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OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

 

DIVISION OF SPONSORED PROGRAMS

Application Review Requirements

The purpose of the research application review by Sponsored Programs staff is to insure that all Downstate Medical Center, Research Foundation and sponsor requirements have been met. Applications will not be submitted (see Campus Application Review and Submission Deadlines) until they are complete and meet all administrative, financial and format requirements.

DMC Application Review & Signature Form

The purpose of the Application Review & Signature Form, an internal form that is not submitted to the sponsor, is to identify certain informational items that will assist in the campus review and approval of the application. In addition, the signature of the Principal Investigator (PI) on a PHS grant application was intended to provide PI certification of compliance to several PHS regulations. As the PI signature is no longer included on the application forms, a new compliance requirement is now mandated whereby DMC agrees to secure and retain a written assurance from the PI prior to submitting an application to the PHS. While this assurance is no longer included on the application, it remains a compliance requirement. Therefore, in order to meet this compliance requirement, the Office of Scientific Affairs / Division of Sponsored Programs will retain the Research Proposal Review/Signature Worksheet for each submitted application (requirement applicable for all sponsors) -- an application will not be submitted without this form. When multiple PIs are proposed in an application, this assurance must be retained for all named PIs.

The DMC Application Review & Signature Form, for every application, including awards made that did not require initial application, such as clinical trial agreements or multiple sponsor accounts, must include the signature of the Department Chair.

In addition to the Application Review & Signature Form, all investigators (with an annual salary of $82,389 or greater for the current calendar year) must complete and submit the SUNY II Disclosure Statement at least annually (or more frequently if the information contained in the disclosure statement has changed).

Application Components - Sponsoring Agency Guidelines

Whether electronic or paper, sponsors are generally very specific about what information, as well as its format, must be included in a grant application. An application must adhere to the content and formating requirements of the sponsor before it will be submitted.

  • Abstract and Research Plan — These sections are reviewed for format, not content, to make sure that required sections (i.e., specific aims, background and significance, preliminary studies, research design and methods) are included, do not exceed the maximum number of pages allowed and adhere to formating requirements.
  • Biosketches for all key personnel — The most recent NIH PHS398 biosketch must be used. Within the 4-page maximum, all three required sections must be completed: A. positions and honors, B. selected publications, and C. research support (List both selected ongoing and completed, during the last three years, research projects, Federal or non-Federal support. Begin with the projects that are most relevant to the research proposed in the application and briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biosketch).
  • Budget and Budget Justification — Detailed budgets are reviewed to make sure that appropriate and allowable costs are included and the correct fringe benefit rate is used when salaries are requested. The personnel section of the budget justification must include the amount of effort to be devoted to the project, either in person months for most federal applications or percent.

                Percent effort to person months effort conversion table
                Fringe Benefit Rate Calculator

Consortium Arrangements

An institution is considered a subgrantee if their investigator is providing substantial scientific input to DMC's study and a budget for costs incurred, including indirect costs, is being added to the funding requested in DMC's application.

If a research grant application includes an investigator at another institution, the materials and documentation listed below must be provided by your collaborator and their institution before the grant application is submitted - the specific format will depend on the application requirements of the sponsor. If DMC will be a subgrantee on a proposal being submitted by another institution, this information must be provided to the applicant institution.

  • Endorsement from Institutional Official that includes an appropriate conflict of interest statement and IRB and/or IACUC approval dates if either human subjects or animal subjects are involved in the proposed study
  • Proposal budget and budget justification
  • Scope of work
  • Copy of F&A (indirect cost) agreement
  • If the project inovlves human subjects, a statement that subgrantee's key personnel have completed their human subjects training program
  • Key personnel biosketches
  • Facilities and equipment descriptions

When a grant award is made for the project with a proposed consortium arrangement, the above information will be used to prepare a subcontract with the other institution.

Human Subjects

Downstate Medical Center is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the "Belmont Report"], regardless of whether the research is subject to Federal regulation or with whom conducted or source of sponsor support. All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable DHHS-supported research, and all other human subject research regardless of sponsorship, except as otherwise noted in the Center's Assurance. Federal (all departments and agencies bound by the Federal Policy) funds may not be expended for research involving human subjects unless the requirements of the Center's Assurance have been satisfied.

When a proposed research project involves the use of human subjects, the grant application must indicate YES and include the DMC assurance number (FWA00003624) and IRB approval date, or "pending" if the application and protocol have not yet been submitted to the IRB for review (see NIH Just-In-Time Requirements).

In addition to the above, investigators proposing to use human subject in their research project must complete the Downstate Investigator Education Program prior to submission of the IRB protocol. Certification that the Principal Investigator and all Key Personnel have completed the training requirement must be provided to NIH (see NIH Just-In-Time Requirements).

Animal Subjects

Consistent with the Public Health Service and U.S. Department of Agriculture guidelines on the Humane Care and Use of Laboratory Animals and the Downstate Medical Center Policies and Procedures for the Care and Use of Laboratory Animals in Biomedical and Behavioral Research and Education, all uses of animals for research, training, or other purposes within the Center must be approved by the Animal Care and Use Committee (ACUC). The ongoing cooperation of all Investigators is vitally important in maintaining the Center's ability to continue to undertake the wide variety of existing and planned research programs involving animals. This requirement is applicable to all uses of animals regardless of the source, internal or external, of support, or the location of the animal, in the DLAR or departmental facilities.

When a proposed research project involves the use of animals, the grant application must indicate YES and include the DMC assurance number (A3260-01) and the ACUC approval date, or "pending" if the application and protocol have not yet been submitted to the ACUC for review (see NIH Just-In-Time Requirements).

Just-In-Time Requirements for NIH

The following documentation is required by NIH prior to a pending award. After being co-signed by the Division of Sponsored Programs, this documentation may be input directly through the NIH eRA Commons system.

  • Current and Pending Support — Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts are not included. Potential conflicts over scientific overlap, commitment/effort overlap or budgetary overlap
  • IRB and/or IACUC protocol approval dates
  • Human subjects Education Program certification

NIH Non-Competing Applications / Progress Reports

All non-competing applications, whether a full continuation application or a scientific progress report, must be reviewed by the Division of Sponsored Programs.

NIH eRA Commons eSNAP procedure