US DOD - Congressionally Directed Medical Research Programs (CDMRP)

Mode of Application

MODE OF APPLICATION

CDMRP General Application Instructions (Version 702) are available here and must be consulted: https://cdmrp.health.mil/funding/pa/General%20Application%20Instructions-702.pdf

In addition, each specific announcement must be carefully read to understand its key elements.

Submission to CDMRP requires 3 steps: Pre-application to the Electronic Biomedical Research Application Portal (eBRAP) and can be done only after registration; Application to Grants.gov; and Application Verification in eBRAP.

IMPORTANT: Whereas submission of Pre-application is MANDATORY, there are two types of pre-applications depending on award mechanism: LOI or pre-proposal. If the pre-application was a pre-proposal, an invitation is required before submission of an Application to Grants.gov.

CDMRP How to Apply webpage: https://cdmrp.health.mil/funding/apply

Signatures: All documents that require signatures must be signed. Both electronic and hand signatures will be accepted. Any document that is signed by hand should be scanned at a resolution of 100-150 dots per inch.

Budget and Financial Info

BUDGET

As it is a Weizmann Institute requirement that the Finance Division approve the budget before the RGP can endorse an application, it is strongly recommended that the budget be submitted for approval as early as possible. Since on occasion the budget must be modified by the researcher further to input received by the Finance Division, the RGP recommends that with the assistance of the Departmental Administrator (Minhalan), the budget be prepared and submitted for approval to the Finance Division before the scientific parts of the application are complete.

APPROVED OVERHEAD BY FOUNDATION

Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

SALARIES AND WAGES

Allowable. More information TBA.

TOSEFET MEHKAR ALLOWANCE

This funding agency allows in its guidelines for the budget submitted for approval to include an explicit sum to be used to pay partially for the salary of PIs. Consequently, in the budget application to this foundation, you may request Tosefet Mehkar Aleph (i.e. a salary supplement which will be paid to you at the expense of the budget approved by the foundation in accordance to the explicit sums which appear in the approved budget for salary to the PI[s]). Please note that further to VATAT regulations, if Tosefet Mehkar Aleph is not requested on a grant from an agency whose guidelines allow for the partial reimbursement of the PI salary, you will NOT be eligible to receive Tosefet Mehkar Aleph or Bet on grants from this agency.

Policy Requirements

A complete listing of CDMRP policy requirements is included in the General Application Instructions (Version 702). The most relevant policy requirements are as follows:

SAFETY AND ENVIRONMENTAL REQUIREMENTS

The U.S. Army Medical Research and Development Command (USAMRDC) Office of Surety and Environment will identify any need for Safety and Environmental compliance review, and documents must be submitted upon request. This will usually be in instances such as use of Army-provided infectious agents or toxins, Biological Select Agents or Toxins, specific chemical agent(s), or pesticides outside of an established laboratory. Additional information is available at: https://mrdc.health.mil/index.cfm/resources/researcher_resources/safety.

RESEARCH INVOLVING ANIMAL USE

The Animal Care and Use Review Office (ACURO) reviews and approves all animal use funded by the award prior to the start of working with animals, including amendments to ongoing projects. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. Although IACUC approval is not required at the time of submission PIs must submit the institutional animal use protocol and IACUC approval of that protocol after the application is selected for funding, in addition to a version of an animal use appendix titled “Research Involving Animals”. For further guidance, visit the ACURO website at: https://mrdc.health.mil/index.cfm/collaborate/research_protections/acuro

IMPORTANT: Make sure to allow at least 3 to 4 months for regulatory review and approval processes for animal studies.

For additional information, send questions via email to ACURO at: usarmy.detrick.medcomusamrdc.other.acuro@mail.mil

RESEARCH INVOLVING HUMAN SUBJECTS

The Office of Human Research Office (OHRO) reviews and approves all DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, human data, or human cadavers, prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review.

IMPORTANT: OHRO’s regulatory review and approval process takes up to 3 months following submission of all required and complete documents. Studies taking place in international settings may require additional time. Therefore, you should allow ample time for this review.

Additional requirements can be found in the OHRO guidance document “Information for Investigators – Human Subjects Research”, which includes the following key requirements:

• A current Institutional Assurance of Compliance- either a DHHS Office for Human Research Protection Federalwide Assurance (FWA) or DOD Assurance.
• Documentation confirming completion of appropriate training of personnel involved in human subject research.
• Informed Consent Forms must include the following:
  • A statement that the DOD is providing funding for the study.
  • A statement that representatives of the DOD are authorized to review research records.
  • In the event that Health Insurance Portability and Accountability Act (HIPAA) authorization is required, the DOD must be listed as one of the parties to whom private health information may be disclosed.

For in-depth information and to access HRPO protocol submission forms, refer to the OHRO website at: https://mrdc.amedd.army.mil/index.cfm?pageid=Research_Protections.hrpo

Questions regarding applicable human subjects protection regulations, policies, and guidance should be directed to HRPO at: usarmy.detrick.medcomusamrdc.otherhrpo@mail.mil

RESEACH INVOLVING THE SECONDARY USE OF HUMAN DATA/SPECIMENS

OHRO will review for compliance and approve all research involving the secondary use of human data, human biospecimens (hereafter referred to as data/specimens). All research involving the use of data/or specimens, not otherwise subject to institutional review, requires a determination letter stating that the project does not constitute “human subjects research” or can be considered “exempt human subjects research” from WIS’ Institutional Review Board (IRB), as well as a concurrence from the OHRO.

For additional guidance and instructions on OHRO review of DOD-funded research activities involving access, use, and analysis of data/specimens, see the guidance document “Information for Investigators – Research with Data/Specimens,” found at: https://mrdc.amedd.army.mil/index.cfm?pageid=Research_Protections.hrpo

RESEARCH INVOLVING RECOMBINANAT DNA

If the project involves the use of recombinant DNA, please make sure that it will be in compliance with guidance provided at Biosafety and Recombinant DNA Policy – Office of Science Policy (nih.gov): https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities/

USE OF HUMAN CADAVERS OR HUMAN ANATOMICAL SUBSTANCE OBTAINED FROM HUMAN CADAVERS

There are policies regarding research, development, test and evaluation (RDT&E), education, or training activities involving human cadavers or human anatomical substances obtained from cadavers (postmortem samples). These can be found at: https://mrdc.amedd.army.mil/assets/docs/orp/Army_Policy_for_Use_of_Human_Cadavers.pdf

Such activities shall not begin before obtaining the USAMRDC Office of Research Protections (ORP) approval.

Additional requirements apply to activities involving exposure of cadavers to impacts, blasts, ballistics testing, crash testing, and other destructive forces. Award recipients must coordinate with the supporting/funding Army organization to ensure that proper approvals are obtained.

Questions regarding submission of human cadaver research for USAMRDC ORP review and approval should be directed to the ORP at: usarmy.detrick.medcomusamrmc.other.hrpo@mail.mil

RESEARCH INVOLVING THE USE OF U.S. FOOD AND DRUG ADMINISTRATION-REGULATED PRODUCTS

Research Involving the Use of U.S. Food and Drug Administration-Regulated Products (i.e., drugs, devices, in vitro diagnostics), in which the focus of the study is on the safety or effectiveness of the product, requires IRB review in accordance with 21 CFR 50 and 21 CFR 56.

CLINICAL TRIAL REGISTERY

Clinical trials that meet the definition on the NIH database (see https://prsinfo.clinicaltrials.gov/ click on “Support Materials (including data element definitions)”) must be registered prior to enrollment of the first patient. Failure to do so may result in a civil monetary penalty and/or the withholding or recovery of grant funds as per U.S. Public Law 110-85.

PIs are required to register applicable clinical trials individually on https://clinicaltrials.gov/ using a Secondary Protocol ID number designation of “CDMRPeBRAP Log Number” (e.g., CDMRP-PC22####). If several protocols exist under the same application, the Secondary Protocol ID number must be designated “CDMRP-eBRAP Log Number-A, B, C, etc.” (e.g., CDMRP-PC22####-A).

PIs conducting phase 3 clinical trials shall submit results of analyses of group differences on the basis of sex/gender, race, and/or ethnicity to clinicaltrials.gov at the time of final report submission. If final analyses of sex/gender and race/ethnicity are not available at the time of the final technical report, a justification and plan ensuring completion and reporting of the analyses must be submitted to USAMRAA (U.S. Army Medical Research Acquisition Activity).

Important Links

CDMRP, GRANTS.GOV, EBRAP HOME PAGES

• CDMRP: https://cdmrp.health.mil/researchprograms
• Grants.gov: https://grants.nih.gov/grants/oer.htm
• eBRAP: https://ebrap.org/eBRAP/public/index.htm

EMAIL SUBSCRIPTION

• CDMRP: https://ebrap.org/eBRAP/programSubscription/Subscribe.htm
• Grants.gov: https://www.grants.gov/connect/manage-subscriptions/
• eBRAP: https://ebrap.org/eBRAP/programSubscription/Subscribe.htm

APPLICATION PROCESS

• CDMRP How to Apply: https://cdmrp.health.mil/funding/apply
• eBRAP Registration: https://ebrap.org/eBRAP/public/index.htm
• eBRAP User Guide: https://ebrap.org/eBRAP/public/UserGuide.pdf

DUE DATES

Dates and Synopsis of Open Program Funding Opportunities: https://cdmrp.health.mil/funding/reftable

AWARD PROCESS

• CDMRP Award Guide for Funded Investigators: https://cdmrp.health.mil/pubs/news/pdf/GuideForFundedInvestigators2019.pdf
• CDMRP Technical Reports, Award & Regulatory Documents submission: https://ebrap.org/eBRAP/public/index.htm

ADDITIONAL INFORMATION

CDMRP Webinar Series: https://cdmrp.health.mil/pubs/webinars/webinar_series