Updates from the Human Research Protection Program: May 2023


New: “Abandoned Draft” Clean-up Project

There are many new study applications in “Draft” mode (have never been submitted to the IRB) in iRIS that have not been touched by the study team in over a year. These are now on outdated versions of the application form which do not include all of the questions currently required for IRB review.

Effective June 30th, 2023, any new study applications that are still in Draft mode and that haven’t been revised since June 30th, 2022, will be labeled as ‘Abandoned Draft.’ Study teams will still be able to view these abandoned draft applications, but they will no longer be editable or submittable.

If you have a new application draft that you have not worked on since June 30th, 2022, and still intend to submit to the IRB, you have 2 options:

  1. Revise or submit it before June 30th, 2023. If prompted by iRIS, you must “convert to new form version” and answer any new questions/sections.
  2. Start a new application. You can copy and paste answers from the Draft version as appropriate. 

New: Self-Service Closure of Exempt Studies

If you have Exempt projects that are complete, you can close them yourself without having to submit a Study Closeout Report to the IRB. It is important to close completed studies so the IRB can accurately report on our active research portfolio. Follow the steps in the iRIS Home Screen Tutorial to close completed Exempts.

New: Help Guide for Attaching Study Documents

When the IRB approves a document attached to an IRB submission, the document is converted to an approved PDF in iRIS. Some documents have characteristics that end up corrupting the file when it is converted after approval, making it no longer accessible. The most common sources of corruption are:

  1. Document is Password Protected
  2. Document has some XML code or special characters

Refer to the new help guide (available on the iRIS Help Site) to identify and fix these documents before submitting them to the IRB.

Updated: Instructions added for A# and P# in the Study Application

The IRB’s Initial Submission Checklist has been updated to include to new items:

  1. If your study involves radiation, submit to the Radiation Safety Committee (RSC). Review the RSC instructions.
  2. Note: Some types of documents are not compatible with the iRIS system (e.g., password-protected, watermarked, XML code, etc.). Follow this guide before submitting your study: Check for (and Fix) Corruptible Files.

Updated: Post-Approval Reporting Guidance

The IRB website guidance on External (off-site) adverse events and the Post-Approval Reporting Requirements Summary Sheet have been updated to clarify the following points about external safety events. Note: “External” refers to any study site that does not rely on the UCSF IRB.

  1. External Safety reports (e.g., SUSARs) are required when the incident results in a change to the study’s risks or necessitates a change to IRB-approved documents.
  2. If a sponsor requires that an external safety event undergo IRB review even when there is no change to study risks, submit the report on the iRIS 'Reporting Form.'

Reminder: Sample IRB Applications Available for Reference

The iRIS Help Site has a growing library of IRB-approved applications to be used as examples of how to answer application questions, and as a guide to some of the branching paths that the application can take for different types of studies. Special thanks to the research teams who have allowed us to post their exemplary applications.

Coming Soon: New Consent Form Templates

New consent form templates will be released this summer. The main goal for the revisions is to provide a form that is easy for participants to understand. Secondary goals are to make the template easier for study teams to use, and to reduce negotiation time with sponsors over consent language. Already-approved consent forms will not need to be updated to the new templates. More information will be provided in a separate bulletin, and there will be a grace period between the announcement and the implementation date.

Coming Soon: New Continuing Review Form

A new version of the Continuing Review Form will be released this summer. Among the many updates to the form, the most notable is this: In order to streamline approvals and prevent expirations, the new form will not permit study teams to submit changes at the time of Continuing Review. This will also eliminate the common problems with version control in consent forms and the study application, which require extensive IRB Analyst and study team effort to resolve. More information will be provided in a separate bulletin, and there will be a grace period between the announcement and the implementation date.

Did you know? IRB Satisfaction Survey 

As part of our ongoing effort to improve service, we request your feedback via a 3-minute survey after each submission approval. The survey link is included in every IRB approval letter and is also accessible from the IRB homepage. Feel free to forward the survey to any member of your research team who can provide feedback about the IRB review experience.