s research success in the candidate’s initial application to the program. This commitment would include discussion of resources available, ability of the scholar to continue to attend the EMRCDP-NS annual meeting for 5 years and the commitment of protected time both during Phase I and for research during the two years after conclusion of K12 support.

Institutional Environment and Commitment to the Program

The Chair of the scholar’s home department plays a critical role in the success of the EMRCDP-NS. The program will directly support relatively few scholars, with the goal that all of those supported will go on to successful, dual careers as clinical EM physicians and productive, well-funded researchers. In order to launch such a career, scholars need a period of outstanding training and mentoring as well as adequate protected time to successfully conduct high quality research and obtain independent funding. Consequently, a successful application to the EMRCDP-NS program must require that Chairs commit to provide the protected time for research as described above. This is critical to ensure that scholars have the time to devote to obtaining strong research funding to continue their research program. In addition, Chairs should make every effort to provide appropriate resources and support, in whatever form needed, to ensure success of the scholar, and should describe these resources and support in the scholar’s application to the program.

It is expected that the EMRCDP-NS program will make at least one in-person site visit to each scholar’s home department to discuss with the scholar, mentor(s), Chair and others involved in the scholar’s activities, the scholar’s progress, needs and any other relevant issues. It is recommended that this first site visit occur within 6-8 months of initial funding. All individuals associated with selected scholars must be willing to participate in this site visit, and commit to it in the application to the program. In addition, the leadership of the EMRCDP-NS may choose to schedule additional, regularly scheduled site visits, either virtual or in-person, as deemed appropriate to the success of the individual scholars or program.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

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)

Slots: Only one application per partnership is allowed. A partnership is defined as a collaboration between at least two different departments/colleges within one institution

Deadlines

Internal Deadline: Friday, June 9, 2023

LOI: August 11, 2023

External Deadline: September 26, 2023

Award Information

Award Type: Grant

Estimated Number of Awards and Anticipated Amount: HEAL may fund up to 4 T90/R90 awards. HEAL intends to commit up to $673,000 (direct cost) for each T90/R90 award in fiscal year 2024. Future year amounts will depend on annual appropriations. HEAL intends to commit, for each award, up to $673,000 (direct costs) in FY2025; $673,000 (direct costs) in FY2026; $673,000 (direct costs) in FY2027; and $673,000 (direct costs) in FY2028.

Who May Serve as PI:

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.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-015.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

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)

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-FD-23-029: Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: May 15, 2023

External Deadline: June 30, 2023, 5pm PT

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $1,750,000

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-029.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

The objective of the Cooperative Agreement is to work directly with an established and experienced technical training provider with CGMP compliant facilities and subject matter expertise and experience to continue the existing training program of the Compounding Quality Center of Excellence as well as research and expand the program with new trainings. These trainings help outsourcing facilities and other stakeholders increase technical capabilities and improve facility operations, by gaining an overview of FDA regulatory framework for compounding, identifying insanitary conditions in their facilities, and implementing appropriate corrective actions. Protecting patients from poor-quality compounded drugs is a shared responsibility among the FDA, outsourcing facilities, compounders, state regulators and other stakeholders. The Compounding Quality Center of Excellence, through training and other modalities, engages proactively with these stakeholders to enhance the quality of compounded drugs for human use.

Training formats may include in-person classroom, laboratory, and cleanroom environments; live, in virtual environments; and self-guided, online and be specifically to the CGMP requirements for the outsourcing facility industry (as opposed to customized training or consulting).

PROJECT DESCRIPTION

The funding opportunity contains three main parts:

1. Instructor-Led, Live In-Person and Virtual Training, 2. Self-guided Online Training, and 3. Registration and Logistical Support.

This Cooperative Agreement seeks support for the following tasks: instructor-led, live in-person and virtual laboratory-based training in CGMP specifically tailored for the entire outsourcing facility industry at or using the firm’s onsite microbiology laboratory and cleanroom facility, self-guided online training tailored specifically for the outsourcing facility industry, and registration and logistical support. Awardee should be able to manage and expand a multi-faceted training program specific to the outsourcing facility industry that includes ongoing administration of multiple in-person, virtual and self-guided online trainings while simultaneously handling all training associated registration/logistics and development and delivery of new in-person, virtual and self-guided online training courses annually.

All three parts will collectively establish the foundation for building a sustainable training program for the FDA Compounding Quality Center of Excellence and its direct technical training partner, the Awardee.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-ES-23-001: Limited Competition: Superfund Hazardous Substance Research and Training Program (P42 Clinical Trial Optional)

Slots: 1

Deadlines

Internal Deadline: Friday, May 26, 2023, 5pm PT

LOI: September 2, 2023

External Deadline: October 2, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: 12

Anticipated Award Amount: Applications may request a budget for direct costs of up to $2 million dollars for each year. Applications may propose a project period of up to 5 years.

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-ES-23-001.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

Research Objectives

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to submit an application for a Superfund Research Program (SRP) Center grant. SRP legislation, under the Superfund Amendments and Reauthorization Act (SARA) of 1986, allows NIEHS the flexibility to create university-based Centers to conduct scientific research to address the wide array of scientific uncertainties facing the national Superfund program. The complex problems related to sites impacted by hazardous substances require the expertise of multiple biomedical research (BMR) and environmental science and engineering (ESE) disciplines. Applicants responding to this Notice of Funding Opportunity Announcement (NOFO) are expected to design a research Center that integrates BMR (e.g., toxicology, epidemiology, mechanistic studies) with ESE (e.g., remediation, geosciences, ecological sciences). The goal of a NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following: responsiveness to mandates; problem-based, solution-oriented research; relevance to SRP and Superfund; innovation; and integration.

Responsiveness to Mandates: SARA Section 311(a) “Hazardous Substances Research and Training,” authorizes NIEHS to create a basic research and training program for the development of:

1) advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health;

2) methods to assess the risks to human health presented by hazardous substances;

3) methods and technologies to detect hazardous substances in the environment; and

4) basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.

To accomplish these mandates, Centers are expected to assemble interdisciplinary research teams with expertise in BMR as well as ESE to advance scientific knowledge using innovative and integrated approaches. Moreover, the SRP’s fourth mandate reinforces the program’s problem-solving mission; whereby, the research generated by SRP Centers would lead to strategies to prevent exposure and/or develop intervention strategies to improve public health. Centers are also expected to facilitate transfer of research findings through coordinated data management and analysis; engage communities with prevention/intervention strategies; share findings to broader audiences; and train the future generation of scientists.

Problem-based, Solution-oriented Research Theme: As an integrated research program, SRP Centers can tackle complex biomedical and environmental science and engineering issues identified by applicable end-users, bringing a mechanistic understanding to solve some of the vexing problems associated with Superfund. Applicants are expected to design Centers that will contribute to solving a scientific problem (or set of problems) related to SRP’s mandates: health effects, risk, detection, and remediation/mitigation of hazardous substances.

Relevance to SRP and Superfund: Given SRP’s broad mandates, it is important for interdisciplinary teams to work together to foster research that addresses relevant exposure pathways. Ultimately, problem-solving research seeks to find answers to inform real-life exposures – both in terms of understanding health implications as well as developing remedies for these exposures. For example, basic research generates mechanistic knowledge upstream of its application, but this research should be contextualized in terms of its relevance to environmental exposures. Furthermore, there is an expectation that interdisciplinary teams have considered multiple vantage points in devising their research approach – showing evidence of crosstalk between health, environmental, and exposure research expertise. For these reasons, applicants should assemble teams to address research challenges within a given mandate area, contaminant, or exposure scenario that may have the greatest potential for supporting the SRP’s goal of protecting human health and the environment from the impact of hazardous substances.

The SRP also considers the diverse research and information needs of its end-users as important criteria for determining relevance. SRP end-users include the Superfund programs at the U.S. Environmental Protection Agency (EPA, https://www.epa.gov/superfund) and Agency for Toxic Substances and Disease Registry (ATSDR, https://www.atsdr.cdc.gov). In addition, agencies such as the National Oceanic and Atmospheric Administration (https://www.noaa.gov), U.S. Geological Survey (https://www.usgs.gov), U.S. Department of Defense (https://www.defense.gov), and the U.S. Department of Energy (https://www.energy.gov) are important end-users of research and technology to manage and mitigate sites impacted by hazardous substances. In addition, the National Science Foundation (https://www.nsf.gov) and other NIH Institutes and Centers (https://www.nih.gov/institutes-nih/list-nih-institutes-centers-offices) may provide valuable opportunities to promote and leverage the findings of SRP research. The SRP also considers as important end-users state, local, and Tribal governments, and communities impacted by hazardous substances. The SRP’s ultimate goal is to protect human health by providing a rigorous scientific basis for effective decision-making by these end-users. Consequently, SRP-funded research is expected to provide fundamentally sound science, while providing data, information, and knowledge to minimize risk and remediate sites impacted by hazardous substances. Therefore, investigators should seek input from end-users mentioned above during application development and identify critical issues for which fundamental science is needed.

Moreover, Centers are expected to demonstrate the following:

Innovation: The SRP strives to push the boundaries of science using the newest technologies and challenging current scientific paradigms. The SRP firmly supports multi-disciplinary research, through the synthesis and extension of disciplinary boundaries that adapt technologies and approaches from one field and apply them to other fields to solve challenging environmental health problems. Forward-looking or ‘‘anticipatory’’ research is critical to identify and address future end-user needs. This may include utilizing cutting-edge research tools or devising more sustainable solutions to address issues associated with hazardous substances.

Integration: Addressing the complex challenges posed by environmental contamination requires an integrated, multidisciplinary approach. The SRP considers integration of a Center’s projects and cores as an important way to target complex problem(s) relevant to the SRP’s mandates. A Center should demonstrate evidence of synergy between its projects and cores – including interaction between biomedical and environmental science and engineering disciplines. Through effective interactions of its components, the Overall Center should demonstrate a systems approach to problem-solving. In addition, the research emanating from the Center and the interaction between the projects and cores should be incorporated into sustainable solutions that consider environmental, social, and economic issues, using a systems approach.

To achieve a broad and sustained impact, SRP Centers are expected to include the following:

Research Projects: Collectively, the Center’s research projects (maximum of six) should represent a range of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center. The Center’s central problem should be addressed by the contributions of these projects and each project should have the necessary biomedical and/or environmental science and/or engineering expertise to address the central problem.

Biomedical Research (BMR) Projects: A minimum of two (maximum of four) BMR projects are required and should address biomedical or human health-related implications of hazardous substances. This includes but is not limited to: toxicology studies, epidemiology, mechanistic studies, genetic susceptibility, computational toxicology, biomedical engineering, preclinical/clinical intervention, or efficacy of prevention studies. Each BMR project should clearly contribute to the overall Center objective, providing a clear step towards identifying solutions to the Center’s identified problem. Projects should be hypothesis-driven or product-oriented research.

Environmental Science and Engineering (ESE) Projects: A minimum of two (maximum of four) ESE projects are required and should address environmental science or engineering implications of hazardous substances. These projects are integral to the protection of human health through predicting, detecting, and preventing exposures. ESE projects include, but would not be limited to: remediation, geochemistry, ecology, civil/environmental engineering, geology, microbiology, fate and transport studies, hydrogeology, and detection sciences. Each ESE project should clearly contribute to the overall Center objective, providing a clear step towards identifying solutions to the Center’s identified problem. Projects should be hypothesis-driven or product-oriented research. The SRP recognizes the importance of new ESE approaches to reduce the amount and toxicity of hazardous substances in the environment. Fostering the development of novel remediation approaches – through designing new remediation platforms or assessing the efficacy of these platforms – is an important contribution in accelerating the cleanup of hazardous substances and preventing exposures. For this reason, all applicants are required to include at least one ESE project that supports SRP’s fourth mandate “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.”

(Please see the “Suggested Research and Activities” document for more information about research areas of interest to the SRP: https://www.niehs.nih.gov/research/supported/centers/srp/assets/docs/srp_funding_opps_suggested_research_and_activities_508.pdf).

Administrative and Research Translation Functions: The SRP requires an Administrative Core in each SRP Center grant application. This core leads the Center, maintains the organization of the Center, and ensures that the projects and cores are being supported to achieve the Center’s goals. In addition, the SRP is committed to fostering translation of scientific accomplishments to support its mandates and defines research translation as “communicating and facilitating the use of research findings emanating from the Center in the manner most appropriate for their application and the advancement of research objectives.” Therefore, all applicants are required to include research translation as a key function of the Center’s Administrative Core to facilitate and coordinate communication of the results, accomplishments, and implications of the Center’s research to end-users, including NIEHS SRP staff, to other SRP Centers, and other applicable end-users in a context that makes the research applicable to the target audience. Additionally, the SRP Strategic Plan (https://www.niehs.nih.gov/research/supported/centers/srp/about/strat_plan/index.cfm) highlights the importance of project specific research translation (PSRT); therefore, the Administrative Core has the critical role in assisting project leaders in translating their research outcomes and activities to appropriate audiences and ensuring the accurate and timely use of products and sharing of findings.

Data Management and Analysis: The SRP acknowledges that integration of data from a broad range of scientific disciplines will be critical to understanding and breaking the link between exposures and disease. In addition, proper data stewardship is needed to ensure that data is treated as a valuable research asset. To support NIH data sharing policies (https://grants.nih.gov/policy/sharing.htm) and promote best principles so data is Findable, Accessible, Interoperable, and Reusable (FAIR), all applicants are required to have a Data Management and Analysis Core (DMAC). The primary purpose of the DMAC is to support the management and integration of data assets across the Center. In addition, the DMAC should support and facilitate the management of data assets, irrespective of dataset size. The DMAC should also establish, coordinate, and monitor processes for data management and analysis and work closely with project/core leaders to ensure high data quality throughout the entire lifecycle of the data. The DMAC also has a coordinating role to work with project/core leaders to identify opportunities for integrating project/core-generated data with other existing datasets. The DMAC should also foster and enable the interoperability of data between BMR and ESE projects, accelerating the impact of the Center’s research.

Community Engagement: The SRP views Community Engagement as an effective way to inform and advance science for public health protection. In addition, the SRP considers the individuals and communities affected by hazardous substances as key end-users and recognizes the opportunity for SRP Center research and activities to achieve positive public health benefits through multi-directional interactions between the Center and impacted communities. Therefore, all applicants are required to include a Community Engagement Core (CEC). The purpose of the CEC is to ensure multi-directional communication between the CEC and the community and to direct best practices and activities in community engagement for prevention and/or intervention – thereby providing potential solutions to communities to reduce or mitigate the impact of hazardous substance exposure. For the purposes of this NOFO and to be consistent with its mandates, CEC activities should address prevention/intervention defined by SRP’s fourth mandate as “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.” Through exposure prevention and intervention, the CEC empowers impacted communities to be full participants in decisions to reduce the amount and toxicity of hazardous substances whether in their homes, their schools, their community, and/or their environment. The CEC activities should also complement the research strengths and problem-solving goals of the Center.

Training: The SRP regards research and training as vital components to the development of the next generation of environmental health science professionals. Therefore, the SRP requires applicants to include a Research Experience and Training Coordination Core (RETCC) to coordinate graduate and postdoctoral level multi-disciplinary research experiences and training in fields related to BMR and ESE research. (Note: SRP mandates specify graduate level training (e.g., Masters, PhD., Post doc); therefore, the SRP defines “trainees” within the program as graduate students and post-doctoral researchers that perform research/activities that are supported by the Center.) The RETCC should reflect the multi-disciplinary nature of the overall research effort of the Center by enhancing cross-training of trainees in disciplines not traditionally linked with the university graduate structure. For instance, trainees pursuing degrees in the ESE areas should be encouraged to understand how their research fits into the context of BMR and vice versa for BMR trainees. (Note: While undergraduates are recognized as a part of the research continuum and allowed to participate in RETCC activities, the RETCC should direct its opportunities for training, integration, and professional development among the graduate and post-doctoral level trainees within the Center.)

Applicants are encouraged to refer to the SRP’s 2020-2025 Strategic Plan (https://www.niehs.nih.gov/research/supported/centers/srp/about/strat_plan/index.cfm) which describes and defines the objectives and goals of the SRP in order to address its mandates. In addition, the SRP Mandates are provided on the following website: https://www.niehs.nih.gov/research/supported/centers/srp/about/index.cfm. Applicants are encouraged to refer to the NIEHS 2018-2023 Strategic Plan: https://www.niehs.nih.gov/about/strategicplan/2018-2023_theme3/index.cfm.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-HG-22-004: Genome Research Experiences to Attract Talented Undergraduates into Genomic Fields to Enhance Diversity (R25 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: June 1, 2023

External Deadline: July 1, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: Approximately 3

Anticipated Award Amount: $1,000,000 in total costs

Who May Serve as PI:

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to NHGRI’s scientific mission. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Participants must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Also, participants must be (a) full-time matriculated students in a baccalaureate degree program at the lead applicant institutions, and (b) have completed one academic year at the lead applicant institution (rising sophomore). An exception is to continue support for a student after graduation if the student has already participated a year or more in the GREAT program. Support could be extended so they can participate through the next summer research experience, if it falls within the two-year time period individuals are allowed to participate in the program.

The PD/PI should be knowledgeable in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The proposed PD/PI should hold a research or clinical doctoral degree (e.g., Ph.D., M.D., or equivalent), and have clearly demonstrated training/mentoring credentials. The PD/PI must have a regular, full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) at the applicant institution, and be actively engaged in research and/or teaching in an area directly related to the mission of the NHGRI. Early-stage investigators are eligible to serve as PD/PIs, as long as doing so will not detract from their research program and career advancement.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-22-004.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://rii.usc.edu/oor-portal/.

Materials to submit include:

(1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
(2) CV – (5 pages maximum)
Please attach in the “Letter of Support/Other” field a document listing collaborators and institutions involved in the partnership.

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

The overarching goal of this NHGRI R25 program is to support educational activities that encourage undergraduates from diverse backgrounds, such as those from groups underrepresented in the biomedical workforce, to pursue further training and careers in the scientific, medical, ethical, social and/or legal areas of genomics research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Research Experiences: Activities should provide undergraduates with exposure to research in NHGRI mission areas, to reinforce their intent to graduate with a science or social science degree, and prepare them for graduate school admissions and/or research careers that contribute to the field of genomics.
Courses for Skills Development: Complementary didactic activities designed expressly for participants in this program are required, especially activities that have the potential to increase opportunities for success at the next career level. The field of genomics is data driven. Special courses/seminars/workshops that introduce participants to fundamental knowledge in genomic data sciences, such as bioinformatics, machine learning, statistics, etc., are especially encouraged. Didactic activities that educate students on the impact of genomics on society are also expressly encouraged.

This Genome Research Experiences to Attract Talented Undergraduates into the Genomic Field to Promote Diversity (GREAT) Program will support collaborative institutional partnerships that provide research education programs for undergraduates enrolled at minority-serving institutions (MSIs) or Institutional Development Award (IDeA)-eligible institutions. A partnership will include a MSI or IDeA-eligible institution, and one or more research-intensive institutions or organizations with a suitable research base for graduate-level training in scientific areas of interest to NHGRI.

Programmatic Approach for GREAT Program

The focus of this GREAT Program is to provide exposure to genomics research to undergraduate students enrolled at MSIs or IDeA-eligible institutions. The program will complement these research experiences with activities to reinforce the student’s intent to graduate and prepare them for graduate school admissions and/or careers in genomics research. For the purposes of this program, the term “genomics” encompasses issues and activities in the scientific, medical, computational, ethical, social and/or legal areas of genomics research that are of interest to NHGRI (see the NHGRI Strategic Vision).

The proposed GREAT Program will provide support for MSIs or institutions in IDeA-eligible states to implement collaborative approaches to genomics research education for students from diverse backgrounds. Through this program, these institutions will establish partnerships with research-intensive institutions or organizations that have a prominent genomics research training environment. Collaborating institutions will work together to design and implement an education program that includes genomics research experiences primarily at the research-intensive institutions/organizations.

Each collaborative partnership must include:

One baccalaureate degree-granting Minority-Serving Institution or an Institution in an IDeA-eligible state to serve as the awardee institution. For specific eligibility requirements, see Section III. Eligibility Information. The Institution will have responsibility for the conduct and oversight of the award, along with the flexibility to determine the optimal configuration with its partner(s) to have the maximum impact.
One or more partnerships supported by subaward with either a Higher Education Institution or Non-Profit/For-Profit Organization with a research-intensive genomics training environment as evidenced by a strong base of NIH or NHGRI extramurally-funded or privately-funded research in genomics. Higher Education Institutions are limited to domestic PhD-granting colleges/universities that receive greater than $7.5 million (total costs) of NIH Research Project Grant (RPG) funding per year over the past 3 fiscal years.

For other aspects of the partnership, mentoring and other educational activities are expected to be conducted at each collaborating component in order to maximize impact of the program. Collaborators should collectively consider all factors that are likely to improve exposure, knowledge, and competency in the scientific, medical, ethical, social and/or legal areas of genomics research for participating students. It is expected that long-term collaborations will be developed to allow faculty and students to have substantive and continuous interactions for the duration of the funded project period and beyond. Lastly, a plan to address any geographical constraints should be developed to ensure students can receive effective mentoring and research educational activities from all collaborating institutions.

Applicants will be expected to develop a genomics research education program where students will be supported for up to two years (part-time during the academic year and full-time in the summer) to conduct genomics research with participating faculty. The goal should be for each student to complete a full two-year research education program, where a significant portion of the research experience for each student takes place at the research-intensive institutions; however, research at the MSI or IDeA-eligible institutions is also encouraged if the research projects and environment are well aligned with NHGRI’s scientific mission. Students must have already completed one academic year of post-secondary education to be eligible; however, completion of two academic years is preferred for participation in the program. The undergraduate students will be supported for up to 15 hours/week during the academic year and 40 hours/week during the summer. While the intent of the FOA is to support enrolled college students during a two-year time period, an allowed exception is to continue support for an individual after graduation through a summer research experience if the student has already participated a year or more in the program.

In addition to research experiences, programs are expected to provide students with outstanding mentoring and education in other critical skills such as leadership, scientific writing and presentation skills, training in rigor and reproducibility and time management. There should be dedicated efforts at providing not only technical expertise, but advice, insight, and professional career skills to students in the program. It is encouraged that mentors will work with participants to design individualized development plans (IDPs) that are compatible with participants’ needs and experience. Dual mentoring is encouraged, with one faculty mentor focused more on scientific mentoring and another on career mentoring, and with mentors at each collaborating institute represented. Additionally, near-peer mentoring is encouraged (e.g. a graduate student who is working with an undergraduate student on a research project). After students complete their research education experience, follow-up mentoring should be conducted for nine months or more.

NIH realizes that quality mentorship is critical to the recruitment and retention of scientists, including those from underrepresented backgrounds, and encourages program activities to improve the caliber of mentorship. As recommended in the 2018 NASEM report on graduate education, “modules for faculty to learn how to advise and mentor students from different backgrounds and to raise awareness and accountability about their role in changing the training and mentoring environment” should be a component of a well-designed program. For example, case-based scenarios may be used to educate mentors on various relevant ethical, professional and cultural issues facing students today, effective communication and mentoring compacts, and effective tools for mentors to address cultural awareness.

Courses for skills development should be integrated across the partnering institutions and uniquely designed to increase undergraduate students’ interest in and preparation to enter Ph.D. degree programs in genomics or a genomics-related field of scientific interest to NHGRI. Depending on the strength of the applicant institution, it is expected that academic and curriculum enhancement activities may vary in how they are formalized and integrated; various strategies, rooted in education research, may be utilized. These approaches may include, but are not limited to: core genomics coursework tailored to students’ backgrounds and needs; curriculum for specialized research techniques; collaborative learning experiences and group activities to convey the excitement and relevance of genomics to students; advisement regarding the number, level, and sequence of courses that students should take to be competitive for graduate school programs in genomics; seminars emphasizing scientific reading comprehension, writing, and oral presentation skills; and research career seminars to help prepare students for the transition from undergraduate to graduate school.

The expected outcome of the GREAT program is enhanced participation of individuals from diverse backgrounds in the NHGRI research workforce who can bring their unique experiences, perspectives and innovation to addressing human disease or the ethical, legal or social implications of genomics research. Other desired program outcomes include completion of bachelor’s degrees, transition to graduate programs in research mission areas relevant to NHGRI, and achievement of subsequent research funding, such as an NHGRI individual fellowship or career development award. Throughout the program, NHGRI will actively monitor the progress towards these outcomes. NHGRI will hold regular meetings with PD/PIs, and PD/PIs and student participants are expected to attend the NHGRI Research Training and Career Development Annual Meeting. The scientific meeting is held in the Spring each year and is a venue for NHGRI-funded trainees and student participants to present their research, network, learn more about the genomics field, and participate in academic and career enhancing activities.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

(CLOSED) PAR-23-171: Diagnostic Centers of Excellence (X01 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior to application due date, but is not required.

External Deadline: May 15, 2024

Recurring Deadlines: May 15, 2025

Award Information

Award Type: “Other.” A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.

Estimated Number of Awards: Funds are not awarded via the X01 mechanism. The total number of approvals for access to DMCC and Network resources is dependent on the number of meritorious applications and the capacity of the Network.

Anticipated Award Amount: Not Applicable; funds are not awarded via the X01 mechanism.

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-171.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

Undiagnosed diseases are defined as long-standing symptoms or elusive medical conditions that have not been diagnosed despite extensive clinical evaluation. Undiagnosed diseases are often due to rare conditions and can include: 1) not recognized, previously described diseases due to very low incidence or prevalence; 2) yet-to-be-described disorders; and 3) rare variations of more common diseases. These conditions present difficult problems for patients, their families, and physicians resulting in a high emotional, physical, and financial burden to patients who may spend many years seeking a diagnosis and path to treatment. Diagnoses in these difficult cases require teams of clinicians and scientists with a wide variety of special expertise. Scientific advances springing from these diagnoses require an organized approach to testing, data analysis, and validation in patients with similar rare conditions or in model organisms.

In 2008, the NIH established an intramural Undiagnosed Diseases Program (UDP) to aid individuals plagued by longstanding medical conditions that elude medical diagnosis. Using a team science approach, comprehensive clinical phenotyping and cutting-edge diagnostic and genomic technologies, the UDP was successful in ending the “diagnostic odyssey” for many individuals with rare, challenging, and difficult-to-diagnose diseases. Based on the success of the UDP, the NIH Common Fund announced in 2012 an expansion of the UDP to form a nation-wide network – the Undiagnosed Diseases Network (UDN) – composed of the NIH UDP and extramural Clinical Sites. Phase I (FY2013-2017) of the UDN included seven Clinical Sites including the UDP, a Coordinating Center, and Core Laboratories to facilitate diagnoses (genome sequencing, testing variants in model organisms, metabolomics, and a biorepository). In Phase II (FY2018-2022), the number of Clinical Sites was expanded to twelve. Since the launch of Phase I, the UDN has been very successful in achieving its objectives by: providing over 600 diagnoses; discovering hundreds of novel disease-associated genes and genomic variants, including new diseases and syndromes; and building an international reputation for establishing exemplary clinical practices, standards, and pipelines for genomics-based diagnoses.

In Phase II, the network was tasked to develop a framework that would continue the mission of the UDN after NIH Common Fund support ends in 2023. To have a broader impact on the clinical practice of undiagnosed diseases in the United States (US), the NIH envisions the UDN evolving into a larger, self-sustained network that, with public and private partners, can provide expert diagnostic services for undiagnosed patients across the nation and foster scientific discovery. The network will also seek to implement strategies that will expand equity and access to health disparity populations. In this new model, the new Network (henceforth referred to as the “Network” in this NOFO) will consist of an NIH-supported Data Management Coordinating Center (DMCC), the UDP, highly qualified and collaborative clinical sites, patients with undiagnosed diseases (referred to as “participants” in this NOFO), patient advocacy groups, and the NIH and other stakeholders including external funding providers and/or resource providers (e.g., Cores or private partnerships that conduct genomics sequencing, gene function studies or other diagnostic services).

The purpose of this NOFO is to solicit proposals from highly qualified clinical sites in the US to join the Network through an X01 Resource Access Program award. Accepted sites will be designated as a “Diagnostic Center of Excellence (DCoE)” and will be responsible for generating participant clinical, phenotypic and sequencing data to be submitted to the DMCC through a Data Use Agreement with the Center. X01 recipients will have access to DMCC resources and infrastructure including access to high-quality phenotypic and genotypic data and collaboration with highly skilled physicians, researchers, and bioinformaticians. Using team science, DCoEs will be able to collaborate with Network members to implement strategies that will expand equity and access to health disparity populations and increase the discovery of new disease-associated genes and genomic variants, immunologic and metabolic abnormalities, as well as environmental insults that are causative in previously undiagnosed patients. DCoEs will be invited to submit their most challenging, unsolved cases for acceptance into the Network, and partner in their evaluation with the Network’s virtual case review committee(s), which will be coordinated by the DMCC.

Successful applicants will demonstrate that they have the appropriate expertise and a track record of diagnosing rare and difficult-to-diagnose disorders, along with the infrastructure and resources needed to conduct the clinical evaluation and DNA sequencing of participants enrolled at their sites. Specifically, applicants will be expected to demonstrate the expertise, independent resources (e.g., institutional support, plans for billing insurance, obtaining support from outside partnerships, etc.), and capacity to:

Enroll a minimum of 5 participants per year who are accepted into the Network, although some sites may have the capacity to enroll more participants. Typically, only the most difficult, unsolved cases will be accepted into the Network (e.g., those cases requiring specialized, non-routine diagnostic testing procedures or collaboration among a team of clinicians and researchers).
Perform comprehensive clinical evaluations of undiagnosed participants enrolled at their site including medical record review, routine and specialized diagnostic testing procedures, consultations, and referral to other sites with necessary expertise if appropriate.
Have the resources (in-house or outsourced) to perform DNA and/or RNA sequencing and re-analysis of existing genome-sequencing data.
Capability to work with Network data stored in a cloud architecture, such as AnVIL.
Have the genomics capability including medical genetics and associated informatics expertise needed to identify pathogenic variants from human genomics sequence data. This includes the infrastructure to return genetic results to study participants and provide post-test genetic counseling.
Demonstrate sufficient clinical metabolomics and other omics expertise to interpret or re-interpret lab and research-grade findings.
Have sufficient clinical staff to review medical records from applicants (so as to enroll a minimum of five cases per year into the Network) and to rigorously discuss the results to arrive at a diagnosis or to interrogate candidate genes.
Collect and store DNA, fibroblasts from skin biopsies, and other biological specimens produced by clinical evaluations as needed for the diagnosis.
Organize incoming records and return results to participants, family members, and referring physicians.
Support a site coordinator or equivalent position to serve as the DCoE’s point of contact for data sharing, case coordination, collaboration, data retrieval for research projects and patient follow-up.

Additional Information

(1) The X01 mechanism does not provide budgetary support for the proposed activities. Successful X01 applications will receive access to DMCC resources and Network data (discussed above), and will have the option to apply for small research grants issued by the DMCC as subawards to DCoE sites (see: RFA-NS-22-051 for more information). The DMCC will provide at least $500,000 Direct Costs (DC) in year 1 and $1M DC per year in years 2-5 to support Network research activities. The subawards (typically in the range of $25-50K DC each) are intended to support: 1) some of the DCoEs’ costs associated with on-site coordination and submitting data to the Network; and 2) pilot research projects such as very early-stage gene function studies in model systems and clinical genomics/metabolomics investigations that are needed to facilitate a participant’s diagnosis. Subawards cannot support clinical trials.

(2) Successful applicants to this NOFO will be expected to incorporate the Network’s infrastructure and operational procedures into their proposed study plans, including coordination, collaboration, and data management through the DMCC and signing onto any agreements or Memoranda of Understanding established by the Network Steering Committee in the next phase of the UDN (see “Network Governance” below). In addition, DCoEs will be expected to work with the DMCC and Steering Committee to develop Network protocols, a Manual of Operations, and participate in Steering Committee, Case Review, diagnostic consultation, and Working Group meetings as established by the Steering Committee.

(3) Successful applicants will be required to consent participants and use a single-IRB managed by the NIH UDP that is consistent with NIH’s Single IRB Policy as described in NOT-OD-16-094 to ethically review Network-wide protocols involving human subjects research.

(4) To gain access to DMCC resources, X01 recipients will be required to submit relevant participant datasets generated at their Site (e.g., clinical, phenotypic, genomic, environmental, covariates, metadata, etc.) to the DMCC through a Data Use Agreement with the Center. The Network’s Steering Committee will develop and implement Network-wide approaches for data submission from DCoEs and timelines including data standards and formatting requirements, along with standards for data use by Network members. The DMCC is responsible for submitting de-identified data to national repositories as required in RFA-NS-22-051.

(5) DCoEs are encouraged to use innovative approaches that increase the efficiency, yield, and cost-effectiveness of the diagnosis (e.g., remote visits, tiered evaluation strategies, use of innovative tools or strategies for record review, etc.), while still providing a comprehensive and expeditious clinical evaluation.

(6) Although DCoEs are encouraged to enroll participants with disorders in any clinical specialty (similar to current UDN operations: UDN Manual of Operations), sites have the option to specialize in one or more areas of clinical practice (e.g., pediatrics, neurology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.).

(7) Applicants are strongly encouraged to enroll participants from health disparity populations and/or to partner with medical institutions that serve under/uninsured and health disparity populations.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.