Please read carefully! Our policy about ZIPLINE Conversion has changed.

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Re:16 WEEKS BEFORE IRB APPROVAL EXPIRES

IRB approval for this study will expire on[expiration date].Your submission is due by [DATE: 8 weeks before expiration].It is your responsibility to renew or close your study before the expiration date.

To CLOSE your study:

Submit a final report on PAPERto the Human Subjects Division, using the APPLICATION: Continuing Review (Status Report), Renew or Close. Select the “Close IRB Application” option on the form. See the last page of the form for additional instructions. If you do NOT submit a final report, your study will be administratively closed sixty (60) days after the expiration date. In some cases, administrative closures must be reported to funding sponsors.

To CONTINUE your study:

Please read carefully! Our policies have changed.

As part of the transition to the Zipline system, researchers must “convert” certain IRB-approved studies that exist on paper to Zipline’s electronic format. This involves entering the study into ZIPLINE as a “new study” using the new ZIPLINE applications forms. This process is called ZIPLINE Conversion.

HSD’s experience with conversions since September and pending changes to the regulations that govern human subjects research indicate that the work of conversion for most low risk studies is greater than the benefit. For this reason, we are now focusing our efforts on the conversion of studies that have been reviewed by the full convened IRB committee.However, HSD may require that other studies be converted if they would benefit from conversion now. HSD staff will contact research teams directly as these are identified.

Any study that is still open and active as of May 2020 will be evaluated for whether conversion would be appropriate for the remaining life of the study. We expect that most minimal risk research will have been completed by this time and that the number of studies that need conversion will be relatively small.

See the table below for information about what to submit. Studies with a committee letter designation of A, B, D, or J are generally required to convert unless the study will close in one year or has completed all study procedures except data analysis. Requirements vary depending upon the status of the research.

Study Status / Submission Requirements
Study will close in 1 year (including all data collection and analysis of identifiable data) / No conversion required. Renew your IRB approval by completing and mailing to HSD the required number of PAPER copies of theAPPLICATION: Continuing Review (Status Report), Renew or Close
No other documents are required. Be sure to include the anticipated closure date in the form (question A.3).
All data/specimen collection completed*; open for data analysis only
*Completed means that all research procedures involving subjects or the obtaining of specimens/records/data have been concluded / No conversion required. Renew your IRB approval by completing and mailing to HSD the required number of PAPER copies of theAPPLICATION: Continuing Review (Status Report), Renew or Close
No other documents are required. Be sure to include the anticipated closure date in the form (question A.3).
Data collection has not yet begun or is ongoing and study letter is EA, EB, ED, or EJ / Conversion is optional. Renew your IRB approval by completing and mailing to HSD the required number of PAPER copies of theAPPLICATION: Continuing Review (Status Report), Renew or Closeor see conversion instructions below.
No other documents are required. Be sure to include the anticipated closure date in the form (question A.3).
Data collection has not yet begun or is ongoing and study letter is A, B, D, or J / Conversion required. Renew your IRB approval by submitting a ZIPLINE Conversion application.
Instructions:
  • Enter the study into ZIPLINE as a “new study”
  • Complete the ZIPLINE web-based SmartForm and upload the ZIPLINE Conversion documents below.
  • Use the Conversion Preparation Checklistand Conversion Quick Tipsfor a successful conversion
  • Do not include information and materials related to research activities that are complete, except as requested in the Status Report form.
  • Do not include modifications to the research. These are generally not permitted at the time of conversion.
  • For more information about Zipline online instructions and tutorials visit theZipline Online Help librarypage on the HSD website.
Conversion documents:
1.ZIPLINE APPLICATION: Status Report, Conversion Study
2.ZIPLINE APPLICATION: IRB Protocol or ZIPLINE APPLICATION: IRB Protocol, No Contact
Question 9.4/7.3 Retention of identifiers should be left unanswered. Question 9.6/7.5 Data and specimen security protections should describe previously approved data security measures (no data security level should be selected).
3. Consent documents. Consent documents are not needed when enrollment is closed unless enrolled subjects will be asked to consent to new procedures. Consent documents must be current IRB approved version, in Microsoft Word format.
4. Applicable ZIPLINE SUPPLEMENTS (e.g. ZIPLINE SUPPLEMENT: Drugs)
5. Relevant supporting documents. Other documents, such as advertisements, questionnaires and drug brochures, should be provided for ongoing research activities only. Grant applications, confidentiality agreements, certificates of confidentiality, radiation safety approvals and IRB authorization agreements do not need to be provided.

Questions.

If you have questions about conversion or cannot complete your conversion studies before the due date (8 weeks before study expiration), please contact [IRB Team Lead] to discuss other options.

[IRB Team Lead Contact Information]

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