PAPER APPLICATION: Continuing Review (Status Report), Renew or Close

Version 5.6

For instructions on how to complete this form, see the last page.

Use this form ONLY when a paper-based Status Report is being submitted. Do not use this form with the web-based Zipline application system or for paper-based applications that are being converted to a Zipline application.

For HSD Office Use Only / Date Received:
[ ] Master Copy / [ ] Approved
[ ] IRB Working Copy / [ ] Disapproved
[ ] Researcher Copy / [ ] Withdrawn
[ ] Full IRB Review Required
[ ] Expedited Review / DORA
CRR #
Approval period from: / To:
Date of IRB action: / Printed name:
IRB Chair or Designee Signature:
Notes:
Research Study Information
Submission Reason / [ ] RENEW IRB application / [ ] CLOSE IRB application
Expiration date of IRB approval
IRB Application # / IRB Committee
IRB Application Title
Lead Researcher Name / Contact Name
Position and/or
academic appointment / Position and/or
academic appointment
Department/Division / Department/Division
Phone # / Phone #
Fax # / Fax #
Campus Box # / Campus Box #
Street address, if applicable / Street address, if applicable
Email / Email
[ ] Person completing this form is the same as the Lead Researcher / [ ] Person completing this form is the same as the Contact
Name of Person Completing This Form
(If not Lead Researcher or Contact): / Email: / Phone:
Name and Mailing Address for all paper-based correspondence
(if blank, correspondence will be directed to contact person, or lead researcher if no contact person)
Name: / Campus Box#: / Other address if not at UW:
  1. Research Activity Status
  1. RENEW IRB application because:

[ ] Enrollment (including screening procedures) not yet begun

[ ] New subject enrollment still in progress

[ ] Enrollment closed but subjects are still undergoing research procedures

[ ] Enrollment closed, all subjects have completed all research-related interventions; and the research remains open only for long term follow-up of subjects

[ ] All subject involvement completed, including follow up; all data, specimens, and records collected; need approval for data analysis only

[ ] Other, explain:

  1. CLOSE IRB application because:

[ ] Enrollment completed, research (and/or follow up) completed (*defined below at the end of Question B.1.), & data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished

[ ] Research never begun

[ ] Other, explain:

  1. ANTICIPATED Date of Closure:
  1. Study Progress
  1. Complete the table below, to provide information about your subject numbers.

Instructions:

  • Use the same groups, and group names/descriptions you’ve used on previous forms.
  • Add more lines to the table as needed, by using the “TAB” key while in the lower right cell
  • If this is your first Status Report, count from the date your research received IRB approval.
  • If you were unable to specify a target number of subject completions when you received IRB approval, put “N/A” in the Approved column for each group.

Definitions:

  • Completedmeans that all research procedures involving the subject or the obtaining of specimens/records/data have been completed for each subject, including any follow-up (such as follow-up access to medical records.)
  • Subjects in repositories are considered completed if no additional data will be obtained from or about them for the purposes of the repository.
  • Ongoing means that subjects are still involved, undergoing research activities, in follow-up, or for which you are still collecting records/data/specimens as of the date you complete this form.
  • If this is your first Status Report, count from the date your research received IRB approval.

# Completions / # Ongoing (subjects still involved) / # Withdrawals, drops, lost
Group Name / Description / Total approved by IRB / A At time of last Status Report / B Since last Status Report / A + B Total to date / C At time of last Status Report / D Since last Status Report / C + D Total to date
  1. For subjects who dropped out, were withdrawn or lost to follow up since your last Status Report, explain:
  • How many were lost to follow up, AND
  • Why each subject chose to withdraw, or
  • Why you withdrew each subject from the research

If this is your first Status Report, describe the dropouts and withdrawals that occurred since the date your research was approved by the IRB.

  1. Are the numbers of subjects participating in your research:

[ ] About what you expected at this time point in your research

[ ] Significantly ahead of what you expected at this time

[ ] Significantly lower than you expected at this time

If the numbers are significantly lower, why? What are your plans to address this?

  1. Provide any additional explanatory information about your research progress and/or subject numbers here:

Reminder: Consider whether the number of completed subjects for which you are approved is still adequate. If not, you should submit a Modification form to increase the number as soon as possible.

  1. Describe the changes in the risks and/or benefits to subjects over the last period of approval. If there are no changes in the risks or benefits, state: “None”.
  1. Summaries

1.Provide an abstract of the research using lay-language. Provide the following:

  • A summary of the purpose of this research activity,
  • A summary of the procedures subjects will undergo, and
  • A description of the subject population(s).

2.Provide a summary of the research progress to date.

  • Do NOT cut and paste from last year’s status report.
  • If you have not yet enrolled subjects, please explain why.
  • Send one copy of each manuscript based on the data from this research, written since the last approval.
  • If you are closing your IRB application, explain what you will do with identifiable data and/or the link to the subjects’ identities.
  1. Unanticipated Problems and Subject Complaints:

An Unanticipated Problem is an event that meets ALL of the following criteria:

  • Unexpected,
  • Related or possibly related to participation in the research, AND
  • Suggests that the research places (or could have placed) subjects or others at a greater risk of harm than was previously known or recognized. This includes physical, psychological, economic, or social harm.

Examples include: severe dizziness when the consent form listed mild dizziness as a risk, and loss of identifiable research data.

NOTE: Events which meet the definition of an unanticipated problem must be submitted using the REPORT: Problems form within 10 business days of discovery. If you have not yet submitted a Problem Report for any such events, do so now. (See SOP Reporting by Researchers.)

1.Describe each unanticipated problem that occurred in the last approval period in the table below (if none, write N/A):

Description of event / Problem Report/Modification #:

2.Provide a description of any complaints received in the last approval period (if none, write N/A):

3.Does this study have a DSMB (Data and Safety Monitoring Board) or other safety monitor?

[ ] Yes [ ] No

If YES: a.) If you have not already, submit a modification to add any DSMB reports received during the last study approval period.

b.) Append all DSMB reports received during the last approval period to this status report.

c.) Explain any concerns that the DSMB had about the study here:

4.Are you aware of any new information from the events described in this section or any other source (e.g. publications) that suggest the research places subjects at greater risk than described in your initial IRB application or subsequent modifications?

[ ] Yes [ ] No

a. If YES, provide an explanation of the new information and its impact on the risk assessment here:

  1. Financial Conflict ofInterest:

1.Confirm by checking the box that the principal investigator on this application has ensured that any investigators (as defined by UW policy GIM 10) added to this research are aware of policy GIM 10 and their responsibility for complying with its relevant requirements.

[ ] Confirmed

2.Has a new financial conflict of interest developed for any investigator since the last IRB approval of this study (that is, since the last Status Report or the approval of the initial application, whichever is most recent)? [ ] Yes [ ] No

a. If YES: Has it been disclosed to the University? (Since August 24, 2012, all disclosures are

made through the University’s online Financial Interest Disclosure system.) final review of this Status Report cannot occur until the disclosure has been made and reviewed by the University, and the outcome has been incorporated into the IRB’s Review.

[ ] Yes [ ] No

  1. Funding:

1.Please fill out the grant and contract information on the following page(s). Include all current and IRB-approved funding for the research, including indirect federal support* even if you think the IRB already has this information.

*Indirect federal support is generic (i.e., not tied to this specific study) federal salary support for the time that any key personnel spend on the research. Examples: Many training grants, fellowships, scholarships, and career development awards.

NOTE:

  • For Center or Program grants, list the Lead Researcher (Principal Investigator) and the Title for each separate project or core.
  • If there is new funding for the research, complete the ModificationForm and submit the form with complete copy of the grant proposal under separate cover.
  • Copy and paste the table below if you have multiple sources of funding.

FUNDING or SUPPORT #1
Support Ended or Never Begun / [ ] All funding has expired
[ ] This study was never funded
Type of Support / [ ] Grant
[ ] Fellowship
[ ] University Funds / [ ] Center Grant
[ ] Gift
[ ] Department Funds / [ ] Training Grant
[ ] Contract
[ ] Other: Describe:
[ ] Subcontract. Provide the following information about the prime/parent grant, contract, or award in the fields directly below:
Principal investigator:
Title of grant, contract, or award:
  • Agency/sponsor:

Funding Agency or Sponsor Name
Award Number
Title of Grant, Contract, Subcontract, or Award
Lead Researcher on Grant, Contract, or Award
What agency processed the funding proposal? / [ ] UW Office of Sponsored Programs
[ ] UW Development Office
[ ] UW Royalty Research Fund
[ ] Puget Sound Blood Center
[ ] Seattle Institute for Biomedical and Clinical Research (SIBCR) / [ ] VA Seattle/American Lake
[ ] VA Boise
[ ] Public Health Seattle/King County
[ ] Fred Hutchinson Cancer Research Center
[ ] Other:
Start Date of Funding / End Date of Funding / OR [ ] Not Applicable
If the above dates have changed since your last Status Report, please explain why (i.e. no-cost extension, etc.)
  1. Attachments (check all that apply):

[ ]Abstracts/published papers(please do not submit more than one copy of each abstract/published paper with your submission)

[ ]Financial Management Plan Letter

[ ]Current consent materials with IRB approval stamp

[ ]DSMB Reports

[ ]Radiation Safety Application and/or approval

[ ]Other, explain:

DO NOT SUBMIT THIS PAGE TO HSD

RENEWAL INSTRUCTIONS

NOTE: Delete these instructions before printing the Status Report Form.

  • Complete this form. It must be typed or printed, not handwritten.
  • Include the following attachments:
  • CURRENTLY APPROVED CONSENT MATERIALS with the IRB approval Stamp visible, if applicable

If you do not have a copy with an IRB approval stamp, contact the IRB staff working on your IRB application, at 206-543-0098.

Do not submit consent materials if the only research activities are now data analysis AND if consent materials have not been used with subjects during the past period of approval.

Do not submit consent materials that have been replaced by updated versions.

Do not submit copies of consent forms signed by individual subjects but rather a copy of the consent form(s)/materials you use to consent prospective subjects.

  • DSMB Reports, if applicable
  • Radiation Safety Committee (206-543-0463) renewal, if applicable
  • One copy of each published paper since last approval, if any
  • If you are requesting changes to your research, use the Modification Form. Do NOT request changes in the status report form.
  • Make the appropriate number of copies (see table below).
  • When preparing double-sided copies, please make sure that each item (e.g. Status Report Form, consent form(s), etc.) begins on the front of a new piece of paper.
  • All attachments must be COLLATED to create complete submission packets.
  • Send your completed packets to the Human Subjects Division six (6) weeks in advance of the IRB approval expiration date.
  • NUMBER OF SUBMISSION PACKETS: Level of review and/or IRB Committee assignment determines how many submission packets you need:

IRB Committee that reviews your research / Submission packets
IRBs A, B, D, and J / 3
For closing your IRB application / 2

CLOSURE INSTRUCTIONS

  • You cannot close the IRB application until the data analysis described in your initial application is complete. For a full discussion on when a study can be closed see: SOP Closure.
  • Complete this form. It must be typed or printed, not handwritten.
  • Send one copy of each manuscript since last IRB approval, if any.
  • NUMBER OF COPIES: Submit the original + 1 copy only. HSD will retain the original and return the second copy to you:
  • When preparing double-sided copies, please make sure that each item (e.g. Status Report Form, published paper, etc.) begins on the front of a new piece of paper.
  • All attachments must be COLLATED to create complete review packets.
  • NOTE: If you allow IRB approval to lapse, HSD will close your IRB application after 60 days, and then report the administrative closure to the following entities:
  • Your department chair, dean, or director (whomever is most appropriate)
  • Your faculty sponsor (if you are a student)
  • The funding source(s)
  • The office processing the funding (e.g., UW Office of Sponsored Programs)

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