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NCCAM Pre-Application Teleconference to Discuss Competitive Revision Applications for Research on Complementary Approaches to Symptom Management in Military and Veteran Populations (R01)

Wednesday, May 15, 2013

NCCAM Funding Opportunity Announcement: PA-13-075

Purpose of Teleconference: On Wednesday, May 14, 2013, NCCAM convened a pre-application teleconference to provide technical assistance to prospective grant applicants. The teleconference provided an overview of the funding opportunity and explained the peer review process. The teleconference also addressed participant questions received via telephone and email.

Application Receipt Dates: July 5, 2013; November 5, 2013; March 5, 2014; July 5, 2014; November 5, 2014; March 5, 2015; July 5, 2015; November 5, 2015

Teleconference Speakers:

Kristen Huntley, Ph.D., NIH/NCCAM, Program Director
Peter J. Kozel, Ph.D., NIH/NCCAM, Scientific Review Officer
Kim Nesbitt, M.A., NIH/NCCAM, Health Program Specialist (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 the award is to encourage NCCAM-funded researchers to collaborate with the Department of Defense (DoD) or Veterans Health Administration (VHA) clinicians or researchers to conduct research on complementary approaches for symptom management and health promotion in military or VA populations. The research proposed should be focused on complementary approaches to pain and symptom management or improving health in U.S. military personnel, veterans, and their families.

Background

This competitive revision FOA is the second phase of NCCAM’s phased approach to encouraging applications in this area: nccam.nih.gov/grants/concepts/consider/military. First I will provide some background information to explain why we are interested in this topic.

  1. The wars in Iraq and Afghanistan have been the longest sustained U.S. military operations since the Vietnam era, sending more than 2.2 million troops into battle, and resulting in more than 6,600 deaths and 48,000 injuries. While many service members return home relatively unscathed and report rewarding experiences, others return with varied complex health conditions and find that readjusting to life at home, reconnecting with family, finding work, or returning to school is an ongoing struggle. High rates of traumatic brain injury, post-traumatic stress disorder, pain disorders, and other co-morbid physical and psychological conditions have been documented.
  2. In May 2010, the Office of The Army Surgeon General’s Pain Management Task Force released their final report, “Providing a Standardized DoD and VHA Vision and Approach to Pain Management to Optimize the Care for Warriors and their Families,” and launched a Comprehensive Pain Management Campaign Plan. One of the objectives specified in the final report was to incorporate complementary and integrative therapeutic modalities into patient centered plans of care [3.66KB PDF]. There has been unprecedented interest in using complementary approaches to help active duty personnel and veterans in these health care settings.
  3. In a separate effort, the Institute of Medicine (IOM) released a Consensus Report entitled “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.” The IOM report encourages Federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. The report also notes that, ideally, most patients with severe persistent pain would obtain pain care from an interdisciplinary team using an integrated approach that would target multiple dimensions of the chronic pain experience—including disease management, reduction in pain severity, improved functioning, and emotional well-being and health-related quality of life.
  4. Finally, NCCAM's Third Strategic Plan, published in 2011, prioritizes research on complementary approaches for pain and symptom management.

NCCAM would like to leverage the substantial interest in complementary approaches in the VA and DoD and is interested in supporting research. To be able to apply or to respond to this particular funding opportunity announcement, you must be the PI of a currently-funded NCCAM grant. We encourage you to talk to the Program Officer on the NCCAM-funded grant prior to developing an application.

The goals of this initiative are:

  1. to encourage data collection and research on complementary, nonpharmacological, or integrative approaches to symptom management and health in military or VA populations
  2. to leverage existing datasets and research infrastructure
  3. to foster collaborations between NCCAM-funded researchers and VA or DoD clinicians or researchers.

The use of PROMIS and NIH Toolbox measures are highly encouraged.

Administrative Points Regarding the FOA:

  • FOA seeks competitive revision applications (formerly called competitive supplement applications).
  • Revision Application: As defined in the Federal-wide SF424 (R&R): An application that proposes a change in 1) the Federal Government's financial obligations or contingent liability from an existing obligation, or 2) any other change in the terms and conditions of the existing award.
    • Note: In general for NIH applicants, #2 would not require the submission of another application. NIH grantees use revision applications to request an increase in support in a current budget period for expansion of the project’s approved scope or research protocol. Applicants must apply and undergo peer review. The previous NIH term was “competing supplement.”
    • Note: The former NIH term “revision,” is now “resubmission.” A revision has a suffix in its application identification number; e.g., S1.
  • NCCAM is encouraging competitive revision applications to augment currently active NCCAM R01 grants.
  • NCCAM-funded researchers should collaborate with VHA or DoD clinicians or researchers.
  • The research proposed should be focused on complementary approaches to pain and symptom management or improving health in U.S. military personnel, veterans, and/or their families.
  • Research related to all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) and veterans is of interest.
  • For the purposes of this program announcement, “complementary, nonpharmacological, or integrative approaches” include, but are not limited to, mind and body interventions such as mindfulness or meditation-based stress reduction approaches, massage, yoga, and acupuncture.
  • “Complementary, nonpharmacological, or integrative approaches to health care” could also include multidisciplinary models of care such as pain clinics, VA hospitals, and clinical health systems that include pharmacological, psychological, and complementary treatment modalities.

Examples of types of research partnerships include but are not limited to:

  • A VA pain clinician or investigator and an NCCAM-funded health services investigator
  • A DoD biomarker researcher and an NCCAM-funded complementary and integrative medicine investigator
  • A VA treatment outcomes investigator and an NCCAM-funded pain researcher
  • Clinical care providers in DoD/VA settings and clinical or basic research scientists funded by NCCAM.

Additional administrative points to be aware of:

  • Budgets for direct costs may not exceed $500,000 per year.
  • Applicants must submit a budget using the same budget format that was used for the parent award.
  • The total project period for an application submitted in response to this FOA may not exceed 2 years.
  • Applicants may request support for up to 2 years, but activities proposed must be completed by the end of the parent grant award period.
  • Grants that are in a no-cost extension period will not be considered for support under this program.
  • R01 Revision Receipt Dates: March 5; July 5; November 5 (Standard dates apply)

Information About the Use of the NIH Revision Application Mechanism:

Revision Applications General Information

  • Used when funds are requested to expand the scope of an existing grant or to meet the needs of a research protocol
  • Revision applications must undergo peer review
  • Formerly called “Competing Supplements”
  • Does not restore funds that were part of standard grant reductions made by the funding NIH Institute or Center
  • Investigators cannot apply until the parent application has been funded
  • May not extend beyond the project period of the parent grant
  • These applications are submitted electronically
  • The activity code must be the same as the parent grant (R01)
  • The title must be the same as the parent grant
  • The PD/PI must be the same as the parent grant; this must be the contact PD/PI for multi-PI applications
  • The budget format (modular or full) must be the same as the parent grant
  • The budget period may not extend (by even one day) the time period of the parent grant
    • Any No-Cost Extension must be in place and reflected in IMPAC before submission.
    • No-Cost Extensions may be activated only 90 days before the end date of the parent grant. Therefore, not all awarded grants may be eligible for a NCE to submit by a specific due date and not every awardee may be able to submit a revision.
  • One-page introduction are to be used for ALL activity codes
  • If one page is not enough space, you should summarize the highlights in the introduction and then elaborate on the nature of the revision and how it will influence or complement the aims, design, and methods of the current award in the 12-page research strategy section (where you will also specifically describe the additional research).
  • Research strategy length is 12 pages
  • Please address data-sharing plans in the application

Information on Review of the Competitive Revision Application:

Please refer to the Program Announcement for instruction on what to include in your applications in response to this FOA. Applications must be submitted electronically using Grants.gov. After submission, the application is referred to a specific Institute or Center (IC), Integrated Review Group (IRG), and ultimately a Scientific Review Officer (SRO).

The primary purpose of peer review is to assess the scientific merit of an application and not how closely the proposed research aligns with the priorities of a particular Institute or Center. Assessment of an application’s match to IC priorities is made by Program Directors, Program Officials, and/or Program Officers, and is not something that review staff or peer reviewers address.

The locus of review for these competitive revision applications will be the original Integrated Review Group (IRG); that is, the IRG at which the parent application was originally reviewed. In most cases this will be a panel at CSR. If CSR created a Special Emphasis Panel (SEP) to review your original application, they may create a SEP to review the competitive revision. If your original application was reviewed at NCCAM in response to a particular RFA, then NCCAM will create an SEP to review your competitive revision.

This FOA uses the standard review criteria for research grant applications: Significance, Investigator(s), Innovation, Approach; and Environment. There is an additional review criterion for this particular FOA: Reviewers will consider the appropriateness of the proposed expansion of the scope of the original project. Additionally, if, in the original review, some component(s) of your original application were not recommended for funding by the original reviewers, applicants should respond to those comments in their competitive revision.

Teleconference Participants’ Questions and Answers

 

Question: I wonder about the 2-year time period. Is it too short to conduct a randomized trial of the intervention used in the parent award in a different population and for a different indication? Could you explain this?
Answer: It depends on the project and how it fits within the scope of your existing grant and your ability to justify the work proposed within the 2-year period. For the example you just described, a new application may be a better strategy.
Question: Do you know when and where this will be reviewed and the earliest possible funding date?
Answer: These will be reviewed in the committee that reviewed the parent award. They will be reviewed every cycle. This FOA expires January 8, 2016. Applications will be reviewed on the same cycle as all other applications submitted each council round and are evaluated or considered in concert with all other applications received each council round.
Question: Can you expand on what symptom management is? Is there a preference for looking at pain or are symptoms such as shortness of breath something that is considered a reasonable topic? Does it have to be related to pain?
Answer: Pain management is a very high research priority. This particular FOA encourages applications for pain management and management of other symptoms. Certainly some of the high priority symptoms that military personnel and veterans are experiencing include symptoms related to anxiety, headaches from TBI, and PTSD.

We encourage a focus on management or amelioration of symptoms people are experiencing, not the use of complementary approaches to treat a specific condition.

Question: So the focus is more on the general symptoms, not so much on a specific disease topic?
Answer: Yes.
Question: Can you expand a little bit on the issue of difference between the supplement and a revision application in terms of the kind of review criteria used and its relationship to the parent grant?
Answer: NIH standard review criteria are used to review the competitive revision applications. See the FOA for the specific review criteria. What used to be called competitive supplements are now called competitive revision applications.
Question: What are the review criteria?
Answer: The review criteria for the supplement will be the standard R-type review criteria: Significance; Investigator(s); Innovation; Approach; and Environment. There is one additional review criterion related to the revision application: the appropriateness of the proposed expansion of the scope of the original, parent project.
Question: In terms of the criteria for supplements, do they have to run fairly close to the parent grant in terms of aims?
Answer: Reviewers will be evaluating the application on the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project.
Question: When you listed-out what complementary nonpharmacological and integrative therapies were, you didn’t mention chiropractic. Is that not allowed?
Answer: That is allowed. The FOA text reads “modalities such as,” so it includes more modalities than I specifically verbalized today.
Question: The goal of this initiative is 1) conduct research, 2) leverage existing data and research infrastructure, and 3) foster collaborations between NCCAM-funded researchers and VA or DOD clinicians or researchers. Are those official review criteria or would that be considered just at the level of council and not in the scientific review?
Answer: That is not one of the standard NIH review criteria. This was our goal, or what we wanted to accomplish by issuing this funding opportunity announcement. Based on meetings we’ve had over the past couple of years, we wanted to try to connect VA clinicians and DOD clinicians and researchers with researchers who have expertise in conducting research on complementary approaches.
Question: Do we need to present the pilot data for collaboration with the VA?
Answer: Pilot data always helps.
Question: Are only those who have participated in the parent grant qualified to participate in this supplement?
Answer: For this particular funding opportunity announcement, only PIs of currently-funded NCCAM grants can submit a competitive revision. A competitive revision application could add key personnel with expertise in the areas that are expanding the scope of the parent grant.
Question: Are the initial grantees and their organizations publicly accessible and are there opportunities to collaborate with them on an existing program that meets the criteria?
Answer: You can look up currently-funded grants on the NIH RePorter Web site. For example, you can look up currently-funded grants in the area of meditation that are funded by NCCAM or that are funded by NIDA. You can look up success rates by mechanism and Institute or Center at NIH.

In NIH RePorter, you can see who is currently funded in your particular area of interest either at NCCAM or across NIH. This could help you determine if there might be anyone who has a research project you may be interested in finding out more about. Potentially you may recognize some of the names from professional meetings and perhaps could forge a collaboration.

Question: Waiting for the fall submission date would allow us to better prepare a strong proposal. Does this put us at a significant competitive disadvantage?
Answer: I would say no, it does not. Certainly my opinion is that it is always better to wait and to develop the strongest proposal possible. This funding opportunity announcement is open until January 8, 2016, and we hope to receive applications every cycle.
Question: How expansive can a project be? If the parent R01 used a CAM modality in a specific disease group, can the revision use that modality in a completely different sample, i.e., veterans, military with pain?
Answer: There’s not a specific prescriptive instruction in this FOA. I would just refer you back to how reviewers are instructed to review these. They are instructed to consider the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project.

It’s really up to you as the applicant to provide a strong rationale for the work proposed and how it expands the scope yet does not propose something so different that it bears little relationship to the parent award.

Question: If you have a currently funded R01 enrolling both veterans as well as non-veterans, is that okay? Is it only for enrolling veterans or can it be also non-veterans?
Answer: This FOA is to expand the scope to include veterans and/or active duty military personnel. So if you’re already enrolling veterans, it would depend upon other ways in which you’re expanding the scope.
Question: Can it be a way to obtain preliminary data for a larger project?
Answer: While the goals of this FOA do not include the collection of pilot data, the work proposed could generate preliminary data for other projects.
Question: Will there be an opportunity to submit a resubmission of a revision?
Answer: Yes, resubmission of Competitive Revision applications is allowed.
Question: How could a resubmission of a revision be allowed if a parent grant would be over?
Answer: In a situation where someone submits a revision application at the end of Year 1 of their parent award, it gets reviewed and gets a score that’s not in a fundable range but has an encouraging review, they can resubmit perhaps the next cycle when they would still have 2 or 3 years left on their grant. However, if timing is such that there would not be time left on the award to complete the proposed work at the time the resubmission was submitted, they could not resubmit a competitive revision application.
Question: Could you tell me if there is money set aside specifically for this FOA or is it just out of the general NCCAM funds and the competition is basically against all other grants submitted to NCCAM?
Answer: There is not a set-aside for this. This is a program announcement which is open for 3 years. The competition is against all other grants submitted to NCCAM.
Question: Is pain management the highest priority or PTSD overall?
Answer: For this particular FOA, both research on complementary approaches for pain management and other symptom management are encouraged.

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

Kristen Huntley, Ph.D.
Program Director
Division of Extramural Research
National Center for Complementary and Alternative Medicine National Institutes of Health
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)
Tel: 301-594-9346
Fax: 301-480-1587
Email: huntleyk@mail.nih.gov

For additional review 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 voice
Fax: 301-480-2419 fax
Email: kozelp@mail.nih.gov