Making a Motion at IRB Meetings

Version Date: June 10, 2013

Primary reviewers not only lead the discussion regarding the submission under review, but are also expected to propose a motion for the committee to vote on. Primary reviewers are encouraged to have a preliminary motion in mind when they arrive at the IRB meeting. Motions are straightforward when no changes are being requested in order for the submission to be approved. However, when the motion is for modifications to secure approval or a deferral it needs to include direction for the study team regarding what is required either to secure final IRB approval or for the committee to reconsider the submission. Outlined below is the range of motions available to IRB members for the specific review types.

Initial Review Applications and Changes of Protocol
Motion When Used
Approved as Submitted
No modifications or clarifications are being requested from the study team in order to secure final IRB approval.
Approved with Administrative Hold
All conditions for IRB approval have been met, but the IRB does cannot approve the study as submitted until further documentation is in place. This motion is used in limited cases, such as ensuring the IRB receives documentation of final VA R&D Committee approval after that committee initially endorses a study or change. Other instances where an administrative hold is appropriate are when IRB approval from another site because there is no coordinating center identified or documentation of an IND or IDE number has been requested but are not yet available.
Modifications Requested
  1. A study team needs to make minor revisions to the IRB application or supporting materials that can be reviewed under expedited procedures to secure IRB approval.
    OR
  2. The committee can specify the revisions to the IRB application or supporting materials such that the response from the study team can be reviewed for simple concurrence with the IRB’s requests.
Deferred If the IRB cannot determine that a study meets ALL of the criteria for IRB approval under the federal regulations (45 CFR 46.111, 21 CFR 56.111, or 38 CFR 16.111) and cannot specify the revisions that would allow the study to be approved under these regulations, then the IRB is required to defer review of the submission. Please note that revisions to consent documents must be minor or specific in order to allow the IRB to request modifications rather than deferring the study. If the IRB is requesting clarifications from study teams rather than specific revisions, a motion for deferral is generally appropriate.

Reportable events encompass unanticipated problems, noncompliance, and new information. New information reports vary widely and are not covered in this guidance; the staff reviewer will advise regarding potential motion in the rare case the new information report requires full IRB review.


Unanticipated Problems
Motion
When Used
Acknowledge report: not an unanticipated problem
The IRB has determined that the report does not meet the institutional definition of an unanticipated problem.
Acknowledge report: unanticipated problem and no additional action required to resolve the report
The IRB determines that the report meets the institutional definition of an unanticipated problem and the plan for preventing similar occurrences and/or informing subjects provided by the study team is sufficient.
Defer: report does not constitute an unanticipated problem but additional action needed to resolve the report
The IRB determined that the report does not meet the institutional definition of an unanticipated problem but additional information or action on the part of the study team is needed to address issues or questions raised by the report.
Defer: additional information needed to determine whether report constitutes an unanticipated problem
The IRB does not think it has sufficient information to determine whether the report meets the institutional definition of an unanticipated problem.
Defer:  report constitutes an unanticipated problem  and additional action required to resolve the report
The IRB determines that the report meets the institutional definition of an unanticipated problem and the plan for preventing similar occurrences and/or informing subjects provided by the study team is not sufficient.

NOTE: When reviewing potential unanticipated problems the IRB also needs to determine whether noncompliance also occurred and, if so, whether the noncompliance is serious and/or continuing.


Noncompliance
Motion
When Used
Acknowledge: not serious or continuing noncompliance and no additional action required
The IRB determines that the report does not meet the institutional definition of noncompliance and no additional information or action is needed from the study team to resolve the report.
Defer: not serious or continuing noncompliance but additional action required
The IRB determines that the report does not meet the institutional definition of noncompliance but additional information or action is needed from the study team to resolve the report.
Defer: a determination related to the report cannot be made
The IRB does not think it has sufficient information to determine if the report meets the institutional definition of noncompliance,  or institutional definition of serious and/or continuing noncompliance.
Defer: preliminary determination of serious and/or continuing noncompliance
During the first review of the event, the IRB determines that the event appears to meet the institutional definition of serious and/or continuing noncompliance. In these cases the IRB should specify whether additional action is needed on the part of the study team to prevent similar noncompliance from occurring in the future and whether any notification to research subjects related to the noncompliance is necessary. The study team will then have an opportunity to respond to the IRB’s requests and the committee will review the response to determine if the preliminary finding of serious and/or continuing noncompliance stands.
Defer: final determination of serious and/or continuing noncompliance  - additional information or action needed

OR

Acknowledge: final determination of serious and/or continuing noncompliance and no additional study team action needed
When the IRB reviews a study team’s response to a preliminary determines that the event meets the institutional definition of serious and/or continuing noncompliance, the IRB should determine if the preliminary finding of serious and/or continuing noncompliance stands. If a final determination of serious and/or continuing noncompliance is made, the IRB must specify whether the noncompliance requires reporting to an external agency, such as the study sponsor, OHRP, the VA, or the FDA. Unfunded studies generally only require internal reporting. Federally funded studies require external reporting. The IRB also may determine that the response requires additional information or action in order to resolve, which would require a deferral.

NOTE: When reviewing potential noncompliance the IRB also needs to determine whether the event also constituted an unanticipated problem.



Keywords:approved, approve, defer, deferred, modifications, IRBM   Doc ID:31523
Owner:Faye L.Group:Health Sciences IRBs
Created:2013-07-10 08:59 CSTUpdated:2017-08-11 12:43 CST
Sites:Health Sciences IRBs
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