Please Note: We Will Not Accept Handwritten Forms

Institutional Review Board

STATUS REPORT on IRB Application No. (IRB No.) with a due date of

IRB application was originally approved by the IRB on (Start Date)

Please Note: We will not accept handwritten forms.

IRB Status Report – Revised November 2003 4

1.0 Principal investigator:

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2.0 Title of study:

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3.0 Activity Status of the Research. Check the appropriate box (double-click on the box and select “Checked”):

Submit 1 electronic copy to and 2 hard copies (one with the original signature) unless otherwise noted.

Active. Enrollment is ongoing. The research study is to be renewed. Include copies of the approved consent and assent forms.

Active. Enrollment is closed. Continuing participation, including follow-up, of those already enrolled. The research study is to be renewed. Include copies of the approved consent and assent forms.

Study is completed. Active data analysis is ongoing. The research study is to be renewed.

Study has not started. The research study is to be renewed. Include copies of the approved consent and assent forms.

Study and data analysis completed. The research study is to be closed.

Study never done. The research study is to be closed. Submit one copy of this form, with items I-III completed.

Other. Please explain. Follow the instructions for the categories above in determining the number of copies and forms to be submitted.

Principal Investigator Assurance

I acknowledge that the information provided in this status report is an accurate and complete description of the research study. I acknowledge that I have provided the IRB the information necessary for its complete review of this continuing research activity. I acknowledge that I am responsible for reporting any emergent problems, serious or unanticipated adverse events, or proposed changes to the research study. I acknowledge that any proposed changes described in this status report will not be put into effect until I receive IRB approval to continue this research.

______

Signature of Principal Investigator Date

IRB Approval:

CHRMC IRB Chairperson______Date______

Approve_____ Disapprove______

Subject to the following conditions: ______

______

Period of approval: From ______Through ______

IRB APPROVAL VALID AS LONG AS APPROVED PROCEDURES ARE FOLLOWED

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4.0 Summary of Research Study

A. Provide a brief, non-technical abstract of the research. The abstract should describe the purpose of the research, the research populations to be enrolled, and the research intervention or procedures that participants will undergo. (Note: you may use the abstract from the original IRB application. However, if there have been substantial changes in the purpose, populations, or procedures, these should be reflected in the abstract.)

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5.0 Research Participants

Patients – From Children’s / Patients – From All Other Sites / Healthy Controls – From Children’s / Healthy Controls – From All Other Sites / *Other - From Children’s / *Other – From All Other Sites
No. of participants approved to enroll
No. of participants enrolled to date
No. of participants enrolled since study last renewed
No. of enrolled participants continuing in study
No. of additional participants needed to complete study**

* If others are enrolled, explain who they are, e.g., parents, siblings, school teachers, health care providers.

** If multicenter study, provide best estimate of number of additional participants to be enrolled at Children’s.

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A. Accrual goals

Is current enrollment of research participants meeting the accrual goals of the research study? Yes No.

If no, explain how this will affect ability to answer the study questions. What steps will be taken to address problems in accrual?

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B. Adverse Events - Children’s

1. Describe any unanticipated adverse events that have occurred to date in research participants enrolled under Children’s IRB approval. (Unanticipated adverse effects would be any effect not previously observed and not currently described in the IRB application and consent form. Unanticipated would also include adverse effects that are more frequent or more severe than previously observed.) Include only events that are likely or possibly related to taking part in the research. Briefly explain how each of these events was handled and how each was resolved for the participant.

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2. Explain if the unanticipated events described in B.1. were reported to the IRB. (Unanticipated events are to be reported to the IRB as they happen. See adverse event reporting guidelines on IRB web page http://irb.seattlechildrens.org/forms/adverse_event_forms/AE_reporting_guidelines.doc

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3. Summarize the anticipated adverse events that have occurred to date in research participants enrolled under Children’s IRB approval. Include only events that are likely or possibly related to taking part in the research. Explain how these events resolved for the participant. (Anticipated adverse events that do not occur with greater frequency or severity are reported on this form to the IRB at the time of renewal of the project).

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4. Have any deaths occurred to date in research participants enrolled in this study? Yes No. If yes, indicate the number of deaths, the cause of each death, and date of death. (Note: any death that is possibly related to participation in the research needs to be reported to the IRB within 7 days.)

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Adverse Events – Other Sites

5. Summarize the adverse events that have occurred to date at the other participating sites. Explain if the events were anticipated or unanticipated. If anticipated, explain if the events were more severe or more frequent than anticipated. Explain how the life-threatening or serious events resolved.

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Adverse Events - Consent Form

6. Are the adverse events that have occurred to date described in the currently approved consent form? Yes No.

If no, explain.

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C. Problems, complaints, protocol deviations, withdrawals – Children’s only

1. Explain if any research participants chose to withdraw from the study or if you or the sponsor withdrew any participants.

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2. Explain any problems or complaints received from the research participants or others about this study. Explain how they were handled.

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3. Explain any protocol deviations or deviations from IRB approved procedures.

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6.0 Study Progress

A. Is there a Data and Safety Monitoring Board (DSMB) associated with this research project? Yes No. If Yes, provide copies of correspondence or reports generated by this Board.

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B. Provide a brief progress report. If you have not yet enrolled research participants please explain why. The progress report should include enough detail to allow review of the study’s progress. Provide one copy of any new manuscripts or publications that have resulted from this project since the last IRB approval.

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C. Describe any new information (publications, presentations) available since the last IRB approval. Explain if this new information indicates a change in the risks or benefits of the research or a need to modify the research.

IRB Status Report – Revised November 2003 4

D. Attachment A describes changes to the research project that were approved by the IRB during the last period of approval. Please review and return the Attachment, either confirming or correcting the information. If there are any inaccuracies or omissions, please explain. If the description of changes is accurate, please confirm.

IRB Status Report – Revised November 2003 4

7.0 Proposed Changes to Study

A. Do you propose any changes to this study at this time? Yes No. If yes, describe. If the changes proposed are major you may need to submit a revised IRB application. Please contact the IRB office if you are making major changes to the study at this time.

IRB Status Report – Revised November 2003 4

B. Do you propose any changes to the consent or assent forms at this time? Yes No. If yes, describe the changes and submit revised forms.

IRB Status Report – Revised November 2003 4

8.0 Funding

Attachment B describes the current information the IRB has in your file regarding awarded and pending funding proposals for this research study. Please review and return the Attachment, either confirming or correcting the information.

IRB Status Report – Revised November 2003 4

A. Are there any corrections to the funding information reported in Attachment B? Yes No. If yes, please describe

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B. Are there any funding proposals, awarded or pending, to support this research study that are not currently listed in Attachment B? Yes No. If yes, provide complete funding information and one complete copy of the funding proposal for the IRB’s review.

IRB Status Report – Revised November 2003 4

9.0 Financial Interests

A. Does any member of the research team or their immediate family have a financial interest in the research or its products that could be or appear to be affected by the outcome of the research? Yes No.

B. Does any member of the research team or their immediate family have a financial interest in the sponsor of the research (e.g., equity interest, speakers bureau, financial compensation for services). Yes No.

If Yes to 9.A. or 9.B., submit a description of the financial interest (this can be a copy of the disclosure statement made by PI or other research team members to Children’s institutional officials.) If there are significant financial interests that require management by the institution, describe the institutional plans for managing the conflict of interest.

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