Compliance 101

The pieces really can fit together – truly!

Lynette M. Schenkel

Director, Responsible Conduct of Research University of Oregon

You hoped compliance was supposed to make life like this….

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But it really feels like this…

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Today’s Puzzle Strategy

• Let’s find the edge pieces first • Do you have any identifiable pieces?

• Grouping pieces into similar colors • Those must have pieces • It takes a whole team to make… • The perfect fit Mission Impossible: Integrating Your Protocol Compliance Activities 4

Finding the Edge Pieces

• Federal Agency Rules & Regulations – NIH, NSF, DoE, DoD, OHRP, OLAW, etc.

• State Laws • Your Institution’s Policies • But Let’s take a closer look at HHS-OIG recently published

DRAFT

guidelines…

(included in your materials as Attachment 1)

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OIG Compliance Guidance

• For recipients of PHS Research Awards • To assist in preventing fraud and abuse • Focused specifically on grant compliance and administration issues • Contains 8 elements “widely recognized as fundamental to an effective compliance program” 6 Mission Impossible: Integrating Your Protocol Compliance Activities

Federal Sentencing Guidelines

(Or, rules will set you free….) • Implementing written policies & procedures • Designating a compliance officer & compliance committee • Conducting effective training and education • Developing effective lines of communication • Conducting internal monitoring and auditing • Enforcing standards through well-publicized disciplinary guidelines • Responding promptly to detected problems • Defining roles & responsibilities and assigning oversight 7 Mission Impossible: Integrating Your Protocol Compliance Activities

COGR Response to Guidelines

Attachment 2

• We disagree with proposed guidelines – HHS & NIH have provided and continue to provide extensive guidance in the broad area of pre- and post award management and the ethical conduct of research – Because guidance issued by OIG, grant recipients will likely view and auditors will treat it as mandatory, not as guidance.

– Promotes proliferation of similar guidance by other federal agencies 8 Mission Impossible: Integrating Your Protocol Compliance Activities

List of Existing Policy-Guidance

• NIH Grants Policy Statement • Compendium of Findings & Observations – Resulting from the Proactive Compliance Site Visits conducted by NIH Office of Extramural Research • ORI - Model policies for managing research misconduct • OHRP – IRB Guidelines • OLAW – Guide for the Use of Laboratory Animals • NIH Objectivity in Research Policy • HHS-NIH – Regulations, policies, guidance regarding stem cells, recombinant DNA, select agents • COGR – Managing Externally Funded Programs at Colleges and Universities • AAMC – Manuals on the Management of Academic Medical School Research Programs • NCURA – Regulation & Compliance (compendium) 9 Mission Impossible: Integrating Your Protocol Compliance Activities

OIG Thoughtful Considerations

• • • Rely on the “8” basic elements, but develop your program suited to your needs

MAY

require a significant commitment of time and resources….

• “Institutions may also want to note that several of the elements of this compliance guidance are considered ‘mitigating factors’ that must be considered as part of a formal debarment action by the [OIG] Department.”

(45 CFR 76.870(l), (n), (p), and (q))

http://a257.g.akamaitech.net/7/257/2422/12feb20041500/edocket.access.gpo.gov/cfr_200 4/octqtr/pdf/45cfr76.860.pdf

(

Included in your handouts as Attachment 3

) Mission Impossible: Integrating Your Protocol Compliance Activities 10

Written Policies & Procedures

• Should be provided to all faculty members and other employees who are affected by them, to students who may be conducting research and to any agents or contractors who may furnish services in connection with research awards.

• Are yours web available?

• Have you determined how your policies are practically implemented?

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The Compliance Officer

• Designate a CP who will have day-to-day responsibility for overseeing and coordinating the compliance program.

• Designating a CP with the appropriate level of authority is critical to the success of the program.

• Should have direct access to the governing body, senior administration & legal counsel.

• Should have sufficient funding, resources & staff… Mission Impossible: Integrating Your Protocol Compliance Activities 12

Compliance Committee

• Should have representation from operations, finance, audit, human resources, and legal as well as faculty members.

• Should have the requisite seniority and comprehensive experience to recommend and implement any necessary changes to policies and procedures.

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Effective Training

• Should include administrators, both at the institution and dept. levels, faculty (including PI’s), other staff, and contractors.

• Areas of training may be identified through internal audits, monitoring, & review of past problems.

• General and specific training should be provided both upon initial employment as well as on some periodic schedule….

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Effective Communication

• Develop confidentiality & non-retaliation policies – You must be prepared to balance this • Use hotlines, email, newsletters, suggestion boxes, etc.

• Employees should be permitted to report matters on an anonymous basis 15 Mission Impossible: Integrating Your Protocol Compliance Activities

Auditing & Monitoring

• Reviews should be focused on particular areas of activity – Post-award grant monitoring – follow the money!

– Post-approval protocol (animal & human subjects) – Environmental health & safety • The reviews should evaluate whether: – The institution has polices covering the areas of risk – The policies were communicated & implemented – The policies were followed Mission Impossible: Integrating Your Protocol Compliance Activities 16

Enforcing Standards

• Clear and specific disciplinary policies should set out the consequences of violating Federal, State requirements, the Institution’s code of conduct or its policies & procedures.

• Each situation must be considered on a case by-case basis, taking into account all relevant factors.

• Intentional and material non-compliance should not be tolerated.

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Responding Promptly

• CP must immediately investigate allegations to determine whether a material violation has occurred.

• The institution should promptly report the existence of misconduct to the appropriate authorities (within 60 days) • Provide information regarding which law was violated, potential financial and scientific impact Mission Impossible: Integrating Your Protocol Compliance Activities 18

Roles & Responsibilities

• Ignorance is not bliss – know your part • Compliance is not solely the CP’s responsibility – More on this later!

• The Institution may be the “responsible legal entity” but the PI accepts “responsibility for the scientific conduct of the project… • Departmental Administrators must not only be accountable, but equally importantly, be supported and protected.

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“Individual ethical behavior is likelier to flourish within a just society. So in order to lead an ethical life one should work for a just society. That is, if most of us will behave about as well as our neighbors, it is incumbent on us to create a decent neighborhood.” Randy Cohen – The Good, the Bad and the Difference

Do you have any identifiable pieces?

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Begin With What You Have

• Take stock of your resources • Make note of and communicate your gaps to the people with the purse strings.

• Tell “horror” stories if necessary

(hopefully they won’t come from your institution.)

• “Catalyzing Events” Mission Impossible: Integrating Your Protocol Compliance Activities 22

•

Reasons to Invest in Compliance

1998 University of Minnesota settles with Government for $32M for profiting from sales of an unlicensed drug

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Expanded Authorities removed for 3 years, 55 required Corrective Actions

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T. Schumacher, Dir., Office of Institutional Compliance, Univ. Minnesota NCURA conference, Nov. 2003

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University estimates that by 2004 it had spent an additional $48M to recover & reorganize

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NCURA Conference, July 2004

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Chair of Surgery asked to resign (1994) and indicted on 18 felony counts (later exonerated on all counts)

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Time Magazine 05/11/95

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Consulting group brought in to help reorganize concluded tenure was a major obstacle to re-engineering, sparked 1996 “Tenure War”

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American Association of University Professors, ACADEME, Vol 85, #6 (1999)

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Marked decrease in NIH awarded funds

University Professors, ACADEME, Vol 85, #6 (1999)

–

American Association of

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Build on Your Existing Resources

• Sponsored Programs Office – Pull together your policies • Can you build from IRB & IACUC resources?

• What help can central business office provide?

• Communicate, educate, implement 24 Mission Impossible: Integrating Your Protocol Compliance Activities

Grouping Pieces into Similar Colors

• Create a compliance website that holds all available information from all areas.

• Appoint one individual (if you don’t have a CP) to be responsible for overseeing and advising • Keep your various groups talking (nascent compliance committee) 25 Mission Impossible: Integrating Your Protocol Compliance Activities

Those Must Have Pieces

HHS Designated Risk Areas • Time & Effort Reporting – Institutions must have effective timekeeping systems – Must have accurate & consistent treatment of “institutional base salary” (IBS) • Proper Allocation of Charges to Projects – It is fraudulent to bank or trade awards between personnel, or charges amongst awards.

• Cost Sharing – The reporting of other financial support is a required element…failure to provide this information could subject an institution to…criminal investigation.

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Those Must Have Pieces

2006 OIG Work Plan –

Attachment 4

• Conflicts of Interest (COI) – Must have written policy, & must report to NIH PI’s COI & how it has been managed, reduced or eliminated • Time & Effort Reporting • Sub-contract Costs & Monitoring – We are responsible to know whether or not our sub-recipients have met their audit requirements (site visits, review of perf., financial reporting, risk assessments) • University Administrative & Clerical Salaries – Are support staff, clerical & grant administrators being incorrectly charged as direct expense?

• Cost Transfers – Are they allowable, are they properly documented? NIH total cost transfer are approaching $20 Billion annually 27 Mission Impossible: Integrating Your Protocol Compliance Activities

Those Must Have Pieces

NSF 2006 Audit Plan –

Attachment 5

• Proper Allocation of Charges to Projects • Subcontract Costs & Monitoring • Close Out Award Financial Management – Disposition of Federally owned property – Overstating IDC recovery • Hurricanes Katrina & Rita – The NSF has >60 awardees in the states effected by the hurricanes.

– Transfer awards for faculty & students temporarily at other institutions; supplemental funding requests; fund grants studying the quick response on natural disasters.

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On Site Review Modules Used during the Site Visit to Conduct the Review of Targeted Areas

•

Time & effort reporting for personnel

• • • • • • • • •

Fringe benefits Travel Consultants Cost Sharing Participant Support Indirect Costs Procurement Subrecipient Monitoring Property

Director, Division of Institution and Award Support 29 Mission Impossible: Integrating Your Protocol Compliance Activities

Take note of the overlap…

• Time & Effort Reporting – HHS-OIG • Allocation of Charges-Cost Transfers – HHS-OIG-NSF • Subcontracts & Monitoring – HHS-NSF Mission Impossible: Integrating Your Protocol Compliance Activities 30

It Takes a Whole Team…

Roles & Resp Matrix –

Attachment 6

• First Base – The PI • Second Base – Dept Grants Admin.

• Third Base – IRB, IACUC • Pitcher – Sponsored Programs Office • Home Base – Institutional Official • Short Stop – Compliance Officer • Outer Field – Ancillary Support Services • Umpire – Agency Auditors & Administrators Mission Impossible: Integrating Your Protocol Compliance Activities 31

Event versus Operational Compliance

• Compliance Officers: – Write policy – Help PI’s, departments, schools create processes and procedures – Provide education or are an educatory resource – Investigate issues of Non-compliance 32 Mission Impossible: Integrating Your Protocol Compliance Activities

Event versus Operational Compliance

• PI’s, Dept Personnel, SPO’s – Incorporate principles of policy into their daily work – Have a general knowledge of applicable regulations and work accordingly – Handle day-to-day issues on their own – Call upon the CP as needed 33 Mission Impossible: Integrating Your Protocol Compliance Activities

Striving for the Perfect Fit

"For a scientist [research administrator], integrity embodies above all the individual's commitment to intellectual honesty and personal responsibility … For an institution, [integrity] is a commitment to creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness…"

- Integrity in Scientific Research

, The National Academy of Sciences Mission Impossible: Integrating Your Protocol Compliance Activities 34

Striving for the Perfect Fit

“…the effectiveness of an ethics and compliance program is not only measured in terms of the channels and messages it uses for communicating with employees; it is also effective in terms of the ways and extent to which it institutionalizes itself…One way to institutionalize itself is the command-and control structure that sets up the program, designs its policies and procedures, and communicates them to the organization….” Mission Impossible: Integrating Your Protocol Compliance Activities 35

Striving for the Perfect Fit

“The other—and far more effective—is the participatory structure that seeks the participation of employees, managers, officers, and directors (and other stakeholders, as appropriate) in the design, implementation, and evaluation of the program…Thus, if an ethics and compliance program is going to be truly effective, it will need to become simply the way the organization goes about its business.” Justification for Suggested Changes to Proposed Amendments to FSGO – Stuart Gilman, Robert Olson, Michael Hoffman.

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Questions?

[email protected]

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