Responsible Conduct of Research :

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Responsible Conduct of Research

• A Framework for Research Administrators and
  Organizations

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Presented by
Lynne Chronister, Assistant Vice
Provost University of Washington Denver, 2008

• Contributions from
• Denise McCartney, Washington University
• Geoff Grant, Partners Health System

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Ensuring Research Protections Principles and
Responsibilities
Conduct of Research Principle Ensures validity
of results/ Maximizes return on public
investment Conflict of Interests Research
Integrity Conflict of Commitment Data, Resource
Sharing, Cyber Security (new) Public Access to
Publications (new)
Protections/Safeguards Principle Provides
safety/welfare of subjects and environment Human
Subjects Animal Welfare HIPAA (new) Environmental
Health Safety Select Agents (new)
Cost Policy/Financial Management Principle Ensure
s fair and reasonable costs to the
Government Reasonable Allocation of Costs Salary
Charges/Effort Reporting Indirect Costs Cost
Sharing
Public Policy Requirements Principle Meets
National Social, Economic, Security
Interests SEVIS/Visas (new) Export controls
(new) Title IX Lobbying Debarment Drug Use

Geoff Grant, May, 2005
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Research Compliance Why?

• Universities have an obligation to maintain the
  publics trust by
• Conducting research ethically and responsibly
• Ensuring proper stewardship of research funds
• Protecting animal and human subjects
• Assuring compliance with federal regulations

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Research Compliance Why?

• Why is there so much emphasis on this topic now?
• The Academic Culture is at risk for compliance
  failures due to
• Decentralized organizations
• Potential for conflicts of interest
• Undefined roles and responsibilities
• Lack of comprehensive training
• Expanded Requirements
• Recent, significant compliance failures at large,
  research institutions

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Research Compliance Why?

• Why is there so much emphasis on this topic now?
• Increased funding for biomedical research
  resulting in greater scrutiny, increased
  inspections
• 4. Findings of liability on the part of
  universities have become more frequent in recent
  years

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Research Compliance Why?

• Why is there so much emphasis on this topic now?
• 5. Successful Qui Tam Lawsuits
• Federal Sentencing Guidelines reduce penalties if
  a fully-functioning corporate compliance program
  is in place. Corporate Integrity Agreements are
  onerous.
• 7. NIH Proactive Compliance Visits have helped
  set standards

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Critical Components !!!

• 1. Instill a Culture of Compliance
• Communication
• Policy development
• 2. Develop an Organizational Structure
• RCR Committee
• Compliance/Integrity/Ethics Officer
• 3. Develop Comprehensive Education and Training
• RCR and Integrity/Ethics

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1. Culture How to Promote Research Integrity,
or Finding Your Voice, Ensuring Research
Protections

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Match Your Approach to Your CultureWhat Will Be
Successful in Your Institution?

• Its all about the shared values in promoting
  outstanding science or research!
• Use language that appeals to the faculty
• Promote institutional core values first and
  foremost
• e.g. excellence in research, research
  protections, code of conduct, stewardship,
  research responsibilities

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• Then find a balance between promoting research
  integrity and providing appropriate programs for
  compliance and accountability
• Requirements are increasingly complex
• Faculty increasingly rely on internal expertise
  and guidance
• Research compliance programs are now an essential
  element of institutional research infrastructure
• every bit as important as research facilities and
  instrumentation
• Unfortunately, the institution and the research
  community need safeguards against fraud and abuse
• Recovery from damage to the reputation or good
  name of the institution is a long term process!

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Communication from the President or Provost

• Letter or Message to Faculty
• Be proactive, exert leadership
• Obviously a currency not be squandered or
  overused
• Time with announcement of a research integrity
  program, office, role, or an education program
  for faculty and/or administrators
• Reference to some other institutional case or
  event

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One Example from Vanderbilt UniversityDivision
of Sponsored ResearchOffice of Compliance
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A Sample of One Institutions Messages

• The Principal Investigator (PI) role at Stanford
  University brings significant rewards and
  responsibilities. PIs are responsible for the
  intellectual direction of research and
  scholarship and for the education and training of
  students. In carrying out these critical tasks,
  PIs are also responsible for compliance with laws
  and regulations that touch on all aspects of the
  research enterprise.
• John Hennessey, President, Stanford in a letter
  to the faculty 2000
• http//www.stanford.edu/dept/DoR/PIship/

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Cite Respected Sources or Distinguished Scientists

• The scientific research enterprise, like other
  human activities, is built on a foundation of
  trust. Scientists trust that the results reported
  by others are valid. Society trusts that the
  results of research reflect an honest attempt by
  scientists to describe the world accurately and
  without bias. The level of trust that has
  characterized science and its relationship with
  society has contributed to a period of
  unparalleled scientific productivity. But this
  trust will endure only if the scientific
  community devotes itself to exemplifying and
  transmitting the values associated with ethical
  scientific conduct. 1
• 1 On Being a Scientist Responsible Conduct in
  Research, Second Edition (1995) ,
• National Academy of Sciences

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2. Consensus on Structure and Function

• Who is responsible?
• What is our Structure?
• What RCR areas are critical?

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How To Begin?

• Draft Outline of plan
• Review of policies (COI, etc.)
• Extensive Survey of Education Training
• Strategic Planning Session
• Engage a Compliance Officer
• Set up a committee
• Write Plan
• Design curriculum
• Teach and Train
• Commit Money!

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Conduct an Institutional Risk Assessment

• Convene group of key faculty and
  administrators from departments and central
  offices
• Run consensus process by
• Appropriate Dean or academic official?
• Associate VP for Research?
• Compliance Officer?
• Internal Audit?

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Research Compliance Program Goals

• Promote high standards of research integrity
• Effectively manage public funds to maximize
  research outcomes
• Protect research subjects
• Assure coordination of compliance programs
• Avoid serious cases of fraud or mismanagement of
  federal funds through self-monitoring
• Assure coordination of compliance programs

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Compliance Program Elements

• Written standards, policies and procedures
• Education, training and communication
• Monitoring
• Audits
• Appointment of a High Level Official
• Mechanism to report violations (e.g. hotline)
• Record Retention policy
• Defined roles and responsibilities

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Compliance Program Models

• Institutional Compliance Program
• Single Compliance Office/Program with a clearly
  identified Compliance Officer
• Research Compliance Program
• Separately established from other compliance
  programs
• Focused on oversight for research compliance

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Compliance Program Models

• Functional Compliance Model
• Traditional organizational models building on
  existing compliance structures
• Increased clarity of roles and responsibilities
• Increased focus on education
• Oversight and/or coordination
• Hybrid Models
• No Model
• No Program

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Washington University Compliance Program

• Roles and Responsibilities of Research Compliance

Research Compliance Functional Areas
University Compliance
Research Compliance

• Develop and maintain Expertise on laws and regs
• Develop and implement Policies and Procedures
• Develop and Provide Edcuational Programs
• Develop and implement methods to monitor
  compliance
• Respond to allegations of wrongdoing

• Develop Promote Principles
• Develop Coordinate Educational Programs
• Facilitate Monitoring
• Respond to allegations of wrongdoing
• Provide Necessary Infrastructure to facilitate
  compliance activities

• Support, assist and verify effectiveness of
  compliance activities
• Develop, revise maintain the Code of Conduct
• Perform audits
• Receive Respond to Allegations of Wrongdoing
• Communicate with the Board

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Washington University Research Compliance Program

• Research Compliance Accomplishments
• Defined roles and responsibility of offices
  accountable for Research Compliance
• Began project to document roles and
  responsibilities of other key offices and
  individuals involved in research

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Washington University Research Compliance Program

• Completed Inventory of Research Compliance
  functional areas
• Policies
• Educational Programs
• Information Systems
• Monitoring/Auditing Programs
• Communication Tools
• Developed, updated and revised polices based on
  inventory results

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Washington University Research Compliance Program

• Enhancing Educational Program
• Research Administrators Forum
• Implemented Research News a web-based
  communication tool targeted at specialized
  audience with associated library
• Hired Director of Research Education
• Departmental Educational Retreats
• Compliance Audit follow-ups
• Developing Administrators Financial Program

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University of Utah

• Began development in 2000
• NIH Proactive Compliance Visit, August 2002
• Increased concern on the part of administration
• Increased concern expressed by faculty and other
  researchers
• Concerted Effort in re-engineering clinical
  studies including financial and regulatory

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How Did Utah Begin?

• Draft Outline of plan begun in 2001
• Revision of numerous policies (COI, etc.)
• Extensive Survey of Educ. Training
• Strategic Planning Session
• 35 participants (compliance admin faculty)
• 1 day
• Strategic plan for structure and function of
  compliance program
• Plan for NIH visit incorporated

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Compliance Mission

• The University of of Utahs research compliance
  program is committed to the achievement of high
  ethical and legal standards of conduct through a
  culture of compliance and conscience that reflect
  our core values.

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Organization Chart
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SampleStanford Roles and Responsibilities
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SampleCommon Elements of an Institution-wide
Compliance Program
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UC Davis Gap Analysis Worksheet
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3. Education and Training

• NIH Training Grant Requirements
• NSF Training Grant Requirements
• America Competes Act Requirements
• RCR training for ALL students and fellows
• It is Right Thing to Do!!!

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Establish Program Parameters

• Comprehensive Programs?
• Select RCR Modules?
• Resources
• Office of Research Integrity
• Responsible Conduct of Research Education
  Consortium (http/rcrec.org)
• PRIMR (Public Responsibility in Medicine and
  Research

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It is not permitted to the most equitable of men
to be a judge in his own cause. Blaise Pascal
(1670)
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References and Resources

• Grant, Geoffrey, Guyton, Odell, Forrester,
  Robert, Creating Effective Research Compliance
  Programs in Academic Institutions, Academic
  Medicine, vol. 74, No., September 1999.
• Walsh, Barbara E., Moran, James, McDougall,
  Gerald, The Compliance Umbrella, Business
  Officer, January 2000,
• American Association of Academic Medical Colleges
  website _at_ www.aamc.org/research/dbr/compliance/mo
  dels.htm

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• Office of Research Integrity www.ori.dhhs.gov/
• Kulakowski, Elliott, Chronister, Lynne, Research
  Administration and Management, Jones and
  Bartlett, 2007.
• OMB Compliance Supplement, March 2008
  www.whitehouse.gov/

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Contact

• Lynne Chronister
• Associate Vice Provost for Research
• University of Washington,
• lchronis_at_u.washington.edu
• 206-543-4043