Procedures for Continuing Review of Research

All approvals are for a period of no longer than one year from the date of the current approval, unless the MDHHS IRB determines a shorter interval is required. Prior to the end of one year from the date of approval, the project must be resubmitted for approval in order for human subjects research to continue. There is no provision for any grace period extending the conduct of research beyond the expiration date of the approval.

Review of a change in the protocol is not considered to be a continuation review and does not alter the expiration date. IRB continuation review that occurs within 30 days before the expiration of an annual approval date may keep the original one-year renewal date for the next year's continuation review. For example, if the original expiration date is 12/31/15 and the continuation review and approval occurs as soon as 12/01/15, the new expiration date can be 12/31/16.

The requirements for approval that apply to initial review also apply to the continuing review of a previously approved project. In order to approve the continuation of previously approved research, the IRB needs at least a protocol summary and a status report on the progress of the research. The status report should include:

  1. The number of subjects accrued,
  2. A summary of any adverse events and/or unanticipated problems involving risks to subjects or others,
  3. A summary of any withdrawals of subjects from the research, or complaints,
  4. A summary of any recent literature, interim findings and amendments or modifications, if any, that are relevant to the research,
  5. Any relevant multi-center trial reports from Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC). This only applies to multi-center clinical trials. Such study-wide reports may satisfy the requirements of #4 without being directly submitted to the local IRB by the author.
  6. A copy of the current informed consent document and any newly proposed one.

The currently approved or proposed consent documents must be reviewed to insure accuracy and completeness. Any significant new findings that may relate to a participant's willingness to continue in the study must be provided in accordance with HHS regulations 45 CFR 46.116 (b) (5). This requirement applies not only during continuation review but whenever such information is learned.

A project that was initially approved by full committee review can only be approved for continuation by full committee review, except for continuing review of research previously approved by the convened IRB as follows:

where:

  • the research is permanently closed to the enrollment of new subjects;
  • all subjects have completed all research-related interventions; and
  • the research remains active only for long-term follow-up of subjects;M/li>

or

  • where no subjects have been enrolled and no additional risks have been identified by either the IRB or the investigator at any site or from any other relevant source; or (c) where the remaining research activities are limited to data analysis.

or

  • continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories for expedited review do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. The latter determination does not need to be made by the convened IRB.

The full set of materials from the initial review, any subsequent modifications and the meeting minutes should be reviewed by the chair, or the chair's designee, and made available to any committee member upon request.

When continuing review of a study does not occur prior to the end of the approval period specified by the IRB, expiration of approval is automatic and the research must stop, unless the IRB determines it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Such a stoppage does not have to be reported to OHRP as a suspension of IRB approval under HHS regulations.

 

 

April, 2015