NCCAM Pre-Application Teleconference to Discuss the Interdisciplinary Complementary and Integrative Health Clinical Research Training Award (T90/R90)

NCCAM Funding Opportunity Announcement: PAR-13-065

Purpose of Teleconference: On January 24, 2011, NCCAM convened a pre-application teleconference to provide technical assistance to prospective grant applicants. The teleconference provided an overview of the research grant submission process, including an in-depth discussion of the funding opportunity, and explained the peer-review process. The teleconference also addressed participant questions received via telephone and e-mail.

Application Receipt Dates: March 4, 2013; January 28, 2014; and January 28, 2015

Teleconference Speakers

Alberto Rivera-Rentas, Ph.D., NCCAM/NIH, Program Director
Peter Kozel, Ph.D., NCCAM/NIH, Scientific Review Officer
Anita Greene, M.A., NCCAM/NIH, Outreach Program Manager (Moderator)

Important information provided about this funding opportunity announcement (FOA) by NCCAM and specific questions and answers asked during the teleconference appear below:

Important Information About the Program Announcement

The purpose of this award is to establish partnerships between institutions with research intensive environments (e.g., T32 and CTSA institutions) and institutions with curricula focused on clinical training of practitioners in complementary modalities and disciplines that also have faculty with a substantial interest in rigorous clinical research.
This partnership is intended to create an enriched environment and program synergy that can develop a research workforce with training expertise in complementary health approaches to carry out rigorous research. This is outlined in NCCAM’s Third Strategic Plan and specifically delineated in Strategic Objective 4: Improve the Capacity of the Field to Carry Out Rigorous Research. Partnerships whether new or old should clearly state how they will meet the program goals and contribute to NCCAM’s strategic plan. Trainees and participants should experience program-supported activities at both institutions. The training program should include a transition plan for the trainees or the participants in the program to move into more mainstream research funding for their career development and to become independent investigators.
Mentors should be research-funded investigators with their own independent research work, funded either by NIH or another agency or foundation.
The program must have three overseeing components: (1) an advisory board (the names of these advisory board members should not be included in the application); (2) the collaborative implementation team or committee, composed of people who will oversee the day-to-day activities of running the program, select trainees and participants, and provide overall management of the program; and (3) an assessment and evaluation component, which can be an external evaluator, an internal evaluator, or a team of people. This component will focus on developing qualitative and quantitative research evaluation methods for the program. It will assess the program at the individual or trainee level, the institutional level and then provide feedback and recommendations to the program administration. The collaborative implementation team or committee should have representation from both institutions. It is important for them to create strong leadership to implement the program.
A letter of intent (LOI) is not required but is strongly encouraged.
If funded, only one institution will receive the Notice of Award; that institution will make a subaward to the partnering institution.
The total award amount is contingent on NIH fiscal year 2013 funding and submission of relevant meritorious applications. The maximum award period is 5 years.
The submission/first official receipt date is March 4, 2013.

Information on Review of the T90/R90

Please refer to the program announcement for instructions on what to include in your letter of intent. Briefly, the LOI should contain the names and institutions of all key personnel, including the principal investigator, members of the collaborative implementation and evaluation teams, and all mentors. Submission of the LOI is very helpful, as it will give the review staff a list of key personnel on each application.

Applications in response to this FOA should be submitted electronically using Grants.gov. After submission, the application is referred to specific NIH institutes or centers, scientific review groups, and scientific review officers (SROs).
The SRO begins the review process by administratively reviewing each application to ensure that it is complete and does not contain any inappropriate material. Application components (which are examined during administrative review) and common issues with them, are identified in subsequent bulleted items.
All key personnel should provide an up-to-date biosketch on the appropriate form. The form includes a personal statement, which should address the roles and contributions the individual will make to the proposed T90/R90 program.
Use of the preformatted data tables for Institutional Research Training grant applications is required and facilitates the efficient peer review of applications. The FOA clearly states that applications that lack the tables will not be reviewed. Additionally, be sure to use the correct version of each table. For this announcement, applicants should use the version for new applications. Data tables do not count toward the 25-page limit. Please refer to this link for data tables: grants.nih.gov/grants/funding/424/index.htm#data.
The FOA has several specific page limits that must be followed. The Specific Aims must be included on one page. Plans for instruction in the Responsible Conduct of Research are limited to three pages. Each biographical sketch (also known as biosketch) may be no more than four pages. There is a 25-page limit on the main body of the application, which includes these sections: Background, Program Plan, and Recruitment and Retention Plan To Enhance Diversity (Attachments 2–4 of Research Training Program Plan Attachments).
The T90/R90 uses the standard formatting limitations common to all NIH grant applications. Specifically, margins should be no less than half an inch. Applicants may use only Arial, Helvetica, or Palatino Linotype or Georgia typefaces that are black font color with a font size of no less than 11 points. No more than 15 characters per inch horizontally and 6 lines per inch vertically are allowed. Detailed grant-writing tips can be found at grants.nih.gov/grants/writing_application.htm.
The FOA states that you can have only one document in the Other Attachments section: the required Program Overseeing Committees document. This single file should contain three documents: two pages on the advisory board (remember not to include the names of the members); three pages on the collaborative implementation team or committee; and three pages on the assessment and evaluation team. This single document should be named Program Overseeing Committees.pdf. Note: This is the only document that should appear in the Other Attachments section.
Only specific sorts of documents may be included in the appendix of Institutional Research Training grant applications. The documents permitted in the appendix include: (1) syllabi for key courses, core courses, electives, and courses in the responsible conduct of research, and survival skills for research; (2) retreat, seminar series, and other program activity agendas, rosters, and schedules for the past 1 or 2 years only; (3) examples of forms used to document training progress and monitoring by the program, such as individual development plans; (4) examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool; (5) list of meetings attended by students and their presentations during the last 2 years only and; (6) student biosketches for current students only—do not include biosketches for prospective students. For reference to these appendix materials, see: grants.nih.gov/grants/guide/notice-files/NOT-OD-11-100.html.
The FOA also states appendix documents should be kept to a minimum. Reviewers may or may not look at the appendix materials; therefore, nothing that is critical to the review of your application should appear in the appendix.
Tables are not allowed in the appendix. NIH guidance clearly states that applicants who present information in tabular form will be considered as having circumvented NIH rules on page limits.
Applicants are allowed to submit specific kinds of postsubmission materials for training and related applications, specifically: (1) updated information and data on applicant-pool admissions, enrollment, appointments, or achievements; and (2) updated faculty research support. The document must be only three pages long in total and must be submitted as a PDF file. Only the institutional authorized organizational representative (AOR, also known as the institutional signing official) may submit the file, which must be sent via e-mail to Dr. Peter Kozel, the Scientific Review Officer (at kozelp@mail.nih.gov), no less than 30 days before the review meeting.
This FOA uses the basic review criteria headings for the institutional training grants, specifically: (1) Program training and environment; (2) Training program directors or principal investigators; (3) Mentors; (4) Trainees/participants; and (5) Training record.
Under these headings, NCCAM has added considerable additional specific elements to each criterion.
This FOA has an additional review criterion, evaluation. Applications will not get a numeric score for this criterion, but reviewers will be asked to provide comments on applicants’ evaluation plans and use those comments when evaluating the application overall.
Applicants are urged to carefully read, understand, and address all of the review criteria in their applications.

Teleconference Participants’ Questions and Answers

Question: What are the requirements for the complementary health institutions?

Answer: Institutions applying for this opportunity should have infrastructure and curriculum focused on clinical training of practitioners in complementary modalities. They should also have faculty with substantial interest in rigorous clinical research. Both the trainees for the T90 and the participants in the R90 are required to have a doctoral degree.

Question: What are the correct dates for the letters of intent?

Answer: Like all Institutional Research Training grant applications, NCCAM accepts T90/R90 applications only once a year. Letters of intent are due 1 month prior to the receipt date. For 2013, the receipt date is March 4, 2013; therefore, letters of intent are due by February 4, 2013. For 2014 and 2015, T90/R90 applications must be submitted by the standard receipt date, January 28, 2014 and 2015; letters of intent are due, therefore, December 28, 2013 and 2014.

Question: What is your approach to physical distance between the partnering institutions?

Answer: We encourage flexibility so that institutions can be creative and innovative. There are various ways that things can be done—from Web-based training to teleconferencing. Applicants are encouraged to describe and document how effective their collaborations are, regardless of whether they are across town or across the continent.

Question: Can you discuss the differences between trainees and participants?

Answer: The National Research Service Award (NRSA) component of the T90/R90 program follows certain NRSA guidelines. The T90 portion is for trainees; the R90 portion does not follow NRSA guidelines.

Question: Can you clarify the different expectations of the didactic training components in the T90 versus the R90 opportunities? There appears to be some overlap.

Answer: The didactic training components of the T90 will take place at research training institutions. These institutions already have the infrastructure and resources in place. The partnership is based on the principle that most research-intensive institutions have strong clinical research infrastructures and resources. In addition, institutions that are focused on clinical practice have more complementary integrative health approaches for clinical research. This FOA seeks and encourages that these activities be connected, but independent, and also be complementary to each other.

Question: Can support for Ph.D.- or master’s-level training be included in the up-to-3 years of training support?

Answer: This FOA does not support academic training. While it does support taking courses, we do not support paying for tuition that might be part of an academic training program.

Question: Is there a formal NIH definition of what constitutes complementary health research?

Answer: In terms of complementary health research, we follow NCCAM’s Strategic Plan, which outlines research priorities—both for research and research training.

Question: How many trainees and participants should we plan for each year?

Answer: It is up to each institution to define this based on their resources, mentors, and previous history of training. The important things, instead of the number, are the essential aim and the expectation of the program. We want people to get training and move on to the next level.

Question: Do you have any expectations of the qualifications of the mentors in terms of experience and funding?

Answer: This is established in the program announcement. It is clear that the mentors need to be funded investigators, either by the NIH or their agencies or foundations. Mentors should be qualified people who are doing research within complementary health and NCCAM’s research priorities and who also have experience in the research training field.

Question: It looks like 3 years of support is preferred in the FOA. It says that it can be a combination of appointment to the T90 portion and the R90 portion. Please explain how this works.

Answer: There is a strong movement at NIH to do individual development plans (IDPs) for trainees. Applicants are encouraged to assess the training pool, designate qualified trainees, and then decide the expected timeframe these individuals need to be able to move to the next step in their career.

Question: Can any of the pilot projects, research experiences, or activities have basic science or animal components, or is it strictly clinical human research?

Answer: It is clinical research but it is up to the institutions to decide. The program announcement did not say what kind of research. However, the proposed research must be within NCCAM research priorities. This can range from basic to translational research. Remember, in these programs Clinical and Translational Science Awards (CTSA) institutions are conducting translational research. So they should have the opportunity maximize their resources and opportunities for trainees and participants.

Question: What is the evaluation process?

Answer: We want to make sure that you have a strong evaluation team that is using qualitative and quantitative methods for evaluation and the ability to assess and study the metrics for success for your individuals. Reviewers will be assessing your evaluation plans and how well they are integrated into the training program as part of their scientific review, so it is very important that your assessment plans are well described. Your programs need to be designed so that they can be evaluated properly.

Question: Can the grant cover release time for faculty to participate?

Answer: Having a substantial amount of money going just in administration and less money going into the trainees and the research training program is not well viewed by either the program or reviewers. I would not recommend using funds that are for the research training program to pay mentors. If trainees or participants have full-time appointments or academic faculty appointments in any of the partnering institutions, applicants must follow both the guidance in the FOA for appointment to any component of the program and their own institutional human resources policies for release time and salaries as appropriate.

Question: How much money is expended toward trainees versus faculty members? Is there guidance on the percentage allowed?

Answer: It is up to the institution to demonstrate its commitment to the program, which is one of the components that should be included in your application (i.e., institutional commitment and support). There is no budget cap on this. If you want to have a very large program and request a lot of money to support it, in principle you can do it. However, NIH policy requires applicants intending to submit an application requesting greater than $500,000 in costs annually to receive permission from the NIH prior to submission.

Question: Is there a minimum full-time equivalent (FTE) requirement for trainees or participants?

Answer: Yes, you have to follow NRSA guidelines for this in terms of dedicated time.

Question: How many applications do you plan to fund?

Answer: As many as the scientific review process rates meritorious.

Question: Can you elaborate a little bit on the transition from the T90 and R90 from one component to another? Can you explain how the T90 portion would differ compared with applicants for the R90 in terms of their research interests, level of training, and professional standing?

Answer: The transition is an option. It is up to the partnership to define at what point one participant is ready to go and get the training for the T90 side, and vice versa. We do not want to prescribe this because NIH wants you to be creative and wants the trainees and participants to experience activities at both institutions. The program is designed to allow applicants’ innovative approaches to create the partnerships and develop the proposed training program. The only requirement is that trainees and participants must have doctoral degrees, as stated in the program announcement because it is a postdoctoral clinical research training program.

NCCAM Contact Information

For additional programmatic questions about this funding opportunity, please contact:

Alberto L. Rivera-Rentas, Ph.D.: Program Director; Training and HIV/AIDS and Special Populations Portfolios; Division of Extramural Research; National Center for Complementary and Alternative Medicine (NCCAM)
National Institutes of Health; 6707 Democracy Boulevard II, Suite 401; Bethesda, MD 20892 (Courier Service - 20817); Tel: 301-443-8372; Fax: 301-480-1587; riverara@mail.nih.gov

For additional review-related questions about this funding opportunity, please contact:

Peter J. Kozel, Ph.D.: Scientific Review Officer; Office of Scientific Review; Division of Extramural Activities; National Center for Complementary and Alternative Medicine (NCCAM); National Institutes of Health; 6707 Democracy Boulevard II, Suite 401; Bethesda, MD 20892 (Courier Service - 20817); Tel: 301-496-8004; Fax: 301-480-2419; kozelp@mail.nih.gov