HT942523SBAA1_11Oct2024.pdf

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 1 for Extramural Medical Research

I. OVERVIEW OF THE FUNDING OPPORTUNITY

United States Army Medical Research and Development Command

DEPARTMENT OF DEFENSE

BROAD AGENCY ANNOUNCEMENT

for Extramural Medical Research

Funding Opportunity Number: HT942523SBAA1

Announcement Type: Initial

Assistance Listing Number: 12.420

Military Medical Research and Development

KEY DATES

Release/Posted Date: October 1, 2022

Closing Date: September 30, 2027, 11:59 p.m. Eastern Time

This funding opportunity announcement is a broad agency announcement (BAA). It is continuously open for a 5-year period, from October 1, 2022, through September 30, 2027, 11:59 p.m. Eastern Time.

This BAA must be read in conjunction with the General Submission Instructions, which are available for downloading from Grants.gov. The General Submission Instructions are located under the “package tab” and can be downloaded by selecting the “Download Instructions” icon when previewing the submission package.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 2

Table of Contents

I. OVERVIEW OF THE FUNDING OPPORTUNITY

I.A. New for Fiscal Year 2023 – Fiscal Year 2027

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Descriptions

II.A.1. Military Infectious Diseases Research Program

II.A.2. Combat Casualty Care Research Program

II.A.3. Military Operational Medicine Research Program

II.B. Award Information

II.B.1. Clinical Trial Support

II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources ...13

II.B.3. Technology Requirements and Standards

II.B.4. Data Sharing

II.B.5. Funds Available and Anticipated Number of Awards

II.B.6. Award Amounts and Periods of Performance

II.B.7. Mechanisms of Support

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.2. Cost-Sharing

II.C.3. Other

II.D. Proposal/Application Submission Information

II.D.1. Where to Obtain the Proposal/Application Submission Package

II.D.2. Content and Form of Proposal/Application Submission

II.D.3. Unique Entity Identifier (UEI) and System for Award Management

II.D.4. Submission Dates and Times

II.D.5. Intergovernmental Review

II.D.6. Funding Restrictions

II.D.7. Other Submission Requirements

II.E. Proposal/Application Review and Selection Information

II.E.1. Criteria for Research Proposals/Applications Without a Clinical Trial

II.E.2. Proposal/Application Selection Process

II.E.3. Integrity and Performance Information

II.E.4. Notification of Proposal/Application Review Results

II.F. Federal Award Administration Information

II.F.1. Federal Award Notices

II.F.2. Administrative and National Policy Requirements

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 3

II.F.3. Reporting Requirements

II.G. Federal Awarding Agency Contacts

II.G.1. eBRAP Help Desk

II.G.2. Grants.gov Contact Center

II.H. Other Information

II.H.1. Contractor/Recipient Qualification

II.H.2. Proprietary Information

II.H.3. Administrative Actions

II.I. Checklist for Research Proposal/Application Submission Without a Clinical Trial

APPENDIX I: RESEARCH AREAS OF INTEREST

I. Military Infectious Diseases Research Program

II. Combat Casualty Care Research Program

III. Military Operational Medicine Research Program

APPENDIX II: CLINICAL TRIALS

I. Important Aspects of Clinical Trials

II. Full Proposal/Application Submission Components for Studies with a Clinical Trial ...68

III. Review Criteria for Research Proposals/Applications with a Clinical Trial

IV. Checklist for Research Proposal/Application Submission with a Clinical Trial

APPENDIX III: DOD AND VA WEBSITES

APPENDIX IV: PROCEDURES FOR ACQUISITION, PROCESSING, STORAGE,

AND SHIPMENT OF BIO-FLUIDS

APPENDIX V: NATIONAL INSTITUTE OF MENTAL HEALTH DATA ARCHIVE

— INFORMED CONSENT

APPENDIX VI: TECHNOLOGY READINESS LEVELS AND KNOWLEDGE

READINESS LEVELS

APPENDIX VII: ACRONYMS AND ABBREVIATIONS

APPENDIX VIII: FY23–FY27 USAMRDC BAA ADDENDUM

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 4

I.A. New for Fiscal Year 2023 – Fiscal Year 2027

The fiscal year 2023 – 2027 (FY23 – FY27) U.S. Army Medical Research and Development

Command’s (USAMRDC) broad agency announcement (BAA) for Extramural Medical

Research contains several changes from previous USAMRDC BAAs. Read each section carefully. Note the following:

• The open period of the BAA is 5 years and will be amended annually with any updates.

• The “Research Areas of Interest” can be found in Appendix I.

• The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, United States Code, Title 31, Sections

6301-6308 (31 USC 6301-6308), which provides the legal criteria to select a procurement contract or an assistance agreement. The award type, along with the start date, will be determined during the negotiation process.

• For assistance agreements:

○ The total period of performance may be proposed for up to a maximum of 4 years in length; additional periods may be considered.

○ Any assistance agreement (grant or cooperative agreement) awarded under this BAA will be governed by the award terms and conditions that conform to the Department of

Defense’s (DOD) implementation of Office of Management and Budget guidance in Code of Federal Regulations, Title 2, Part 200 (2 CFR 200), “Uniform Administrative

Requirements, Cost Principles, and Audit Requirements for Federal Awards.” DOD implementation is located in Chapter XI of 2 CFR.

• For contract awards:

○ The total period of performance may be proposed for up to 5 years in length; additional periods may be considered.

○ Any contract awarded under this BAA will be governed by the various provisions of the

Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition Regulation

Supplement (DFARS).

• For other transactions:

○ Regarding Other Transaction Agreements (OTAs) that utilize the authority within 10 USC

4021 and 4022, the period of performance will be dependent upon each specific award made.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 5

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

The USAMRDC’s mission is to provide solutions to medical problems of importance to the

American Service Member at home and abroad, as well as to the general public at large. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology (S&T), operational requirements, military threat assessments, and national defense strategies. Extramural research and development programs play a vital role in the fulfillment of the objectives established by the USAMRDC.

General information on the USAMRDC can be obtained at https://mrdc.health.mil/.

This BAA is intended to solicit extramural research and development ideas using the authority provided by 10 USC 4001. The BAA is issued under the provisions of the Competition in

Contracting Act of 1984 (Public Law 98-369), as implemented in FAR 6.102(d)(2) and 35.016 and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 35.016, projects funded under this BAA must be for basic and applied research to support scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on development of a specific system or hardware solution. Research and development funded through this BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge. This BAA utilizes competitive procedures in accordance with 10 USC 2302(2)(B) for the selection for award of S&T proposals/applications. For the purposes of this BAA, S&T includes activities involving basic research, applied research, advanced technology development, and, under certain conditions, may include activities involving advanced component development and prototypes.

The selection process is highly competitive, and the quantity of meaningful submissions (both pre-proposals/pre-applications and full proposals/applications) received typically exceeds the number of awards that available funding can support.

This BAA provides a general description of USAMRDC’s research and development programs, including Research Areas of Interest, evaluation and selection criteria, pre-proposal/pre-application and full proposal/application preparation instructions, and general administrative information. Specific submission information and additional administrative requirements can be found in the document titled, “General Submission Instructions,” which is available on

Grants.gov along with this BAA.

Proposal/application submission by extramural organizations through Grants.gov requires use of the Workspace interface, which separates the proposal/application package into individual forms. Applicants must create a Workspace in Grants.gov, complete the required forms, and submit their proposal/application Workspace package.

The management agent for this BAA is the Congressionally Directed Medical Research

Programs (CDMRP). The CDMRP manages the electronic Biomedical Research Application

Portal (eBRAP) system, pre-proposal/pre-application and full proposal/application receipt and review, and other key process oversight. Refer to Section II.G, Federal Awarding Agency

Contacts, for additional information.

https://mrdc.health.mil/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 6

The USAMRDC’s supporting acquisition office, the U.S. Army Medical Research Acquisition

Activity (USAMRAA), will be the awarding and administering office for proposals/applications selected for funding, unless approval is obtained from the USAMRAA Senior Contracting

Official to allow another federal acquisition office to execute and administer an award.

II.A. Program Descriptions

II.A.1. Military Infectious Diseases Research Program

Infectious diseases (IDs) pose a significant threat to the operational effectiveness of current and future U.S. Armed Forces. Current and future forces must be prepared to deploy globally and

(potentially) on short notice. The U.S. Armed Forces may be called on to operate in areas of the world where IDs present substantial and immediate health risks to DOD personnel. Current national military strategy specifies a worldwide force protection capability that requires surveillance, prevention, diagnosis, and treatment to protect the U.S. Armed Forces against potential ID threats. Future operational scenarios pose increased impact of IDs as natural environmental disease barriers become degraded, enabling rapid spread of diseases across dense urban environments and the population existing within. For example, highly communicable bacterial and viral diseases, multi-drug resistant organisms, and vector- borne diseases will pose significant challenges in dense urban environments during Multi-Domain Operations (MDO).

The mission of the Military Infectious Diseases Research Program (MIDRP) is to plan, coordinate, and oversee the DOD requirements-driven medical solutions that prevent, diagnose, and treat endemic and emerging ID threats to the total force maximizing Service Member readiness and operational effectiveness.

Research Areas of Interest:

• Prevent naturally occurring ID threats to eliminate their impacts on operational readiness of

DOD personnel.

○ Prevention is the most desirable ID countermeasure because it prevents disease from occurring (vs. treatment post-infection), is the most cost-effective approach, and reduces unit loss rate.

• Treat naturally occurring ID threats to eliminate their impacts on operational readiness of

DOD personnel.

• Diagnosis centers on prediction of infection to identify the ID BEFORE it is a problem and is integral to appropriate treatment, especially in settings of austere medical capabilities or during near-peer conflict with overwhelming numbers of casualties. Improved diagnosis and treatment of ID casualties is necessary to protect the U.S. Armed Forces. Due to the ever-increasing resistance to presently available treatments, continued countermeasure development needs to be pursued.

Research Areas of Interest to the MIDRP are found in Appendix I.I. Applicants are urged to read and consider these before preparing their proposals/applications.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 7

II.A.2. Combat Casualty Care Research Program

The Combat Casualty Care Research Program (CCCRP) provides integrated capabilities for current and future operations to reduce the mortality and morbidity associated with major combat-related trauma across the spectrum of combat casualty care, including point-of-injury and pre- or out-of-hospital care, the spectrum of en route care, and facilities-based treatment. A primary emphasis of the CCCRP is to identify and develop medical techniques, knowledge products, and materiel1 (medical devices, drugs, and biologics) for early intervention in life-threatening battle injuries and prolonged care.2 Because battlefield conditions impose severe constraints on available manpower, equipment, and medical supplies available for casualty care, the CCCRP places an emphasis on medical interventions that can be used within the battle area or as close to it as possible before or during medical evacuation. Preferred medical techniques and materiel that can be used by combat medics must be easily transportable (i.e., small, lightweight, and durable in extreme environments and handling). Devices must be easy to use and require low maintenance, with self-contained power sources as necessary. The CCCRP is interested in existing technologies for which concept and/or patient care efficacy have already been demonstrated, but require improvement to meet military requirements. Development and validation of in vitro and in vivo assessment models that represent military-relevant conditions in wounded Warfighters, as well as those that incorporate a systems biology approach when they can be used to identify and describe the safety and efficacy of novel technologies in patients in a predictable manner.

Research efforts are needed in principles, therapies, and technologies to enhance self- and buddy aid, also referred to as tactical care; techniques, methods, or materiel to improve basic and advanced life support for all injured persons; monitoring, sustainment, and management of all injured casualties during episodes of delayed care or prolonged care; and enhanced capability for triage of large numbers of casualties and staged treatment in the field. The principal causes of death among Service Members who die within the first hour of wounding are hemorrhage and traumatic brain injury (TBI). TBI can also occur as a result of blast and blast overpressure injuries sustained during training.

The CCCRP supports additional aspects of casualty care. These include drugs, devices, and/or novel surgical techniques to decontaminate, debride, protect, monitor, repair, and/or stabilize complex bone and soft tissue wounds to mitigate secondary tissue damage; improvements to blood products and blood product delivery; novel solutions for non-compressible hemorrhage;

treatments for moderate, severe and penetrating TBI drugs, devices, and therapeutic techniques to manage severe burn injured casualties to ensure adequate fluid resuscitation, prevent and treat burn shock, stabilize large and deep burn wounds to prevent secondary burn wound progression and infectious complications, promote severe burn wound closure with functional skin recovery, treat burn inhalation injury, and prevent dysregulated systemic metabolism following severe burn; acute and chronic pain; regenerative medicine for tissue/function restoration; and, advanced resuscitative care, organ support and critical care solutions. The CCCRP is also

1 Materiel is defined as equipment and supplies of a military force.

2 Prolonged care is defined as field medical care applied beyond “doctrinal planning timelines” by a North Atlantic

Treaty Organization (NATO) Special Operations Combat Medic or higher in order to decrease patient mortality and morbidity. It utilizes limited resources and is sustained until the patient arrives at an appropriate level of care.

Rasmussen TE, Baer DG, Cap AP, et al. 2015. Ahead of the Curve. J Trauma Acute Care Surg 79:S61-64.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 8 interested in the development of sensors; diagnostic and prognostic algorithms; data gathering or capture modalities; processors and autonomous care solutions to improve our capability for remote triage, monitoring, and management of casualties; and products to maintain casualties during prolonged evacuation. Regenerative medicine solutions with potential for early in-theater use will also be considered.

The CCCRP also focuses on the innovations required to reset our wounded Service Members, both in terms of duty performance and quality of life. Innovations developed from CCCRP-supported research efforts are expected to improve restorative treatments and rehabilitative care to maximize function for return to duty (RTD) or civilian life. Medical technologies (drugs, biologics, and devices) and treatment/rehabilitation strategies (methods, guidelines, standards, and information) that will significantly improve the medical care that our wounded Service

Members within the DOD healthcare system are of particular interest. Implementation of these technologies and strategies should improve the RTD rate of Service Members, the time to RTD, clinical outcome measures, and quality of life, as well as reduce the hospital stay lengths, clinical workload (patient encounters, treatments, etc.) of caregivers, and initial and long-term costs associated with restorative and rehabilitative or acute care.

The CCCRP supports the conduct of military-relevant clinical research aimed at translating knowledge or materiel from basic and preclinical trauma research into clinical practice. This includes, but is not limited to, inflammatory and immunological mechanisms behind injury, consequences, and recovery scenarios, more-effective surgical care at points of injuries, battlefield care, en route care in all types of austere conditions/environments, single- and multi-center clinical trials performed in the civilian setting to clarify the safety, efficacy, and optimal use of products stemming from the previously mentioned research areas. Comparative effective clinical studies may be encouraged in areas of trauma care where a number of potential known approaches exist and require further investigation to inform selection of the most promising technologies. Novel manufacturing technologies necessary to translate innovative therapies or devices into clinical development are a focus.

The CCCRP supports the conduct of military-relevant, large-data research projects, including the use of large databases of common elements from trauma research projects (preclinical, translational, and clinical). Such studies should directly contribute to or effectively enable the data-driven conduct of combat casualty care. Examples include, but are not limited to, post-hoc analysis of data from completed trauma research projects, meta-analyses of a number of otherwise separate but completed studies, and the ability to harmonize data from planned or ongoing but otherwise separate research studies. All projects should adhere to a core set of reporting standards for rigorous study design.

Research related to injuries caused by novel and emerging weapons systems or unique combat environments is also considered. The CCCRP supports research in combined injury that focuses on the care of casualties` that have sustained both polytrauma and or burn injuries in addition to injuries related to a chemical, biological, radiological, or nuclear scenario. Work is also considered related to medical countermeasures for acute ionizing radiation injury in the areas of post-exposure mitigation and pre-exposure prophylaxis.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 9

This DOD funded program requires that all TBI-related clinical research data with at least

50 subjects funded by this program be shared through the jointly supported DOD-National

Institutes of Health (NIH) Federal Interagency TBI Research Informatics System (FITBIR).

Recipients will be required to upload study data annually and in accordance with the FITBIR data submission policies. There is no fee to use the FITBIR, and detailed guidance and policies, including a cost estimator tool for budgeting considerations, can be found at https://fitbir.nih.gov.

Likewise, all trauma-related clinical research data from studies with at least 50 subjects that are funded by this program may be required to be shared through the National Trauma Research

Repository (NTRR). Recipients will be required to upload study data annually and in accordance with the NTRR data submission policies. There is no fee to use the NTRR, and detailed guidance and policies, including a cost estimator tool for budgeting considerations, can be found at https://ntrr.nih.gov/.

While there is no direct charge to users of the FITBIR and NTRR, a project estimation tool is available to help estimate costs and manpower needs that may be associated with data submission.

The Research Areas of Interest to the CCCRP are found in Appendix I.II. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.3. Military Operational Medicine Research Program

The mission of the Military Operational Medicine Research Program (MOMRP) is to protect, optimize, sustain, and enhance the readiness and performance of Service Members and their

Families by developing effective biomedical countermeasures against operational stressors, as well as to prevent and mitigate physical and psychological injuries and threats during training and operations. The MOMRP supports Army Biomedical Performance Enhancement, Human

Dimension, MDO, Soldier Lethality, Dense Urban Environment/Subterranean Operations, Army

Modernization Priorities, with emphasis on Soldier Lethality and informing Future Vertical Lift

Platform Development, Health Services Support, Protection and Survivability, and the DOD

Total Force Fitness concepts.

The MOMRP supports research focused on addressing and delivering actionable solutions across the military life cycle for critical biomedical problems facing the military today and in the future.

Service- and platform-specific issues are addressed through close coordination with all services to prevent unnecessary duplication of effort.

The MOMRP is divided into four Research Areas of Interest (with examples of types of research efforts shown in parentheses):

1. Environmental Health and Protection (detecting, monitoring, countermeasure development and performance optimization while operating in extreme environmental

[heat/cold/altitude/underwater] and during contaminant/toxicological exposures).

2. Injury Prevention and Treatment (validated military performance and readiness assessment tools and metrics, physiological mechanisms, diagnostic capabilities, and optimal treatment of neuromusculoskeletal injury, neuromusculoskeletal injury RTD standards and strategies, https://fitbir.nih.gov/ https://ntrr.nih.gov/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 10 neurosensory-related injury, and countermeasures against aviation stressors; blast-induced injury mechanisms (primary [blast overpressure], secondary [penetrating ballistic fragments or debris], tertiary [accelerative injury], and quaternary [burns or exposure to toxic substances], blast injury mechanisms [auditory and non-auditory], ballistic/blunt trauma, and accelerative injury prevention strategies; and enhance understanding of bioeffects and mitigation of emerging threats accounting for Warfighter sex differences).

3. Physiological Health and Performance (biomedical performance enhancement, performance and recovery nutrition, weight balance optimization, cognitive health and performance sustainment in the face of operational challenges, restorative sleep and fatigue management, resilience to operational and environmental stressors, and the medical aspects of manned-unmanned teaming).

4. Psychological Health Prevention and Treatment (solutions for early identification of and scalable treatments for achieving remission of psychological/behavioral health diagnoses such as posttraumatic stress disorder [PTSD], adjustment disorders; combat and operational stress reactions (COSR)/acute stress reactions, integrated primary prevention of harmful behaviors, including but not limited to suicide, sexual assault and harassment, alcohol/substance misuse, violence and ostracism, Service Member resilience to psychological threats and injuries, and

Family readiness).

More information on these Research Areas of Interest can be found in Appendix I.III. Applicants are urged to read and consider these before preparing their proposals/applications.

The MOMRP is particularly interested in proposals/applications and products that incorporate integrated biomedical approaches (e.g., systems biology), and Warfighter sex differences in training and operational environments. Proposals/applications are encouraged to leverage existing resources and infrastructure to support life cycle logistics and sustainability as well as consider integrated biomedical approaches (e.g., systems biology).

Guidance for research studies targeting military families and children: (1) In accordance with

Department of Defense Instruction (DoDI) 1402.5 and Army Directive 2014-23, Child Care

National Agency Check and Inquiries, background investigations are required for all individuals who have regular contact with military dependents under 18 years of age. All individuals who regularly interact with children under 18 years of age in Army-sponsored and -sanctioned programs are required to undergo specific initial background checks and periodic reverifications.

Investigators who propose work involving contact with military dependents under 18 years of age should plan for the additional time and funds required for such investigations. (2) Per

Department of Defense Education Activity (DoDEA) Administrative Instruction 2071.3, DoDEA approval is required for research studies involving DoDEA school personnel, school facilities, students, sponsors, and/or data. Investigators proposing to conduct any research activities involving DoDEA schools should plan for the additional time (~3-6 months) and effort required to obtain approval from DoDEA to conduct such activities. Procedures and requirements for the review and approval of a research study request can be found at https://www.dodea.edu/datacenter/research/requests.cfm. (3) Per Army Regulation AR 608-18, “The Family Advocacy Program,” the Family Advocacy Research Subcommittee will review, https://www.dodea.edu/datacenter/research/requests.cfm

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 11 coordinate, and recommend approval and dissemination of all family advocacy research, evaluation projects, and research publications within the Department of the Army.

II.B. Award Information

This BAA may be used to support applied research, preclinical research, clinical research, and clinical trials/testing (or equivalent). BAA proposals/applications that include a clinical trial have additional proposal/application and review requirements (see Appendix II). The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research.

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 placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. Note: Food and Drug

Administration (FDA)-regulated clinical investigation is always a clinical trial, but not all clinical trials are FDA clinical investigations.

Research Involving Human Anatomical Substances, Human Data, Human Subjects, or

Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human data human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow up to 3 months to complete the OHRO regulatory review and approval processes following submission of all required and complete documents to the OHRO. Refer to the General Submission Instructions, Appendix 1, and the Office for Human Research Protections Office Resources and Overview document available on the eBRAP “Funding Opportunities & Forms” web page

(https://ebrap.org/eBRAP/public/Program.htm) for additional information.

If the proposed research involves more than one institution, plans for the multi-institutional structure governing the research protocol(s) should be outlined. In addition, a written plan for single IRB review arrangements must be provided for research conducted in the United States involving more than one institution. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements. Communication and data transfer between or among the collaborating institutions, as well as how specimens and/or imaging products obtained https://ebrap.org/eBRAP/public/Program.htm

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 12 during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed on by all participating institutions is also required for multi-institutional clinical research/trials.

Research Involving Animals: All research funded by the BAA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use

Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.

Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in S.C. Landis et al., “A call for transparent reporting to optimize the predictive value of preclinical research,” Nature 2012, 490:187-191

(https://www.nature.com/articles/nature11556). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Applicants should consult the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported.

The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.

II.B.1. Clinical Trial Support

Investigator(s) proposing a clinical trial should refer to Appendix II for a detailed description of the requirements for such a proposal/application. The pre-proposal/pre-application submission process should be performed as described in Section II.D.2.a. Full proposal/application submission is described in Appendix II. Refer to Appendix II, Section IV, Checklist for Research

Proposal/Application Submission With a Clinical Trial, in preparing the full proposal/application.

For projects proposing a clinical trial:

• If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required for the study, the IND/IDE application must be submitted to the FDA by the proposal/application submission. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND/IDE is not required. Refer to

Attachment 12, Regulatory Strategy (Appendix II), for further details.

• If the clinical trial of an investigational product will be conducted at international sites, evidence that an application has been submitted to the relevant national regulatory agency of the host country(ies) is required by the above deadlines.

• Clinical trials must be initiated no later than 12 months after the award date.

Note: The government reserves the right to withhold or withdraw funding if an IND or IDE is necessary to conduct the study but has not been obtained within 6 months of the award date.

https://www.nature.com/articles/nature11556 https://arriveguidelines.org/arrive-guidelines

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 13

II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources

Principal Investigators (PIs) are encouraged to integrate and/or align their research projects with

DOD and/or Department of Veterans Affairs (VA) research laboratories and programs and existing clinical trial networks. Collaboration with the DOD or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix

III.

Use of DOD or VA Resources: If the proposed research involves access to active-duty military or Veteran patient populations and/or DOD or VA resources or databases, the proposal/application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Use Attachment 2: Supporting

Documentation, to provide relevant documentation to demonstrate access to DOD or VA populations or resources. Refer to the General Submission Instructions, Appendix 1, for additional information.

45 CFR Section 46.114 (Cooperative Research) of the Common Rule requires any institution located in the United States that is engaged in cooperative research to rely upon approval by a single IRB for that portion of the research that is conducted in the United States. For multi-site studies with collaborating VA institutions engaged in non-exempt human subjects research, and for which the use of a single IRB is determined to be not appropriate for the particular research context, a memorandum from the VA Office of Research and Development approving exception of the single IRB requirement must be sought and provided to the OHARO OHRO during the human research protection official review of the project.

Access to certain DOD or VA patient populations, resources, or databases may only be obtained by collaboration with a DOD or VA investigator who has a substantial role in the research and may not be available to a non-DOD or non-VA investigator if the resource is restricted to DOD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DOD or non-VA investigator collaborating with the DOD and/or VA. If the proposal/application is recommended for funding, the government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s).

Conducting DOD-Funded Human Research with Military Populations: There are unique requirements and prohibitions for compensating DOD-affiliated personnel for study participation and for conducting research with military Service Members or their Families/children and research with populations from U.S. Special Operations Command may require additional reviews and approvals. Additional information regarding conducting DOD-funded human research with military populations can be found at https://mrdc.health.mil/assets/docs/orp/conducting_research_military_Pop_dod_may_2021.pdf.

II.B.3. Technology Requirements and Standards

Any technology-based research products/prototypes (such as devices, mobile apps, software, information technology (IT) infrastructure, etc.) that expect to interact with military health IT https://mrdc.health.mil/assets/docs/orp/conducting_research_military_Pop_dod_may_2021.pdf

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 14 systems should conform with accepted industry and DOD Information Management/IT standards for interoperability, cybersecurity, as well as the DOD Architecture Framework (DoDAF) and viewpoints, as follows:

a. DoDAF and viewpoints

b. DoDI 8500.01 March, 14, 2014, “Cybersecurity”

c. DoDI 8510.01 July 19, 2022, “Risk Management Framework (RMF) for DoD Information

Technology (IT)”

d. Any products expected to provide data to Military Health System (MHS) Genesis, the new

DOD Military Electronic Health Record system (which is the military version of Cerner

Millennium commercial-off-the-shelf electronic health record), should be aimed toward meeting the Health Level 7 and Fast Healthcare Interoperability Resources standards in order to ultimately provide integration with MHS Genesis.

e. All software-based research products, including computer code, software code, data, and metadata, should be provided as deliverables, and electronic versions need to be able to be uploaded to standards-based electronic repositories. Metadata (i.e., the data dictionary and data model) as well as data (i.e., cases) generated in the research should be provided in an industry standard format for access by the government in an open source data repository of electronic deliverables.

f. Any information systems that are owned or operated by the contractor that processes, stores, or transmits Federal contraction information, not intended for public release, is subject to the basic safeguarding requirements detailed under FAR 52.204-21, Basic Safeguarding of

Covered information Systems.

g. OTAs may establish non-standard requirements.

II.B.4. Data Sharing

The USAMRDC intends that information, data, and research resources generated under awards funded by this BAA be made available to the research community and to the public at large. The government reserves the right to identify repositories for submission of data for archive. For additional guidance, refer to the General Submission Instructions, Appendix 2, Section K.

A number of research areas utilize Common Data Elements (CDEs) to facilitate the sharing of data to promote collaboration, accelerate research, and advance knowledge in specific topic areas. In accordance with the White House Office of Science and Technology Policy memorandum, “Increasing Access to the Results of Federally Funded Research,” and Executive

Order (EO) 13625 and the National Research Action Plan (NRAP) responding to the EO, “Improving Access to Mental Health Services for Veterans, Service Members, and Families”

(August 31, 2012), federally funded research is required to be conducted in a manner that promotes public access to scientific data. In cases of psychological health and TBI, use of CDEs continues to be required. The USAMRDC strongly encourages applicants to incorporate CDE measures appropriate to each field of study, such as:

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 15

• PhenX Core and Specialty collections, which are available in the Mental Health Research, Substance Abuse and Addiction, and Research Domains Collections of the PhenX Toolkit

(https://www.phenxtoolkit.org/index.php) in all studies involving human subjects, as applicable.

• Spinal cord injury research CDEs developed through the collaboration of the International

Spinal Cord Society, the American Spinal Injury Association, and the National Institute of

Neurological Disorders and Stroke CDE team, as referenced at Spinal Cord Injury | National

Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (nih.gov).

• Military Suicide Research Consortium CDEs were developed across two consortium phases and can be found here at the VA

(https://www.hsrd.research.va.gov/centers/core/sprint/msrc.cfm).

TBI research data elements must be reported using the NINDS TBI CDEs or entered into the

FITBIR data dictionary as new, unique data elements (UDEs). For the most current version of the NINDS TBI CDEs, go to http://www.commondataelements.ninds.nih.gov. Assistance will be available to help the researchers map their study variables to specific CDEs and ensure the formats of the CDEs collected are compatible with the FITBIR. Use of the TBI CDEs is required wherever possible in an effort to create standardized definitions and guidelines about the kinds of data to collect and the data collection methods that should be used in clinical studies of TBI. Use of UDEs is strongly discouraged and subject to program approval.

If the project includes the collection of bio-fluids, such as blood, saliva, urine, etc., the PI may be required to include a set of collection variables and patient phenotypic data in order to standardize the quality of bio-fluid studies. The suggested procedures for acquisition, processing, storage, and shipment of bio-fluids can be found in Appendix IV.

For projects involving TBI, PIs may be required to report data to the FITBIR

(https://fitbir.nih.gov/).

For studies that will enroll subjects with psychological health disorders, awardees may be requested to submit data to the National Institute of Mental Health Data Archive (NDA) https://nda.nih.gov/. The NDA is a data repository run by the National Institute of Mental Health

(NIMH) that allows researchers studying mental illness to collect and share de-identified information with each other. Such studies may require the inclusion of specific language in the informed consent form which references the NDA (see Appendix V).

OTAs may establish unique data sharing requirements.

II.B.5. Funds Available and Anticipated Number of Awards

The funding amount for this BAA is unspecified, and the number of awards is indeterminate and contingent upon funding availability. Selection of research projects is a highly competitive process and is based on the evaluation of the proposal/application’s technical merit, programmatic considerations, and the availability of funds. The quantity of meaningful submissions received normally exceeds the number of awards that the available funding can https://www.phenxtoolkit.org/index.php https://www.commondataelements.ninds.nih.gov/Spinal%20Cord%20Injury https://www.commondataelements.ninds.nih.gov/Spinal%20Cord%20Injury https://www.hsrd.research.va.gov/centers/core/sprint/msrc.cfm http://www.commondataelements.ninds.nih.gov/ https://fitbir.nih.gov/ https://nda.nih.gov/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 16 support. Any funding that is received by the USAMRDC and is appropriate for a research area described within this BAA may be utilized to fund proposals/applications.

II.B.6. Award Amounts and Periods of Performance

There are no specified funding limitations identified for a proposal/application submitted under this BAA. A budget should be commensurate with the nature and complexity of the proposed research. Researchers should submit budgets that include the entire period of performance of the research project. Budgets should include all direct and indirect costs, based on supportable, verifiable estimates. The budget for the full proposal/application should not differ significantly from the Pre-Application Budget Summary Form provided in the pre-proposal/pre-application submission.

Period of performance may differ depending upon the type of funding mechanism awarded under this BAA. For an assistance agreement, the total period of performance may be proposed for up to 4 years in length; additional periods may be considered. For research and development contract awards, the total period of performance may be proposed for up to 5 years in length;

additional periods may be considered. For OTAs that utilize the authority within 10 USC 4021 and 4022, the period of performance will be dependent upon each specific award made. Because the nature and scope of each proposed research project will vary, it is anticipated that the size and duration of each award will vary. Start dates will vary, depending on when proposals/applications were submitted and reviewed and the negotiation process. However, no proposal/application submitted under this BAA will be considered for funding after 24 months from the date of submission.

Organizations seeking additional or continuation funding must work with their respective

PIs to submit new pre-proposals/pre-applications and be invited to submit full proposals/applications.

Refer to the General Submission Instructions, Section III.A.5, for additional information regarding the Research & Related Budget.

II.B.7. Mechanisms of Support

The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement

Act of 1977, as amended (31 USC 6301-6308), which provides the legal criteria to select a procurement contract or an assistance agreement. Refer to the General Submission Instructions, Appendix 2, Section D, for additional information.

Proposers awarded a Grant, Cooperative Agreement, Technology Investment Agreement (TIA), Other Transaction for Research or Prototypes, based on their response to this BAA, shall follow the applicable rules and regulations governing these various award instruments but, in all cases, should appropriately identify any potential restrictions on the government’s use of any

Intellectual Property contemplated under the award instrument in question; refer to Attachment

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 17

8: Data and Research Resource Sharing Plan. This includes both noncommercial Items and commercial Items.

II.B.7.a. Procurement Contract: A legal instrument that, consistent with 31 USC 6303, reflects a relationship between the federal government and a state government, local government, or other entity/contractor when the principal purpose of the instrument is to acquire (by purchase, lease, or barter) property or services for the direct benefit or use of the federal government.

Contracts are primarily governed by the following regulations:

a. FAR

b. DFARS

II.B.7.b. Grant: A legal instrument that, consistent with 31 USC 6304, is used to enter into a relationship:

a. The principal purpose is to transfer a thing of value to the recipient to carry out a public purpose of support or stimulation authorized by a law or the United States, rather than to acquire property or services for the federal government’s direct benefit or use;

b. In which substantial involvement is not expected between the federal government and the recipient when carrying out the activity contemplated by the grant; and

c. No fee or profit is allowed.

II.B.7.c. Cooperative Agreement: A legal instrument that, consistent with 31 USC 6305, is used to enter into the same kind of relationship as a grant (see definition “grant”), except that substantial involvement (collaboration, participation, or intervention in the research) is expected between the federal government and the recipient when carrying out the activity contemplated by the cooperative agreement. The term does not include “cooperative research and development agreements” as defined in 15 USC 3710a. No fee or profit is allowed.

II.B.7.d. Other Transactions for Research: The USAMRDC will also consider the use of

Other Transactions for Research as a vehicle for award under this BAA. In accordance with 10 USC 4021, “Research projects: transactions other than contracts and grants,” such other transactions shall not be entered into unless the following conditions are satisfied:

a. To the maximum extent practicable, no other transaction entered into shall provide for research that duplicates research being conducted under existing programs carried out by

DOD.

b. The funds provided by the government under another transaction authorization shall not exceed, to the extent that the Secretary of Defense determines practicable, the total amount provided by other parties to the other transaction.

II.B.7.e. Other Transactions for Prototypes: The USAMRDC will also consider the use of

Other Transactions for Prototypes as a vehicle for award under this BAA. In accordance

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 18 with 10 USC 4022, Prototype projects; transactions other than contracts and grants: “No official of an agency shall enter into a transaction (other than a contract, grant, or cooperative agreement) for a prototype project under the authority of 10 USC 4022 unless one of the following conditions is met:

a. There is at least one…