IRB
Updates to IRB Applications
September 25, 2009
The OSU IRB application forms have been updated to clarify and improve information exchange between investigators and the IRBs. A summary of the major changes is provided below:
Initial Review of Human Subjects Research and Appendices – v 2.2
- Revised Financial Conflict of Interest question and note to reflect new screening process and provide disclosure examples
- Revised Funding question and note to clarify request for copy of grant proposal, include the source of additional support, and delete section for RF proposal number
- Additional questions to elicit information about multi-site research
- Revised term “adults unable to consent” to “decisionally impaired adults”
- Additional question and clarifications for participant identification, recruitment, and selection
- Revised Confidentiality section to create two sections - “Privacy of Participants” and “Confidentiality of Data”
- Revised Risk question to replace checkboxes with request to describe all expected risks
- Appendix E (Devices) – added details about new COM/OR review; added question about device accountability, storage, and recordkeeping
- Appendix F (Drugs and Biologics) – added details about new COM/OR review; added question about drug/biologic accountability, storage, and recordkeeping
- Appendix W added for the inclusion of Decisionally Impaired Adults (replaces questions in main application)
- Other minor changes including reformatting, addition of clarification statements/terms, and updated hyperlinks
Continuing Review of Human Subjects Research and Appendices – v 2.2
- Revised Financial Conflict of Interest question and note to reflect new screening process and provide disclosure examples
- Revised Funding question and note to clarify request for copy of grant proposal, include the source of additional support, and delete section for RF proposal number
- Revised term “adults unable to consent” to “decisionally impaired adults”
- Other minor changes including reformatting, addition of clarification statements/terms, and updated hyperlinks
Amendment/Changes to Research and Appendices – v 2.2
- Added statement to clarify that it is not required to resubmit the Initial IRB Application for review of amendments
- Added signature box and review for Change in PI
Effective Date: November 1, 2009 (new versions must be used by this date)
