DoD Traumatic Brain Injury and Psychological Health, Health Services Research Award

Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRP research programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope.The FY23 TBIPHRP HSRA intends to bridge the gap between research, practice, and policy by building a knowledge base on how interventions, clinical practices/guidelines, tools, and policies can be deployed to targeted populations at the appropriate time at the point of need. Funding from this award mechanism must support clinical research or clinical trials but cannot be used for preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects, human subject data/records, and human anatomical substances. This award may not be used to support studies requiring an exception from informed consent (EFIC).The FY23 HSRA may support (not all inclusive):• Research that accelerates the uptake and implementation of evidence-based research into clinical practice.• Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real-world” settings• Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines• Analysis of existing data or resources to inform clinical practice• Modification of established clinical tools for their intended population or environment• Analysis of existing clinical tools to maximize patient-relevant outcomes• Identification and analysis of the circumstances that create a need to stop or reduce (“de-implement”) the use of interventions, tools, policies, and guidelines hat are ineffective, unproven, low-value, or harmful are within scope• Analysis of TBI and/or psychological health outcomes associated with the implementation of clinical practice guidelines, evidence-based practices, and process improvementsThe following are important aspects of the FY23 TBIPHRP HSRA:• Precision Medicine Approaches: When appropriate, the TBIPHRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individual’s unique characteristics.• Community-Based Participatory Research: The application must include Community- Based Participatory Research (CBPR) approaches in the development and execution of the clinical research/trial. CBPR approaches should be documented in Attachments 11 and 12.• Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical research/trial is required.• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Inquiry Review Board [IRB] review) are exempt from this requirement.• Clinical Trial Start Date: If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date.• Intervention Availability: If applicable, the application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Funded clinical trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). Funded trials are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section B, for further details.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to study the safety, effectiveness, and/or efficacy outcomes of an intervention. (3) Outcomes research and health services research that do not fit under the definition of clinical trial. Excluded from the definition of clinical research are in vitro studies that utilize human tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.
Categories: Science and Technology and other Research and Development.