Why all the current emphasis on compliance?

1. Research ComplianceMcLean DRAWJanuary 19, 2010Mary H. MitchellPHS Director of Research Compliance

2. Why all the current emphasis on compliance? • Compliance is part of the bargain when we accept funds from external sponsors. • When we accept sponsored funding, we accept • Statutes • Regulations • Sponsor policies • Award terms and conditions

3. What is the effect of non-compliance? • Loss of grant funding • Vulnerability to audit/suit • Large settlements/fines and corrective actions • Administrative sanctions • Debarment or suspension • Adverse publicity – damage to reputation • Loss of public confidence • Loss of donor confidence.

4. The Results of Non Compliance: Significant Audits/Settlements Florida International UnivEffort Certification & Direct Costs$11.5 million University of MinnesotaMisuse federal funds $32 million Johns Hopkins Univ Effort Certification$2.7 million Univ California/San Francisco Animal Care Allegations $92,500 fine Univ of Southern California Questioned Costs HHS/OIG Audit $400,000 New York University Medical CenterInflated research grant costs$15.5 million East Carolina Univ Questioned Costs HHS/OIG Audit $2.4 million Public DemandforImproved Control Mayo FoundationMischarging federal grants $6.5 million Univ Alabama/BirminghamEffort Certification & Clinical Research Billing $3.4 million Cornell Medical Clinical Research Issues & Effort Reporting $4.4 million Yale University Costing & Accounting Issues $7.6 million Northwestern University Committed Time/Effort $5 million

5. What happened? • Nothing that couldn’t happen anywhere else. • Good people misguided as to how to do the right thing. • Lack of documentation to support actions.

6. What has changed? • Largest research budgets in history. • Increased public demand for accountability. • New administration committed to accountability and transparency. • Increasing use of qui tam provisions of False Claims Act. • Increasing level of unfunded mandates putting pressure on institutions to do more with less.

7. What is Research Compliance? Scientific Integrity Principle: Ensures validity of results/ Maximizes return on public investment Conflict of Interest Conflict of Commitment Research Integrity Data, Resource Sharing, Cyber Security Public Access to Publications Cost Policy/ Financial Management Principle: Ensures fair and reasonable costs to the Government Cost Principles Salary Charges/Effort Reporting Indirect Costs Cost Sharing Clinical Trials Billing Welfare of Subjects and the Environment Principle: Provides safety/welfare of subjects and environment Human Subjects Animal Welfare HIPAA Environmental Health & Safety Select Agents Radiation Access Social and Political Requirements Principle: Meets National Social, Economic, Security Interests SEVIS/Visas Export Controls Race, Gender & Handicap Equality and Education Lobbying Debarment Drug Use *Adopted with permission from Geoff Grant 2

8. Conflict of interest Gifts Vendor Relationships HIPAA Professional Behavior Good Clinical Practice Data Monitoring Billing Coding Contracting Data Monitoring Quality Assurance Grants Management Time & Effort Cost Sharing Cost Transfers Grant Preparation Award Management Subcontracts IRB IACUC Lab Safety Export Controls Compliance Issues We Address Daily

9. Examples of Financial Compliance Issues • Effort • Inaccurate effort reporting • “Too much effort” • Incomplete forms describing existing support on applications – “other support” • Failure to meet cost sharing commitment • Misallocation of costs • Excessive cost transfers • Unallowable costs • Adherence to special award requirements • Inadequate subrecipient monitoring • Inadequate institutional oversight. • ARRA spending and reporting.

10. Examples of Non-financial Compliance Issues • IRB issues: protocol approval, renewal, reporting of violations or adverse events • IACUC issues: protocol approval, renewal, reporting violations or adverse events • NIH Conflict of interest requirements • Research misconduct

11. Compliance is a Shared Responsibility (1) • PI Compliance Statement/Assurance on Research Proposal Coversheet: I certify that the STATEMENTS HEREIN ARE TRUE, COMPLETE and ACCURATE to the best of my knowledge. I am aware that any FALSE, FICTITIOUS, OR FRAUDULENT statements or claims may subject me to CRIMINAL, CIVIL OR ADMINISTRATIVE PENALTIES. I agree to accept responsibility for the SCIENTIFIC CONDUCT of the project and to provide the required PROGRESS REPORTS if a grant is awarded as a result of this application.

12. Compliance is a Shared Responsibility (2) • Institutional Assurance by Signing Official I certify (1) to the statements contained in the list of certifications and (2) that the STATEMENTS HEREIN ARE TRUE, COMPLETE and ACCURATE to the best of my knowledge. I also provide the required assurances and agree to comply with any resulting terms if I accept an award. I am aware that any FALSE, FICTITIOUS, OR FRAUDULENT statements or claims may subject me to CRIMINAL, CIVIL OR ADMINISTRATIVE PENALTIES.

13. Partners Code of Conduct • Committed to conducting affairs in accordance with the highest ethical and legal standards. • Conduct affairs in compliance with both letter and spirit of the law. • Our reputation is a priceless asset. • http://library.partners.org/PartProd/webserver/custom/trovedemoframeset.asp?FI=%22Compliance+%26+Business+Integrity%2FLegal%22&DI=Code+of+Conduct&P2=1&w=1024&h=768&c=32&HU=EmptyURL

14. Raising Concerns • Does this action comply with the laws, regulations, policies and procedures that apply to us? • Is it consistent with our policies? • Does it protect and serve the best interests of our patients and research subjects? • How do you feel about it? • Does it pass the Boston Globe test?

15. Raising Concerns • Partners Non-Retaliation Policy • Retaliation of any kind is prohibited. Any person who violates this policy will be subject to corrective action. • Where to go? • Supervisor • Human Resources • McLean Research Management • McLean Compliance • PHS Research Compliance

16. Partners Research Integrity Policy • Policy available at http://library.partners.org/PartProd/webserver/custom/trovedemoframeset.asp?P2=1&w=1280&h=1024&c=32&HU=http:++pulse.partners.org+policies+index.htm

17. HMS Faculty Policies on Integrity in Science • Guidelines for Investigators in Scientific Research • Guidelines for Investigators in Clinical Research • Principles and Procedures for Dealing with Allegations of Faculty Misconduct • Faculty of Medicine Statement on Research Sponsored by Industry • Policy on Conflicts of Interest and Commitment • Guidelines for Editors and Authors of Medical Textbooks • Authorship Guidelines • Guidelines for Attribution of Credit and Disposition of Research Products • Letters of Reference • Policies are available at http://www.hms.harvard.edu/integrity/

18. What You Can Do • Know the terms of awards. • http://grants.nih.gov/grants/policy/nihgps_2003/index.htm • Know Activities/Changes Requiring NIH Prior Approval • For example, 25% reduction in effort, change in scope, transferring work off-site. • Know When Reports Are Due • Facilitate PI Management of Grant Account • Know/implement the NIH Cost Principles • Charges must be reasonable, allowable, allocable & conform with institutional policies • Reconcile accounts regularly • Provide oversight & monitor collaborator (sub-recipient) activities • Personnel Management • Collect/submit COI forms • Timely completion of semi-annual effort reporting • Laboratory Management • Secure/maintain IBC approvals • Data Management – Record Retention

19. What We All Can Do • Understand the regulations • Ask questions • Do the right thing • Document transactions at the time they occur

20. Questions McLean Research Management • Pete Paskevich • 617-855-2922 • Raquel Espinosa • 617-855-2868 • John Cavanaugh • 617-855-2285 McLean Compliance • Marcia Widmer • 617-855-2598 Partners Research Compliance • Mary Mitchell • mmitchell14@partners.org • 617-954-9597

21. Final Note Partners Compliance HelpLine 800-856-1983