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Fred Hutch policy requires that all proposed changes to an Institution Review Board-approved research study must first receive IRB review and approval prior to implementation. The Research Modification Form, or Modification, is used for this purpose.
Generally, a new application, rather than a research modification, may be required when two of the three P's (purpose, population or procedures) change.
This page covers the following information:
NOTE: The Modification requires a principal investigator signature and date as well as other considerations. If any section of the form is incomplete, IRB may return the form.
For additional information, see the Fred Hutch policy on Modification to Ongoing Activities.
A Modification must be submitted when:
NOTE: For sites that do not use Fred Hutch as the IRB of record and are just being coordinated by Fred Hutch, updates to the list of coordinated sites on the Multi-Center Supplement need only be submitted with the Continuation Review Report. Individual modifications are not required unless the study involves an investigator-held Investigational New Drug, where external performance sites are reviewed through the External Performance Site Assessment Committee process. In such cases, modifications must be submitted to add new performance sites.
The IRB requires only original documents. These include the following:
All documents must be single-sided. Please do not use staples.
Keep a complete set of the documents submitted to the IRB for the study’s records.
Some special considerations regarding research modifications include the following:
Clinical Research Division: Some modifications may require further review by the Scientific Review Committee chair, and a biostatistician. Please download the CRS Modification Form from the Clinical Research Support website.
Sponsor trials: When a sponsor requests a modification, the letter or memo from the sponsor must be submitted along with the Modification and the revised document(s).
Public Health Sciences Division: Some modifications may require further review by the SRC chair or designee. Please download the CRS Modification Form from the Clinical Research Support website.
Accessing medical records from the University of Washington or Seattle Children's: Studies that will access medical records from these institutions prior to obtaining consent or authorization must meet the following requirements:
Approved with minor modifications: Requests to change the study status to "approved" should include the final funding agreement and/or external committee's approval document. In addition, if applicable, include the response to the IRB Committee's minor contingencies per the result letter. All requirements listed in the result letter must be submitted at the same time.
Reopening accrual: Requests to reopen a study to accrual should include a justification; for example, a brief summary of interim results.
Change in funding: Please submit an original completed Funding Source Supplement along with a copy. Please go to the Funding Source Document Review Policies for specific information regarding the review process. A modification form is not required to remove a funding source from a study.
Closing an exempt or cooperative review study, or ending an IRB Authorization Agreement when Fred Hutch was relying on the offsite institution's IRB for review: Only submit a Modification. A final report is not required.
Prepare a Modification. The following information must be included and should be explicit:
IRB approvals for modifications take two to three weeks to process. When modifications receive final approval, the IRO will forward one copy of the stamped, approved document(s) to the contact person listed on the RMF.
If the IRB chair determines full committee review is warranted, the modification will be scheduled for the next appropriate agenda date.