UW Research

Frequently-Asked Questions

What changes require a Modification or a Report of New Information? (added 03.12.2020)

Modification requests are NOT REQUIRED if you are halting, rescheduling, or delaying study enrollment UNLESS those actions are at the request of the funding agency, study sponsor, or data & safety monitoring group.

Modification requests are REQUIRED and IRB approval must be obtained before you change study procedures (including consenting processes) for new or existing participants. Example: You want to administer new and follow-up study questionnaires over the phone instead of in-person, or you want to do an in-home visit for assessment of surgical recovery instead of having participants come into the clinic.

There are some limited exceptions to the requirement for a Modification: For IRB-approved applications that do not specify whether a procedure is remote versus in-person, you do not need to submit a Modification.

Check with your HSD Team or hsdinfo@uw.edu if you have questions. Be sure to include the following information in your Modification:

  • Potential impact on subject safety and protections
  • Potential impact on scientific integrity and/or benefits of the study
  • Plan for how existing subjects will be notified (if their participation will be affected by the Modification)
  • Number of existing participants affected by the proposed change (if any)
  • Date of proposed change implementation

Reports of New Information (RNI) are NOT REQUIRED for halting, suspending, re-scheduling or delaying procedures for current participants except for studies with ALL of the following characteristics:

  • The study involves an Intervention (i.e., not observational or no contact), and
  • The study involves more than minimal risk to the participants (i.e., it was initially reviewed by the full convened IRB instead of minimal risk “expedited” review), and
  • The suspension potentially has an impact on safety monitoring or the study’s scientific integrity

Reports of New Information (RNI) are REQUIRED when you

  • Have had to implement changes to study procedures (including halting, delay, or revision of monitoring procedures) to prevent an immediate apparent hazard to one or more participant and did not have time to obtain prior IRB approval, or
  • Are halting, suspending, re-scheduling or delaying procedures for current participants in studies with ALL of the following characteristics:
    • The study involves an Intervention (i.e., not observational or no contact), and
    • The study involves more than minimal risk to the participants (i.e., it was initially reviewed by the full convened IRB instead of minimal risk “expedited” review), and
    • The suspension potentially has an impact on safety monitoring or the study’s scientific integrity
Added 03.12.2020