Institutional Institutional Research ComplianceResearch Compliance

Juliann Tenney, JDJuliann Tenney, JD

Research Compliance and Privacy OfficerResearch Compliance and Privacy Officer

Director, Institutional Research Compliance Director, Institutional Research Compliance ProgramProgram

Today’s Objectives:Today’s Objectives:

Setting the stage – describe the Setting the stage – describe the environment for research/clinical trials environment for research/clinical trials – What is our context?– What is our context?

Review and clarify concepts such as Review and clarify concepts such as what qualifies as research, auditing, what qualifies as research, auditing, monitoring, quality assurance and monitoring, quality assurance and quality improvementquality improvement

Introduce the Institutional Research Introduce the Institutional Research Compliance OfficeCompliance Office

Evolution of Expectations:Evolution of Expectations:

From “Do the Right Thing” to From “Do the Right Thing” to documentation documentation and verificationand verification that the right thing has been done that the right thing has been done (including remediation when facts indicate (including remediation when facts indicate otherwise).otherwise).

Why?Why?

Failure of institutions and leadership to Failure of institutions and leadership to practice and enforce ethical and appropriate practice and enforce ethical and appropriate organizational behavior.organizational behavior.

Resulting In (or Resulting In (or PerceivedPerceived to Result In): to Result In):

Abuse of Human and Animal Research Abuse of Human and Animal Research Subjects, Loss of Public Trust, Tarnished Subjects, Loss of Public Trust, Tarnished Reputations, Fines, Sanctions, Decreased Funding Reputations, Fines, Sanctions, Decreased Funding (Grants)(Grants)

For Every Action there is an equal and opposite For Every Action there is an equal and opposite reaction –reaction –

Newton’s Third LawNewton’s Third Law

False Claims Act, 1863False Claims Act, 1863

Human Subjects Protection (Common Rule), Human Subjects Protection (Common Rule), Nuremburg Code, Decl. of HelsinkiNuremburg Code, Decl. of Helsinki

Federal Sentencing Guidelines and AmendmentsFederal Sentencing Guidelines and Amendments

Sarbanes-Oxley (Internal controls and Non-retaliation Sarbanes-Oxley (Internal controls and Non-retaliation against “whistleblowers”)against “whistleblowers”)

Privacy Legislation (HIPAA, Gramm-Leach-Bliley, State Privacy Legislation (HIPAA, Gramm-Leach-Bliley, State Identity Theft Protection Statutes)Identity Theft Protection Statutes)

Patriot Act, Foreign Corrupt Practices, Export Control, Patriot Act, Foreign Corrupt Practices, Export Control, etc.etc.

Evolving complex, often inscrutable, compendium of Evolving complex, often inscrutable, compendium of “Guidelines” from every administrative unit with “Guidelines” from every administrative unit with oversight responsibility/authorityoversight responsibility/authority

Emerging Culture of Integrity in the Emerging Culture of Integrity in the Research and Clinical Studies Research and Clinical Studies Environment “encouraged” by Environment “encouraged” by EnforcementEnforcement

Prescriptive: One Prescriptive: One MUSTMUST (laws, (laws, regulations)regulations)

Selective/Targeted Enforcement: Selective/Targeted Enforcement: Representatives from governmental Representatives from governmental agencies interpret guidance, direct agencies interpret guidance, direct institutional policy adjustmentsinstitutional policy adjustments

• • The organization’s The organization’s leadership and governingleadership and governingauthority must be knowledgeable about the contentauthority must be knowledgeable about the contentand operation of its compliance programand operation of its compliance program• • The organization’s governing authority mustThe organization’s governing authority mustexercise exercise reasonable oversightreasonable oversight regarding the regarding theimplementation and implementation and effectivenesseffectiveness of the program of the program• • Specific Specific high-level personnel must be assignedhigh-level personnel must be assigneddirect responsibilitydirect responsibility for ensuring implementation for ensuring implementationand effectiveness of the compliance programand effectiveness of the compliance program• • Such personnel must be given sufficient resourcesSuch personnel must be given sufficient resourcesand report directly to the governingand report directly to the governingauthority or appropriate subgroup of the governingauthority or appropriate subgroup of the governingauthorityauthority

Federal Sentencing Guidelines have Federal Sentencing Guidelines have become the catechism for become the catechism for compliance:compliance:

• • The organization must institute The organization must institute effective trainingeffective trainingprogramsprograms for the governing authority, leadership, for the governing authority, leadership,employees, and, as appropriate, agentsemployees, and, as appropriate, agents• • The organization must The organization must audit and monitoraudit and monitor its its

programprogramfor effectiveness and conduct ongoing riskfor effectiveness and conduct ongoing riskassessments to refine its program and reduce theassessments to refine its program and reduce therisk of violationsrisk of violations• • The organization must have an The organization must have an anonymousanonymousreportingreporting system for employees system for employees• • The organization must establish The organization must establish appropriate appropriate

incentivesincentivesand disciplinary measuresand disciplinary measures to ensure reporting, to ensure reporting,compliance, and correction of violationscompliance, and correction of violations

Federal Sentencing Guidelines, Federal Sentencing Guidelines, ContinuedContinued

Institution Penalty Effort

Document / Accounting

Controls

Clinical Trial / Medicare

Billing

Florida International University $11.5M X X

The Mayo Foundation $6.5M X

Northwestern $5.2M X X

Weill Medical College/Cornell $4.3M X X X

Univ. Alabama, Birmingham $3.4M X X

Harvard, Beth Israel $3.25M X

Johns Hopkins University / Bayview $2.6M X

University of California at Irvine $2.3M X

East Carolina $565k - $1.8M X X

Univ. Massachusetts Med School $282k X X

University of Connecticut $2.5M X X

University of Washington $35M X

Rush University Medical Center $1M X

Mission Statement - a Work in Mission Statement - a Work in ProgressProgress or “Do you all ‘Do’ compliance to or “Do you all ‘Do’ compliance to us?”us?”

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

Program Objectives:Program Objectives:

Dissemination of “current” compliance requirementsDissemination of “current” compliance requirements Providing the structure for management of conflict of Providing the structure for management of conflict of

interestinterest Receipt and resolution of expressions of concern Receipt and resolution of expressions of concern

(“whistleblower” communications)(“whistleblower” communications) Providing assistance with the coordination and Providing assistance with the coordination and

management of agency reviews, audits and management of agency reviews, audits and investigationsinvestigations

Service as a resource for “local” implementation of Service as a resource for “local” implementation of compliance objectivescompliance objectives

Providing a conduit to leadership regarding Providing a conduit to leadership regarding compliance issuescompliance issues

Service as a facilitator to bring together officials from Service as a facilitator to bring together officials from across the institution to address issues that across the institution to address issues that transcend departmentstranscend departments

Component Parts of Research/Clinical Trial Enterprise Component Parts of Research/Clinical Trial Enterprise (most have some, some have all)(most have some, some have all)

Clinical Trials Support OfficeClinical Trials Support Office

Sponsored Programs OfficeSponsored Programs Office

Institutional Review Boards offering varying Institutional Review Boards offering varying degrees degrees of assistance of assistance

ProvidingProviding

Education (compulsory, for and by whom?)Education (compulsory, for and by whom?)

Help with protocol development, including budgetHelp with protocol development, including budget

Drafting (ex.: informed consent forms)Drafting (ex.: informed consent forms)

Finances (approvals, reconciliation)Finances (approvals, reconciliation)

Effort reportingEffort reporting

(What happens to “orphan” protocols where there is no (What happens to “orphan” protocols where there is no outside sponsor?)outside sponsor?)

The “hanging chad” of clinical research:The “hanging chad” of clinical research:

monitoring and auditing independent of that provided monitoring and auditing independent of that provided by sponsorsby sponsors

to ensure protocol conducted with integrityto ensure protocol conducted with integrity that the protocol is conducted as approved by that the protocol is conducted as approved by

the the Institutional Review Board, Institutional Review Board,is well organized,is well organized,addresses conflict of interest,addresses conflict of interest,informed consent,informed consent,and proper sources are billedand proper sources are billed

Monitoring vs. AuditMonitoring vs. Audit

Monitoring: Monitoring: Performed by personnel charged with Performed by personnel charged with trial compliance trial compliance operationaloperational responsibility; regular, on-going.responsibility; regular, on-going.

Audit: Audit: Ensures that those with trial compliance Ensures that those with trial compliance responsibility are doing what they have responsibility are doing what they have been charged to do (by all governing been charged to do (by all governing sources). Independently verified, sources). Independently verified, not not operational,operational, may be internal or external may be internal or external to the institution.to the institution.

Conclusion …Conclusion …

Are we there yet?Are we there yet?

Questions?Questions?

Thank you!Thank you!

Contact Information:Contact Information:

Institutional Research Compliance Institutional Research Compliance OfficeOffice843-9953843-9953

501 Bank of America Building501 Bank of America Building