All appropriate materials from those studies recommended for continuing review under the "Convened Board Review" category shall be made available to all members of the convened IRB prior to scheduled IRB meetings. After presentation by the primary and/or secondary reviewers and deliberations at IRB meetings, any IRB member may motion for an action. For a motion to pass, the majority of voting members present must vote affirmatively. The convened IRB may approve motions and thereby take any of the actions relative to continuing studies indicated below:
1) APPROVED AS SUBMITTED
This motion defines the study as approved as submitted, with no further action requested or required. In this case, the HSRO shall inform the Principal Investigator in writing of the approval and its duration. The Principal Investigator shall be informed by the HSRO in writing of the IRB approval and its duration.
2) APPROVED AS MODIFIED BY THE IRB
This motion defines the continuing study as approved with revisions, clarifications or other changes to the protocol or to the informed consent or other documents made by the IRB. In this case, the HSRO shall inform the Principal Investigator in writing of the changes made by the IRB and of the IRB approval of the study including those changes and also including the duration of approval.
The letter to the Principal Investigator from the HSRO shall state that the Principal Investigator must conduct the study as modified by the IRB in accordance with the IRB approval. If the Principal Investigator does not accept the changes made by the IRB, he/she:
a) May withdraw the study, appeal to the IRB or make revisions to the study for reevaluation by the IRB; AND
b) May not continue the study beyond the previous approval period. In this circumstance, the study shall be suspended on the day that the previous IRB approval has expired.
3) DEFERRED FOR SUBSEQUENT EXPEDITED REVIEW BY THE IRB CHAIR OR DESIGNEE
This motion defines that the IRB has agreed to approve the continuing study but with conditions that require revisions and/or clarifications that the IRB determined to be nonsubstantive and minor and not directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111. Such revisions or clarifications may be reviewed and approved by the IRB Chair or designee on an expedited basis.
Required revisions or clarifications must be submitted to the HSRO by the Principal Investigator within 30 calendar days following notification to the Principal Investigator by the HSRO unless the IRB requires a due date that is different from that occurring 30 days following notification.
Pursuant to this motion, the HSRO shall notify the Principal Investigator that the revisions and/or clarifications shall be reviewed on an expedited basis by the IRB chair or designee. The IRB shall clearly specify the action(s) needed and who has the authority to review and approve the revised or requested materials on an expedited basis. A letter shall be forwarded to the Principal Investigator by the HSRO indicating the specific required action(s) and the fact that the documents may be returned for review on an expedited basis and that another convened IRB review may not be required unless the study is deferred to the convened IRB by the IRB Chair or designee. The letter shall also define that the study has been deferred and that the continuing report has not received IRB approval and that, if approval is not given prior to the date that prior IRB approval lapses, the study must be suspended on that expiration date. The study may not be continued beyond the expiration date of the prior approval and the suspension of the study will continue until the continuing report is approved.
Continuing Review of a study that is deferred for subsequent expedited review by the IRB Chair or designee must occur within one year of the date that the fully-convened IRB deferred the study and set conditions for its expedited re-review rather than the date that the minor changes were approved on an expedited basis by the IRB Chair or IRB-designee.
If revisions and/or clarifications are submitted after the due date, the Chair/designee may seek an explanation from the Principal Investigator and/or:
a) Defer the study to the convened IRB for its review and approval/disapproval; OR
b) Defer the study to the IRB for withdrawal. If the IRB withdraws the study the Principal Investigator may re-submit a new application for the study incorporating the revisions and/or clarifications from the prior IRB review; OR
c) Find the explanation and the revisions and/or clarifications acceptable and approve the study for continuation.
4) DEFERRED FOR SUBSEQUENT RE-REVIEW BY THE IRB
This motion defines that the study proposed for continuation needs revisions or clarifications from the Principal Investigator for subsequent approval by the convened IRB. This motion shall pertain when the convened IRB has determined that the revisions or clarifications are substantive and directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111. In this case, the Principal Investigator shall be informed by the HSRO in writing of the needed revisions and/or clarifications and the requirement that these revisions or clarifications be submitted within 30 days calendar days unless otherwise specified by the IRB. The letter should make clear that the continuing study is not approved and that it must be suspended on the date that prior approval expires unless it is subsequently approved for continuation prior to that expiration date. If a study that is deferred for subsequent re-review by the IRB is suspended because of a lapse in approval, this suspension will continue unless/until approval for continuation is approved by the convened IRB.
If the study is subsequently approved by the convened IRB, the HSRO shall inform the Principal Investigator of this approval and that the date of approval is the date that the fully-convened IRB gave final approval to the study.
If revisions and/or clarifications are submitted after the due date, the HSRO shall seek an explanation from the Principal Investigator and the IRB may either conduct its review or it may withdraw the study. If the IRB withdraws the study, the Principal Investigator may re-submit a new application for the study incorporating the revisions and/or clarifications from the prior IRB review.
This motion defines the situation if the IRB is unable or unwilling to review and/or vote on a continuing study or other matter. This may occur if the quorum is lost, pertinent documents are unavailable or the scope of IRB expertise is not considered sufficient for appropriate decision-making. Although the Principal Investigator may be notified of this motion, no action by the Principal Investigator is required.
The fact that the review of a continuing study is tabled by the IRB does not change the expiration date of the prior approval or the consequences of a lapse in such approval.
This motion defines the continuing study as not approved by the IRB for reasons directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111 such as that the study requires major changes or that current knowledge leads to the belief that it is not likely to be feasible without a complete reassessment of the protocol by the Principal Investigator and/or sponsor. In this case, the HSRO shall inform the Principal Investigator in writing of the disapproval. The letter shall include a description of the reasons why the IRB has taken this action and shall inform that the Principal Investigator has an opportunity to respond to the IRB in person or in writing with justification for a reversal of the decision or a proposal to change the protocol, which may be a basis for IRB reconsideration. If the Principal Investigator appeals the disapproval, it is the responsibility of the IRB Chair and members to ensure that there is a fair hearing of the appeal.
The fact that an appeal by the Principal Investigator is on-going does not change the expiration date of the prior approval or the consequences of a lapse in such approval.