Why all the current emphasis on compliance?
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Transcript of Why all the current emphasis on compliance?
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
• [email protected]• 617-954-9597
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Final Note
Partners Compliance HelpLine
800-856-1983