As part of the Human Research Protections’ ongoing efforts to reduce investigator burden and to increase efficiency, the IRB Application has undergone an update, with many new features. The major changes include:
- IRB Registration through completion of the application and revised Appendix R
- Updated IRB Appendices
- International Research (Appendix H)
- Use of FDA-Approved Drugs & Investigational Drugs or Biological Products in Clinical Investigations (Appendix J)
- Use of FDA Approved or Cleared Devices and Investigation Devices in Clinical Research Studies (Appendix K)
- IRB Reliance Worksheet (Appendix R)
- Request for Short Forms (Appendix Q)
- Appendices will no longer auto-generate in the application. Instead a list of appendices to be completed will be provided once the application is completed with a link to the appendices on the Applications & Forms page, subsection Human Research Protections @ http://www.research.uci.edu/forms/index.html
- Questions added to determine if a study meets the definition of an applicable clinical trial for registering and reporting on CT.gov
- Ability to select Department Chair, Division Chief, or Institute Director. Upon submission of the application, a PDF copy of the IRB Application will be sent to the designee by email for signature
- Revised instructional text including updated instructions for adding study team members
Other enhancements include:
- Re-ordered sections for a better flow
- Updated Research Performance Sites section
- Simplified Subject Populations / Data Sources section
- Enhanced Research Procedures section allows for indication of the phase of the clinical trial
- New Informed Consent Process section provides consent options in a clearer format
- Revised Other UCI Committee Reviews section that lists only those committees approvals required prior to IRB review
- Scientific / Scholarly Review section allows researchers to indicate how scientific merit review was obtained, as applicable
- New section to list radioactive machines or materials to be used for research purposes. Also includes information about what requires Radiation Safety Committee (RSC) subcommittee review versus full committee review. RSC subcommittee review is concurrent with IRB review.
The updated IRB Application form will be available on April 18, 2017.
VERY IMPORTANT NOTE: Any pending drafts using the current version of the IRB Application will be removed on April 17, 2017 at 3 pm, prior to the release of the updated IRB Application. Please submit any pending draft IRB Applications ASAP!
