1. WHO IS WATCHING? WHAT ARE THEY WATCHING? WHY SHOULD I CARE? WHAT SHOULD I DO?

2. RASG Meeting January 19, 2005 Adrian A. Shelton Research Compliance Officer adrian_shelton@unc.edu 962-0338

3. WHO IS WATCHING Research? FEDERAL REGULATORS DOJ: grant funding, false claims, etc – effort reporting, salary reporting, cost allocation, research billing, HE stem cell research regs HHS: human subjects research review, informed consent, scientific misconduct Various: Export controls, data and materials security

4. WHO IS WATCHING Research? STATE REGULATORS Accounting practices Much more information on this topic will come from Stan Koziol

5. WHO IS WATCHING Research? UNIVERSITY ADMINISTRATORS Campus research review processes OSR and OCT IRB IACUC COI EHS OTD

6. WHO IS WATCHING Research? THE PUBLIC Conflict of Interest Informed Consent

7. WHAT ARE THEY WATCHING?  IRB review and approval for all human subjects research  Informed consent  Resource accounting: Cost allocations, salary reporting Time and effort certifications Clinical research billing  Research information availability (COI, publication restrictions, etc.)  Research information security issues (HIPAA, export controls, classified research)  Research materials controls (HE stem cells, select agents, etc)

8. WHY SHOULD I CARE? The Department is responsible for administering the research contract or grant: Department judges PI is competent to perform this research Department gives approval for PI to perform this research as described Department is responsible for ensuring that resources are accurately budgeted and approved for this research Department is responsible for ensuring that regulatory requirements are met by PI.

9. WHY SHOULD I CARE? CRIMINAL PENALTIES FINANCIAL PENALTIES LOSS OF RESOURCES BAD PUBLICITY AND LOSS OF GOODWILL/SUPPORT (internal and external) OPERATIONAL RESTRICTIONS ADDITIONAL COSTS

10. WHAT SHOULD I DO? At the beginning of the research project Review the IPF carefully for accuracy and completeness because it includes significant department obligations for the life of the project. This is the most cost effective time to head off potential problems. Are all resources (personnel, funds, facilities, equipment, materials) accurately budgeted and approved? Are all the relevant costs included? Are the costs accurately calculated? Is cost matching identified? Approved? Is the percentage effort reasonable relative to existing obligations?

11. Review the IPF carefully for accuracy because it includes department obligations Are security issues adequately understood and addressed? Classified research, export controls (includes regs re foreign nationals participating in the research, travel, data sharing, etc), proprietary or other confidential information, very sensitive materials (select agents, human embryonic stem cells, etc.)

12. Review the IPF carefully for accuracy because it includes department obligations Have all required institutional reviews occurred? Institutional Review Board IACUC Conflict of Interest Institutional Biosafety Committee Radiation safety Lab Safety

13. WHAT SHOULD I DO? At beginning of research project Support the initial contract and grant review process What would happen if we just hurried up and signed the agreement without review and negotiation? Isn’t it mostly just petty “wordsmithing?” What about PI signing agreements that do not include payment obligations?

14. Provisions that can come back to create significant trouble – words have real meaning Additional performance requirements that create costs not included in the budget (additional reports, deadlines, security obligations, etc.) Financial restrictions (can’t spend money as PI thought) Publication restrictions (can’t publish as PI plans) Personnel restrictions (can’t include the grad student planned) Certifications that are fraudulent (e.g. COI not adequately disclosed and reviewed) Intellectual property transfers (PI’s output owned by second party) Restrictions on PI’s other research

15. WHAT SHOULD I DO? During the research project Check to ensure required annual reviews are occurring - IRB, IACUC, COI etc Ensure that effort certification is timely and accurate Document all cost sharing Avoid late cost transfers and make sure to have appropriate justification for any that occur Maintain supporting documentation for all costs Any budget or personnel changes – comply with requirements for reporting and approval Program income must be reported On time delivery of required PI reports or other deliverables

16. WHAT SHOULD I DO? At the end of the research project At end of research project Timely final reports and deliverables of PI Timely final accounting of revenues and expenditures including adjustments and cost transfers and any residuals

17. WHAT SHOULD I DO? PI is leaving UNC-Chapel Hill Exit checklist Prior to PI departure Unexpired contracts or grants for PIs research? Notify OSR and OCT Human subjects research? Notify IRB Animal research? Notify IACUC Research animals? Notify DLAM What is disposition of PI’s UNC-CH lab facilities, equipment, materials? Notify EHS Unsponsored research projects? Clarify arrangements for students or other trainees, co investigators, etc. Intellectual Property (licensing agreements, etc)? Notify OTD

18. How can we help each other? Call OSR or other research review unit or Research Compliance Officer for help if questions or concerns arise. Collaborate on checklists and other tools Other ideas?