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

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 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 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.  vedemoframeset.asp?FI=%22Compliance+%26+Busine ss+Integrity%2FLegal%22&DI=Code+of+Conduct&P2=1 &w=1024&h=768&c=32&HU=EmptyURL 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 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 vedemoframeset.asp?P2=1&w=1280&h=1024&c=32&H U= vedemoframeset.asp?P2=1&w=1280&h=1024&c=32&H U=

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

18 What You Can Do  Know the terms of awards.   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 Raquel Espinosa John Cavanaugh McLean Compliance Marcia Widmer Partners Research Compliance Mary Mitchell

21 Final Note Partners Compliance HelpLine