Responsible Conduct of Research: A Framework for Research Administrators and Organizations


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Introduce to Research Compliance, the Critical Components and how to promote Research Integrity and ensure Research Protection.

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Responsible Conduct of Research: A Framework for Research Administrators and Organizations

  1. 1. Responsible Conduct of Research : A Framework for Research Administrators and Organizations
  2. 2. Presented by: Contributions from: Denise McCartney, Washington University Geoff Grant, Partners Health System Lynne Chronister, Assistant Vice Provost University of Washington Denver, 2008
  3. 3. 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) Public Policy Requirements Principle: Meets National Social, Economic, Security Interests SEVIS/Visas (new) Export controls (new) Title IX Lobbying Debarment Drug Use 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: Ensures fair and reasonable costs to the Government Reasonable Allocation of Costs Salary Charges/Effort Reporting Indirect Costs Cost Sharing Geoff Grant, May, 2005 Ensuring Research Protections Principles and Responsibilities
  4. 4. Research Compliance – Why? <ul><li>Universities have an obligation to maintain the public’s trust by: </li></ul><ul><ul><li>Conducting research ethically and responsibly </li></ul></ul><ul><ul><li>Ensuring proper stewardship of research funds </li></ul></ul><ul><ul><li>Protecting animal and human subjects </li></ul></ul><ul><ul><li>Assuring compliance with federal regulations </li></ul></ul>
  5. 5. Research Compliance – Why? <ul><li>Why is there so much emphasis on this topic now? </li></ul><ul><ul><li>The Academic Culture is at risk for compliance failures due to </li></ul></ul><ul><ul><ul><li>Decentralized organizations </li></ul></ul></ul><ul><ul><ul><li>Potential for conflicts of interest </li></ul></ul></ul><ul><ul><ul><li>Undefined roles and responsibilities </li></ul></ul></ul><ul><ul><ul><li>Lack of comprehensive training </li></ul></ul></ul><ul><ul><ul><li>Expanded Requirements </li></ul></ul></ul><ul><ul><li>Recent, significant compliance failures at large, research institutions </li></ul></ul>
  6. 6. Research Compliance – Why? <ul><li>Why is there so much emphasis on this topic now? </li></ul><ul><ul><li>Increased funding for biomedical research resulting in greater scrutiny, increased inspections </li></ul></ul><ul><ul><li>4. Findings of liability on the part of universities have become more frequent in recent years </li></ul></ul>
  7. 7. Research Compliance – Why? <ul><li>Why is there so much emphasis on this topic now? </li></ul><ul><ul><li>5. Successful Qui Tam Lawsuits </li></ul></ul><ul><ul><li>Federal Sentencing Guidelines reduce penalties if a fully-functioning corporate compliance program is in place. Corporate Integrity Agreements are onerous. </li></ul></ul><ul><ul><li>7. NIH Proactive Compliance Visits have helped set standards </li></ul></ul>
  8. 8. Critical Components !!! <ul><li>1 . Instill a Culture of Compliance </li></ul><ul><ul><ul><li>Communication </li></ul></ul></ul><ul><ul><ul><li>Policy development </li></ul></ul></ul><ul><li>2 . Develop an Organizational Structure </li></ul><ul><ul><ul><li>RCR Committee </li></ul></ul></ul><ul><ul><ul><li>Compliance/Integrity/Ethics Officer </li></ul></ul></ul><ul><li>3 . Develop Comprehensive Education and Training </li></ul><ul><ul><ul><li>RCR and Integrity/Ethics </li></ul></ul></ul>
  9. 9. 1. Culture: How to Promote Research Integrity, or Finding Your Voice, Ensuring Research Protections
  10. 10. Match Your Approach to Your Culture What Will Be Successful in Your Institution? <ul><li>It’s all about the shared values in promoting outstanding science or research! </li></ul><ul><ul><ul><li>Use language that appeals to the faculty </li></ul></ul></ul><ul><ul><ul><li>Promote institutional core values first and foremost </li></ul></ul></ul><ul><ul><ul><ul><li>e.g. excellence in research, research protections, code of conduct, stewardship, research responsibilities </li></ul></ul></ul></ul>
  11. 11. <ul><ul><ul><li>Then find a balance between promoting research integrity and providing appropriate programs for compliance and accountability </li></ul></ul></ul><ul><ul><ul><ul><li>Requirements are increasingly complex </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Faculty increasingly rely on internal expertise and guidance </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Research compliance programs are now an essential element of institutional research infrastructure </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>every bit as important as research facilities and instrumentation </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><li>Unfortunately, the institution and the research community need safeguards against fraud and abuse </li></ul></ul></ul></ul><ul><ul><ul><li>Recovery from damage to the reputation or good name of the institution is a long term process! </li></ul></ul></ul>
  12. 12. Communication from the President or Provost <ul><li>Letter or Message to Faculty </li></ul><ul><ul><li>Be proactive, exert leadership </li></ul></ul><ul><ul><li>Obviously a currency not be squandered or overused </li></ul></ul><ul><ul><li>Time with announcement of a research integrity program, office, role, or an education program for faculty and/or administrators </li></ul></ul><ul><ul><li>Reference to some other institutional case or event </li></ul></ul>
  13. 13. One Example from Vanderbilt University Division of Sponsored Research Office of Compliance
  14. 14. A Sample of One Institution’s Messages <ul><li>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. </li></ul><ul><li>John Hennessey, President, Stanford in a letter to the faculty 2000 </li></ul><ul><li> </li></ul>
  15. 15. Cite Respected Sources or Distinguished Scientists <ul><li>“ 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] </li></ul><ul><li>[1] On Being a Scientist: Responsible Conduct in Research, Second Edition (1995) , </li></ul><ul><li>National Academy of Sciences </li></ul>
  16. 16. 2. Consensus on Structure and Function <ul><li>Who is responsible? </li></ul><ul><li>What is our Structure? </li></ul><ul><li>What RCR areas are critical? </li></ul>
  17. 17. How To Begin? <ul><li>Draft Outline of plan </li></ul><ul><li>Review of policies (COI, etc.) </li></ul><ul><li>Extensive Survey of Education & Training </li></ul><ul><li>Strategic Planning Session </li></ul><ul><li>Engage a Compliance Officer </li></ul><ul><li>Set up a committee </li></ul><ul><li>Write Plan </li></ul><ul><li>Design curriculum </li></ul><ul><li>Teach and Train </li></ul><ul><li>Commit Money! </li></ul>
  18. 18. Conduct an Institutional Risk Assessment <ul><ul><li>Convene group of key faculty and administrators from departments and central offices </li></ul></ul><ul><ul><li>Run consensus process by: </li></ul></ul><ul><ul><ul><li>Appropriate Dean or academic official? </li></ul></ul></ul><ul><ul><ul><li>Associate VP for Research? </li></ul></ul></ul><ul><ul><ul><li>Compliance Officer? </li></ul></ul></ul><ul><ul><ul><li>Internal Audit? </li></ul></ul></ul>
  19. 19. Research Compliance Program Goals <ul><li>Promote high standards of research integrity </li></ul><ul><li>Effectively manage public funds to maximize research outcomes </li></ul><ul><li>Protect research subjects </li></ul><ul><li>Assure coordination of compliance programs </li></ul><ul><li>Avoid serious cases of fraud or mismanagement of federal funds through self-monitoring </li></ul><ul><li>Assure coordination of compliance programs </li></ul>
  20. 20. Compliance Program Elements <ul><li>Written standards, policies and procedures </li></ul><ul><li>Education, training and communication </li></ul><ul><li>Monitoring </li></ul><ul><li>Audits </li></ul><ul><li>Appointment of a High Level Official </li></ul><ul><li>Mechanism to report violations (e.g. hotline) </li></ul><ul><li>Record Retention policy </li></ul><ul><li>Defined roles and responsibilities </li></ul>
  21. 21. Compliance Program Models <ul><li>Institutional Compliance Program </li></ul><ul><ul><li>Single Compliance Office/Program with a clearly identified Compliance Officer </li></ul></ul><ul><li>Research Compliance Program </li></ul><ul><ul><li>Separately established from other compliance programs </li></ul></ul><ul><ul><li>Focused on oversight for research compliance </li></ul></ul>
  22. 22. Compliance Program Models <ul><li>Functional Compliance Model </li></ul><ul><ul><li>Traditional organizational models building on existing compliance structures </li></ul></ul><ul><ul><li>Increased clarity of roles and responsibilities </li></ul></ul><ul><ul><li>Increased focus on education </li></ul></ul><ul><ul><li>Oversight and/or coordination </li></ul></ul><ul><li>Hybrid Models </li></ul><ul><li>No Model </li></ul><ul><li>No Program </li></ul>
  23. 23. Washington University Compliance Program <ul><li>Roles and Responsibilities of Research Compliance </li></ul>University Compliance Research Compliance Functional Areas Research Compliance <ul><li>Support, assist and verify effectiveness of compliance activities </li></ul><ul><li>Develop, revise & maintain the Code of Conduct </li></ul><ul><li>Perform audits </li></ul><ul><li>Receive & Respond to Allegations of Wrongdoing </li></ul><ul><li>Communicate with the Board </li></ul><ul><li>Develop and maintain Expertise on laws and regs </li></ul><ul><li>Develop and implement Policies and Procedures </li></ul><ul><li>Develop and Provide Edcuational Programs </li></ul><ul><li>Develop and implement methods to monitor compliance </li></ul><ul><li>Respond to allegations of wrongdoing </li></ul><ul><li>Develop & Promote Principles </li></ul><ul><li>Develop & Coordinate Educational Programs </li></ul><ul><li>Facilitate Monitoring </li></ul><ul><li>Respond to allegations of wrongdoing </li></ul><ul><li>Provide Necessary Infrastructure to facilitate compliance activities </li></ul>
  24. 24. Washington University Research Compliance Program <ul><li>Research Compliance Accomplishments </li></ul><ul><ul><li>Defined roles and responsibility of offices accountable for Research Compliance </li></ul></ul><ul><ul><li>Began project to document roles and responsibilities of other key offices and individuals involved in research </li></ul></ul>
  25. 25. Washington University Research Compliance Program <ul><li>Completed Inventory of Research Compliance functional areas </li></ul><ul><ul><li>Policies </li></ul></ul><ul><ul><li>Educational Programs </li></ul></ul><ul><ul><li>Information Systems </li></ul></ul><ul><ul><li>Monitoring/Auditing Programs </li></ul></ul><ul><ul><li>Communication Tools </li></ul></ul><ul><li>Developed, updated and revised polices based on inventory results </li></ul>
  26. 26. Washington University Research Compliance Program <ul><li>Enhancing Educational Program </li></ul><ul><ul><li>Research Administrators Forum </li></ul></ul><ul><ul><li>Implemented Research News – a web-based communication tool targeted at specialized audience with associated library </li></ul></ul><ul><ul><li>Hired Director of Research Education </li></ul></ul><ul><ul><li>Departmental Educational Retreats </li></ul></ul><ul><ul><li>Compliance Audit follow-ups </li></ul></ul><ul><ul><li>Developing Administrators Financial Program </li></ul></ul>
  27. 27. University of Utah <ul><li>Began development in 2000 </li></ul><ul><li>NIH Proactive Compliance Visit, August 2002 </li></ul><ul><li>Increased concern on the part of administration </li></ul><ul><li>Increased concern expressed by faculty and other researchers </li></ul><ul><li>Concerted Effort in re-engineering clinical studies including financial and regulatory </li></ul>
  28. 28. How Did Utah Begin? <ul><li>Draft Outline of plan begun in 2001 </li></ul><ul><li>Revision of numerous policies (COI, etc.) </li></ul><ul><li>Extensive Survey of Educ. & Training </li></ul><ul><li>Strategic Planning Session </li></ul><ul><ul><li>35 participants (compliance admin & faculty) </li></ul></ul><ul><ul><li>1 day </li></ul></ul><ul><ul><li>Strategic plan for structure and function of compliance program </li></ul></ul><ul><ul><li>Plan for NIH visit incorporated </li></ul></ul>
  29. 29. Compliance Mission <ul><li>“The University of of Utah’s 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”. </li></ul>
  30. 30. Organization Chart
  31. 31. Sample: Stanford Roles and Responsibilities
  32. 32. Sample: Common Elements of an Institution-wide Compliance Program
  33. 33. UC Davis Gap Analysis Worksheet
  34. 34. 3. Education and Training <ul><li>NIH Training Grant Requirements </li></ul><ul><li>NSF Training Grant Requirements </li></ul><ul><li>America Competes Act Requirements: </li></ul><ul><ul><li>RCR training for ALL students and fellows </li></ul></ul><ul><ul><li>It is Right Thing to Do!!! </li></ul></ul>
  35. 35. Establish Program Parameters <ul><li>Comprehensive Programs? </li></ul><ul><li>Select RCR Modules? </li></ul><ul><li>Resources: </li></ul><ul><li>Office of Research Integrity </li></ul><ul><li>Responsible Conduct of Research Education Consortium (http:/ </li></ul><ul><li>PRIM&R (Public Responsibility in Medicine and Research </li></ul>
  36. 36. It is not permitted to the most equitable of men to be a judge in his own cause. Blaise Pascal (1670)
  37. 37. References and Resources <ul><li>Grant, Geoffrey, Guyton, Odell, Forrester, Robert, Creating Effective Research Compliance Programs in Academic Institutions, Academic Medicine, vol. 74, No., September 1999. </li></ul><ul><li>Walsh, Barbara E., Moran, James, McDougall, Gerald, The Compliance Umbrella, Business Officer, January 2000, </li></ul><ul><li>American Association of Academic Medical Colleges website @ </li></ul>
  38. 38. <ul><li>Office of Research Integrity / </li></ul><ul><li>Kulakowski, Elliott, Chronister, Lynne, Research Administration and Management, Jones and Bartlett, 2007. </li></ul><ul><li>OMB Compliance Supplement, March 2008 </li></ul>
  39. 39. Contact <ul><li>Lynne Chronister </li></ul><ul><ul><li>Associate Vice Provost for Research </li></ul></ul><ul><ul><li>University of Washington, </li></ul></ul><ul><ul><li>[email_address] </li></ul></ul><ul><ul><li>206-543-4043 </li></ul></ul>