Notice of Special Interest: NCCIH Administrative Supplements to NCATS CTSA Programs for Scholars Pursuing Complementary Health Research Career Development

Notice Number: NOT-AT-20-010

Key Dates
Release Date: April 13, 2020
First Available Due Date: October 01, 2020
Expiration Date: October 04, 2023

Related Announcements
PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)

Purpose

Background
The purpose of the National Center for Complementary and Integrative Health (NCCIH) Administrative Supplement to the National Center for Advancing Translational Sciences (NCATS)-supported Clinical and Translational Science Awards (CTSA) program is to develop a pipeline of qualified clinician-scientist investigators with complementary and integrative health degrees and expertise conducting clinical or translational research on complementary clinical interventions for NCCIH high-priority research topics. This Notice of Special Interest (NOSI) will support additional scholar slots to those KL2 grants currently approved under the CTSA Program. Eligible scholars for the additional slots must have a doctoral, clinical complementary and integrative health degree (e.g.., D.A.O.M., D.C., D.O., D.P.T., and/or N.D.).

NCATS CTSA KL2 Program
The KL2 Institutional Career Development Core at each CTSA Program hub supports research experience and career guidance activities expected to foster high-impact research careers in translational science. The KL2 program provides educational resources and access to research resources offered across the CTSA hub and integrated across multiple departments, schools, and clinical research institutes. The hubs promote a team science approach to research collaboration that includes a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics, and bioengineering).

NCCIH Supplements to NCATS KL2 Program
The goal of this NCCIH KL2 Administrative Supplement program is to leverage the CTSA program network to enhance and foster research training in NCCIH high-priority research areas (e.g., pain management) for additional scholars with clinical complementary and integrative health degrees (e.g., D.A.O.M., D.C., D.O., D.P.T., and/or N.D.). This initiative directly responds to the National Advisory Council for Complementary and Integrative Health Working Group Report on Clinician-Scientist Workforce Development, and in particular, its Recommendation #2: “Continue to support a variety of career paths to the goal of clinician-scientist, addressing specific roadblocks in each type of path. As part of this effort, develop innovative approaches to support research training for clinicians with complementary and integrative health degrees.”

The goals of this KL2 Administrative Supplement program are consistent with the NCCIH Strategic Plan. This KL2 Administrative Supplement program encourages the formation of interdisciplinary research teams with the required expertise to conduct high-quality studies. The NCCIH-supported KL2 scholars will become members of a large collaborative research network prepared to tackle the biomedical challenges of today and tomorrow to improve human health.

NCCIH Programmatic Requirements
PDs/PIs of active CTSA KL2 programs will recruit and nominate scholars for NCCIH KL2 administrative supplement awards. The applications are expected to propose:

The research experience supported under this NOSI is intended to enhance the scholar’s transition to an independent research career as a principal investigator or subject matter expert in a collaborative team science approach. In addition, this program is intended to provide a foundation for subsequent grant applications and support for continued research training, or for independent research funding from NIH or other sources. KL2 PD(s)/PI(s) should encourage scholars to submit applications for fellowships, individual career development awards, research grants, and other sources of independent support before the supplement period ends.

Scholar candidates may propose to conduct basic, mechanistic, clinical, or observational research on a natural product or mind and body approach. Prospective scholars are encouraged to justify how this mentored research experience will lead to subsequent grant applications. The proposed KL2 supported research should be designed to include pilot studies, formative work, feasibility studies, observational studies, and/or secondary analyses, as appropriate. NCCIH will not support applications proposing to examine efficacy, effectiveness, or “preliminary efficacy” through this funding opportunity.

KL2 PD(s)/PI(s) and potential scholars are strongly encouraged to contact NCCIH program staff to discuss their concepts prior to submitting their application.

The following topics are considered of high programmatic priority for natural products research:

  • Basic or translational studies to better understand the mechanisms of action of a natural product for symptom management. Studies to understand the bioavailability and pharmacokinetics of a natural product are also of interest.
  • Early phase human clinical trials to study the postulated mechanism of action of a natural product when it is used for symptom management, particularly management of pain conditions, mental health conditions such as those commonly managed in primary care (e.g., mild to moderate depression, anxiety, and posttraumatic stress), or sleep disturbance.
  • Basic or mechanistic studies or an early phase human clinical trial to examine the effects of probiotics or other natural products on gut-microbiome interactions with the brain and/or immune system.
  • Rigorously designed observational studies or secondary data analyses of a natural product.

The following topics are considered of high programmatic priority for mind and body research. High-priority mind and body or integrative approaches include spinal manipulation or mobilization, massage, tai chi, qi gong, yoga, acupuncture, hypnosis, guided imagery, progressive relaxation, meditation, biofeedback, mindfulness techniques, or complex approaches like music- and art-based therapies:

  • Studies of a high-priority mind and body approach for symptom management, particularly for management of pain conditions, mental health conditions such as those commonly managed in primary care (e.g., mild to moderate depression, anxiety, and posttraumatic stress), or sleep disturbance.
  • Studies of a high-priority mind and body approach for promotion of psychological resilience or well-being or for promotion of healthy eating and physical activity.
  • Basic or translational studies to better understand potential mechanisms of action for a high-priority mind and body intervention.
  • Formative work or early stage clinical studies to adapt or refine a high-priority mind and body intervention and/or examine the feasibility and acceptability of the intervention.
  • Rigorously designed observational studies or secondary data analyses on a high-priority mind and body approach.

NCCIH intends to commit $500,000 per fiscal year to fund KL2 supplement applications.

Application and Submission Information

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

  • PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

  • Application Due Date(s) – October 1, 2020; October 1, 2021; and October 3, 2022; by 5:00 p.m. local time of applicant organization.
  • For funding consideration, applicants must include “NOT-AT-20-010” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
  • The supplement application must comply with all of the Parent FOA requirements for the KL2 program.
  • Requests may be for a minimum of 2 years and a maximum of 4 years of consecutive funding for each scholar, consisting of 12-month appointments (depending on the eligibility of the parent award). The requested number of years of support must align with the typical length of appointments at the parent KL2 program.
  • Scholar appointment(s) must be able to be fulfilled within the active parent project period.
  • Only existing awardees of KL2 active awards are eligible to apply.
  • The process for Streamlined Submissions using the eRA Commons cannot be used for PA-18-591.
  • Applicants are strongly encouraged to notify the program contact at NCCIH that a request has been submitted in response to NOT-AT-20-010 to facilitate efficient processing of the request.
  • Applicant organizations may submit more than one application to this NOSI. Each application should include only one named candidate for the supplement. Use unique project titles for each application to ensure our systems treat each application as a distinct submission.
  • Application budgets must reflect the actual needs of the proposed project with the following limitations:
  • NCCIH will contribute up to $100,000 per year toward the salary of the KL2 scholar supplement award recipient. The award requires the scholar to devote a minimum of 9 person-months (75 percent of full-time professional effort) to conducting clinical or translational research on complementary health interventions for NCCIH high-priority research topics. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to salary at the time of award.
  • Other Direct Costs: The KL2 supplement budget may include funds to support the scholar's research project and career development activities. Applicants may request up to $25,000 per year to cover the following expenses: (a) tuition and fees related to career development; (b) research expenses such as supplies, equipment, and technical personnel; (c) travel to scientific meetings and research training workshops; and (d) statistical services.
  • Mentor support may be requested for up to $10,000 per year in associated laboratory or other research-related expenses. Salary support for mentors excluding laboratory- or research-related expenses is not an allowable budget item. Travel support for mentors is not an allowable budget item.

Instructions for Electronic Application Submission through Grants.gov: Use the “Apply” button(s) in Part I of the PA-18-591 program announcement to access the application forms package posted at Grants.gov.

When presented with more than one form package, use the form package with Competition ID “FORMS-E-ADMINSUPP-K12-KL2-KM1-D43.”

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

Program Plan (may not exceed 12 pages):

  • Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with the NCCIH mission.
  • Research Program Plan: The proposed plan should align with the missions of NCCIH and the NCATS CTSA program. Describe how the proposed project will contribute to the scholar’s career goals and path to independence. Present a timeline for research and training activities and potential publications and grant applications for future support.
  • Career Development Plan: Describe key activities of the candidate scholar during the supplement, including mentored team science activities, didactic coursework (including formal degree programs if appropriate), and other activities. Describe how the proposed training experiences will enhance the candidate’s clinical and translational science skills and prepare them for an independent research career.
  • Mentoring Faculty: Provide information about the program faculty team who will be involved in the supplement activities, including the complementary health expertise and experiences and active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. Provide details on how the mentoring will occur (e.g., frequency and mode), and how the scholar’s progress will be monitored during the supplement award period. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.
  • Vertebrate Animals: Complete this section if the scholar will design and conduct their own independent vertebrate animal research. Approval by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution is required prior to award.

Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program. Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned proposed research project. The letter should provide assurance that the candidate scholar will be able to devote a minimum of 9 person-months (75 percent of full-time professional effort) to the supplement project. The letter should confirm that the scholar will be supported by the KL2 if the supplement is funded. The letter should also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the scholar for the research project.

Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Senior/Key Person form:

  • List the PD/PI as the first person (regardless of their role on the supplement activities).
  • List Senior/Key Personnel who will be serving as members of the scholar’s mentoring team.
  • List the scholar proposed to be added through this supplement. Scholars for this supplement support must have an eRA Commons account, and the scholar’s Commons Username must be entered in the Credential field.
  • Biographical sketch Senior/Key Personnel: Include a biographical sketch of the KL2 PD/PI(s) and of each of the individuals who will compose the scholar’s mentoring team. The personal statement of each individual who will serve on the scholar’s mentoring team should include a description of his/her specific role in mentoring the scholar.
  • Biographical sketch Scholar: The personal statement of the scholar’s biographical sketch should include a description of their research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NCCIH KL2 supplement award. Relevant factors include previous training and research accomplishments in complementary and integrative health research and any source(s) of current funding.

Budget forms: Using the R&R budget form, only include funds requested for the additional supplement activities.

R&R Other Project Information form, Facilities and Other Resources attachment: Describe how the scientific environment in which the career development activities will be done contributes to the probability of the scholar’s success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Program hub training resources, describe the training resources that are available to the scholar.

PHS Human Subjects and Clinical Trials Information form: Complete this form if the scholar will design and conduct their own independent human subjects research. Approval by the reviewing Institutional Review Board is required prior to award. . Adherence to all the NIH policies for human subjects research must be ensured, if additional human subjects' involvement is planned for the supplement component.

Awardee-selected projects that involve human subjects research and/or animal research require prior approval by NIH prior to initiation. The awardee institution will provide NIH/NCATS with a written study package. The contents of the study package can be guided by a posted NCATS Prior Approval checklist (https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/prior-approval-of-planned-research-involving-human-subjects/).

Inquiries

Please direct all inquiries to:

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov

Carol Merchant, M.D., MPH
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0605
Email:merchantc@mail.nih.gov