Building a Culture of Compliance in the Age of

EnforcementNCURA - R6/7 Regional Meeting

Debra Murphy

Research Integrity and Assurance

Arizona State University

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ASU Prospective

• Office of Research Integrity and Assurance – provides resources to assist faculty & administrators to facilitate, achieve & maintain ethical principles and comply with federal, state and university regulations governing research.

• Areas supported include research policy development,

human subjects, animal care, conflict of interest, biosafety, research misconduct, export controls, & the responsible conduct of research.

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Objectives for Today

Together we will explore options and identify best practices for developing and growing a research compliance program within a culture of compliance in a atmosphere of shared responsibility and partnership.

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Areas Supported

– Native Americans– Conflict of Interest– Export Control including

screening for visa eligibility and visitors

– Animal Care & Use (IACUC)

– Biosafety

– Human Subjects Protections (IRB) – 2 Committees – –RCR–Publication Waivers (>90 day delays; RSP 406)–Proprietary Research/Security–Misconduct in Science

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Institution-wide

Federal Regulations

Program needs/regs

Award Specific Terms and Conditions

Copyright 2002 Atlantic Information Services Inc.

The Compliance Pyramid

Definitions

Compliance

Black’s Law Dictionary»Submission»Obedience»Conformance

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Compliance

Webster’s Dictionary– The act or process of complying to a desire,

demand, or proposal or to coercion– Conformity in fulfilling official requirements;– The ability of an object to yield elastically when a

force is applied: FLEXIBILITY

Culture

- set of values, conventions or social practices associated with a particular field, activity, or societal characteristic

- shared attitudes, values, goals, and practices that characterizes an institution or organization

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Partnership

- a legal relation existing between two or more persons contractually associated as joint principals in a business

- the persons joined together in a partnership

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Responsibility for Institutional Culture Begins at the Top

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Who are the Players?

- Institutional Officials (VP, Deans, Chairs)

- Principal Investigators

- Research Integrity Office

- Sponsored Programs Central Administration

- Departmental Administrators

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Who are the Players?

Don’t forget the external players

- State Regulators

- Sponsor Representatives

- Enforcement Partners (OBA, OHRP, FDA, FBI, Local Law Enforcement)

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Shared Responsibility

Researcher

Institution Regulators

Culture of Compliance

The three legged stool approach – each leg is required for success

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What are the Federally Imposed Requirements & Programs– Animal Use & Care Programs– Human Subjects Protection Programs– Conflict of Interest -- institutional and individual– Scientific Misconduct– Whistleblower policies & procedures– Environmental Health and Safety Programs (Biosafety,

Select Agents, Occupational Health)– Export Controls

Program Areas to Remember

– Agency Regulations– Federal Demonstration Partnership– University Policies & Guidelines– National concerns and impact of research since

9/11 (Select Agents, Foreign Nationals, Publication restrictions, Sensitive but not classified export controls.

Designing Collaborative Programs that Work

One Size May Not Fit All

• Considerations for local environments• Immerging versus Enterprise Research

Programs• Centralized Compliance Models• Decentralized Compliance Models• Find a program that meets your structure and

culture

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Building Shared Resources

• Biggest Headaches for Research Administrators

• How to collaboratively solve challenges

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Planning for SuccessInvolve all necessary members of the University community in the decision making– Ensure that faculty and principal investigators are involved in

every phase of the reviews, the development of the new policies and procedures, and the practices

– Make sure that upper management is on board with each step and is supportive

– Involve the department staff and the grants administrators– By-in by all parties makes compliance programs work

Thinking Ahead

Time to do a policy review– Are policies & procedures adequate for today’s climate?– Are policies well known by those who need to know them through

the institution?– Are they followed?– How are they communicated?

Develop Outreach Programs to Education & Train --everyone from faculty to secretary -- and don’t forget the senior administration!!– Web-based training – Formal in-class workshops– Brochures and “Topics of Interest”– Video taped programs to loan out– Conferences

Sharing What you Learn

Is it Working

• Monitor --develop an appropriate way to tell. Plan to continue this for as long as the program lasts

• Require formal reviews from outside & inside the institution.

• Consider an advisory review system

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Age of EnforcementConsider the Risk of Non-Compliance

- You Name it

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Age of Enforcement

Consider the Risk of Non-Compliance

•Negative Publicity (It’s your name – your reputation•Loss of Reputation•Civil and Criminal Penalties•Harm to participants•Suspension or Debarment

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Age of Enforcement

•USDA inspection models•fCOI revisions from PHS – anticipated (Congressional Interest•RCR – NSF plans to implement site reviews•OBA Site Visits•OHRP and FDA IRB reviews (cause and not

for cause)•Presidential Commission on International Human Subjects rights

Enforcement is Essential• Develop appropriate sanctions• Make sure they are well known

and well documented• Apply the sanctions

consistently and consciously• Make sure senior management

will support the enforcement activities

• Be reasonable and just

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“BE FLEXIBLE AND DEVELOP A PRINCIPLED BASED PROGRAM NOT A RULE BASED ONE”

CreditsMy appreciation to colleagues a the National Council of

University

Research Administrators, the Federal Demonstration Project, the

National Institutes of Health, and the National Science Foundation for

the wonderful web based and shared resources they have made

available. Much of this presentation is from them…

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Questions?

• Contacts: Debra Murphy, Director, ASUdebra.murphy@asu.edu; 965-2179

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