Office of Research Integrity and Office of Research Integrity and AssuranceAssurance

E. Ray Stinson, Ph.D.E. Ray Stinson, Ph.D.Assistant Vice President for Research Compliance Assistant Vice President for Research Compliance

Director, Officer of Research Integrity and Director, Officer of Research Integrity and AssuranceAssurance

October 16, 2006October 16, 2006

Why have an Office of Research Integrity Why have an Office of Research Integrity and Assurance (ORIA)?and Assurance (ORIA)?

As the role of the academic institution has As the role of the academic institution has increased, so have the expectations of the increased, so have the expectations of the publicpublic

As public support for research and sponsored As public support for research and sponsored programs has increased so has the expectation programs has increased so has the expectation of the public for the academic community to of the public for the academic community to behave ethically and in keeping with the behave ethically and in keeping with the ethical norms of the communityethical norms of the community

Why Recent Interest in Research Why Recent Interest in Research Compliance?Compliance?

Expansion of the definition of the mission of Expansion of the definition of the mission of an academic institutionan 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 Research – 1940’s – V. Bush vision of combining

educational role and research roleeducational role and research role• Economic Development – 1980’s – Bayle-Dole Economic Development – 1980’s – Bayle-Dole

ActAct

Public ConcernPublic Concern

While the public is increasingly While the public is increasingly supportivesupportive of the of the resultsresults and the and the productsproducts that are the consequence of that are the consequence of research, they are also increasingly research, they are also increasingly concernedconcerned about about the the ethical stepsethical steps that researchers take to accomplish that researchers take to accomplish those results 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

Consequences of Individual ConcernsConsequences of Individual Concerns

Individual concerns leads toIndividual concerns leads to Public Discussion which leads to Public Discussion which leads to

RegulationsRegulations oror VoluntaryVoluntary ComplianceCompliance

with Ethicalwith EthicalPrinciplesPrinciples

Examples of Regulations and GuidanceExamples of Regulations and Guidance

Human ParticipantsHuman Participants• 45 CFR 4645 CFR 46• 21 CFR 50, 5621 CFR 50, 56• 38 CFR 1638 CFR 16• 45 CFR 160, 16445 CFR 160, 164 (HIPAA)(HIPAA)

• OHRP Guidance on Financial Conflict of InterestOHRP Guidance on Financial Conflict of Interest

Examples of Examples of Laws, Regulations, PrinciplesLaws, Regulations, Principles

Animal Welfare ActAnimal Welfare Act• 9 CFR Chapter 19 CFR Chapter 1• PHS Policy on Humane Care and Use of Laboratory PHS Policy on Humane Care and Use of Laboratory

Animals Animals • Guide for the Care and Use of Laboratory Animals, ILAR Guide for the Care and Use of Laboratory Animals, ILAR • U.S. Government Principles for the Utilization and Care of U.S. Government Principles for the Utilization and Care of

Vertebrate Animals Used in Testing, Research, and Vertebrate Animals Used in Testing, Research, and Training Training

Additional ExamplesAdditional Examplesof Regulationsof Regulations

Biological AgentsBiological Agents Radiation SafetyRadiation Safety Chemical SafetyChemical Safety Export ControlsExport Controls Certificates of Environmental ComplianceCertificates of Environmental Compliance

Charge of ORIACharge of ORIA

1.1. develop a framework for coordinating, monitoring, and develop a framework for coordinating, monitoring, and supporting the university research-related compliance supporting the university research-related compliance activities, activities,

2.2. establish a team of professional staff qualified and trained to establish a team of professional staff qualified and trained to provide high-level administrative support to faculty provide high-level administrative support to faculty compliance committees, compliance committees,

3.3. conduct post-protocol monitoring and auditing (quality conduct post-protocol monitoring and auditing (quality assurance) programs in such key areas as human and animal assurance) programs in such key areas as human and animal subjects and use of biohazardous agents, subjects and use of biohazardous agents,

4.4. conduct the annual disclosure of Conflict of Interest and conduct the annual disclosure of Conflict of Interest and Commitment and provide staff support to the University Commitment and provide staff support to the University Conflicts Committee, Conflicts Committee,

Charge of the ORIACharge of the ORIA

5.5. provide greater coordination for the development and provide greater coordination for the development and delivery of educational and training activities in the key delivery of educational and training activities in the key compliance areas, compliance areas,

6.6. develop and deliver a campus-wide program on the develop and deliver a campus-wide program on the Responsible Conduct of Research (RCR), Responsible Conduct of Research (RCR),

7.7. assure the development of written policies and procedures assure the development of written policies and procedures that foster an institutional commitment to stewardship and that foster an institutional commitment to stewardship and compliance, compliance,

8.8. assure prompt institutional response to detected problems, assure prompt institutional response to detected problems, support corrective action, and ensure necessary reporting to support corrective action, and ensure necessary reporting to federal agencies, and federal agencies, and

9.9. draft comments on behalf of Cornell on proposed regulations draft comments on behalf of Cornell on proposed regulations impacting institutional compliance. impacting institutional compliance.

ORIA Primary ResponsibilitiesORIA Primary Responsibilities

TrainTrain Provide Administrative SupportProvide Administrative Support Process Improvement and Audit ActivitiesProcess Improvement and Audit Activities Lead and/or Participate in Accreditation Lead and/or Participate in Accreditation

ReviewsReviews Maintain Assurances and CertificatesMaintain Assurances and Certificates

ORIA Primary ResponsibilityORIA Primary Responsibility

Subject Areas for TrainingSubject Areas for Training• Responsible Conduct in ResearchResponsible Conduct in Research

Data acquisition, management, sharing, and ownershipData acquisition, management, sharing, and ownership Mentor/trainee responsibilitiesMentor/trainee responsibilities Publication practices and responsible authorshipPublication practices and responsible authorship Peer reviewPeer review Collaborative scienceCollaborative science Human participantsHuman participants Research involving animalsResearch involving animals Research Integrity and MisconductResearch Integrity and Misconduct Conflict of Interest and CommitmentConflict of Interest and Commitment

ORIA Primary ResponsibilityORIA Primary Responsibility

Additional Subject AreasAdditional Subject Areas• Export ControlsExport Controls• Use of Restricted Access DatasetsUse of Restricted Access Datasets• Research Conflict ResolutionResearch Conflict Resolution

Educational ActivitiesEducational Activities

Training Activities provided by ORIATraining Activities provided by ORIA• Online Training SessionsOnline Training Sessions• Seminars and Discussions Groups Seminars and Discussions Groups • Remedial Training after a Process Improvement Remedial Training after a Process Improvement

Review and/or AuditReview and/or Audit Acknowledge existing educational activities Acknowledge existing educational activities

conducted by Schools, Colleges, Offices, etc.conducted by Schools, Colleges, Offices, etc.• Supplement those activities as neededSupplement those activities as needed

Documentation Training ActivitiesDocumentation Training Activities

ORIA Primary ResponsibilitiesORIA Primary Responsibilities

Provide Administrative SupportProvide 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)

ORIA Primary ResponsibilitiesORIA Primary Responsibilities

Process Improvement and Audit ActivitiesProcess Improvement and Audit Activities• Matching of Proposals to Protocols and Standard Matching of Proposals to Protocols and Standard

Operating ProceduresOperating Procedures• Random Process Improvement ActivitiesRandom Process Improvement Activities• Comprehensive For Cause AuditsComprehensive For Cause Audits

ORIA Primary ResponsibilitiesORIA Primary Responsibilities

Lead and/or Participate in Accreditation Lead and/or Participate in Accreditation Reviews Accreditation Reviews Accreditation • AAALAC – Animals SubjectsAAALAC – Animals Subjects• AAHRPP – Human ParticipantsAAHRPP – Human Participants

Maintain Assurances and CertificatesMaintain Assurances and Certificates

AssurancesAssurances Human ParticipantsHuman 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 Act American with Disability Act

Contact IndividualsContact Individuals

Hima Vatti, Associate DirectorHima Vatti, Associate Director Export ControlsExport Controls

Michelle DeStafano, Research Michelle DeStafano, Research Compliance Coordinator (IACUC Compliance Coordinator (IACUC and UCHS)and UCHS)

Matthew Aldridge, Education Matthew Aldridge, Education CoordinatorCoordinatorMaria Golonski, Process Improvement Maria Golonski, Process Improvement CoordinatorCoordinator

CommitteesCommittees

Sarah Demo, UCHS CoordinatorSarah Demo, UCHS Coordinator Toni Andres, IACUC CoordinatorToni Andres, IACUC Coordinator Sue Babcock, IACUC Administrative Sue Babcock, IACUC Administrative

AssistantAssistant Maria Golonski, IBC Coordinator Maria Golonski, IBC Coordinator

(Acting)(Acting) Yasmin Koolsam, Administrative Yasmin Koolsam, Administrative

AssistantAssistant

ORIA Contact InformationORIA Contact Information

E. Ray StinsonE. Ray Stinson ers39@cornell.eduers39@cornell.edu

General ORIA OfficeGeneral ORIA Office 35 Thornwood Dr., Suite 50035 Thornwood Dr., Suite 500 Ithaca, NY 14850Ithaca, NY 14850 607 255-3943 (Office)607 255-3943 (Office) 607 255-0758 607 255-0758

(Fax)(Fax) oria@cornell.eduoria@cornell.edu (email post office box) (email post office box)