Compliance and the Pre-award Administrator: Addressing Compliance at the Proposal Stage

1. Compliance and the Pre-award Administrator: Addressing Compliance at the Proposal Stage Amanda Snyder - University of Maryland, Baltimore Debbie Newton – The University of Tulsa

2. What do we mean by “Compliance”? • Definition: the state or act of conforming with or agreeing to do something • Involves compliance with federal, state, institutional, and sponsor regulations and policies/procedures

3. Why practice compliance duringthe proposal phase? • Comply with federal and state regulations • Apply institutional policies consistently • Minimize institutional liability • Educate and protect the investigator(s) • Minimize award negotiations/acceptance issues • Streamline project implementation • Reduce post-award problems • Gain the respect of your faculty • Gain the love and adoration of your post-award colleagues • AVOID SURPRISES

4. Major areas of compliance we can address during the proposal phase • Includes (but is not limited to…) • Human Subjects • Vertebrate Animal Use • Use of Biohazards, Recombinant DNA, Radiation, Select Agents • Export Control • Financial Concerns – Effort Reporting, Cost Sharing, Budgeting, OMB Circulars • Subcontracts • Conflict of Interest • Specific sponsor requirements

5. Human Subjects Involvement • Institutional Review Board (IRB) • Timeline for protocol approval process • Roles & responsibilities • At what point does sponsor require documentation of approval • Training Requirements • Human Subjects Protection • HIPAA • Are they addressed properly in the proposal? • Budget • Patient Care Costs • Medicare Billing Analysis

6. Use of Vertebrate Animals • Institution Animal Care and Use Committee (IACUC) approvals • Timeline for protocol approval process • Roles & responsibilities • At what point in process does sponsor require the approval documentation • Training Requirements • Have appropriate sections been included in the proposal? • Budgeting for animals purchases, animal housing & care

7. Use of Biohazards, Select Agents, Recombinant DNA, Radiation, etc. • Institutional Reviews and Approvals • Timeline for approval process • Roles & responsibilities • What sponsor requirements exist • Training Requirements

8. Export Controls • Collect data when working with international sponsors, collaborators, subcontractors, and consultants • Covers not only physical shipments, but transmission of information • Can be an issue when bringing collaborators to US campuses as they may receive restricted information • Approvals and licenses take time to obtain

9. Financial Concerns • OMB Circular A-21 (budgets) • Allowable: • Reasonable • Allocable • Consistent Treatment • Direct vs. Indirect Costs • Equipment maintenance agreements • Administrative salaries • OMB Circular A-110 • Cost Sharing • Allowability

10. Financial Concerns • Cost Sharing • Required (% of project cost vs. % of request) • Required vs. Allowed • “Voluntary” cost share • Tuition, Indirect costs, Academic year effort, volunteer time • Committed effort of faculty • Percent time • Course release(s) • Summer compensation • Salary caps

11. Financial Concerns • Subcontractors vs. Consultants vs. Vendors/Contractual services • Tuition charges • Limits on indirect costs • Industrial agreements

12. Subcontracts • Subcontractor vs. Consultants vs. Vendors/Contractual services • Flow down compliance requirements • NSF/NIH training requirements • PHS Conflict of Interest requirements • Subcontractor review of solicitation/contract • Indirect cost rate agreement • Debarment and suspension • Required certifications

13. Conflict of Interest • Federal Conflict of Interest policy • PHS Conflict of Interest policy • Disclosures must be submitted prior to proposal submission • Verification of subcontractor compliance • Industrial agreements • University start-up companies

14. Sponsor Specific Requirements • Terms and Conditions • Limit effort • Limit IDC recovery • Limited proposal submissions from an institution • Eligibility requirements • Restrictions on foreign nationals • Publication restrictions • Intellectual property rights • Confidential information • Specific payment instructions/limitations (i.e. payment upon APPROVAL of deliverables)

15. Institutional Policies • Faculty workload • Cost of living and merit increases • Tuition policy • Graduate assistantships • Who is allowed to be the PI? • Conflict of interest • Intellectual Property • Travel (reimbursement and foreign travel) • Procurement policy

16. Tools available to the Pre-award Administrator • Institutional Routing • Data Collection • If electronic, ability to run reports • If electronic, ability to send • Necessary Approvals • Training • Understand the basic issues surrounding compliance issues • You don’t need to be the expert, but you need to know where to go for more info and who in your institution IS the point of contact • COMMUNICATION!

17. Tools available to the Pre-award Administrator • Proposal routing form • Contracted compliance assistance (Visual Compliance) • NCURA colleagues • List serves (RESADM-L, NCURA Collaborate) • University officials • Post-Award Office

18. What tools do you use?

19. Summary Compliance - Meeting the requirements of a variety of regulations and policies/procedures involving federal, state, institutional and sponsor requirements. • Know what the issues are and who is responsible at your organization for each • Learn how to recognize what may become a compliance issue • Address them up front • Document, Document, Document

20. Questions?

21. Contact Information • Debbie Newton, Director of Research and Sponsored Programs, The University of Tulsa • 918-631-2192 • deborah-newton@utulsa.edu • Amanda Snyder, Assistant Director, Sponsored Programs Administration, University of Maryland, Baltimore • 410-706-5590 • asnyd007@umaryland.edu