IRB form_Modification

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					Institutional Review Board
1100 Fairview Ave. North, J6-110, Seattle, WA 98109-1024 Telephone 667-5900 (FHCRC)

Protocol Modification Form
Date Received _____________________
Revision or amendment # assigned by sponsor or PI: Phone Phone

Date Investigator Contact Person STUDY TITLE:

IR #

Protocol #
Version date (if applicable)

Mailstop Mailstop

A. GENERAL INFORMATION 1.0 REASON FOR MODIFICATION: List the modification(s), the rationale for each modification(s) below. If “Reason for the Modification” is more than a simple administrative change (e.g. funding change, change in study staff) please describe it on a separate page and append it to this form.


MATERIAL REVISED/AMENDED: Check all the documents that are being modified at this time. Include One (1) Track Change version of each modified document to facilitate IRB review of the proposed modification(s). Consent Form Letters of Approach Protocol Protocol Synopsis Questionnaire Investigator’s Report from Sponsor or Other: Brochure (please provide Investigator Describing a summary of changes) Premature Closure of Study LEVEL OF PRIORITY: Does this modification require IRB review within 24 hours of the IRO receipt of this request? NO YES → If yes, please check the applicable boxes: Patient waiting for treatment. Date & time of treatment: Adding New Funding Source with urgent deadline, Deadline Due: Approval required prior to consenting any additional new research participants. Note: the PI is responsible for assuring that no new participants are enrolled and consented prior to the approval of this modification. Other, please describe:


As PRINCIPAL INVESTIGATOR, I acknowledge that no modifications will be put into effect without Institutional Review Board (IRB) approval, which is contingent on IBC and RSC approvals when required, except where necessary to eliminate apparent immediate hazards; I also acknowledge that I will provide the IRB all the information on the research project necessary for its complete review. NOTE: Only the Principal Investigator or designee listed on this Protocol Modification form can sign the application.

Typed (print) Name



This shaded box is for IRO only IRB Committee (Reg ID):  A (021)  B (022)  C (5619) Expires 04-29-2012 Assurance #: FWA00001920 Expires 12-03-2011

 Expedited

 Full

Agenda date _________________________ Revision/Modification__________________

____________________________________ Approval Signature, Chair or Designee

______________________ Date

_____________________________ Printed Name

Dates of IRB Approval_____________________________TO____________________________________________

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IR #

Protocol #

B. REGULATORY CONSIDERATIONS FOR IRB REVIEW 1. This modification involves: (please check all that apply) Research Design and/or Resources Risks to Participants or Others in Relation to Anticipated Benefits Participant Selection or Recruitment/Approach Process Consent Process and/or Compensation Methods for Documenting Consent Potential Willingness of Research Participants to Continue to Take Part in This Study Monitoring of the Data being collected Privacy of Research Participants and/or Confidentiality of Research Participants’ Data None of the above If you checked any of the boxes above, please summarize the changes below.

Additional Considerations: (please check all that apply and respond in the box below) A. Is there a change in dosing? NO YES → please summarize the change in dosing. B. Do you plan to enroll or access identifiable data from a new vulnerable population not already approved by the IRB? NO YES → please include additional safeguards that will be added to the protocol to ensure the safety and welfare of this new population. C. Do you plan to re-consent previously enrolled research participants as a result of this modification? NO YES → please outline the re-consenting process.

C. OTHER REGULATORY AND/OR ADMINISTRATIVE REVIEW REQUIREMENTS 1. Does this modification involve the addition of a new funding source? NO YES → submit a completed Funding Source Supplement. 2. Does this modification involve the addition of or any change in the deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA, into human subjects (human gene transfer)? NO YES → respond to A and B: A. Please indicate the site where the recombinant material will be transferred to the human subjects and contact the IBC staff at the site to determine what biosafety review and documentation is required. Fred Hutchinson Cancer Research Center (Biosafety Officer at 667-4045) University of Washington (Biosafety Officer at Seattle Cancer Care Alliance (Research Implementation Officer at 288-1287)
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IR #

Protocol #

B. Does the institution checked above require IBC review? NO YES → please provide date of IBC contact and provide the status of IBC review. Date of IBC contact: Approved and the Institutional Biosafety Committee (IBC) approval document is appended. Pending 3. Does this modification involve a change in radiation exposure to research participants or the addition of any radiation exposure? NO YES → is Radiation Safety Committee Review required? NO YES → (see guidelines for radiation safety review) If yes, please respond to A and B: A. What is the status of the Radiation Safety Committee review of this modification? Approved and the radiation safety committee approval document is appended Pending. B. Does the "risks" section of the informed consent(s) address this change in radiation risk(s)? YES NO → explain why the consent form(s) does not describe the risk(s).

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