Research Modification Form

• When to submit a Research Modification Form?
• How many copies to submit?
• When does a Modification require a new application?
• Special Considerations
• Submission Instructions

 Research Modification Form

The Research Modification Form requires the Principal Investigator's signature and date as well as other considerations. If any section of the form is incomplete, the form may be returned to you.

 Research Modification Form  [download word doc] 

When to submit a Research Modification Form

The Research Modification Form must be submitted when:

• Any change 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 to the protocol, consent, advertising, questionnaires, or any other study documents are made. This includes minor editorial modifications or corrections. Adding or removing a funding source.
• Adding new performance sites / individual investigators when FHCRC is acting as the coordinating center;
• Closing an exempt or cooperative review study;
• Ending an IRB Authorization Agreement when FHCRC was relying on an offsite institution's IRB for review 

How many copies to submit

The IRB requires ONLY the ORIGINAL DOCUMENTS.

The original documents include:

Research Modification Form One (1) track change version of each modified document to facilitate IRB review of the proposed modification(s)   Clean version of each modified document All documents must be single-sided. Please do not use staples. It is recommended that a complete set of the documents submitted to the IRB be kept for your records.

When does a modification require a NEW IRB application?

Generally speaking, when two of the three P's change (Purpose, Population or Procedures), a NEW application may be required.

Special Considerations

Clinical Research Division (CRD) Some modifications may require further review by the Scientific Review Committee (SRC) or Clinical Investigator Meeting (CIM) Chair, and a Biostatistician.  Please download the Scientific Review Revision Form from Clinical Research Support website (this is not a requirement for Minimal Risk or Exempt studies).  If you have any questions, please contact Clinical Research Support.

Sponsor Trials When a Sponsor is requesting a modification, the letter/memo from the Sponsor must be submitted along with the PMF and the revised document(s).

Public Health Sciences Division (PHS) Some modifications may require further review by the SRC Chair or designee. Please download the "Modification Checklist for Scientific Review Committee" from Clinical Research Support website (Protocol Review Requirements / Ongoing Protocol Review). Please download the Scientific Review Revision Form. [Scientific Review Revision Form]

Accessing Medical Records from UW or Seattle Children's Studies that will access medical records from the University of Washington (UW) or Seattle Children's prior to obtaining consent or authorization must meet the following requirements: Request for a Waiver of Consent - complete and submit a Waiver of Consent Supplement  [download Word doc] Request for a HIPAA Authorization - complete and submit a HIPAA Supplement and Waiver of Authorization  [download Word doc] Complete a confidentiality agreement of the appropriate institution after receiving IRB approval from FHCRC. UW PIs submitting an UW Consortium application must also submit this form. Note: It is the PI's responsibility to obtain the signature from the respective institution's human subjects department. UW Confidentiality Agreement Form — Please contact the University of Washington Human Subjects Division at (206) 543-0098 with any questions regarding this document. Seattle Children's Oath of Confidentiality Form — Please contact Seattle Children's IRB at (206) 987-7820 with any questions regarding this document.

Approved with minor modifications Requests to change your study status to Approved should include the final funding agreement and/or external committee’s approval document (e.g. radiation safety committee) and if applicable, 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 a completed Funding Source Supplement along with a copy of the Funding Source Document. Please go to the Funding Source Document (FSD) Review Policies for specific information regarding the review process for funding source documents.  A modification form is not required to remove a funding source from a study.  [download Word doc]

Multi-center activities IRB Certification of Approval - adding a new performance site when FHCRC is acting as the coordinating center.  You may also new/need to submit a revised Mulit-Center Supplement Form. IRB Authorization Agreement - when the offsite institution will rely on the FHCRC IRB for review and approval. Individual Investigator Agreement - adding a new collaborating investigator to the study

Closing an Exempt or Cooperative Review Study or Ending an IRB Authorization Agreement when FHCRC was relying on the offsite institution's IRB for review Only submit a Research Modification Form.  A final report is not required.

Submission Instructions

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

• IR File Number of the already approved application
• Name of the principal investigator requesting the modification
• List of all the modification(s) and Rationale for each modification. A summary listing the specific changes to a document(s), the page number(s) that is/are being modified and the rationale for the change must be included with each Protocol Modification Form. If not, the modification may be returned to you. For example, "protocol, page 3, paragraph 5, adding the new risk of.... because....."
• If the Sponsor is requesting the changes, the memo/letter from the Sponsor must be submitted along with the RMF;
• Check the applicable Materials/Documents that are being added or being revised with this 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 checkboxes.  
  
  • Dose Change — If the modification involves either increasing or decreasing the dose, a summary of the change must be included.
  • 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. 
  • 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 updated January 15, 2010
  • Institutional Biosafety Committee Review
  • Radiation Safety Committee Review

Modifications take two to three weeks to process for IRB approval. Once the modification receives final approval, the IRO will forward one copy of the stamped approved document(s) to the Contact Person. If the IRB chair determines full committee review is warranted, the PI and contact person will be notified by email. The modification will be placed on the next appropriate agenda date.