WHEN IS INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL NECESSARY FOR A STUDY?
[Also see Decision-Support Flow Chart] The basic requirements are contained in the Code of Federal Regulations (Title 45, Part 46, Section 102) which is quoted below. It is necessary to obtain MUOT IRB approval for any RESEARCH which involves HUMAN SUBJECTS. That is, research involving a living individual about whom an investigator (whether professional or student) conducting research obtains: 1. Data through interventions or interactions with the individual, or 2. Identifiable private information INTERVENTION includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. INTERACTION includes communication or interpersonal contact between investigator and subject. PRIVATE INFORMATION includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has bee
Related Questions
- Our organization requires review of all research projects by our Institutional Review Board (IRB). Do we need to secure final IRB approval for the proposal process?
- Do I need Institutional Review Board (IRB) approval at time of submission of grant application?
- WHEN IS INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL NECESSARY FOR A STUDY?
