1. Institutional Research Compliance Juliann Tenney, JD Research Compliance and Privacy Officer Director, Institutional Research Compliance Program

2. Today’s Objectives:  Setting the stage – describe the environment for research/clinical trials – What is our context?  Review and clarify concepts such as what qualifies as research, auditing, monitoring, quality assurance and quality improvement  Introduce the Institutional Research Compliance Office

3. Evolution of Expectations: From “Do the Right Thing” to documentation and verification that the right thing has been done (including remediation when facts indicate otherwise). Why? Failure of institutions and leadership to practice and enforce ethical and appropriate organizational behavior. Resulting In (or Perceived to Result In): Abuse of Human and Animal Research Subjects, Loss of Public Trust, Tarnished Reputations, Fines, Sanctions, Decreased Funding (Grants)

4. For Every Action there is an equal and opposite reaction – Newton’s Third Law  False Claims Act, 1863  Human Subjects Protection (Common Rule), Nuremburg Code, Decl. of Helsinki  Federal Sentencing Guidelines and Amendments  Sarbanes-Oxley (Internal controls and Non-retaliation against “whistleblowers”)  Privacy Legislation (HIPAA, Gramm-Leach-Bliley, State Identity Theft Protection Statutes)  Patriot Act, Foreign Corrupt Practices, Export Control, etc.  Evolving complex, often inscrutable, compendium of “Guidelines” from every administrative unit with oversight responsibility/authority

5. Emerging Culture of Integrity in the Research and Clinical Studies Environment “encouraged” by Enforcement Prescriptive: One MUST (laws, regulations) Selective/Targeted Enforcement: Representatives from governmental agencies interpret guidance, direct institutional policy adjustments

6. The organization’s leadership and governing The organization’s leadership and governing authority must be knowledgeable about the content and operation of its compliance program The organization’s governing authority must The organization’s governing authority must exercise reasonable oversight regarding the implementation and effectiveness of the program Specific high-level personnel must be assigned Specific high-level personnel must be assigned direct responsibility for ensuring implementation and effectiveness of the compliance program Such personnel must be given sufficient resources Such personnel must be given sufficient resources and report directly to the governing authority or appropriate subgroup of the governing authority Federal Sentencing Guidelines have become the catechism for compliance:

7. The organization must institute effective training The organization must institute effective training programs for the governing authority, leadership, employees, and, as appropriate, agents The organization must audit and monitor its program The organization must audit and monitor its program for effectiveness and conduct ongoing risk assessments to refine its program and reduce the risk of violations The organization must have an anonymous The organization must have an anonymous reporting system for employees The organization must establish appropriate incentives The organization must establish appropriate incentives and disciplinary measures to ensure reporting, compliance, and correction of violations Federal Sentencing Guidelines, Continued

9. Mission Statement - a Work in Progress or “Do you all ‘Do’ compliance to us?” The Institutional Research Compliance Program is an initiative committed to advancing the highest standards of ethics, integrity, honesty, and to compliance with all applicable laws, regulations and policies governing research, privacy and conflict of interest. The program strives to promote best practices and ethical behavior as well as to deter activity contrary to these standards by (a) anticipating risk, and (b) encouraging strong stewardship and management accountability at all levels, in collaboration with institutional colleagues responsible for compliance implementation.

10. Program Objectives: Dissemination of “current” compliance requirements Dissemination of “current” compliance requirements Providing the structure for management of conflict of interest Providing the structure for management of conflict of interest Receipt and resolution of expressions of concern (“whistleblower” communications) Receipt and resolution of expressions of concern (“whistleblower” communications) Providing assistance with the coordination and management of agency reviews, audits and investigations Providing assistance with the coordination and management of agency reviews, audits and investigations Service as a resource for “local” implementation of compliance objectives Service as a resource for “local” implementation of compliance objectives Providing a conduit to leadership regarding compliance issues Providing a conduit to leadership regarding compliance issues Service as a facilitator to bring together officials from across the institution to address issues that transcend departments Service as a facilitator to bring together officials from across the institution to address issues that transcend departments

11. Component Parts of Research/Clinical Trial Enterprise (most have some, some have all) Clinical Trials Support Office Sponsored Programs Office Institutional Review Boards offering varying degrees of assistance Providing Education (compulsory, for and by whom?) Help with protocol development, including budget Drafting (ex.: informed consent forms) Finances (approvals, reconciliation) Effort reporting (What happens to “orphan” protocols where there is no outside sponsor?)

12. The “hanging chad” of clinical research: monitoring and auditing independent of that provided by sponsors to ensure protocol conducted with integrity that the protocol is conducted as approved by the Institutional Review Board, that the protocol is conducted as approved by the Institutional Review Board, is well organized, addresses conflict of interest, informed consent, and proper sources are billed

13. Monitoring vs. Audit  Monitoring: Performed by personnel charged with trial compliance operational responsibility; regular, on-going.  Audit: Ensures that those with trial compliance responsibility are doing what they have been charged to do (by all governing sources). Independently verified, not operational, may be internal or external to the institution.

14. Conclusion … Are we there yet? Questions? Thank you!

15. Contact Information: Institutional Research Compliance Office Institutional Research Compliance Office843-9953 501 Bank of America Building