Award Review, Negotiation, Etc.

Award Review, Negotiation, Etc. Mary E. Schmiedel, JD, CPCMGeorgetown University Monique Anderson University of Maryland Tolise Miles Children’s National Medical Center

Basics of Award Review Verify PI & institutional information Period of performance Amount awarded & accuracy of budget Award terms and conditions Research terms Agency specific Problematic terms Prior approvals

Terms and Conditions Cost Sharing Is the award subject to the NIH salary cap? Does PI have an academic year salary in excess of $134,775? Did any section of the proposal include references to amounts or percentages of effort that will be covered by your institution? Carry forward of unobligated balances FDP members should have automatic authority Export Controls & OFAC Compliance Are there any restrictions on publications or participation of foreign nationals? Will the project involve travel to foreign countries subject to OFAC embargoes or sanctions?

Terms and Conditions FFATA – Federal Financial Accountability & Transparency Act Requires that subawards be reported into www.fsrs.gov Do you require that the subawardee institution have a DUNS number and sign the agreement first? E-Verify Applicable to federal contracts over $100K Requires expedited I-9 process What is your institution’s process?

Terms and Conditions NIH Public Access Policy Requires that any peer reviewed manuscript that is funded in whole or part with NIH funds be deposited with PubMed Central upon acceptance for publication Conflict of Interest (COI) NIH & NSF require disclosures of conflict of interest If personnel have conflicts, conflict management plan must be in place prior to expenditure of NIH award funds NIH must be notified of any conflicts

Terms and Conditions Human Subjects Has the project been approved by the IRB? Have all relevant project personnel completed training in the protection of human subjects? Does the human subjects research start right away or is it delayed (so that IRB approval is secured later)? Responsible Conduct of Research (RCR) Requirement for training in the responsible and ethical conduct of research be provided to postdocs, graduate and undergraduate students funded by NSF Does your institution participate in CITI? Training modules for COI, human subjects and RCR

Terms and Conditions Collection/storage of protected data Is a data use agreement involved? Does your PI understand that data use agreement applies only to the signing institution so if he/she moves to another institution or another location within the University, a new or updated agreement may be required Ownership of intellectual property (IP) Are there any restrictions in the award? Does the award require that any IP be made available to the public without restriction? Confidentiality provisions – may present publication issues Are the links to all the websites correct so that you are sure what other terms apply?

Terms and Conditions FFATA – Federal Financial Accountability & Transparency Act Requires that subawards be reported into www.fsrs.gov Do you require that the subawardee institution have a DUNS number and sign the agreement first? E-Verify Applicable to federal contracts over $100K Requires expedited I-9 process What is your institution’s process?

Terms and Conditions Human Subjects Has the project been approved by the IRB? Have all relevant project personnel completed training in the protection of human subjects? Does the human subjects research start right away or is it delayed (so that IRB approval is secured later)? Responsible Conduct of Research (RCR) Requirement for training in the responsible and ethical conduct of research be provided to postdocs, graduate and undergraduate students funded by NIH and NSF Does your institution participate in CITI? Training modules for COI, human subjects and RCR

Award Set Up Considerations Changes in performance periods Preaward costs Rebudgeting Compliance approvals Written verification of approval and training Conflict of interest Written verification of conflict management plans & verification of training Carry forwards of unobligated balances

Award Set Up Considerations Timeliness What is your institution’s policy on setting up at-risk accounts? Does your institution require the PI to prepare a revised budget if the awarded amount differs from the proposed amount

Next Steps After Award Do you need to meet with your PI and department administrator about next steps? Charging personnel to award Tracking of cost sharing Does the project involve any consulting agreements or subawards? Do you have all the relevant information to prepare and issue the subaward or other related agreements? Consider contacting your PI rather than waiting for them to contact you

Questions Mary Schmiedel schmiedm@georgetown.edu (202) 687-3911 Monique Anderson manders1@umd.edu (301) 405-6272 Tolise Miles tmiles@childrensnational.org (301) 565-4253

Award Review, Negotiation, Etc.