IRB Responsibilities. Marisue Cody, PhD September 6, 2006 Baltimore, MD . Authority & Responsibilities. United States Code (U.S.C.) Code of Federal Regulations (CFR) VHA Directives VHA Handbooks VHA Manuals OHRP Guidance FDA Guidance. Oversight Authority.
Marisue Cody, PhD
September 6, 2006
… a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to “generalizable” knowledge.
(38 CFR 16.102d)
…means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) data through intervention or interaction with the individual, or(2) identifiable private information
More detail, plus some extras:
Prior to initiation
8. Additional protections for vulnerable subjects
Additional VA requirements:
9. Conflict of interest is evaluated and managed
10. Ensure Investigator educational requirements and certifications
Requires submission of a written progress report that includes:
Written Progress Report (cont.)