- Administrative withdrawal of initial submissions of research is an action taken by OPRS to permanently withdraw a proposal after it has been reviewed and given either conditions required to secure approval or been deferred, and the investigator has not responded to the IRB’s request within 90 days.
- Administrative withdrawal of an amendment to previously approved research is an action taken by OPRS to permanently withdraw the submission after it has been reviewed and given either conditions required to secure approval or been deferred, the investigator has not responded to the IRB’s request within 90 days, and the Assistant Director (AD) (or designee) has consulted with the Chair (or designee) to determine whether the withdrawal of the submission may affect subject safety.
- Administrative withdrawal of continuing review is an action taken by OPRS to permanently withdraw the submission after it has been reviewed and given either conditions required to secure approval or been deferred, the investigator has not responded to the IRB’s request within the designated timeframe as indicated on the correspondence from the IRB, and the research has lapsed in IRB approval.
- The RiSC software application (IRB #s 1, 2, 3) has a mechanism for the AD for each IRB (or designee) to monitor the status of the board’s protocols on a weekly or bi-weekly basis.
- Administrative Withdrawal of Research (Initial Review).
- The conditions required to secure approval and deferral letters sent by the IRB to investigators following convened or expedited review of an initial submission or an exempt submission indicate the 90 day period for the investigator to respond to the IRB’s request. Specifically the letter notes that a reminder letter will be sent if no response is received within 60 days and 30 days later the submission will be administratively withdrawn from the review process and the IRB will not take any further action.
- If no response to the IRB’s requests has been submitted by the investigator at approximately 60 days, a reminder is sent to the investigator.
- If no response to the IRB’s requests has been submitted by the investigator approximately 90 days after the conditions required to secure approval or deferral letters were originally sent, the submission is administratively withdrawn from the review process and no further action is taken. The withdrawal is communicated to the investigator.
- Administrative Withdrawal of Amendments.
- The conditions required to secure approval and deferral letters sent by the IRB to investigators following convened or expedited review of an amendment to previously approved research or an amendment to an exempt determination indicate the 90 day period for the investigator to respond to the IRB’s request. Specifically the letter notes that a reminder letter will be sent if no response is received within 60 days and 30 days later the submission will be administratively withdrawn from the review process and the IRB will not take any further action.
- If no response to the IRB’s requests has been submitted by the investigator at approximately 60 days, a reminder is sent to the investigator.
- If no response to the IRB’s requests has been submitted by the investigator approximately 90 days after the conditions required to secure approval or deferral letters were originally sent, the AD (or designee) consults with the Chair (or designee) to determine whether the withdrawal of the submission may affect subject safety. If it is determined that the amendment submission does not affect subject safety, the amendment submission is administratively withdrawn from the review process and no further action is taken. The withdrawal is communicated to the investigator.
- The investigator must submit the withdrawn amendment as a new amendment if he/she wishes to continue to pursue approval of the amendment by the IRB.
- Administrative Withdrawal of Continuing Reviews.
- The conditions required to secure approval and deferral letters sent by the IRB to investigators following convened or expedited review of a continuing review submission remind the investigator of the approaching, or possibly, passed expiration date.
- The investigator is to respond to the conditions required to secure approval and deferral letters as soon as possible to avoid lapse in IRB approval. If the research lapses in IRB approval, then the submission may be administratively withdrawn and the research closed due to lapse as per the UIC HSPP policy Lapse in IRB Approval.
- Research Reviewed by CHAIRb.
- The policies and procedures stated above are followed for protocols reviewed by CHAIRb with the exception that the CHAIRb coordinator and/or AD will monitor the status of the CHAIRb protocols on a weekly or bi-weekly basis via the CHAIRb Portal.
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Version (#, date)
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Replaces (#, date)
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Summary of changes
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1.0, 07/28/15
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NA
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Policy created. Information was previously included in Study Closure, Lapse in IRB Approval and Withdrawal of Research, which has been separated into three policies.
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1.1, 10/13/15
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1.0, 07/28/15
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Revised policy to specify “administrative” withdrawals. Editorial revisions.
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1.2, 01/05/16
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1.1, 10/13/15
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Addition of CHAIRb specific language.
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