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 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 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 Expansion of the definition of the mission of an academic institution Education – Traditional MissionEducation – Traditional Mission Service – Late 1800’s – Land Grant InstitutionsService – Late 1800’s – Land Grant Institutions Research – 1940’s – V. Bush vision of combining educational role and research roleResearch – 1940’s – V. Bush vision of combining educational role and research role Economic Development – 1980’s – Bayle-Dole ActEconomic 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 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 ParticipantsHuman Participants Animal SubjectsAnimal Subjects Scientific MisconductScientific Misconduct Financial MismanagementFinancial Mismanagement Financial Conflict of Interest and CommitmentFinancial Conflict of Interest and Commitment

5. Consequences of Individual Concerns Individual concerns leads to Individual concerns leads to Public Discussion which leads to Public Discussion which leads to RegulationsorVoluntary Compliance with Ethical Principles RegulationsorVoluntary Compliance with Ethical Principles

6. Examples of Regulations and Guidance Human Participants Human Participants 45 CFR 4645 CFR 46 21 CFR 50, 5621 CFR 50, 56 38 CFR 1638 CFR 16 45 CFR 160, 164(HIPAA)45 CFR 160, 164(HIPAA) OHRP Guidance on Financial Conflict of InterestOHRP Guidance on Financial Conflict of Interest

7. Examples of Laws, Regulations, Principles Animal Welfare Act Animal Welfare Act 9 CFR Chapter 19 CFR Chapter 1 PHS Policy on Humane Care and Use of Laboratory AnimalsPHS Policy on Humane Care and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals, ILARGuide 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 TrainingU.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

8. Additional Examples Regulations Biological Agents Biological Agents Radiation Safety Radiation Safety Chemical Safety Chemical Safety Export Controls Export Controls Certificates of Environmental Compliance Certificates of Environmental Compliance

9. Charge of ORIA 1. develop a framework for coordinating, monitoring, and supporting the university research-related compliance activities, 2. establish a team of professional staff qualified and trained to provide high-level administrative support to faculty compliance committees, 3. conduct post-protocol monitoring and auditing (quality assurance) programs in such key areas as human and animal subjects and use of biohazardous agents, 4. conduct the annual disclosure of Conflict of Interest and Commitment and provide staff support to the University Conflicts Committee,

10. Charge of the ORIA 5. provide greater coordination for the development and delivery of educational and training activities in the key compliance areas, 6. develop and deliver a campus-wide program on the Responsible Conduct of Research (RCR), 7. assure the development of written policies and procedures that foster an institutional commitment to stewardship and compliance, 8. assure prompt institutional response to detected problems, support corrective action, and ensure necessary reporting to federal agencies, and 9. draft comments on behalf of Cornell on proposed regulations impacting institutional compliance.

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

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

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

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

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

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

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

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