1. Research Compliance McLean DRAW January 19, 2010 Mary H. Mitchell PHS Director of Research Compliance

2. 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. 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. 4 The Results of Non Compliance: Significant Audits/Settlements Public Demand for Improved Control Johns Hopkins Univ Effort Certification $2.7 million University of Minnesota Misuse federal funds $32 million New York University Medical Center Inflated research grant costs $15.5 million Mayo Foundation Mischarging federal grants $6.5 million Yale University Costing & Accounting Issues $7.6 million Northwestern University Committed Time/Effort $5 million Univ Alabama/Birmingham Effort Certification & Clinical Research Billing $3.4 million East Carolina Univ Questioned Costs HHS/OIG Audit $2.4 million Univ of Southern California Questioned Costs HHS/OIG Audit $400,000 Florida International Univ Effort Certification & Direct Costs $11.5 million Univ California/San Francisco Animal Care Allegations $92,500 fine Cornell Medical Clinical Research Issues & Effort Reporting $4.4 million

5. 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. 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. 2 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 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 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 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

8. 8 Compliance Issues We Address Daily  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

9. 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. 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. 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. 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. 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/tro vedemoframeset.asp?FI=%22Compliance+%26+Busine ss+Integrity%2FLegal%22&DI=Code+of+Conduct&P2=1 &w=1024&h=768&c=32&HU=EmptyURL http://library.partners.org/PartProd/webserver/custom/tro vedemoframeset.asp?FI=%22Compliance+%26+Busine ss+Integrity%2FLegal%22&DI=Code+of+Conduct&P2=1 &w=1024&h=768&c=32&HU=EmptyURL

14. 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. 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. 16 Partners Research Integrity Policy  Policy available at http://library.partners.org/PartProd/webserver/custom/tro vedemoframeset.asp?P2=1&w=1280&h=1024&c=32&H U=http:++pulse.partners.org+policies+index.htm http://library.partners.org/PartProd/webserver/custom/tro vedemoframeset.asp?P2=1&w=1280&h=1024&c=32&H U=http:++pulse.partners.org+policies+index.htm

17. 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/ http://www.hms.harvard.edu/integrity/

18. 18 What You Can Do  Know the terms of awards.  http://grants.nih.gov/grants/policy/nihgps_2003/index.htm 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. 19 What We All Can Do  Understand the regulations  Ask questions  Do the right thing  Document transactions at the time they occur

20. 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. 21 Final Note Partners Compliance HelpLine 800-856-1983