Office of Research UMDNJ School of Health Related Professions

1. Office of Research UMDNJ School of Health Related Professions An Overview of the SHRP Research Process (http://shrp.umdnj.edu/research/index.htm)

2. The Mission of the Office of Research is to provide an infrastructure dedicated to facilitating research and research-related activities of faculty, administration, students and staff within SHRP. RESPONSIBILITIES OF THE OFFICE OF RESEARCH? • To SUPPORT investigators at SHRP by PRE-SUBMISSION REVIEW of their applications for extramural funding (PRE-AWARD PROCESS) • To ENSURE that final draft documents supplied to Legal Management are COMPLETE and IN COMPLIANCE with UMDNJ policies (SUB-AWARDS) • To ENABLE SHRP faculty to be current with new initiatives which could potentially impact their applications for funding support (e.g. ELECTRONIC SUBMISSION to the NIH) • To ADVOCATE for SHRP faculty with offices supporting the research enterprise (e.g. IRB, Grants and Contracts, Legal Management) • To ADMINISTER research-related programs (e.g. Summer Student Research; Foundation Grants; Educational Research Grants) • To MONITOR IRB submissions • To TRACK awards • To PROMOTE interdisciplinary collaboration SHRP Research Club

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9. Research Related Programs • Summer Student Research Interns • $2000 stipend to graduate student to assist faculty research • Faculty member must be full-time and have a terminal degree which included a research component • SHRP/Foundation Faculty Research Grant • $20,000 grant to support faculty research efforts which are expected to lead to subsequent external funding • Faculty must be full-time and have a terminal degree which included a research component • SHRP/Foundation Educational Research Grant • $2000 grant to support educational research – especially investigations of the efficacy of distance education or the development of innovative and novel educational techniques which will expand and enhance distance education • SHRP/Foundation Bridge Funding • On a limited bases available to support faculty research in need of additional funds while preparing for submission to an external funding source SHRP Research Club

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11. The “GAFA” Who Signs ? Box 1 PI Box 2 Chair Box 3 Grants Box 4 Assoc Dean Box 5 Legal Box 6 Finance IRB IACUC Lab Safety IBC Box 1 Box 5 Box 2 Box 6 Box 3 Box 4 SHRP Research Club

12. Financial Disclosure Form http://njms.umdnj.edu/research/orsp/documents/fdfnew_000.doc SHRP Research Club

13. Pre-submission Review of Funding Applications Budget Pre-review Conflict of Interest Institutional Approvals Application Pre-review PI submits the funding announcement; the administrative components of the application (10 working days in advance) PI submits the final application (3 working days in advance). Ensure that Institutional information is correct. PI forwards budget to Grants & Contracts. Grants & Contracts pre-reviews budget and returns it to PI for revisions or with a verbal approval within 24 hrs. PI circulates Financial Disclosure Forms for signatures of Key Personnel and their Chairs. Potential Conflicts of Interest are reviewed in ORSP. PI submits protocol to IRB, IACUC and IBC as needed and enters status on GAFA form. SHRP Research Club

14. Pre-Submission Review To facilitate Pre-Submission Review The following administrative items are required ten (10) working days prior to submission: • Completed Face Page • Abstract • Budget and Justification • Resources Page (if required) • Biosketches/CV’s (if required) • Compliance Reviews (if required) • Checklist (if required) SHRP Research Club

15. Final Proposal The following items are required three (3) working days prior to submission: • Final Proposal for submission • Hard copy, if mailed • Email, flash drive or CD (electronic submission) • PI Signature Form (NIH submission ONLY) • Fully Executed Transmittal and Approval Form (GAFA) • Fully Executed Financial Disclosure Form (FDF) SHRP Research Club

16. Key Points to Remember Grants and Contracts Budget Review: The Office of Grants and Contracts requires a minimum of 24 hours for budget review and approval (though if you ask nicely, they’ll often do the review while you wait). This must be completed before submitting your grant. Our representative in G&C is Jose (as it would be pronounced in Joseph) Ambazhachalil (2-6496) G&C is mostly concerned with 3 things: • that you’ve gotten people’s salaries right; • that you’ve used the proper percentage in calculating fringe benefits (if you’re not sure, check http://www.umdnj.edu/cntrlweb/ • that you’ve used the proper indirect rate (if unsure – call grants and contracts for the proper rate (these vary by funding agency), don’t forget to ask them for the date of the Agreement as you’ll need it for your application, and while you’re at it, make an appointment for your review. SHRP Research Club

17. Key Points to Remember Compliance Reviews: If proposal requires compliance review (Legal, IRB, IACUC, Ethics, HIPAA) Protocols should be submitted to the appropriate compliance office(s) simultaneously. Each office/review has it’s own timeline and schedule. Information can be found at: • http://www.umdnj.edu/hsweb - office of Human Subjects Protection • http://www.umdnj.edu/research/iacuc - UMDNJ Research Office • http://www.umdnj.edu/complweb - UMDNJ Compliance Office (Ethics, HIPAA) • http://www.umdnj.edu/legalweb - Legal Note: It is important that investigators follow these guidelines to ensure that their proposals receive the “most complete” review. Submission procedures apply to paper applications, as well as those submitted electronically. SHRP Research Club

18. PRE-SUBMISSION REVIEW OF GRANT APPLICATIONS PI Circulates GAFA and FDF for Signatures This can take a number of days if it requires legal/finance review PI submits Budget to Grants & Contracts Usually complete in 24 hours PI submits Protocols for Review Submit these for pre-approval prior to submission deadline Once all signatures are in place, application is ready for submission Institutional “Sign-Off” “Submit” SHRP Research Club

19. Sign Off Process Final approval packet includes: • GAFA/Transmittal and Approval Form • FDF (Financial Disclosure Form) GAFA is to be completed in its entirety, including approval date and protocol number for any Compliance Units involved. See GAFA/Transmittal and Approval Form FDF must be signed by all key personnel and countersigned by the Dept. Chair. If Chair is also the PI, FDF will be countersigned by Dean or Assoc. Dean. NOTES: GAFA will not be signed by Institutional Official until all approvals and other related documents are received. FDF’s indicating conflict of interest will be reviewed within SHRP and if necessary will be forwarded to the COI committee for review and resolution. SHRP Research Club

20. Sign Off Process Cont’d Complete packet is routed for GAFA signatures in the following order: • PI signs Box #1 • Dept. Chair approves and signs Box #2 • Grants & Contracts approves and signs Box #3 • Packet is sent to the Assoc. Dean for final review and signature • Completed packet is ready for submission SHRP Research Club

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22. The PI & Sponsor negotiate a draft contract triggering 4 PARALLEL processes. Institutional Approvals Budget Pre-review Conflicts of Interest Legal Pre-review PI sends a draft copy via email to LEGAL for pre-review. LEGAL interacts directly with Sponsor to generate a draft contract which is returned to the PI with a pre-approval tracking number. PI forwards budget to Grants & Contracts. Grants & Contracts pre-reviews budget and returns it to PI for revisions or with a verbal approval. PI circulates Financial Disclosure Forms for signatures of Key Personnel and their Chairs. Potential Conflicts of Interest are reviewed by Assoc Dean. PI submits protocols to IRB, IACUC and IBC as needed and enters status on GAFA form SHRP Research Club

23. Process for SubAwards, Contracts and Research Agreements Proposals requiring sub-recipient expertise: PI contacts potential sub-recipient for: 1. Statement of Work (SOW) The “How and Why” of the project. Must be as detailed as possible 2. Budget & Justification 3. Letter of Intent countersigned by institutional official See letter of intent SHRP Research Club

24. Sample Letter of Intent SHRP Research Club http://njms.umdnj.edu/research/orsp/rates_forms.cfm

25. Process for SubAwards, Contracts and Research Agreements Proposal preparation: Sub-recipient information is incorporated into the proposal. Sub-recipient budget is included as a direct cost on NJMS budget This information is submitted as part of the overall proposal review process. (G&C Administrator will review for compliance and completeness and correctly identified GAFA information) While sponsor considers proposal for funding the following actions should occur simultaneously: • PI and sub-recipient draft the terms of agreement • Draft is sent to Legal for pre-review and negotiation • Budget is sent to Grants and Contract for pre-review • Protocols are sent to appropriate compliance office NOTE: Above actions are required for sub-recipient as well SHRP Research Club

26. Process for SubAwards, Contracts and Research Agreements • When an Award is Made: • PI requests any additional documents needed from sub-recipient: • Appropriate approvals, F&A rate Agreement, etc. PI makes necessary adjustments based on: • flow down from award terms and conditions • comments from Grants and Contract re: Budget • comments from Legal pre-review and negotiation Once all documents are received and all issues are addressed the PI can prepare the final approval package and route for signature. SHRP Research Club

27. Sign Off Process Final approval packet includes: • GAFA/Transmittal and Approval Form • FDF (Financial Disclosure Form) GAFA is to be completed in its entirety, including approval date and protocol number for any Compliance Units involved. See GAFA/Transmittal and Approval Form FDF must be signed by all key personnel and countersigned by the Dept. Chair. If Chair is also the PI, FDF will be countersigned by Dean or Assoc. Dean. NOTES: GAFA will not be signed by Institutional Official until all approvals and other related documents are received. FDF’s indicating conflict of interest will be reviewed within SHRP and if necessary will be forwarded to the COI committee for review and resolution. SHRP Research Club

28. Sign Off Process Cont’d Complete packet is routed for GAFA signatures in the following order: • PI signs Box #1 • Dept. Chair approves and signs Box #2 • Grants & Contracts approves and signs Box #3 • Packet is sent to ORSP for final review and signature PI forwards fully executed agreements to sub-recipient Business Manager is able to assist PI’s in setting up Purchase Orders (PO’s) and Invoicing for payments for work performed. SHRP Research Club

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30. What is Electronic Research Administration (eRA)? Conducting research administration in an integrated and automated environment. It encompasses both pre- and post-award processes that involve the administrative and regulatory aspects of grants. SHRP Research Club

31. The Most Common Pre-Award eRA mechanisms • Grants.gov (ORSP) • eRA Commons (ORSP) • NSF Fastlane (ORSP) SHRP Research Club

32. Submitting final Grant Application Electronically Notify the Office of Research as soon as possible that you are submitting. Stay in contact with the Office of Research. Submit your administrative pages 10 working days prior to deadline (hard copy or electronically) Note: good idea to circulate the GAFA for approvals at this time as well. Three (3) business days prior to the deadline, submit your final version along with GAFA and FDF to the Office of Research. SHRP Research Club

33. When the PI submits the final grant application Advise the Office of Research as soon as possible Submit your administrative pages 10 working days prior to deadline (hard copy or electronically) Note: good idea to circulate the GAFA for approvals at this time as well. Pl should provide the final version of the application to the Office of Research (along with the GAFA and FDF) BEFORE they submit the application to ensure the PI is compliant with university and agency guidelines. SHRP Research Club

34. Grants.gov(All Federal Agencies) www.grants.gov • …single, unified storefront for all customers of federal funds to electronically find funding opportunities and electronically apply for funds • Individuals are not required to register with Grants.gov – Institutions must register. SHRP is already registered. For NIH grants, applicants must be registered with the eRA Commons in order to submit a grant electronically. SHRP Research Club

35. eRA Commons(NIH ONLY)https://commons.era.nih.gov/commons/ • NIH portal used for various functions of grant management, including electronic submission of applications. This portal can also be used by PI and post- and pre-award staff. • A few of the functions of eRA Commons include submitting eSNAP progress reports, JIT, no-cost extensions, PI can also check reviewer comments, and check grant status. • Registration with eRA Commons is completed by the Office of Research. Contact Maria Constanten (2-0200) or Bob Denmark (2-5410) to arrange for registration. SHRP Research Club

36. NSF Fastlane(National Science Foundation)www.nsf.gov NSF’s portal to submit grant applications, request no-cost extensions, and progress reports Note: Parts of this presentation were adapted from materials originally prepared by the Office of Research and Sponsored Programs – New Jersey Medical School – Martin Schwarz, Director SHRP Research Club