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IRB Applications and Forms Latest Revisions

April 2008 Revisions

e-Application for IRB Review

  1. Added a link to the Determination of non-Human Subjects Research form.
  2. Level of Review – added a link to the levels of review to aid investigators in determining the correct level of review
  3. Lead Researcher – added section for Lead Researcher to specify their UCI affiliation
  4. Procedures – revised the option for indicating when scanning methods (e.g., CT scan, Dexa, etc.) will be used
  5. Data Safety - completion of Appendix S is now required for all clinical investigations.
  6. Hazardous Agents – added the heading Controlled Substances and included a section for specifying any controlled substances that will be used as part of the study
  7. Committee Reviews – removed the Dean’s Scientific Review Committee option and added the Institute for Clinical and Translational Science (ICTS) and Radioactive Drug Research Committee (RDRC).
  8. Appendix B – Revised options and added instructional text: If studying both pregnant women and neonates, the option for pregnant women should be selected on this page and children should be selected as a study population on the Populations page so Appendix D can also be completed.

Previous Revisions

August 2006 Revisions

e-Continuing Protocol Application

  1. Section 2 – moved Study Progress question to this section
  2. Section 6 – updated definition of disclosable financial interest
  3. Updated instructions throughout module.

e-Modification Request

  1. Investigator must determine type of changes – Minor (expedited review) vs. Significant (requires full Committee review)
  2. Section 1: added questions about subject accrual and study progress
  3. Updated instructions throughout module.

July 2006 Revisions

Protocol Narrative

  1. Section 3: Revised wording to elicit information concerning the ordering of study procedures (i.e., chronological description of study procedures, timing of procedures) and how subject privacy will be protected while data is being collected.
  2. Section 4: Revised wording to elicit information about how the target sample size was determined.
  3. Section 5: Added reminders for submitting recruitment advertisements for IRB approval.
  4. Section 6: Revised wording to elicit information concerning how informed consent will be obtained from subjects (i.e., the process of informed consent); Added reminders for completing the required Appendices for informed consent waivers.
  5. Section 9: Revised wording to elicit information concerning how the study team will respond to adverse events and manage unanticipated problems when they occur.
  6. Section 12: Revised wording to clarify electronic data storage and retention options.

April 2006 Revisions

Biomedical Consent

  1. Update Costs and Compensation for Injury Language

March 2006 Revisions

Protocol Narrative

  1. Add hyperlink to instructions
  2. Combine Section 1A and 1B - Purpose and Background of the Research
  3. Add instructions to include Faculty Sponsor as Co-Researcher
  4. Number questions within sections (e.g. Sections 6 and 7)

Biomedical Consent

  1. Update Costs and Compensation for Injury Language
  2. Remove signature lines from Experimental Bill of Rights

Experimental Subject's Bill of Rights

  1. Remove signature lines