HACKENSACK UNIVERSITY MEDICAL CENTER Research Department Policies and Procedures Manual
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1 Policy Name: Research Grant Submissions Process HACKENSACK UNIVERSITY MEDICAL CENTER Research Department Policies and Procedures Manual Policy #: SPO_003 Effective Date: 01/01/2009 Page 1 of 9 GENERAL Purpose To inform HackensackUMC researchers about the submission process of a research grant application to the Sponsored Programs Office Policy All sponsored projects must be submitted to the Research Department for review before they are submitted to sponsors. If awarded, the award is formally made to the Medical Center; accordingly all applications must be reviewed and approved prior to submission by appropriate institutional official (s), who must assure that HackensackUMC guidelines as well as sponsor s guidelines are followed during the submission process. All sponsored research projects will be coordinated with and submitted through the Department of Research. Sponsored Projects refers to grant submissions receiving external support for the conduct of research, scholarly work, training and services that have defined performance requirements. Administration The Chairman, Department of Research is responsible for the administration and subsequent revisions to the procedure. I. PROPOSAL DEVELOPMENT II. PROPOSAL REVIEW BY SPONSORED PROGRAMS OFFICE III. PROPOSAL REVIEW AND AWARD NOTIFICATION BY SPONSOR IV. DEFINITIONS APPENDIX PROCEDURE I. PROPOSAL DEVELOPMENT 1) Identification of Funding Opportunities- Sponsored Programs Office can help investigators find funding opportunities which match their respective research interests. 2) Once an investigator decides to pursue a funding opportunity, he/ she can utilize the Clinical Trials Advisor and the Biostatistician with study design and formation. 3) The Sponsored Programs Office will aid in gathering all components of the required research grant submission. PROPOSAL SUBMISSION A. Gifts Vs. Sponsored Project At times, the distinction between a gift and a research sponsored project is not clear. Generally a sponsored project has the following characteristics - Receives either direct of indirect support for the conduct of a research activity from an external sponsor. - Specific project involves any of the following: human subjects, vertebrate animals, biological hazards including radioactive materials and recombinant DNA, human body substances, or infectious agents.
2 Administrative Policy Manual - External support by the sponsor is dependent on HackensackUMC carrying out specific activities as outlined in the research application; delivery of specific goods, services or other deliverables by HackensackUMC; specific period of performance; and detailed financial accountability/ reporting to the sponsor Gifts on the other hand are donations or unrestricted funds given voluntarily by a donor. Generally, there is no specific good, service, or work deliverables exchanged as part of accepting the gift; financial reporting of gift expenses are not shared with the donor unless specifically requested by the donor. All gifts should be coordinated with and managed through the Hackensack University Medical Foundation. Examples of Gifts include endowments, capital projects and various unrestricted funds. B. Common Features of Federally Sponsored Projects 1) The Sponsored Programs Office (SPO) is the central administrative office for submitting research grant proposals and accepting awards on behalf of Hackensack University Medical Center for extramural research. It is the responsibility of the Principal Investigator (PI) to coordinate with SPO for timely submissions. 2) PI Eligibility- Any full time, part-time, emeritus, and voluntary physician/ faculty of HackensackUMC is eligible to serve as Principal Investigators (PI) and/or Co-Investigators on a grant submission. Fellows can serve as a PI on a study if an appropriate mentor is listed on the application. Other individuals who want to submit an application should contact SPO to confirm their eligibility. 3) The federal government has created one electronic portal for external research submissions, Grants.Gov., which allows access to the 26 federal grant-making agencies. Since grants are awarded to and submitted by the HackensackUMC, PI s and administrative staff are not authorized to submit proposals, accept grants or execute contracts on behalf of HackensackUMC. 4) Electronic submissions via Grants.Gov are due 3 days before the agency s deadline. This will give adequate time for the SPO to provide a thorough review as well as request any changes which need to be made for a successful submission. C. Common features of Non- Federal External Support for Research 1) Non-Federal support of research projects is available through funding from pharmaceutical companies, foundations and other private sponsors. 2) Pharmaceutical sponsored studies which involve human subjects should be submitted through Click Commerce for both Institutional and IRB approvals. 3) Sponsored project submissions to foundations and other private sponsors should be submitted through the Sponsored Programs Office. 4) Unlike federally sponsored grants, most Foundations have paper submissions although many have been moving towards electronic submissions. D. Submission Requirements Page 2 of 8
3 1) All sponsored submissions excluding pharmaceutical sponsored studies should be submitted with SPO form 1*, attached as Exhibit A. The research submission should also include a. External Grant Application b. Budget c. Budget Justification SPO form 1 ensures that the Principal Investigator and other key personnel involved in the study have the appropriate approval and support of the proposed research from their departmental Chairman. SPO form 1 also monitors federal regulatory requirements of FCOI, Suspension and Debarment and Certification of Institutional Compliance. PI certifications- By signing the SPO form, the PI certifies that the information submitted in the sponsored application is true, complete and accurate to the best of the PI s knowledge; PI and all key personnel (KEY PERSONNEL) have reported their Financial Conflict of Interest according to the Medical Center s Research FCOI s policy; and that Key Personnel are not suspended or debarred from submitting or conducting a federal study. Department Certifications- The Chairman s signature certifies the following: o The PI has the allotted time and required facilities and resources to carry out the study; o Salary arrangements and budget requests are accurate 5) SPO reviews applications to ensure compliance with HackensackUMC policies as well as the Sponsor s policies. 6) Federal Grants will be submitted electronically by the Chairman of Research or his designee, the Sponsored Programs Manager. The authorized institutional official for sign-off on nongovernmental grants is the Chairman of Research. 7) Each sponsor will have its own review process. The time from submission of an application to notification of funding varies by Sponsor since each has its own review/decision/notification process. 8) SPO provides the following services to assist the PI in a successful research submission: a. Identification of funding opportunities from various sponsors excluding pharmaceutical companies targeted towards their research interests. b. Assist in preparation of research submission to external sponsor. c. Assist in preparation of JIT documents for NIH submissions. E. Subcontracts/ Subawards HackensackUMC can act as a subcontractor to another institution when an institution other than HackensackUMC is the original recipient of the award. The original recipient of a grant is known as the prime grantee/contractor. HackensackUMC can also act as the Prime Grantee/Contractor and issue subcontracts/subawards to other participating institutions. HackensackUMC as a Subcontractor: When HackensackUMC serves as a subcontractor to another institution, there are certain forms which need to be submitted to the Sponsored Programs Office at the time of submission. Page 3 of 8
4 Administrative Policy Manual - SPO form 1 - Budget - Budget Justification - Main contact info. at Prime Institution SPO will issue a letter of intent to establish a subcontract after it reviews the proposal. Once the grant/contractor is awarded, the Prime Contractor will send a Subcontract Agreement to HackensackUMC for execution. The Chairman of Research will sign off on all subcontract agreements. HackensackKUMC as a Prime Contractor: When HackensackUMC submits an application with another institution as a subcontract, HackensackUMC will submit the following items to the Sponsored Programs Office - SPO form 1 - External Application - Budget - Budget Justification - Subcontractor s Budget and Budget Justification - Letter of intent to subcontract from the Subcontracting Institution Once HackensackUMC is granted an award, HackensackUMC will prepare a subcontract for its participating subcontracting institutions. II. PROPOSAL REVIEW BY SPONSORED PROGRAMS OFFICE 1) Scientists and Physicians must contact the Sponsored Programs Office at least one week prior to grant submission deadline. 2) SPO will review and request any changes which need to be made according to the Sponsor s and Medical Center s guidelines. 3) For all electronic submissions or those agencies which require an electronic copy of the application to be send to a specified individual within the agency, the Sponsored Programs Manager will submit all of these types of applications. III. PROPOSAL REVIEW AND AWARD SELECTION BY SPONSOR 1) Most sponsored proposals have a six month to a nine month turnaround time from date of submission to the start date of the project. 2) Prior to a Sponsor selecting a project or grant for an award, the Sponsor usually contacts the Principal Investigator or Sponsored Programs Office for additional or supplementary information such as the IRB approval. 3) Once a grant is chosen for award, the award letter is sent to the Sponsored Programs Office via an or an award letter. The award acceptance process is described in the Award Acceptance and Continuation Policy. Page 4 of 8
5 IV. DEFINITIONS Co-Investigator- Other collaborating faculty or individuals. Code of Federal Regulations: As required by Executive Order 12549, Debarment and Suspension, and implemented at 45 CFR Part 76, for prospective participants in primary covered transactions, as defined at 45 CFR Part, 76, Sections and (1) The prospective primary participant certifies to the best of its knowledge and belief, that it and its principals: (a) Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded by any Federal department or agency; (b) Have not within a three-year period preceding this proposal been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State or local) transaction or contract under a public transaction; violation of Federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property; (c) Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity (Federal, State or local) with commission of any of the offenses enumerated in paragraph (1)(b) of this certification; and (d) Have not within a three-year period preceding this application/proposal had one or more public transactions (Federal, State or local) terminated for cause or default. (2) Where the prospective primary participant is unable to certify to any of the statements in this certification, such prospective participant shall attach an explanation to their proposal. Cooperative Agreements Cooperative Agreements are similar to grants, but also typically involve a significant level or direction and or participation from the Sponsor. FCOI- financial conflict of interest as per HakcensackUMC administrative policy on Financial Conflict of Interests. Grant- Grants may be obtained for a wide variety of project types, including research, service, training, education, and planning. The distinctive feature of grants is that they are usually awarded to an institution for a project which originated with the institution and is designed according to specifications and methodology which originated with an institution. In order words, investigators receive a grant for a project they wish to do, provided it is also within the scope of interest of the granting agency. Grants generally do no have a specific deliverable and there is no substantial involvement between the funding agency and the recipient during the award period. Grants.Gov- Grants.gov is the single Federal source for finding and applying for competitive discretionary grants for more than nine hundred Federal competitive grant programs. Here, you ll discover standardized grant information, application packages, and application processes across all 26 Federal grant making agencies. Finding and applying for Federal grants has never been more streamlined or consistent. IACUC- Institutional Animal Care and Use Committee reviews and approves all research involving vertebrate animals. Page 5 of 8
6 Administrative Policy Manual Institutional Certification- : PI certifies that the information submitted on within the application is true, complete and accurate to the best of my knowledge. Any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties. If funded, the PI agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. IRB- Institutional Review Board reviews and approves all research involving human subjects. JIT- Just-In-Time mechanism is used by the National Institutes of Health in which Investigators are requested for supplementary information once their proposal has been chosen for funding. Key Personnel- Personnel who are directly involved in the design and conduct of the study and whose roles cannot be substituted by other individuals. NIH Definitions Request for Application (RFA): The official statement that invites grant or cooperative agreement applications to accomplish a specific program purpose. RFAs indicate the amount of funds set aside for the competition and generally identify a single application receipt date. Request for Proposals (RFP): Announces that NIH would like to award a contract to meet a specific need, such as the development of an animal model. RFPs have a single application receipt date and are published in the NIH Guide for Grants and Contracts. Program Announcement (PA): An announcement by an NIH institute or center requesting applications in the stated scientific areas. Generally, money is not set aside to pay for them. PI- Principal Investigator is the lead investigator of a study and is responsible for the overall scientific conduct and bears and the financial accountability of the disbursement of study funds. Sponsor- External entity which gives funding or scientific direction in how a research project is carried out. Sponsored Programs Office (SPO)- Administrative Office within the Research Department which coordinates the submission of proposals for sponsored projects to external funding sources; also ensures that project proposals and awards comply with Medical Center and Sponsor s policies. Suspension and Debarment- refers to certification requirements under 45CFR Part 76, "Government Debarment and Suspension (Non-procurement)" and "Government wide Requirements for Drug-Free Workplace" and 45CFR Part 93. REVIEWED BY Dr. Robert Korngold Dr. Peter Gross Medical Advisory Board Page 6 of 8
7 HACKENSACK UNIVERSITY MEDICAL CENTER Sponsored Programs Office (SPO Form1) Financial Interest Disclosure Form For Investigators with NIH/PHS and NSF Proposals PROJECT TITLE: PRINCIPAL INVESTIGATOR: FUNDING AGENCY OR SPONSOR: DEPT: PROJECT START DATE: Study Personnel Information Role Name (Last, First, MI), Title Degree Department/Division Principal Investigator/Program Director: Co-Investigator (Co-I)/Key Personnel: Co-I/Key Personnel: Co-I/Key Personnel: Co-I/Key Personnel: A. Financial Conflict of Interest The Department of Health and Human Services (HHS) final rule on financial conflicts of interest (FCOI) policy (effective August 24, 2012) requires transparency and accountability for those seeking Public Health Service (PHS) funding. The goal is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting by establishing standards under NIH grants or cooperative agreements will be free from bias resulting from study team member s financial conflicts of interest. 1. For this proposal, is there any potential for real or perceived financial conflicts of interest (FCOI) that needs to be disclosed? Please refer to Institution s FCOI policy regarding PHS financial conflict of interest regulation (42 CFR 50 subpart F) and definition of Significant Financial Interest (SFI). A SFI exists if the value received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. yes no 2. If yes, please describe the name of the entity with which you have an FCOI and the nature of the FCOI (e.g. consulting fees, travel, spouse is employee, etc.). You do not have to disclose payments from HackensackUMC for yourself or your immediate family. You also do not have to disclose payments from public or non-profit organizations if they are for lectures, seminars, or service on advisory committee. Financial interest in a company that are the result of your holding shares in a mutual fund or being a member of the HackensackUMC s retirement plan or similar pooled funds do not need to be reported, as long as you do not control the selection of investments. Page 7 of 8
8 Administrative Policy Manual 3. Does your grant involve a contract, subcontract or collaboration with an outside institution or group? yes no 4. If yes, please provide collaborator s list of key personnel. In accordance with PHS financial conflict of interest regulations (42 CFR 50 subpart F), the investigator attests that neither they, nor their immediate family member have significant financial conflict of interest (FCOI) with respect to the above grant application. If the status of FCOI changes with respect to this grant; the individual would notify the Chairman of the Department of Research and follow HackensackUMC s Conflict of Interest in Research policy in terms of the reporting and resolution of FCOI in research. B. Certification of Suspension and Debarment (Required for all PI and Co-Investigators listed on PHS sponsored studies) As a potential participant on a federal grant, PI and Co-investigators, attest to the best of their knowledge that they have not been suspended or debarred from engaging in research sponsored by DHHS as noted in 45 CFR 76, Government-wide Debarment and Suspension (Nonprocurement). C. Certification of Institutional Compliance (Required for all PI s on PHS sponsored studies) PI certifies that the information submitted on within the application is true, complete and accurate to the best of my knowledge. Any false, fictitious or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties. If funded, the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. Signature: Print Name: Title: Date: Page 8 of 8
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