Office of Research Integrity and Assurance

1. Office of Research Integrity and Assurance E. Ray Stinson, Ph.D. Assistant Vice President for Research Compliance Director, Officer of Research Compliance and Assurance April 28, 2006

2. Why have an Office of Research Compliance and Assurance (ORIA)? • As the role of the academic institution has increased, so have the expectations of the public • As public support for research and sponsored programs has increased so has the expectation of the public for the academic community to behave ethically and in keeping with the ethical norms of the community

3. Why Recent Interest in Research Compliance? • Expansion of the definition of the mission of an academic institution • Education – Traditional Mission • Service – Late 1800’s – Land Grant Institutions • Research – 1940’s – V. Bush vision of combining educational role and research role • Economic Development – 1980’s – Bayle-Dole Act

4. Public Concern • While the public is increasingly supportive of the results and the products that are the consequence of research, they are also increasingly concerned about the ethical steps that researchers take to accomplish those results • Human Participants • Animal Subjects • Scientific Misconduct • Financial Mismanagement • Financial Conflict of Interest and Commitment

5. Consequences of Individual Concerns • Individual concerns leads to • Public Discussion which leads to • Regulations or Voluntary Compliance with Ethical Principles

6. Examples of Regulations and Guidance • Human Participants • 45 CFR 46 • 21 CFR 50, 56 • 38 CFR 16 • 45 CFR 160, 164 (HIPAA) • OHRP Guidance on Financial Conflict of Interest

7. Examples of Laws, Regulations, Principles • Animal Welfare Act • 9 CFR Chapter 1 • PHS Policy on Humane Care and Use of Laboratory Animals • Guide for the Care and Use of Laboratory Animals, ILAR • U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

8. Additional ExamplesRegulations • Biological Agents • Radiation Safety • Chemical Safety • Export Controls • Certificates of Environmental Compliance

9. Charge of ORIA • develop a framework for coordinating, monitoring, and supporting the university research-related compliance activities, • establish a team of professional staff qualified and trained to provide high-level administrative support to faculty compliance committees, • conduct post-protocol monitoring and auditing (quality assurance) programs in such key areas as human and animal subjects and use of biohazardous agents, • conduct the annual disclosure of Conflict of Interest and Commitment and provide staff support to the University Conflicts Committee,

10. Charge of the ORIA • provide greater coordination for the development and delivery of educational and training activities in the key compliance areas, • develop and deliver a campus-wide program on the Responsible Conduct of Research (RCR), • assure the development of written policies and procedures that foster an institutional commitment to stewardship and compliance, • assure prompt institutional response to detected problems, support corrective action, and ensure necessary reporting to federal agencies, and • draft comments on behalf of Cornell on proposed regulations impacting institutional compliance.

11. ORIA Primary Responsibilities • Train • Provide Administrative Support • Process Improvement and Audit Activities • Lead and/or Participate in Accreditation Reviews • Maintain Assurances and Certificates

12. ORIA Primary Responsibility • Subject Areas for Training • Responsible Conduct in Research • Data acquisition, management, sharing, and ownership • Mentor/trainee responsibilities • Publication practices and responsible authorship • Peer review • Collaborative science • Human participants • Research involving animals • Research Integrity and Misconduct • Conflict of Interest and Commitment

13. ORIA Primary Responsibility • Additional Subject Areas • Export Controls • Use of Restricted Access Datasets • Research Conflict Resolution

14. Educational Activities • Training Activities provided by ORIA • Online Training Sessions • Seminars and Discussions Groups • Remedial Training after a Process Improvement Review and/or Audit • Acknowledge existing educational activities conducted by Schools, Colleges, Offices, etc. • Supplement those activities as needed • Documentation Training Activities

15. ORIA Primary Responsibilities • Provide Administrative Support • University Committee on Human Subjects • Institutional Animal Care and Use Committee • Biosafety Committee • Conflict of Interest and Commitment (2007)

16. ORIA Primary Responsibilities • Process Improvement and Audit Activities • Matching of Proposals to Protocols and Standard Operating Procedures • Random Process Improvement Activities • Comprehensive For Cause Audits

17. ORIA Primary Responsibilities • Lead and/or Participate in Accreditation Reviews Accreditation • AAALAC – Animals Subjects • AAHRPP – Human Participants

18. Maintain Assurances and Certificates • Assurances • Human Participants • Animal Care • Certificates • Certificates of Environmental Compliance • Drug Free Workplace • Affirmative Action • American with Disability Act