Modifications

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 Modification Supplement, 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:

• When to submit a Modification
• How many copies to submit
• Special considerations
• Submission instructions

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.

When to Submit a Modification

A Modification must be submitted when:

• any change is proposed to the research plan, consenting process, population, planned enrollment, source of subjects, or other aspects of the research outlined in the initial application questions;
• any change is proposed to the protocol, consent, advertising, questionnaires or any other study documents are made;
• any minor editorial modifications or corrections are made;
• a funding source is added or removed;
• ending an IRB Authorization Agreement when Fred Hutch was relying on an offsite institution's IRB for review;
• closing an exempt or cooperative review study; or when
• the PI of the IRB file is changing (Modification must be signed by current PI and submitted with an acceptance memo from the proposed new PI).

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.

How Many Copies to Submit

The IRB requires only original documents. These include the following:

• The Modification
• One track-change version of each modified document to facilitate IRB review of the proposed modifications
• A clean version of each modified document

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.

Special Considerations

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:

• Complete and submit a Waiver of Consent Supplement.
• Complete and submit a HIPAA Supplement and Waiver of Authorization.

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.

Multicenter activities:

• An IRB Authorization Agreement is required when the offsite institution will rely on the Fred Hutch IRB for review and approval.
  
• An Individual Investigator Agreement is required when adding a new collaborating investigator to the 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.

Submission Instructions

Prepare a Modification. The following information must be included and should be explicit:

• IRO file number of the already-approved application
• Name of the PI requesting the modification
• List of all the modification(s) and rationale for each. A summary listing the specific changes to a document(s), the page number(s) being modified and the rationale for the changes must be included with each Protocol Modification Form. For example, "protocol, page 3, paragraph 5, adding the new risk of ___ because ___." If a summary list is not included, the modification may be returned.
• If the sponsor is requesting changes, submit the memo or letter from the sponsor along with the Modification.
• Check the applicable materials/documents that are being added or being revised with the modification.
• Level of priority: Examples of valid reasons for priority review are revisions involving patients waiting for treatment, changes in risk and confidentiality concerns. Printing deadlines, routine changes to study documents, and impending staff vacations are not considered valid reasons for priority review requests.
• Regulatory considerations for IRB review: Check the appropriate check boxes. (1) Dose change: If the modification involves either increasing or decreasing the dose, a summary of the change must be included. (2) Inclusion of a vulnerable population: If the modification involves the inclusion of a vulnerable population, please include the additional safeguards that will be added to the protocol to ensure the safety and welfare of this new population. (3) If the modification involves the re-consenting of previously enrolled research participants, include the re-consenting process.
• Change in funding: Please submit a completed Funding Source Supplement.
• Institutional Biosafety Committee review.
• Radiation Safety Committee review.

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.