405: IRB meeting determinations
The purpose of this policy is to describe potential meeting determinations.
As a result of its review, the IRB may decide to approve, defer (pending minor clarifications), defer (pending additional full board review) or disapprove the protocol. Except when the expedited review procedure is used, the determination will be made by a vote of a majority of the quorum. When reviewed via expedited review, the reviewers may approve or defer pending changes or they may determine that a full-board review is required. Expedited reviewers cannot disapprove a protocol; if they do not agree on approval it will be reviewed by the full board.
3. Specific policies
The IRB may make one of the following determinations as a result of its review of research submitted for initial review or for continuing review:
The protocol and accompanying documents are approved as submitted. Final approval will commence on the day the study is approved by an action of the convened IRB or chair, or designee of the IRB, and expire within one (1) year of the approval date, but not later than the day preceding the date of review.
Approvals may depend on conditions to be met by the investigator. The conditions for continued approval and the time frame (if any) within which they must be met will be clearly stated in the approval letter. If the conditions of the approval are not met, approval may be withdrawn.
Approved pending minor clarifications and/or modifications
The IRB will stipulate specific revisions that require simple concurrence or agreement by the investigator. These stipulations must be clear enough so that the reviewer needs minimal judgment to determine whether the protocol, consent, advertisement, or other document was modified as requested by the IRB.
Clarifications and/or modifications will be discussed and voted upon during the IRB meeting, as well as terms of approval, duration of approval, any other determinations that need to be discussed, and level of risk.
The IRB chairperson will assign the reviewers (IRB chair, primary, secondary and tertiary when appropriate, or the IRB coordinator) the task of reviewing the information provided by the investigator. If the designated IRB reviewer determines that the investigator has not made the appropriate responses to the IRB’s request, the reviewer may request additional information or send the response back for full IRB review at a convened meeting. Upon satisfactory review, approval will be issued.
The approval date is issued as of the date that the requested information or materials are verified.
The expiration date will be one year (minus one day) from the date of the convened meeting, e.g. July 27, 2014 to July 26, 2015.
Approval is usually one year, but may be given for a lesser period of time based on; the relative perceived level of risk to the subject population, previously reported issues with the drug, biologic or device, previous issues with the PI, nature and location of the study, or the vulnerability of the study subject population.
Subjects must not be recruited into the study until final approval has been issued.
Approval withheld pending major clarifications and/or modifications
The IRB requests any additional information, any clarifications, or any modifications that cannot be described as specific revisions that require simple concurrence by the investigator. The convened IRB must review the responsive materials. If the convened IRB approves the research based on the responsive materials, the following apply:
The approval date is issued as of the date of the IRB meeting in which the study was approved.
Expiration date: The expiration will be one year (minus one day) from the approval date, but may be given for a lesser period of time (less than one year) based on the relative perceived high level of risk to the subject population, previously reported issues with the drug, biologic or device, previous issues with the principal investigator (PI), nature and location of the study, or the vulnerability of the study subject population.
Subjects will not be recruited into the study until final approval has been issued.
Significant questions are raised by the proposal requiring its reconsideration after additional information is received from the investigator and/or sponsor. Tabling cannot be given through the expedited review mechanism and may only be given by a majority vote at a convened meeting of the IRB.
The proposal fails to meet one or more criteria used by the IRB for approval of research. Disapproval cannot be given through the expedited review mechanism and may only be given by majority vote at a convened meeting of the IRB.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|IRB coordinator||Document all IRB decisions in the minutes.
|Chair||Ensure all determinations are discussed and voted upon.|
|Chair or designee||Review and sign all IRB decision letters.|