SPS Round Table The Use of Human Participants in Research Office of Research Integrity and Assurance (ORIA) April 17, 2007

Presenters E. Ray Stinson, Ph.D. –Assistant Vice President for Research Compliance; Director, ORIA Matthew Aldridge –Education Coordinator, ORIA Sarah Demo –IRB Coordinator, ORIA

General Comments Research Proposal vs. IRB Protocol –One to Many and Many to One Relationship –Research Proposal not required for an IRB Protocol IRB Protocol Always required if –Activity meets definition of Research –Activity meets definition of Human Participants Research Proposal is highly desirable but not always required –Institutionally supported –Extramurally supported

Research Proposal vs. IRB Protocol Only selective individuals have the responsibility to submit a research proposal for funding (Faculty, Students) Everybody (Faculty, Students, Staff, non Cornell employee) has the responsibility for an IRB Protocol, if the regulations apply

Name Change Since the 1960’s the IRB at Cornell University has been named the University Committee for Human Subjects Effective February 2007, the name has been changed to –Institutional Review Board for Human Participants –Abbreviated to the IRB

IRB for Human Participants Reason for Name Change –Generic Name for all committees that are charged with reviewing research involving human participants –Presidential Commission recommended that investigators use the term Human Participants instead of Human Subjects be used to reflect Humans are participating in research and not simply the object of the research Acknowledge the principle that that individuals give consent to participate (Respect for Persons)

IRB for Human Participants Faculty voted in February for a New Charge to the IRB Cornell’s Commitment to Protecting Human Participants –Definitions –Organizational Roles –Charge –Membership –Administrative Support –Annual Report to the Faculty Charge will soon to be located on the newly redesigned IRB web site

IRB for Human Participants 1.ORIA is working on the development of an Institutional Policy on the Use of Human participants in Research Project will take approximately 1 year to complete 2.ORIA and IRB are working on new Policies and Procedures 16 Policies and Procedures have been identified 7 are currently being developed 3 have been approved by the IRB