February 8, 2007.ppt

Tentative and Preliminary – For Discussion Purposes Only eResearch: University of Michigan Business Finance Forum Marvin G. ParnesAssociate Vice President for Research Executive Director of Research Administration The Big Picture – Research at U-M At any given time, more than 5,000 externally sponsored research projects are underway at UM UM has about 7,000 active research studies involving human subjects, all of which must receive annual scrutiny from a number of campus boards and committees UM uses over 400,000 animals in research each year. Studies involving animals are also subject to review to ensure compliance Proposal Statistics – FY2005 Proposals Submitted Total 5,230 (2,502 Federal) Dollar Value $3,282,880,553 ($2,686,777,794 Federal) Awards Received Total 2,375 (904 Federal) Dollar Value $780,795,422 ($605,410,738 Federal) Overview of Research Administration A Brief History of Human Subjects Research in the US 1974: National Research Act and IRB System Congressional hearings directed by Senator Edward Kennedy in 1973,culminating in National Research Act of 1974 Established modern Institutional Review Board (IRB) system Established the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research In 1978, the Commission issued the Belmont Report The Belmont Report Eightdocument explaining the three principles IRB members use to evaluate the ethics of specific research proposals: Respect for persons Beneficence Justice Code of Federal Regulations (CFR) Specific legal requirements originating from Belmont Report are covered in: CFR Title 21: Food and Drugs CFR Title 45: Public Welfare UM Institutional Review Boards The IRB System IRB = Institutional Review Board Board for the review and approval of all research involving human subjects conducted at the institution (i.e., UM) Who is on the IRB? Physician scientists Non-physician scientists Social/Behavioral scientists Non-scientists (e.g., community mem