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Compliance Perspectives
SRA 2002 Annual Meeting
Orlando, Florida
October 29, 2002
Faculty
• Diane Dean, DirectorDivision of Grants Compliance and OversightOffice of Policy for Extramural Research Administration, OER, NIH
• Susan Sherman, Senior AttorneyOffice of the General Counsel, DHHS
Division of Grants Compliance and Oversight
Wendy BaldwinDeputy Director for Extramural
Research, OER
Regina WhiteDirectorOPERA
Diane DeanDirector, Division of Grants Compliance and Oversight
Cheryl ChickAssistant Grants Compliance Officer
Susan KaubleAssistant Grants Compliance Officer
Gail GibbonsDirector, Division of
Grants Policy
James Cain, DirectorDivision of ExtramuralInformation Systems
Compliance is…
• The effective management of public funds to maximize research outcomes
• The avoidance of fraud, institutional mismanagement and poor management of Federal funds
• An institutional commitment– more likely to be present and effective if it is
established as an institutional expectation
Compliance Begins at Home
• You must be in compliance with institutional as well as Federal requirements
• When you have a policy or procedural question, start at your institution - institutional requirements may be more restrictive
• Read the Notice of Grant Award
A Few Ground Rules
• Grant awards are made to institutions
• Recipients of NIH grant funds must comply with all applicable Federal statutes, regulations, and policies
• By drawing funds from the HHS Payment Management System, grantees agree to the terms and conditions of the grant award
What Does the Data Show?
• Steady increase in grant related allegations since FY99– approximately 80% of caseload
• Most allegations are institutional vs. individual• Most allegations involve large universities• Problem areas include improper cost
allocation/cost transfers, time and effort reporting issues, unallowable grant charges, accelerated expenditures and large unobligated balances
Common Contributors to Compliance Problems
• Inadequate resources
• Roles and responsibilities of institutional/Federal staff not clearly defined or understood
• Outdated or nonexistent policies and procedures
Common Contributors to Compliance Problems
• Inadequate staff training and education
• Inadequate management systems (e.g., effort reporting, financial management)
• Perception that internal control systems are not necessary
Compliance Basics• Don’t wait for a catastrophe to start thinking about
compliance!• Establish compliance as an institutional expectation and
responsibility– formalize compliance function – renew institutional commitment to compliance
• Establish an expectation of “zero tolerance” – mechanism for concerns to be heard
• Define roles and responsibilities and communicate them– the PI is part of the solution
Compliance Basics• Develop policies and procedures
– Write them down and make them accessible– revisit source documents and stay current – keep forms simple– give attention to the detail of implementation– define roles and responsibilities
• Assign oversight responsibility– responsibility = authority– include in policies and process
Compliance Basics• Develop a continuing training program for new
and existing staff– Yes, you can train a PI
– evaluate content and effectiveness
• Management systems should be driven by policy– oversight mechanism
– they should provide reliable and current information
Compliance Basics• Perform risk assessments and implement appropriate
internal controls– focus on high-risk events – periodically test for effectiveness and reevaluate
• Utilize internal audit– keep your finger on the pulse– problems are an educational opportunity– input on policies and procedures
• Communicate– discussion groups, brown bags, staff sessions, emails,
newsletters, one-on-one meetings
(auditors are our friends)
NIH Proactive Compliance Site Visits
Objective• Move from reactive noncompliance to proactive
compliance
Purpose• To assess the level of understanding of certain
Federal/NIH requirements• To assist in ensuring compliance with NIH requirements• To minimize/eliminate incidents of noncompliance
Proactive Compliance Site Visit Summary: FY2000-FY2002
26 institutions:
20 universities/medical schools
4 non-profits (3 AIRI institutions)
2 hospital
Geographic diversity
Expanded education-outreach seminar
NIH Proactive Compliance Site Visits: Outcome
Proactive Compliance Site Visits: A Compendium
Subject matter focus
Regulations/policies/guidelines
Summary observations
Examples of compliance in action
Available on Grants Compliance and Oversight page http://grants.nih.gov/grants/compliance/compliance.htm
Newly updated
Important Information
• OMB Circulars (A-110/A-21/A-122/A-133)
• HHS regulations (45 CFR Part 74 or 92 and 42 CFR Part 52)
• NIH Grants Policy Statement
• Notice of Grant Award/special terms and conditions
• Institutional policies
NIH Actions: Objective
• To ensure continued progress on current and future NIH-supported research activities while minimizing risks to Federal funds
NIH Actions
• Technical assistance • Conduct collaborative education and training • High-risk designation• Engage institution in cooperative and interactive
relationship in implementing corrective actions (Corrective Action Plan)– address problem areas– increase oversight
NIH Actions
• Special terms and conditions of awards• Loss of carryover authority• Cost disallowances• Suspension/termination of award• Improved Systems and PoliciesImproved Systems and Policies
Some Useful Websites
• Grants Page/OER homepage: http://grants.nih.gov/grants/oer.htm
• Grants Policy:http://grants.nih.gov/grants/policy/policy.htm
• NIH Grants Policy Statement (3/01)http://grants1.nih.gov/grants/policy/nihgps_2001/
• NIH Guide for Grants and Contracts:http://grants.nih.gov/grants/guide/index.html
• OMB Circulars:www.whitehouse.gov/omb/circulars/
Parting Thoughts
• Mutual need to assure compliance • Mutual need to implement proactive
compliance measures• Collaborative relationship -- NIH and grantees
are partners and stewards• You can make a difference no matter where
you are in the organization• Compliance is everyone’s responsibility
Enforcement: Correcting Problems
Retroactively
Common Complaints
• Human subjects protection
• Animal welfare
• Research misconduct
• Financial mismanagement
• Grants administration
Human Subjects Protection
• Informed consent procedures may be inadequate/ patients may not be properly informed of the risks and benefits of participating in a clinical trial
• Researchers may be putting patients into clinical trials when the patients should not participate in that particular research project
Human Subjects Protection
• The Institutional Review Board (IRB) may fail to properly review a research proposal, may be keeping inadequate records of its review, or holding meetings without proper attendance and/or preparation
• Researchers are not reporting adverse affects of investigational drugs used on clinical trials to the Food and Drug Administration (FDA) or failing to obtain permission from the FDA to commercialize a product
Animal Welfare
• Animal care practices or protections may not be adequate
• Institutional Animal Care and Use Committee (IACUC) may not be following proper procedures for approval of animal research protocols, or may be keeping inadequate records, or holding meetings without proper attendance
• Significant problems with animal care and use not being appropriately reported
Research Misconduct
• Researchers falsifying or fabricating research data in laboratory notebooks, grant applications, progress reports to NIH, publications, patent applications
• Plagiarism by researchers
Financial Mismanagement
• Researchers and/or administrative staff incorrectly reporting time and effort that researchers spend on grants
• Failing to report program income earned from projects supported with grant funds
• Researchers being paid with grant funds when they are not working on the project
Financial Mismanagement
• Research grant funds used for activities that are not part of the project
• Improper accounting of overhead costs• Improper transfers of funds across
research projects• Failure to report financial conflicts of
interest, or other research support
Grants Administration
• Lack of institutional oversight of principal investigators• Unclear designation, understanding of roles and
responsibilities of researchers and administrators• Lack of training in and understanding of compliance
issues• Widespread financial problems• Failure to properly monitor and keep track of
expenditures, time and effort, and other compliance requirements
Who You Will Hear From and What
They Will Do
HHS Office for Human Research Protections (OHRP)
• Formerly the Office for Prevention from Research Risks (OPRR)
• Conduct investigations
• Contact you for additional information
• Conduct site visits and interview staff
HHS Office for Human Research Protections (OHRP)
Possible Actions
• Restrict your “assurance” which will require increased oversight, monitoring, and reporting for particular projects
• Suspend an assurance for all or part of an institution, preventing some or all research on patients from continuing until corrective actions have been taken as specified by the OHRP
HHS Office for Human Research Protections (OHRP)
Possible Corrective Actions
• Changing the structure of the IRB and the way it does business
• Re-reviewing research protocols that the IRB has previously approved
• Seeking additional informed consent from patients who participate in research
Food and Drug Administration (FDA)
Possible Actions
• Suspending a research project or all research at an institution
• Withdrawing a researcher’s authorization to use an investigational drug, preventing the researcher from conducting any research regulated by the FDA
NIH Office of Laboratory Animal Welfare (OLAW)
• Conduct investigations
• Contact you for additional information
• Conduct site visits and interview staff
NIH Office of Laboratory Animal Welfare (OLAW)Possible Actions
• Restrict your “assurance” which will require increased oversight, monitoring, and reporting for particular projects involving laboratory animals
• Suspend an assurance for all or part of an institution, preventing some or all research on animals from continuing until corrective actions have been taken as specified by OLAW
NIH Office of Laboratory Animal Welfare (OLAW)
Possible Corrective Actions
• Changing the structure of the IACUC and the way it does business
• Re-reviewing research protocols that the IACUC has previously approved
• Requiring changes in laboratory animal care and research practices
HHS Office of Research Integrity (ORI)
• Reviews investigations of research misconduct conducted by the institution
• May ask for further information or further investigation
• Recommends a finding to the Office of the Assistant Secretary for Health, HHS
HHS Office of Research Integrity (ORI)
Possible Actions
• Increased supervision• Ineligibility to serve in any advisory role to the
Department• Debarment from eligibility for federal funding,
(i.e., the researcher cannot receive any Federal funding for a specified period)
Possible NIH Actions Based on ORI Findings
• Recover grant funds that have been awarded to a researcher who has been found to have committed research misconduct
• Require a new principal investigator or new key personnel work on the project
NIH Office of Management Assessment (OMA) and HHS Office
of the Inspector General (OIG)
• Conduct investigations
• Ask for, or subpoena, information
• Conduct audits/reviews
• Interview staff
OMA and OIG Possible Actions
• Recommend action against institutions or individuals
• Recommend that current research grant funds be restricted, suspended, or terminated
• Recommend that funds previously awarded be recovered by the NIH
• Recommend that individual researchers (or even institutions) be debarred
NIH Office of Policy for Extramural Research Administration (OPERA)
• Will ask for information
• Make site visits to interview staff and determine if policies are being implemented and understood
OPERAPossible Actions
• Recommend that NIH impose special conditions on all or some grants
• Designate all or part of an institution as “high risk”
• Require a corrective action plan to remedy identified problems in grant administration
OPERAPossible Corrective Actions
• Establishing policies for roles and responsibilities
• Additional training and education
• Code of conduct for staff
• Increased reporting requirements
And What About Litigation?
• Any of the human subjects, animal welfare, financial, or research problems discussed, and others, can be referred to the Department of Justice (DOJ) for legal action by the agency or by an individual at your institution (qui tam actions)
• The DOJ works with the Office of the General Counsel (OGC) at DHHS, and with the OIG to investigate and litigate cases
Department of Justice
• Determine if civil or criminal action is justified based on the False Claims Act or other applicable statutes, and/or common law theories
• Seek to recover money, up to three times the amount misspent, and corrective actions
• Litigate, and, when appropriate, negotiate settlement
Qui Tam Actions
• Intervention in Qui Tam actions is rare
• DOJ and HHS only intervene when serious allegations are confirmed
• The Government may bring its own case under the False Claims Act
When Litigation May Be Pursued
• Significant amount of funds misspent under a single grant, or many grants
• Significant research misconduct that affects field of research or clinical research
• Significant deviation from grants administration requirements on a single grant or many grants
Useful Websites• HHS homepage – http://www.os.dhhs.gov/• NIH homepage – http://www.nih.gov/• Office of Extramural Research –
http://grants.nih.gov/grants/welcome.htm#offices• Office for Human Research Protections –
http://ohrp.osophs.dhhs.gov/index.htm• Office of Laboratory Animal Welfare –
http://grants.nih.gov/grants/olaw/olaw.htm• Office of Research Integrity – http://ori.dhhs.gov/• Office of Management Assessment –
http://oma.od.nih.gov/• Food and Drug Administration – http://www.fda.gov/• Office of the Inspector General – http://oig.hhs.gov/
