Research ComplianceMcLean DRAW

January 19, 2010

Mary H. MitchellPHS Director of Research Compliance

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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

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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.

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The Results of Non Compliance: Significant Audits/Settlements

Public Demandfor

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 FoundationMischarging federal grants $6.5 million

Yale UniversityCosting &

Accounting Issues

$7.6 million

Northwestern University

Committed Time/Effort$5 million

Univ Alabama/Birmingha

mEffort 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

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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.

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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.

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What is Research Compliance?

Scientific IntegrityPrinciple:

Ensures validity of results/Maximizes return on public investment

Conflict of InterestConflict of Commitment

Research IntegrityData, Resource Sharing, Cyber Security

Public Access to Publications

Welfare of Subjectsand the Environment

Principle:Provides safety/welfare of subjects and environment

Human SubjectsAnimal Welfare

HIPAAEnvironmental Health & Safety

Select AgentsRadiation Access

Cost Policy/Financial Management

Principle:Ensures fair and reasonable costs

to the Government

Cost PrinciplesSalary Charges/Effort Reporting

Indirect CostsCost Sharing

Clinical Trials Billing

Social and PoliticalRequirements

Principle:Meets National Social, Economic,

Security Interests

SEVIS/VisasExport Controls

Race, Gender & Handicap Equality and Education

LobbyingDebarmentDrug Use

*Adopted with permission from Geoff Grant

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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

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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.

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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

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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.

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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.

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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+Business+Integrity%2FLegal%22&DI=Code+of+Conduct&P2=1&w=1024&h=768&c=32&HU=EmptyURL

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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?

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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

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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

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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/

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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

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What We All Can Do

Understand the regulations Ask questions Do the right thing Document transactions at the time they occur

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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

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Final Note

Partners Compliance HelpLine

800-856-1983