OpportunityTitle: Psychological Health Traumatic Brain Injury Research Program Concept Award
Description: The PH/TBI Research Program Concept Award is intended to support the exploration of a highly innovative new concept or untested theory that addresses an important problem relevant to one or more of the FY09 PH/TBI topic areas. The Concept Award is not intended to support a logical progression of an already established research project but, instead, allows Principal Investigators (PIs) the opportunity to pursue serendipitous observations. This award mechanism supports high-risk studies that have the potential to reveal entirely new avenues for investigation. Proposals must describe how the new idea will enhance existing knowledge of PH/TBI or create an entirely new avenue for investigation. Research completed through a Concept Award may provide sufficient preliminary data to enable the PI to prepare a proposal for future research. All applications must specifically and clearly address the military relevance of the proposed research. Collaboration with military researchers and clinicians is encouraged. Use of human subjects and human biological substances: These awards are designed to support human research that falls under the categories of Exempt status or Expedited Review by the IRB of Record (DOD Directives 3216.02 and 6200.2). The Federal Regulations establish nine categories that IRBs may use to invoke the expedited review process (32 CFR 219 and 21 CFR 56). There are six categories of research that are eligible for exempt status (32 CFR 219 and 45 CFR 46). Studies that do not qualify for either exempt or expedited status during review at any level will be administratively withdrawn and will not be funded. Additional information may be found on the US Army Medical Research and Materiel Command (USAMRMC) Human Research DOD PH/TBI Research Program Concept Award 6 Protection Office website [ https://mrmc.amedd.army.mil/rodorphrpo.asp] and US Department of Health and Human Services Office for Human Research Protections (OHRP) [http://www.hhs.gov/ohrp/policy/]. Encouraged DOD Collaboration and Alignment: Military relevance is a key feature of this award. Therefore, PIs are strongly encouraged to collaborate, integrate, and/or align their research projects with military and/or VA research laboratories and programs. The following websites may be useful in identifying information about ongoing DOD areas of research interest within the FY09 PH/TBI Research Program topic areas: Defense Technical Information Center http://www.dtic.mil Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury http://www.dcoe.health.mil Defense and Veterans Brain Injury Center http://www.dvbic.org/ Center For Deployment Psychology http://www.deploymentpsych.org/ Deployment Health Clinical Center http://www.pdhealth.mil/ Center For The Study of Traumatic Stress http://www.centerforthestudyoftraumaticstress.org/ National Center for Telehealth and Technology http://www.t2health.org/ Congressionally Directed Medical Research Programs http://cdmrp.army.mil U.S. Army Medical Research and Materiel Command https://mrmc.amedd.army.mil Air Force Research Laboratory http://www.wpafb.af.mil/afrl Navy and Marine Corps Public Health Center www-nmcphc.med.navy.mil/main.htm U.S. Department of Veterans Affairs, Office of Research and Development www.research.va.gov Office of Naval Research http://www.onr.navy.mil/ U.S. Army Research Laboratory http://www.arl.army.mil U.S. Naval Research Laboratory www.nrl.navy.mil Defense Advanced Research Projects Agency: http://www.darpa.mil/ U.S. Army Medical Research Acquisition Activity http://www.usamraa.army.mil Naval Health Research Center http://www.nhrc.navy.mil/ U.S. Department of Defense Blast Injury Research Program https://blastinjuryresearch.amedd.army.mil Office of the Under Secretary of Defense for Acquisition, Technology and Logistics http://www.acq.osd.mil/ Use of Military Populations: Describe the military population(s) to be used for the proposed study, if applicable. Coordination of access to various military populations is described below. 1. Active Duty, National Guard, Reserve troops, and/or military patient populations (not CENTCOM Area of Responsibility): Unless the PI has an already established Service member population, access to Active Duty, National Guard, or Reserve troops must be coordinated DOD PH/TBI Research Program Concept Award 7 through the CDMRP. PIs who do not have a previously established study population should not contact unit Commanders at this time or during preparation of the proposal submission. If selected for funding, the PI will be provided guidance on how to obtain access to the appropriate population. 2. CENTCOM Area of Responsibility military populations: Access to military populations in these areas is very limited and will be coordinated through the CDMRP as described above. Research conducted using military populations in Iraq is conducted with oversight by the Multi-National Force-Iraq (MNF-I). PIs that are outside of this system and submit a research proposal designed to recruit patients within MNF-I must coordinate with the in-theater Deployed Combat Casualty Research Team charged with facilitating an in-theater review, and be approved by the MNF-I Command and the MNF-I designated Institutional Review Board (IRB). The same is true for research conducted in Afghanistan in the US Forces-Afghanistan (USFOR-A) Area of Responsibility. PIs who are outside of this system and submit a research proposal designed to recruit patients within USFOR-A must coordinate with the in-theatre Deployed Combat Casualty Research Team charged with facilitating an in-theatre review, and be approved by the USFOR-A Command and the USFOR-A designated IRB. If selected for funding, CDMRP will assist with guidance on how to obtain the required in-theatre approvals. Given the constraints of wartime operations, investigators without an ongoing collaboration with an appropriate military investigator should strongly consider alternatives to conducting in-theater research. DOD-supported human subjects research can only be conducted by institutions (including those in-theater) with approved Federal Assurances of Compliance from the Human Research Protection Office (HRPO). It is strongly suggested that proposals necessitating the use of this population involve civilian and non-deployed military populations as an alternative. 3. Department of Veterans Affairs (VA) Medical Centers patient populations: Access to patient populations from VA Medical Centers or use of information from VA data systems must be coordinated by the PI. PIs who submit a research proposal designed to recruit patients from a VA Medical Center or use information from VA data systems, and who do not have an appointment at one of the VA Medical Centers, must include a collaborator with a VA appointment. This collaborator must be willing to assume the role of PI for the VA component of the research.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: PA HELP:  301-619-7079; cdmrp.pa@amedd.army.mil &lt;br/&gt;eReceipt HELP:  301-682-5507; help@cdmrp.org