NIH-DoD-VA Pain Management Collaboratory Technical Assistance Webinar Summary

NCCIH Technical Assistance Webinar
January 23, 2017

NIH-DoD-VA Pain Management
Collaboratory Funding Initiative

Moderated by

Anita McRae-Williams, M.A., Division of Extramural Research, National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Speakers

Eve Reider, Ph.D., Division of Extramural Research, NCCIH, NIH

Smita Bhonsale, Ph.D., U.S. Army Medical Research and Materiel Command (USAMRMC)

Martina Schmidt, Ph.D., Office of Scientific Review, NCCIH, NIH

Ranjana Banerjea, Ph.D., M.B.A., Office of Research and Development, Veterans Health Administration, U.S. Department of Veterans Affairs

Background

There is growing awareness that chronic pain and its management is a major concern for military service members and veterans living in the United States today, many of whom were among the 2.5 million active military deployed since 2001 in Operations Enduring Freedom, Iraqi Freedom, and New Dawn in Iraq and Afghanistan. Among this population, chronic pain frequently coexists with other problems including mental health issues, substance abuse, and sleep disturbances. It is not uncommon for these issues to be treated with opiate/opioid drugs. To improve capacity, tools, and skills available to medical providers for managing chronic pain in this population, and to reduce reliance and increasing dependence on opiate/opioid drugs, a new initiative has been launched as a joint activity of the National Institutes of Health (NIH), the Department of Defense (DoD), and the Department of Veterans Affairs (VA). The NIH-DoD-VA Pain Management Collaboratory is an unprecedented cooperative activity involving seven NIH institutes, centers, and offices (ICs)—NCCIH, NINDS, NIDA, NIAAA, NICHD (NCMRR), ORWH, NINR*—plus the Clinical and Rehabilitative Medicine Research Program (CRMRP) and the Military Operational Medicine Research Program (MOMRP) at DoD and Health Services Research & Development (HSR&D) program at the VA. This initiative builds on three ongoing activities: a long-term history of collaboration between the NIH, DoD, and VA, the NIH Health Care Systems Research Collaboratory, and the work and most recent report of the NCCIH Advisory Council Working Group, entitled Strengthening Collaborations with the U.S. Department of Defense and U.S. Department of Veterans Affairs: Effectiveness Research on Mind and Body Interventions.

As part of this initiative, NIH recently released two new funding opportunity announcements (FOAs): AT17-002: NIH-DoD-VA Pain Management Collaboratory-Coordinating Center (U24); and AT17-001: NIH-DoD-VA Pain Management Collaboratory-Pragmatic Clinical Trials Demonstration Projects (UG3/UH3).

grants.nih.gov/grants/guide/rfa-files/RFA-AT-17-002.html

grants.nih.gov/grants/guide/rfa-files/RFA-AT-17-001.html

These FOAs were discussed at a webinar on January 23, 2017, and the content of the webinar is summarized in this document. The webinar presented the highlights of the announcements; please see the announcements for details regarding information needed for submitting applications.

The stated goal of AT17-001 and AT17-002 is to develop the capacity to implement cost-effective large-scale clinical research in military and veteran health care delivery organizations focusing on nonpharmacologic approaches to pain management and other comorbid conditions.

AT17-002: Coordinating Center (U24)
AT17-001: Pragmatic Trials Demonstration Projects (UG3/UH3)

The studies that AT17-001 and AT17-002 are intended to support will be conducted in the context of health care systems serving military personnel, veterans, and their families. Academic researchers can submit applications for these initiatives; however, studies conducted in the military health care context should include military researchers, and studies conducted in the veteran health care context should include veteran researchers.

The primary outcomes of interest are pain reduction, ability to function in daily life, quality of life, and reduced dependence on or discontinuation of pain medication. The secondary outcomes pertain to coincident reduction or reduced severity of comorbid conditions common among patients seen in the military and/or veteran health care system.

Expected modalities of treatment to be examined include primarily nonpharmacologic approaches, such as meditation, mindfulness training, movement intervention, manual therapy, neuromodulation, psychological and behavioral interventions, or combinations of the above modalities (based on an integrative approach). Applications that apply integrative models of multi-modal care are of special interest.

For this initiative, there will be a single coordinating center (CC) to support the pragmatic clinical trials (PCTs). Each funding agency or IC will support, or co-support, PCTs to fit their priorities. The steering committee will include the Program Officer/Project Scientist, the PCT PIs, and CC PI(s), and will hold monthly calls, two 1½-day NIH-DoD-VA Pain Management Collaboratory program meetings in the first year, and annual in-person meetings in subsequent years. The CC will establish cores/workgroups for common themes important to most, if not all, of the trials.

AT17-002 (U24) Duration and Budget

Total duration is 6 years.

Direct costs for the first 3 years may not exceed $1.3 million per year. Direct costs for years 4 to 6 may not exceed $1.0 million per year.

NIH intends to commit $2 million in FY2017 to fund one award (NCCIH, NIDA, ORWH).

AT17-001 (UG3/UH3) Duration and Budget

Total duration of up to 6 years, with up to 2 years in the UG3 planning phase and a maximum of 4 additional years in the UH3 implementation phase. Approval of funding for the UH3 phase is conditional on performance during the UG3 phase, as measured by achieving the approved milestones.

The UG3 phase budget is limited to $500,000/year in direct costs for up to 2 years. The UH3 phase budget is limited to $1 million/year in direct costs for up to 4 years.

Collectively, the agencies intend to fund approximately five to seven UG3 awards. Each agency or IC will fund their own grants, with some ICs providing co-funding of grants.

The Coordinating Center (U24)
Goals/Objectives of the CC

• The CC will develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of pragmatic clinical trials in partnership with health care systems focused on military personnel, veterans, and their families.
• The CC will work collaboratively with, and provide technical, design, and other support to Demonstration Project teams, to develop and implement a research protocol.
• The CC will widely disseminate NIH-DoD-VA Pain Management Collaboratory-endorsed policies and best practices and lessons learned for implementing research within health care settings that deliver health care to U.S. military personnel, veterans, and their families.
• The U24 will not provide data coordination activities for the pragmatic trials—each trial will have their own complete plan for data collection, analysis, quality control, etc.

Pragmatic Clinical Trials Demonstration Projects (UG3/UH3)
Goals/Objectives of the PCTs

• Phased cooperative agreement research applications will be submitted to conduct efficient, large-scale pragmatic clinical trials Demonstration Projects.
• All projects will be milestone-driven, and moving to the implementation phase (UH3) will be dependent upon the successful progress made during the planning phase (UG3).
• The Demonstration Projects will generally be performed within large health care systems that utilize electronic health records (EHRs) to leverage data collection that occurs in health care delivery rather than requiring independent research data collection.
• Teams can implement methods to enhance completion of EHR data with patient-reported outcomes as needed.
• A reference document specifying the full criteria for PCTs can be found here: cmaj.ca/content/180/10/E47.full
• In brief, as applied to AT017-001, a PCT should test an intervention, or compare interventions that are robust, apply broadly to patient populations, and are suitable for use in health systems serving military personnel, veterans, and their families, with the broad goal of determining whether the intervention improves health and adds value to the utilization of health care resources.

UG3 Milestones and the UG3/UH3 Transition

• Projects “should” or “must” include well-defined milestones for the UG3 planning phase and annual milestones for the UH3.
• Three months prior to the date of the planned transition, the applicant will be required to submit a detailed transition request for the UH3 phase. UH3 transition requests will undergo an administrative review to determine whether the Demonstration Project will be awarded the UH3.
• Transition to the UH3 phase of the project will occur only if an administrative review process determines that the UG3 planning milestones have been successfully met, and that the UH3 phase can proceed with confidence of success, and availability of funds.

Research Strategy U24

• 30-page limit (required)
  – Specific Aims (one page) (required)
  – Rationale and plans (required)
  – CC transition plan (expected)
• Should demonstrate willingness to cooperate with PCT Demonstration Project teams, NIH, DoD, and VA in the development and design of research approaches, methods, processes, policies, and tools used in this program (expected)
• Should provide evidence of sufficient expertise to lead five to seven PCTs/workgroups (expected)
• Team to have experience conducting PCTs in military and veteran health care (required)
• Resource and software sharing plans (expected)

Research Strategy UG3/UH3

• 30-page limit combined UG3 and UH3 phases (required)
  –Specific Aims (one page) combined for UG3 and UH3 phase (required)
  –Rationale and plans for UG3/Rationale and plans for UH3 (required)
  –Milestones for UG3 (required)
  –Milestones for UH3 (required)
• Budgets for both phases (required); to include support for program director(s)/PI(s) to travel to two 1½-day NIH-DoD-VA Pain Management Collaboratory program meetings in the first year, and an annual meeting in subsequent years in the greater Washington, D.C., area
• Letters of support to be included from Health Care System Partners (required)
• Resource and data sharing plan (expected)

VA Research Focus

Sufficient evidence exists for the inclusion of yoga, tai chi, and exercise as first-line, recommended therapies for chronic musculoskeletal pain. VA would like to see improved implementation in clinical practice and improvement in patient retention.

Some questions of interest (within the context of pragmatic trials):

• Conduct pragmatic trials to understand VA care delivery. Develop strategies to assess high-quality pain care and compare different treatment models. Examine the feasibility of delivering collaborative care remotely.
• Examine effect of combining regular treatments with other therapies; e.g., assess optimal sequencing of acupuncture, massage, chiropractic, exercise/movement with other nonpharmacologic and pharmacologic approaches.
• Study minimum effective dosage and assess duration of effect. Compare different levels of model intensities
• Identify effective strategies to engage and sustain benefits from these therapies. Also, determine patient characteristics that may predict treatment response.
• Conduct long-term prospective observational study of pain treatment, including psychological and behavioral therapies.
• Identify optimal self-management strategies; i.e., group visits, health coaching, self-treatment.
• Develop a consensus set of outcome measures to be used in pain research.
• Test the effectiveness of community-based interventions for veterans.

DoD Research Focus
Pain Management Capability Gaps

• Better chronic pain management strategies for primary care providers in non-deployed settings
• Lack of knowledge of patient outcomes following chronic pain management treatment—evidence-based practice lacking
• Inadequate treatments for chronic pain management
• Limited strategic communication approaches for educating providers, patients, family members, and unit leaders
• Chronic pain management following trauma and in resource-limited environments
• Inadequate knowledge of the operational utility of chronic pain management far-forward
• Lack of clinical practice guidelines (CPGs) for best practices for assessment and management of chronic pain in a rural/austere environment

Suggested Research Questions for PCTs

• Studies to test the effect of system-level innovations to improve implementation of established guidelines for nonpharmacologic approaches to pain management and comorbid conditions
• Studies focusing on testing the timing, optimum components, and overall benefit of an individualized integrated package of nonpharmacologic modalities such as exercise, mind and body therapies, and other complementary health approaches
• Evaluation of team-based versus provider-driven models of health care delivery, particularly in settings in which military personnel or veterans normally receive care; evaluation of other factors critical to optimize pain care in primary care settings
• Assessment of the effectiveness of integrative pain management strategies to reduce the transition from acute to chronic pain, for example in the peri-operative period
• Evaluating sex and gender differences for optimizing treatment

Key Points for Successful Administrative Review
Conducted by the Center for Scientific Review (CSR) and NCCIH

• Application will not be reviewed if incomplete, noncompliant, or nonresponsive.
• Application will not be reviewed if proposed budget exceeds stated budget limit.
• PIs on UG3/UH3 must commit ≥20% effort.
• PIs on U24 must commit ≥30% effort.
• Foreign institutions are not eligible
• Foreign components are allowed.

Appendix may include:

• Clinical trial protocols
• Investigator's brochure from Investigational New Drug (IND)
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments.

Applications will not be reviewed if appendix contains materials not specifically listed in NOT-OD-16-129 or in the FOA.

Post-submission documents may include:

• Up to 3 pages describing updated Specific Aims or Research Strategy, late-breaking research findings. and/or new letters of support or collaboration
• Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)
• Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
• Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
• Adjustments resulting from natural disasters
• Adjustments resulting from change of institution (e.g., PI moves to another university)
• News of an article accepted for publication (a copy of the article should not be sent)
• News of a professional promotion or positive tenure decision for any program directors /PIs and senior/key personnel.

For more information, please refer to NOT-OD-13-030 and NOT-OD-10-115.

NOTE: Post-submission material is due 30 days prior to scheduled review.

Due Dates

Letter of Intent (LOI): February 1, 2017 Application: March 3, 2017 Review Meeting: June 2017 Award Decision: October 2017

LOI should include:

• Descriptive title
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of all key personnel
• Participating institution(s)
• Number/title of relevant FOA.

Send LOI to:

Martina Schmidt, Ph.D., NCCIH
E-mail: SchmidMa@mail.nih.gov

Note: Continuous submission policy does not apply. Note: Late applications may be eligible for review, if criteria stated in NOT-OD-15-039 apply.

Program Contacts

NCCIH: Eve Reider, ereider@mail.nih.gov

VA: Ranjana Banerjea, Ranjana.Banerjea@va.gov

CRMRP, DoD: Smita Bhonsale, smita.i.bhonsale.ctr@mail.mil

MOMRP, DoD: Ronald Hoover, ronald.l.hoover.civ@mail.mil

NIDA: Will Aklin, aklinwm@mail.nih.gov

NINDS: Michael Oshinsky, michael.oshinsky@nih.gov

NIAAA: Mark Egli, megli@willco.niaaa.nih.gov

NICHD (NCMRR): Alison Cernich, Alison.Cernich@nih.gov

ORWH: Lisa Begg, beggl@od.nih.gov

NINR: Martha Matocha, matocham@mail.nih.gov

Questions

Question 1: Can a PI/researcher apply for both FOAs (AT17-001 and AT17-002)?

Answer: Yes, but that person cannot receive funding awards in response to both applications because this would be a conflict of interest. If a PI is a participant on two teams, one team applying for U24, the other team applying for UG3/UH3, and both receive awards, a substitute will need to be found for that person on one team or the other.

Question 2: Is the UG3/UH3 intended to support work of clinicians or interventionists?

Answer: Yes, but budget limit for FOA AT17-001 may prohibit direct delivery of clinical interventions. In other words, the resources required to support clinician intervention are expected to be too costly. In the context of this FOA, interventions are expected to be delivered by the health care institution/organization participating in the associated PCT and/or CC. The goal is to leverage ongoing delivery of care for greater benefit and improved outcomes by introducing new training programs, new approaches to delivery of care, or new approaches for tracking outcomes. Ideally, data on patient care and use and efficacy of interventions will be obtained from EHR data that is already being collected passively. However, active data collection may be required and would be appropriate under the FOA.

Question 3: Can two groups of investigators with overlapping groups receive funding for both U24 and UG3/UH3?

Answer: The answer is basically the same as the answer to question 1. This will not be allowed due to potential conflicts of interest. The relevant PIs will need to be replaced on either the U24 or the UG3/UH3, in order to avoid a conflict of interest.

Question 4: Are applicants required to be affiliated with a VA and/or military hospital, or are PIs affiliated only with an academic institution eligible to apply?

Answer: PIs affiliated only with an academic institution are eligible to apply if they include military and/or vateran researchers in the application, dependent upon the focus of the application (e.g., military personnel and/or veterans).

Question 5: What activities should be carried out in the UG3 phase?

Answer: The UG3 is a 2-year planning phase intended to allow the research team to carry out any activity required to prepare for the UH3 phase. For example, prepare to or actively extract EHR data for subsequent analysis, obtain IRB approval, develop pilot measures, etc.

Question 6: Should the PCTs in the UG3/UH3 enroll patients at more than one institution/center?

Answer: Yes. It is preferred that the PCT demonstration projects involve patients at more than one institution, but this is not formally stated as a requirement in the FOA.

Question 7: Are PIs with an NIH and/or DoD affiliation but no VA affiliation eligible to apply?

Answer: It is strongly recommended that PIs have some connection to the VA and DoD or minimally, are already collaborating with one or more PIs affiliated with the VA and DoD.

Question 8: Is the UG3/UH3 mechanism specific for pragmatic clinical trials?

Answer: Yes.

Question 9: Is there a limit on the number of references that can be included?

Answer: There is no page limit on the number of reference that can be included.

Question 10: Are appendices allowed?

Answer: Yes, appendices are allowed. Applications will not be reviewed if appendix contains materials not specifically listed in NOT-OD-16-129 or in the FOA.

Question 11: Is there a Partnering PI option for the UG3/UH3 (pragmatic trial) submission?

Answer: Yes, there is a multiple PI option or one PI with co-investigators option.

Question 12: We are interested in applying for the NIH-DoD-VA UG3/UH3 (RFA-AT-17-001). Although the UG3 is for a 2-year planning phase, if we have resources and facilities in place, are we able to conduct the clinical trial during year 2 of the UG3 if planning is complete in year 1?

Answer: Yes, you can request 1 year of UG3 planning support and up to 4 years of UH3 support. Note that the 1-year planning may not be sufficient for the multi-site IRB approvals necessary for a pragmatic trial.

Question 13: What is the article linked in the slide discussing the components of pragmatic trials? The link provided in the slide did not bring up a functioning page or PDF.

Answer: Thorpe, KE, et al. (2009). A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 180 (10). E47-E57. Published at www.cmaj.ca on Apr. 16, 2009. An abridged version of this article appeared in the May 12 issue of CMAJ. This article was published simultaneously in the May 2009 issue of the Journal of Clinical Epidemiology (www.jclinepi.com).

Question 14: So are pragmatic trials not always what you want to fund? For example, Ranjana mentioned that they were looking for a consensus on outcomes for pain research. This work would not necessarily need a pragmatic trial. I was wondering if there are any restrictions on the number of proposals that could be submitted by the same research team.

Answer: A pragmatic trial design is a requirement of the RFA. Questions on measurement and consensus have to be framed within the pragmatic trial proposed or could be proposed as a future dissemination and implementation activity after the pragmatic trial is completed.

Question 15: Does each co-investigator listed in the application need to submit a Letter of Support?

Answer: No, this is not a requirement.

Question 16: During the planning phase, it seems possible that aspects of the pragmatic trial might change, which in turn might influence the budget for the pragmatic trial. So when we submit the budget for the pragmatic trial, is it set in stone, or could it be adjusted during the planning phase?

Answer: The budget could be shifted across different categories, but it must remain within the budgetary cap allowed for the UH3 phase.

Question 17: For integrative interventions, do you prefer or expect investigators to assess which components of an integrative, multi-component intervention work best? Or do you just want to know whether the intervention as a whole works effectively?

Answer: Either approach is possible. Typically, pragmatic trials evaluate whole interventions and do not attempt to establish the efficacy of individual components or the mechanisms of the components of the intervention.

Question 18: Also, do you advise the use of designs such as SMART (Sequential, multiple assignment, randomized trial) as part of a pragmatic clinical trial paradigm?

Answer: The design of the trial should be whatever makes the most sense in the context of implementing a pragmatic trial.

Question 19: For the UG3/UH3, would a focus on a specific pain condition (for example, low back pain) be considered less significant or responsive than encompassing a broader category of clinical conditions?

Answer: No, any pain condition can be studied as part of the study as long as it can be done within the context of a pragmatic trial.

Question 20: Is the DoD interested in research in the several U.S. Family Health Plans systems?

Answer: The funding initiative is interested in health care systems serving military personnel, veterans, and their families. If there are several U.S. Family Health Plan systems serving this population, then they are of interest

Question 21: How much expectation is there that findings be expected to be disseminated outside the VA/DoD settings?

Answer: The primary importance is addressing the needs of treating pain and its co-occurring conditions in military personnel, veterans, and their families. It is not necessary that the pragmatic trial attempt to generalize beyond these settings for the proposed application.

Question 22A: Am I correct in my understanding that VA and DoD organizations/facilities are eligible applicants for the NIH-DoD-VA Pain Management Collaboratory Coordinating Center (U24)?

Answer: Federal institutions receiving NIH awards can get a little complicated. However, NIH does award grants to Federal agencies and institutions as long as:

• “Eligible Agencies of the Federal Government” appears on the Funding Opportunity Announcement (FOA)
• The Federal institution meets the other eligibility requirements of the grant program as specified within the FOA
• Their own legislation allows them to receive grants from NIH.

As far as determining the eligibility of the Federal institution, that is initially left up to the applicant organization to make that determination. Once NIH makes a determination to award, then the Grants Management Specialist will also have to ensure that the applicant is eligible to receive that award as well.

Question 22B: Will the application be kicked out of the system if the applicant is not eligible?

Answer: We cannot confirm if Grants.gov or ASSIST validates organizational eligibility beyond matching it up to what is stated in the Eligibility section of the FOA. We will refer to Chapter 17 Grants to Federal Institutions and Payments to Federal Employees Under Grants in the NIH Grants Policy Statement. The titles are hyperlinked for your convenience:

17.1 GENERAL NIH may award grants to Federal entities.

17.2 ELIGIBILITY In general, Federal institutions are eligible to apply for NIH grants, including research project grants. Specific eligibility will be stated in each FOA.

Question 23: Do you have examples of milestones for the UG3 and UH3?

Answer: The milestones for the UG3 involve activities the study would need to accomplish in order to be ready to conduct the implementation phase. This would involve obtaining IRB approval, Human Research Protection Office approval if it’s a military study, pilot testing recruitment procedures, testing use and extraction of EHR records, testing of other measures, perhaps obtaining additional sites, etc. See the FOA for further examples.

Question 24: How much flexibility is there on the UH3 budget that was submitted at this time, after the UG3 is completed?

Answer: There is flexibility, given circumstances may change. The budget could be shifted across different categories, but it must remain within the budgetary cap allowed for the UH3 phase.

Question 25:< UG3 and UH3 Demonstration projects: Are letters of support only accepted from actual health care system partners (i.e., VA), or would letters from other related sources be allowed (e.g., state legislative offices supporting VA)?

Answer: Letters of support are required from the health care system that will be utilized for conducting the pragmatic trial. Letters of support from related sources can be included but do not replace the need for letters of support from the actual health care system partners.

Question 26: For the AT17-001: Is there a limit on the number of references that can be included?

Answer: There is no page limit on references.

Question 27: Is it an appropriate use of the UG3 to identify and screen potential study sites from within a defined group (e.g., VA substance abuse clinics from the pool of VA hospitals with such clinics)?

Answer: Yes, finalizing the sites that will be used for the UH3 from a list of possible sites proposed in the initial application can be done as part of the planning phase. It would be best to have determined the number of sites needed in order to carry out the study design and have letters of support from them at the time of submission of the application. One could obtain additional sites as part of the UG3 phase in order to increase power or if sites drop out during the UG3 phase.

Question 28: Would pragmatic trials evaluating outcomes from a surgical intervention be considered appropriate if the intervention were to result in a reduction of pain/pain management requirements?

Answer: Yes, some of the participating agencies are interested in this topic of research. Please contact the appropriate scientific contact for the NIH institute or center, VA, or DoD that is a best fit with your area of research to assure that there is interest in the idea you are proposing.

Question 29: Do all participating sites need to be identified before submission? Or could site recruitment be an objective of the planning phase?

Answer: It would be best to have the sites needed in order to carry out the study design. One could add additional sites as part of the UG3 phase with the goal of increasing power or to replace sites that drop out during the UG3 phase.

Question 30: Are letters of support required for all co-investigators? And can you make the distinction between HCS and co-investigators?

Answer: Letters of support are needed from the Health Care Services, saying that they support the research being completed in their setting. Co-investigators are researchers working on the project. Letters of support by co-investigators are encouraged but not required. Generally, letters of support are part of the Research PLAN (not the research strategy section). There is no page limit on the number of letters of support that can be submitted.

Question 31: I see that this is the one budget requirement for this RFA—are there any other requirements or suggestions you have for the budget?

Applications must budget for project PD(s)/PI(s) travel to attend two, one-and-a-half-day NIH-DoD-VA Pain Management Collaboratory program meetings in the first year, and an annual meeting in subsequent years in the greater Washington, D.C., area.

Answer: No, there are no other specific budget requirements.

Question 32: If the demonstration sites are specifically required to provide their own data ingestion/capture solution(s) for their project, what is the level of technical support expected for the Coordinating Center, especially regarding the data sharing and software sharing agreements?

Answer: The expected level of technical support is to provide knowledge and expertise to facilitate working through different types of barriers in different areas that pragmatic trials encounter during the planning and implementation phases.

Question 33: Historically we have been told that we can’t use NIH funds to pay salaries of VA employees due to some federal funding rules. How will that be handled for this mechanism?

Answer: VA investigators need to submit applications through their academic institutions or through a nonprofit agency so that they can obtain salary support for the research from non-VA sources, since most VA researchers are term employees. VA investigators should discuss with their VA research office or use other VA offices as resources that have done this previously.

Question 34: Are VA applications being accepted?

Answer: The VA is participating in this funding initiative and VA applications are being accepted only through the NIH application process.

Question 35: How would an academic institution coordinate budgets with a VA institution?

Answer: An academic institution would need to discuss with the local VA how this could be worked out.

Question 36: The U.S. FHP are TRICARE providers. One of the slides indicated a preference for the study of different treatments in different settings. What does "different settings" mean? In other words, would different settings include different installations/VA? Would it include different clinical services within one site? Both?

Answer: Different settings could be different Military Treatment Facility or VA settings. It could also be different clinics within a single VA setting, if multiple clinics are available to allow a large and diverse patient population for the trial. The idea here is that these are pragmatic trials and the use of more sites is encouraged.

Question 37: Is the DoD interested in research in the several U.S. Family Health Plans systems?

Answer: The funding initiative is interested in health care systems serving military personnel, veterans, and their families. If there are several U.S. Family Health Plan systems serving this population, then DoD is interested in including these U.S. Family Health Plans.

Additional Comments

Applicants may submit appropriate documents and requests for approval to either the NIH central IRB or to their local IRB. The latter may be appropriate for UH3s that plan to involve three or less than three sites.

Applicants should note that all studies involving active military or veterans must also seek approval from the Human Research Protection Office.

Funding will be awarded incrementally during the UG3/UH3 phases by both DoD and VA.

Applicants should note that these awards are exempt from VA budget caps, although NIH budgets caps do apply.

Applicants may want to refer to Health Care Collaboratory Resources available at the website for the NIH Health Care Systems Research Collaboratory.