Transcript Slide 1

Research Compliance
McLean DRAW
January 19, 2010
Mary H. Mitchell
PHS Director of Research
Compliance
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?
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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.
The Results of Non Compliance:
Significant Audits/Settlements
Florida International Univ
Effort Certification &
Direct Costs
$11.5 million
University of Minnesota
Misuse federal funds
$32 million
Univ of Southern California
Questioned Costs
HHS/OIG Audit
$400,000
East Carolina Univ
Questioned Costs
HHS/OIG Audit
$2.4 million
Univ
Alabama/Birmingham
Effort Certification &
Clinical Research Billing
$3.4 million
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Univ California/San Francisco
Animal Care Allegations
$92,500 fine
Public Demand
for
Improved Control
Johns Hopkins Univ
Effort Certification
$2.7 million
New York University Medical
Center
Inflated research grant costs
$15.5 million
Mayo Foundation
Mischarging federal grants
$6.5 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
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 Integrity
Principle:
Ensures validity of results/
Maximizes return on public investment
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
Conflict of Interest
Conflict of Commitment
Research Integrity
Data, Resource Sharing, Cyber Security
Public Access to Publications
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
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
*Adopted with permission from Geoff Grant
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Compliance Issues We Address Daily
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Conflict of interest
Gifts
Vendor Relationships
HIPAA
Professional Behavior
Good Clinical Practice
Data Monitoring
Billing
Coding
Contracting
Data Monitoring
Quality Assurance
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Grants Management
Time & Effort
Cost Sharing
Cost Transfers
Grant Preparation
Award Management
Subcontracts
IRB
IACUC
Lab Safety
Export Controls
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
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Misallocation of costs
Excessive cost transfers
Unallowable costs
Adherence to special award requirements
Inadequate subrecipient monitoring
Inadequate institutional oversight.
ARRA spending and reporting.
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+Busine
ss+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?
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Supervisor
Human Resources
McLean Research Management
McLean Compliance
PHS Research Compliance
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
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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
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Understand the regulations
Ask questions
Do the right thing
Document transactions at the time they occur
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
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