Regulations (45 CFR 46.103/21 CFR 56.108) require prompt reporting to the IRB of changes in a research activity including study completion and closing.
Studies approved under exempt criteria do not require submission of a final report. Rather, Principal Investigators may close exempt studies by submitting an affirmation in writing to the HSRO that study activities are complete.
Prinicipal Investigators may recommend closure of studies approved under expedited criteria or by the convened IRB if all of the following conditions are met:
1) All subject enrollment at UM-approved sites is complete; AND
2) All data (including study follow-up data) pertaining to human subjects have been collected; AND
3) No further human subject interaction is planned for the purpose of research; AND
4) No further analysis of identifiable private information or biological specimens is to be conducted.
Industry sponsored studies may be closed upon recommendation of the Principal Investigator if either of the following apply:
1) The University of Miami site is closed by the sponsor. In this case, the final report must include a notification (letter or email) from the sponsor or sponsor's representative indicating that the University of Miami site is closed and that individually identifiable data are no longer being collected on subjects at this site [NOTE - Data analysis may be ongoing by the sponsor at another site, but data analysis may not be ongoing by the UM Principal Investigator]; OR
2) The Principal Investigator has withdrawn his/her participation in the sponsor's protocol. In this case, the Principal Investigator must include a copy of the notification to the sponsor (letter or email) with the final report
To close a non-exempt study, the Principal Investigator must submit a final report specific to that study.
If IRB approval of a study has lapsed prior to approval of a final report, the study shall be suspended and the final report must include a description of activities that have occurred in the study since approval of the prior continuing report.
Final reports may be reviewed and approved by an “expedited” process. This expedited review may be conducted by an IRB chair, an IRB-designee or an administrative-designee. In this circumstance, the reviewer may approve the final report and close the study or, if appropriate, he/she may defer a decision and refer the final report to the convened IRB.
Final reports may be reviewed and approved by an administrative-designee only if all of the following conditions have been met:
1) All subjects have finished their final research visits and enrollment is permanently closed with no prospect for further data collection or any continuing human subject interactions or interventions for the purpose of research; AND
2) If the study has a sponsor, either the sponsor or the sponsor representative has indicated in writing that the study is completed at the University and that study closure is requested or the Principal Investigator has withdrawn his/her participation in the sponsor's protocol and has given written notification of this withdrawal to the sponsor; AND
3) All data (including study follow-up data) pertaining to human subjects has been collected; AND
4) Data analysis of identifiable private information at the University is complete; AND
5) All study documents (e.g. adverse event reports, study deviations etc) have been reviewed. If any of these above conditions do not apply and/or if there is any new information about risk or subject safety included in the final report that was not previously reported and/or for any other reason the administrative designee believes appropriate, the final report shall be referred to the IRB chair or IRB designee for approval or deferral to the convened IRB.
If the final report is referred to the convened IRB, the panel shall decide among the actions indicated below:
The Principal Investigator shall be informed in writing by the HSRO. The determination letter shall inform the Principal Investigator of any IRB required actions and that study records must be retained for at least three years.
With this decision, the IRB shall specify what action(s) needs to be taken and who has the authority for subsequent review including that of revised or requested materials. A memo shall be sent to the Principal Investigator by the HSRO indicating the specific action (s) required of the Principal Investigator. There must be full compliance with the required revisions and/or clarifications before the final report can be approved.
This motion shall result if the IRB is unable or unwilling to review and/or vote on a final report. 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 shall be notified of this motion by the HSRO, action may or may not be required by the Principal Investigator.
The final report is not approved by the IRB for reasons specified in a Letter of Disapproval to the Principal Investigator from the HSRO. The Principal Investigator may respond to the IRB with written justification for a reversal of the decision or a proposal to change the conditions underlying the final report which may be a basis for IRB reconsideration.
The Principal Investigator may request to attend a scheduled IRB meeting to discuss the disapproval.
If a Principal Investigator terminates employment or other association with the University, he/she must submit a final report to the IRB or transfer the study to another Principal Investigator via an amendment which requires approval by the department chair and IRB. If the departing Principal Investigator is unwilling or unable to provide such an amendment, the academic department chair or the director of the university institute/center that provides oversight to the study may take such action or the HSRO may seek to administratively close the study.
A study may also be administratively closed by an IRB chair, an IRB-designee or an administrative-designee without a final report from the Principal Investigator if the Principal Investigator (or the department chair or university institute/center director in the case where a principal investigator is unavailable) affirms in writing to the HSRO that the study was never initiated after IRB approval and that no subjects were enrolled. If the study was sponsored, the Principal Investigator must also submit written documentation (letter or email) to the HSRO that:
1) The sponsor has notified the Principal Investigator that the study is being discontinued or closed; OR
2) The Principal Investigator has notified the sponsor that he/she no longer wishes to participate in the study and the study is being discontinued or closed. A copy of this notification should be provided by the Principal Investigator to the HSRO.