NCCAM Pre-Application Teleconference To Discuss the NIH Parent K24 Midcareer Investigator Award and NOT-AT-11-003

September 7, 2011

NCCAM Funding Opportunity Announcement: PA 11-195

Purpose of Teleconference: On Wednesday, September 7, 2011, NCCAM convened a pre-application teleconference to provide technical assistance to prospective applicants. The teleconference provided an overview of the research grant submission process, including a discussion of the grant mechanism used, preparation of the grant application, and the peer review process. It also addressed participant questions.

Application Receipt Date: October 12, 2011

Teleconference Speakers

Linda Duffy, Ph.D, NCCAM
David Wilde, M.D., NCRR
Iris Obrams, M.D., NCRR
Dale Birkle Dreer, Ph.D., NCCAM
Peter Kozel, Ph.D., NCCAM
Anita Greene, M.A., NCCAM (Moderator)

Important information provided about this funding opportunity announcement (FOA) by NCCAM and NCRR Program Officers and NCCAM Office of Scientific Review subject matter experts appears below.

Important Information About the Program Announcement

• The purpose of the award is to include a partnership of the K24 Midcareer awardees with the CTSA consortium. NCCAM strongly recommends partnering with a CTSA, although it is not mandatory.
• This partnership is intended to create an enriched environment and program synergy that can improve the success of CAM midcareer clinical investigators to build nationally recognized clinical translational research improving research capacity, multidisciplinary research environments, and robust training research programs.
• In brief, synergy is based on the principle that the CTSA resource-enriched environment demonstrates a multidisciplinary approach that provides core resources and expertise on an economy of scale and that is relevant to NCCAM's Third Strategic Plan and complements the clinical translation and research interests of the K24 recipients.
• The eligibility requirement is the same as the Parent K24, which requires the eligible candidate to have a health professional doctoral level degree or its equivalent. In addition, the K24 recipient should be an established, midcareer investigator with a high level of productivity, including R01 or equivalent independent research funding.
• The recipient should have a track record of success in mentoring, and successful applicants are typically (but not always) at the associate professor level. Initially eligible applicants who intend to continue being committed mentors after reaching the full professor level are also encouraged to apply.
• NCCAM convened a working group that identified several critical needs to be met. One need is mentoring junior clinical scientists—especially K23 and other early career investigator trainees—to increase the pool of CAM investigators who remain in sustainable CAM research careers in academic medicine.
• It is expected that, as part of NCCAM's intended use of the K24 mechanism, mentors will increase their commitment to junior clinical investigators to enhance research productivity and increase the pool of well-trained CAM researchers within the CTSA environment.
• NCCAM feels the K24 award will thereby provide protected time to the midcareer clinician scientists for advancing research within an enriched CTSA consortium. In addition, mentoring clinical translational investigators with a stated purpose of pursuing clinical research careers in CAM in a variety of academic research settings will be greatly enhanced if they partner with the CTSA.
• In terms of the mentoring component, applicants are expected to demonstrate their CAM expertise in program areas that are relevant to NCCAM's Third Strategic Plan (available at nccam.nih.gov/about/plans/2011/. Applicants' research and contributions to the field, and mentoring success with trainees, including K23 and residents and fellows, should also be evident in the application.
• Applicants are strongly encouraged to identify specific CTSA multidisciplinary collaborators, consortium activities, and core resources that individual trainees will access to accelerate and enrich the training experience.
• K24 recipients are strongly encouraged to establish their mentoring capacity, including publication records and successful competition for research support in areas that are directly related to the proposed training program. Mentors' qualifications in areas directly related to the proposed research training should also be evident in the application.
• A mentoring plan and progress evaluation within the plan are required components of the K24 application. The mentoring plan should include a description of the availability of new clinical investigators for mentoring, their previous training and specialization, their plans for recruitment and selection, the types of education or research experience to be provided, and the capacity to which the candidate for the K24 award can serve as a mentor.
• Applicants who partner with a CTSA must describe how the mentoring plan will be integrated with the curriculum of the partnering CTSA. Candidates must also describe a plan for supporting the research of their mentees during the period of the K24 award.
• K24 applicants may include a variety of measurable criteria for tracking; for example, overviews of trainee career development plans, timelines, trainee population polls, the number of trainees to be recruited, the course curriculum endorsed by CTSA Education and Clinical Committees, the strategies for participation at national meetings, peer-reviewed publications, and any new research funding by K24 recipients or the trainees.
• If the K24 applicant is partnering with the CTSA, it is critical to have detailed letters of endorsement and support from the department chairs for the protection of time, as well as the CTSA Director or Education and Clinical Committee Chair's endorsement conveying strong institutional support, including filling the mentorship and research role proposed as integral members of the CTSA consortium.
• The CTSA parent institution must also ensure an adequate pool of CAM-interested trainees within their institutional configuration.
• The total award amount is contingent upon the NIH FY2012 funding and the submission of relevant meritorious applications. The total project period cannot exceed 5 years.
• Salary for levels of effort between 3 and 6 person-months with 25 to 50 percent full-time professional effort is based on a full-time, 12-month staff appointment. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale.
• NCCAM will provide up to $50,000 per year for research expenses, including technical personnel, supplies and equipment, travel, and statistical support.
• The submission/first official receipt date is October 12, 2011.
• One competing renewal for 3 to 5 years is possible for K24 recipients upon successful progress achieved in the initial period. The renewal application must demonstrate continued peer-reviewed funding and continued need for protected time and commitment to mentorship in advancing the research program.

CTSA Overview

• CTSA, the acronym for Clinical and Translational Science Award, aims to develop clinical translational research infrastructure consortiums under one large grant instead of individual grant mechanisms. CTSAs include both clinical transalational research infrastructure and educational elements.
• The current 60 CTSAs in the United States are parent institutions, frequently with partnering institutions co-named in their applications. Awardees may be located at a parent institution or at a partnering institution.
• Mentors are placed in the CTSA environment because CTSAs are a magnet for bringing junior investigators into the system—both through T32 pre-doctoral and post-doctoral programs and through a K12 program for more advanced clinicians and clinical scientists. These junior investigators learn the basics of clinical research, build on educational programs, apply for other grants, and develop their careers.
• Mentoring is a critical element; without mentoring many junior investigators will not be successful. NCCAM is trying to embed K24 investigators into the CTSA environment, and once there, these investigators can identify potential candidates they would like to mentor and start on projects related to NCCAM priorities.
• Partnering with a CTSA allows investigators access to the many built-in core resources of the CTSA so they do not have to independently request and assemble them in their own grants. Many CTSA cores will provide laboratory services, regulatory services, and consultation support for IRB protocol review and approval.
• For example, investigators who will be involved with the FDA do not have to know how the agency works; the CTSAs has an FDA liaison who understands the process. This feature is a relief to many investigators who know little about the workings of the FDA.
• Investigators who partner with a CTSA can easily identify CTSA resources, including access to young investigators. Staff at the CTSA parent or partnering institution become part of the CTSA and conduct their research in that infrastructure environment.
• The CTSAs are built on a cooperative agreement, which means that both the institution and NIH take active roles in the oversight of the CTSA program. Consequently, the program evolves with the needs of the investigators.
• This proposed NCCAM use of the NIH K24 parent funding opportunity aims to determine how the K24 program will develop in stronger partnerships, particularly with CTSAs, and how NCCAM investigators can enter into the CTSA infrastructure and use resources to both enhance their own research and find potential mentees.
• For more information about the CTSA cores, please visit the comprehensive Web site www.ctsacentral.org, specifically the Education and Career Development Key Function Committee because they are particularly relevant to this undertaking.
• For additional information, contact the CTSA office at 301-435-0790. Your call will be directed to a staff member who can respond to your question.

Review Requirements and Process

• Unlike some of the other K applications, no letters of reference or letters from mentors are to be included in the midcareer development award.
• The application requires a letter from the CTSA director or someone else in a relevant position, possibly the director of the education component that documents the CTSA's role in the K24 mentoring program. That letter needs to be included in the application in the Other Attachments section. (The Other Attachments section is not part of the page limits.)
• An institutional commitment letter is also required. It can be provided by the applicant's department chair or someone else with the authority to verify that the investigator will get the appropriate amount of release time to conduct the activities proposed in the application.
• In summary, two letters are needed: (1) a letter stating the institution's commitment to the candidate's research career development (as described on page 10 of the FOA). This letter should come from the applicant's institution—specifically from the department chair or dean—stating the institution's commitment to the project and the fact that the applicant has release time and (2) a letter from the CTSA director to distinguish those applications that are going to be collaborating with a CTSA. The CTSA director of the partnering institution should talk about the kinds of resources they are committed to provide, including an adequate pool of CAM-interested trainees. The review panel looks carefully at these two letters because they document the level of support from the institution.
• Several years ago, NIH created strict page limits on grant applications, and about a year ago, new page limits were put in place for the K applications.
• There is a strict limit of 12 pages total for items 2, 3, 4, and 11, which relate to the candidate's background. Most applicants take about one page to describe their immediate and long-term career objectives and experience with patient-oriented research. They should include their objectives about mentoring clinical investigators and experience in research and mentoring.
• Many applicants provide information about the people they have mentored in the past, such as their names, specialties, and research projects. (This is described in detail on page 8 of the FOA.)
• Also in that section, the applicant should describe how the protected time is going to be parceled out to relieve the investigator from patient care and other responsibilities so that he or she will be able to execute the mentoring and research project requirements.
• Item 3 (part of the 12-page limit) is a description of the applicant's career, goals, and objectives.
• Item 4 describes the career development and training activities that the applicant will undertake during the K24 period. (These are both described on page 9 of the FOA.)
• The last section (which must fit within the 12-page limit) is the research strategy. Using one page for the candidate's background and one page for career goals and development and training activities leaves 10 pages to succinctly describe research strategy.
• The research strategy section should have a specific aims page, much like an R01. Two items should be discussed in the research strategy section. The first item is currently supported research. A huge amount of detail is not needed, but there should be sufficient information for the reviewers to understand what the applicant is doing currently and how it would provide opportunities for mentoring. The second item is the proposed research strategy. For example, how will new research to be done under this award help augment the applicant's research skills and those of the mentees? (The requirements of the research strategy section are described in detail on pages 10 and 11 of the FOA.)
• In addition to those sections, there is a one-page section about training in the responsible conduct of research. This section is factored into the overall impact/priority score of the application but is evaluated by the reviewers as "acceptable" or "unacceptable." In this section, describe a plan for how instruction in the responsible conduct of research will be provided. Applications lacking a plan for training in the responsible conduct of research will be considered incomplete and may be delayed in the review process or may not be reviewed.
• The mentoring plan of the application has a six-page limit. This is where the specific details about how the junior investigators will be mentored under this award. If the applicant is partnering with a CTSA, describe how that mentoring plan will be integrated into the curriculum of the CTSA and will take advantage of any resources that the CTSA is providing.
• In terms of the review process, the reviewers will follow the review criteria that are laid out in the FOA (beginning on page 12). It is very important that the applicant looks at these criteria when beginning to develop the application and that all the criteria have been addressed before submitting the application.
• Reviewers will use the following criteria to evaluate the applicant-mentor: the quality of the grant support and the applicant's research, mentoring experience, and commitment to mentoring.
• One of the review criteria focuses on the plan for providing mentoring, whether those plans are adequate in terms of supervision of the mentees, opportunities that will be provided to the mentees, and the integration of appropriate clinical research curricula. The reviewers will not evaluate the current, funded research of the mentor; instead, they want to know how the current and proposed research will provide mentoring opportunities and foster the development of the careers of both the mentor and the mentees. Reviewers will be looking at the scientific and technical merit of the proposed research as well.
• The section on environmental and institutional commitment is where the reviewers will evaluate the CTSA's involvement and other institutional resources and whether the environment, the availability of mentees, and other such factors will be adequate to support the proposed work.
• Additional criteria that the reviewers factor into the final impact score are inclusion of women, minorities, and children, protection of human subjects and/or animals (if applicable), and use of biohazards.
• No specific review criteria are geared directly to the CTSA, but the reviewers will be paying close attention to the environment and the nature and scope of the collaboration with the CTSA.

Participant Questions and Answers

Question: I'm currently an assistant professor and I'm about to submit my package for promotion to associate, but it's not going to happen for the October deadline. I assume I'll have to wait for next year's application since I haven't officially been promoted yet, correct?

Answer: I think in a case-by-case basis, you really have to look at the compelling basis of your application apart from the dependency on a K24 coming through that may or may not influence your promotion process. These are definitely separate issues and if there is any doubt in terms of your midcareer status, it may be something that you want to seriously look at postponing submission of your application until the February or June 2012 submission dates, with the knowledge that there's only one resubmission now in application submission processes.

Question: With the K24 effort, do we need to generate new data and build a new research area?

Answer: The idea is for the K24 recipient to have protected time to expand the program of research development in new avenues among your clinical investigator team. So you don't want it so disparate that it is seen as a disconnect, but at the same time it needs to be independent enough to build independent funding and career development planning and this should be evident to reviewers who are looking at the application.

Question: Multiple mentors: Does this mean another mentor can also put their effort on the K24 application?

Answer: The conceptual idea of multidisciplinary environment and expertise is that you want the K24 awardee to be integrated with the CTSA to synergize the expertise and the resources at a level that could not happen without it. When you are using a CTSA, you want to be able to have a unique matching of the resources and expertise and multidisciplinary potential at the consortium environment with the program of research that you are developing. In doing so, most likely there will be instances where there may be a senior mentor, but there may be a co-mentoring need; for example, if you're developing a technology or you're looking at a specific mechanism of action. There can be many reasons why there might be a co-mentoring capability here, and the investigator is going to be working between two, three, or four of you. In addition, the K24 typically would not have explicit budgetary support for such a mentor. The K24 is intended to protect time for the principal investigator. It is an individual award in that sense, and you wouldn't be adding budget support for the other senior investigators who might be providing mentoring.

Question: Can you tell me how many awards NCCAM is likely to make in fiscal year 2012?

Answer: There is no set-aside for this program; thus, NCCAM can make as many awards as are judged meritorious and for which there are sufficient funds.

Question: I have heard that there is a historical matching of NCCAM T32 grants with NCCAM K24 grants. Can you speak to that?

Answer: In the past that was true. That is, investigators who obtained T32 awards could subsequently apply for K24s, which would provide them with some salary support while they were the PIs of the T32. This still could happen. People who have obtained T32 awards and are in environments where there is a participating CTSA are certainly encouraged to apply for a K24. In essence this can integrate or further integrate the T32 program within the CTSA. There's a big emphasis in the K24 on having R01 or R01 level support. It is really important that the candidate have a strong research program of their own. This is a very explicit requirement of the parent K24, and NCCAM is currently following that guideline. That is, we really want to see the midcareer investigators with a program of research that is funded at an independent, peer-reviewed level, R01, U01, or other equivalents. This is in addition to training programs like the T32.

Question: If a CTSA does not have CAM-related courses now, do I need to require them to develop new courses in CAM?

Answer: There's no necessity to develop a new course. One creative way of looking at this is to determine how well you will integrate within the CTSA environment; for example, being a member of the faculty team and sharing your expertise in course curricula, workshops, or other multidisciplinary training activities. Thus, this does not prevent you from expressing your interest with the CTSA directors, but it doesn't require that you have to develop a new course either.

Question: Tell us about the use of the $50,000 per year research fund. Any restriction on what these funds can be used for?

Answer:

The $50,000 is restricted to research extensions for the research component of the program of research. It can include technical personnel, supplies, and equipment and may also include travel to research and training meetings and may support statistical services which are separate from the salary support for the K24 recipient. It's not a lot of money. It's just a small fund to support some functions of the K24. This is one of the reasons why it is absolutely essential to have independent, peer-reviewed funding as a PI. That is really a very critical question because if you understand that, you understand why the PI must have research support independent of the K24 in the avenues of research that they are trying to expand in their own CAM program.

In addition, the availability of other R01 or equivalent research grant funding to the PI is a scorable review criterion. Reviewers will be commenting in their critiques. Thus, applicants must state compellingly both the need and the justification for use of the research funds appropriate to the program of research or the training. The funds that the K24 provides to support the research project are relatively small, so the K24 requires applicants to have additional funds to support the project. These funds should ideally come from an R01 or equivalent research grant. Whether or not such funds are available and whether or not they are sufficient to support the proposed research are considerations in the scorable review criteria and should be addressed by applicants in their application.

In summary, the K24 provides up to $50,000 in research funds intended for support of mentee activities that are considered needed and justified. However, this is the critical reason why mentors are expected to be independently funded at the level of the R01 or equivalent in order to develop the research project activities of mentees within the scope of the mentor's independently funded program of research.

Question: I was wondering how important previous mentoring of others [is] because I'm also currently [at] the assistant professor level and often have to carve out time to help folks. But it's very much not a formal thing, especially being at the assistant professor level.

Answer:

The midcareer award is typically intended at the associate professor level, not assistant. The track record of success of your mentoring relative to your trainee's ability to publish, ability to obtain independent funding in terms of what contributions are being made to the field by you and your team or your mentees—these are all ways for you to present in the application itself your commitment and your capacity as a mentor. Reviewers will look at this objectively from a review perspective.

It's not just a matter of quantity, but also a matter of quality. For example, how many people have you previously mentored, what is their publication history, what is their grant funding history, what are they doing now, where are they? These are all important characteristics in demonstrating your success as a mentor. Typically the quality of the mentoring capacity is something that's very important to reviewers when assessing applications.

One of the gap areas that NCCAM identified—retaining promising CAM researchers in a sustainable environment, especially in academic medical settings—has been a real challenge.

One way of bridging that gap is to look for quality investigators who serve in the capacity of mentoring where it could enhance the capacity of programs to build not only networks and national reputations, but really enhance the training research program for the K24 recipient and mentees.

The importance that the CTSAs place on the educational pipeline is on mentoring because the one required component for any CTSA is a description of a K12 training program. The K12 typically targets clinical fellows or perhaps early assistant professors and really gives them the ABCs of clinical research where they receive didactic training, propose a clinical trial, and then go through all of the steps in preparing that trial: writing the protocol, getting it through the IRB, running the trial, recruiting subjects, and then preparing data analysis and manuscript publications so that they will emerge at the end of that training as an independent investigator. That is why it's so important for the mentors to be there because when they first enter into a K12 program many of these are physicians who have spent their training time learning clinical skills but have never been in a research lab.

Thus, to take a mentor who is capable of showing mentees how to take their clinical training and then learn research skills on top of that [so] that they have a broad perspective of how to solve clinical research problems is just really one of the most important facets of the CTSA. CTSAs provide core labs and infrastructure, but without the mentor/mentee relationships and the clinical research that results from that, it doesn't do much good to have infrastructure. And we place a very high value on the educational component of both the T32 at the pre-doc level and the K12 at post-doc level. The mentor is critical to both pre- and the post-doc training. In the CTSA environment, you will be welcomed because we've lost a generation of mentors for one reason or another, and it's difficult to bring up that new generation through the pipeline until we embed mentors specifically with a purpose of training the next generation.

Question: NCCAM does not require a new research area be proposed, right? Does that mean we can only use our current research projects?

Answer:

If you look at the research strategy component section (on page 10 of the FOA), there is detailed guidance on this topic. There is no need to provide extensive detail with regard to ongoing, funded research; however, there is additional guidance in that section about information that should be provided about currently supported research.

And you want to describe that relative to what you are proposing to develop within a program-specific framework. Projects with the various investigators should all tie together in your areas of expertise that you are developing. In addition, there shouldn't appear to be a disconnect between what you're proposing, what you have funding for, how you are growing your program, and what you are proposing to do. It should be new lines of research within your areas of expertise as CAM researchers.

Question: What is the indirect cost rate on the K24?

Answer: As with all Ks, the indirect cost rate is capped at 8 percent.