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NCCIH Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development (PA-18-920) Technical Assistance Webinar

NCCIH Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development (PA-18-920) Technical Assistance Webinar

October 2, 2018

Purpose of the Webinar:

On Tuesday, October 2, 2018, the National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) and National Center for Advancing Translational Sciences (NCATS) hosted a technical assistance webinar to provide an overview of a new training collaboration between NCCIH and the NCATS Clinical and Translational Science Award (CTSA) program.

See PA-18-920: NCCIH Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development (Admin Supp Clinical Trial Optional)

Webinar Speakers:

  • Carol Merchant, M.D., M.P.H., Program Director, Division of Clinical Innovation, NCATS
  • Lanay Mudd, Ph.D., Program Director and Training Director, Division of Extramural Research, NCCIH
  • Anita McRae-Williams, M.A., Outreach Communications Program Manager, Division of Extramural Research, NCCIH (Webinar Moderator)

This report summarizes information provided during the webinar including (1) background information about the NCATS CTSA and NCCIH; (2) how the new funding opportunity will work; (3) eligibility, research scope, budget, review criteria, and important dates; and (4) answers to participants’ questions.

Background on the CTSA Program

The CTSA program was launched in 2006 to re-engineer and advance the clinical and translational research enterprise. In 2011, NCATS was launched, with a mission to catalyze the generation of innovative methods to enhance the development, testing, and implementation of diagnostics and therapeutics. After a 2013 review of the program by the Institute of Medicine (now the National Academy of Medicine), new goals were incorporated into the CTSA program with the ultimate objective of bringing more treatments to more patients efficiently and effectively. One of these goals was to foster a well-trained research workforce that can implement high-quality, multidisciplinary team science.

More than 50 research institutions currently receive funding from the CTSA program. Many resources are available at these institutions to help people design and conduct clinical and translational research. All of these institutions provide a mentored KL2 program to support career development for postdoctoral scholars seeking additional training and expertise in clinical and translational science. The KL2 is the parent grant for the funding opportunity being discussed today. The KL2 program provides a minimum of 2 years of support for scholars interested in pursuing clinical or translational science. Applicants for the current funding opportunity may wish to check with Dr. Merchant at merchantc@mail.nih.gov or Dr. Mudd at Lanay.mudd@nih.gov to find out whether their institutions are partners with or affiliates of the CTSA program.

The funding opportunity announcement (FOA) being discussed today responds to a 2014 recommendation of the Physician-Scientist Workforce Working Group convened by the NIH Director. That working group recommended that NIH institutes and centers leverage the existing resources of the CTSA program to obtain maximum benefit for training and career development of early-career clinician-scientists. Although the working group’s name included the title "physician-scientist,” the title was applied more broadly to include clinician-scientists such as dentist-scientists, veterinarian-scientists, and nurse-scientists and the complementary and integrative health workforce may be included as well. The KL2 program is designed to support research opportunities for clinician-scientists who are at a critical point in the research career pipeline when many are lost to industry or clinical practice.

Background on NCCIH

The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health approaches and their roles in improving health and health care, with the vision that this evidence base will inform decision making by the public, by health care professionals, and by health policymakers. The Center’s 2016 Strategic Plan included an objective to support research training and career development opportunities to increase the number and quality of scientists trained to conduct rigorous research on complementary and integrative practices and to foster interdisciplinary collaborations and partnerships.

NCCIH funds research on mind and body practices such as acupuncture, massage therapy, meditation, and yoga, as well as natural products such as herbs, dietary supplements, and probiotics. The Center is interested in these approaches for a range of outcomes and populations. NCCIH has a strong strategic priority of understanding nonpharmacologic approaches for pain but is also interested in mechanisms of action, establishing biological signatures, understanding how complementary approaches can be used for disease prevention and health promotion, and hard-to-manage symptoms other than pain, such as stress and anxiety.

NCCIH’s purpose with this FOA is to leverage the CTSA program network to enhance and foster training of clinician-scientist investigators with complementary and integrative health degrees who are interested in conducting clinical and/or translational research on complementary interventions for NCCIH high-priority research topics. The Center seeks to develop a pipeline of qualified clinician-scientists with complementary and integrative health training. This effort responds to the recommendations of a working group of NCCIH’s advisory council as well as the NIH working group mentioned earlier.

How the Funding Opportunity Will Work

The administrative supplements discussed here will provide funding for an extra slot in CTSA KL2 programs to support 2 to 5 years of training for an individual scholar with a clinical background in complementary and integrative health practices. Program Directors (PDs)/Principal Investigators (PIs) of CTSA KL2 programs will recruit and nominate scholars for the extra slot. Applications must propose an individualized program of translational science education and career development, appropriate mentors to support research and career goals, and a research experience integrated with the KL2 career development core and aligned with NCCIH’s strategic plan and high-priority topics. The KL2 program must be currently active with at least 2 years of funding remaining at the time of award.

Eligibility

  • Candidate scholars must meet the following eligibility criteria:
  • Doctoral level clinical complementary and integrative health degree (e.g., D.A.O.M., D.C., D.O., D.P.T., and/or N.D.)
  • Citizen or noncitizen national of the United States or lawfully admitted for permanent residence at the time of award
  • Staff appointment at the application institution or a partnering institution at the time of award
  • No history of significant NIH funding (i.e., cannot have been a PD/PI of an R01, P01, R29, or K award)
  • No pending K-award application that duplicates any part of the KL2 at the time of award.

Research Scope

The scope of the proposed research may include basic, mechanistic, clinical, or observational research, within the context of clinical and translational science, on a natural product or mind and body approach for any NCCIH high-priority topic. Additional information is provided in the FOA.

Pilot studies, formative work, feasibility studies, observational studies, and secondary analyses are all welcome, but NCCIH will not support applications proposing to examine efficacy, effectiveness, or “preliminary efficacy” because the amount of funding will not support a fully powered efficacy study. It is important to justify how this mentored research experience will help to support subsequent grant applications.

Budget The budget for this award may include:

  • Up to $100,000 per year for salary to support 75 percent effort by the scholar
  • Up to $25,000 per year to cover tuition and fees related to career development, research expenses, travel to scientific meetings/training workshops, and/or statistical services
  • Up to $10,000 per year for mentor support for laboratory or other research-related expenses (but not salary).

Scholars must be appointed for at least 2 years and may be appointed for as long as 5 years. The appointment cannot exceed the maximum length of appointment in the parent KL2 program.

Review Criteria

  • Applications will be reviewed administratively by NCCIH and NCATS program staff. They will not go through peer review. The administrative review criteria are as follows:
  • Likelihood that the award will enhance the scholar’s potential for an independent scientific research career in complementary and integrative health
  • Appropriate clinical expertise
  • Likelihood for the scholar to develop a strong clinical and translational research program or to develop collaborative expertise and contribute as a strong member in team science approaches
  • Appropriate qualifications of the proposed mentors
  • Availability of active research funding to support the scholar’s proposed project
  • Clear commitment of the sponsoring institution to appoint the scholar if the supplement is awarded and to ensure that the required minimum of the scholar’s effort will be devoted directly to research training and career development activities (letter of support)
  • Alignment of the proposed research experience with NCCIH high-priority areas, appropriate scoping of the project for a KL2 experience, and likelihood that the project will yield preliminary data to support a subsequent grant application.

Dates

Applications are due December 1, 2018 and must be submitted electronically. NCCIH/NCATS review will be completed by January 31, 2019, and the earliest start date is March 1, 2019. Start dates will be aligned with the start date of the next funding period for the KL2 award.

Concluding Points

Interested scholars may use NIH Project Reporter to identify KL2 PD/PIs. Interested PD/PIs may wish to recruit eligible scholars already at their institutions or contact NCCIH-supported training program PIs and/or funded K24 mentors to identify potential scholars. Dr. Mudd Lanay.mudd@nih.gov can also help with this “matchmaking” process.

Applicants are urged to contact Dr. Mudd Lanay.mudd@nih.gov at NCCIH or Dr. Merchant merchantc@mail.nih.gov at NCATS before submitting an application.

Summary of Questions and Answers

What kind of staff appointment does the potential scholar need to have?

In line with KL2 requirements, candidates must have a full-time appointment at the parent institution or a partner institution as a postdoctoral research associate, adjunct instructor, or tenure-track professor.

Can multiple scholars be proposed for the same CTSA institution?

Yes, but NCCIH will only support up to two scholars at a single institution. However, as long as the applications are distinct from one another, multiple scholar applications may be submitted. It would be wise to discuss the proposed scholars and projects with Dr. Mudd Lanay.mudd@nih.gov before submitting applications.

Does the scholar need a faculty appointment at the CTSA institution to apply?

See the answer to the first question above. Please note that scholars must already have a doctoral-level degree. Those who are still working toward a doctorate are not eligible.

Will NCCIH be taking applications at a later date?

This FOA has a single receipt date of December 1, 2018. NCCIH considers this a pilot program. Similar funding opportunities may be available in the future, but the current FOA has only one receipt date.

Are scholars allowed to propose a new clinical trial as part of their research plan?

Yes, but the scope of the trial needs to be appropriate for the level of support. A small-scale feasibility trial would be possible; an efficacy trial would not. NCCIH will not support applications proposing efficacy or effectiveness work. Applicants who propose a clinical trial need to complete the appropriate forms for NIH clinical trials and adhere to NIH clinical trial policies.

Would a scholar with a clinically oriented Ph.D., such as a degree in clinical psychology, and a research interest in complementary medicine be eligible?

No. Applicants for this funding opportunity need a doctoral clinical degree in complementary and integrative health. Those with other degrees may wish to contact Dr. Mudd at Lanay.mudd@nih.gov to find out about NCCIH career development opportunities appropriate for their qualifications.

How do I determine whether a participating partner institution is part of a given CTSA institution?

One way is to search online at the institution for CTSA programs. You can also contact Dr. Merchant at merchantc@mail.nih.gov or Dr. Mudd at Lanay.mudd@nih.gov to confirm whether the institution is a partner or affiliated institution with one of the CTSA hubs.

Would an individual with a Ph.D. in music therapy be eligible?

Yes. Music therapy would be considered a complementary and integrative health background. Contact Dr. Mudd at Lanay.mudd@nih.gov for further information.

Can you elaborate on the “significant” prior NIH funding that scholars cannot have?

The FOA gives very clear guidelines. Individuals who have been a PD/PI on an R01, a P01, a center grant, an R29, or subprojects of P01s or center grants are not eligible. Former PD/PIs of NIH K awards or the equivalent are also not eligible. But individuals who previously had a small grant, such as an R03 or R21, a dissertation award, or a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award remain eligible. If you are unsure about eligibility, contact Dr. Mudd at Lanay.mudd@nih.gov.

In order to be considered for the KL2 appointment, do candidates need to have a professional license to practice?

No. It is the terminal degree that is considered, not licensure. Applicants must have completed their terminal degree before applying. The University of Washington CTSA website is https://www.iths.org/about/about-iths/.

Does the PI of the CTSA submit multiple applications, one for each possible scholar?

Yes. PIs should submit separate applications for each scholar they wish to support. NCCIH will only fund up to two scholars at a given institution.

Additional Comments From the Speakers

The CTSAs are a network of talented investigators. Please take advantage of this network and consider how you can expand your current work. Since this FOA supports funding for an extra slot, individuals with complementary and integrative health backgrounds are not competing against other scholars applying for the KL2 program. We hope many people will take advantage of this opportunity, and we are excited about the potential for this partnership to launch clinician-scientist careers. The goal of this KL2 experience is to provide scholars with the background that will enable them to apply for subsequent grants, such as individual K awards.

NCCIH and NCATS encourage potential applicants to contact Dr. Merchant at merchantc@mail.nih.gov or Dr. Mudd at Lanay.mudd@nih.gov to see whether their proposed projects and potential scholars are aligned with this FOA.