Continuing Review of an Approved and Ongoing Protocol

IRB Scheduled Continuing Review (SCR)

Per federal regulations outlined in 45 CFR 46.109(e), an canonical, federally-sponsored human subjects study must exist reviewed, at least annually, by the IRB.  For this standing review, the IRB reviews the:

• Study protocol;
• Informed consent and other documentation or materials; and
• Whatsoever agin events (AEs) or other reportable events (ORIOs) that occurred during the current approval period.

The IRB may recommend modifications or updates to a study upon standing review.The continuing review process is not used to update an IRB application at the fourth dimension of renewal.The study team would submit these changes for IRB review via the subpoena process.

Under the revised Common Rule, the following no longer requires continuing review:

• Most of the new studies (i.e., those approved after January 21, 2019) that qualify for expedited review
• Studies approved prior to Jan 21, 2019 that have completed subject intervention/interaction, where the activity is limited to either the final analysis of identifiable data/biospecimens or involves accessing follow-upwards clinical information from procedures that subjects would undergo as part of clinical intendance.

​The IRB may crave continung review for projects, but must document the reason to do so.  Common reasons include, but are not limited to:

• The project sponsor requires continuing review
• The project involves additional regulatory oversight, such as conflict of interest (COI) direction.
• The research will exist conducted internationally or at non-UM sites
• An subpoena or incident written report reveals new findings that require additional oversight
• The investigator has had previous serious non-compliance or a pattern of non-serious not-compliance

Standing review is required for research that is regulated by the Food & Drug Administration (FDA).

SCR Requirements

At U-M the continuing review procedure is chosen a Scheduled Continuing Review (SCR).  The SCR is an online form completed in U-M's eResearch Regulatory Management (eRRM) system by a member  of the report squad to:

• Report the electric current status of the research project to the IRB, inclduing the number of subjects enrolled; and
• Initiate the IRB review for the renewal of approval prior to the study's expiration date.

Study teams receive an automated email from eRRM at 90, 60, and 30 days prior to a study'south expiration date as a reminder to submit an SCR, but it is the Principal Investigator's responsibility to ensure that the SCR is submitted in a timely mode for IRB review.

Lapse in IRB Approving

A human being subjects study must retain active IRB approval until the study team has completed the work (east.one thousand., all papers submitted and analyses completed) on the research, or until the data has been completely deidentified, including the destruction of whatsoever keys or codes linking the data to field of study identifiers. If the study requires standing review and the approving period expires (i.e., lapses), all inquiry activeness must stop until IRB blessing is re-established.  This ways no new subjects may be enrolled in the study, no data may be nerveless, and data analysis is discontinued.  The only exception is when stopping the activity would jeopardize the welfare of the subject.  This exception is very rare for the type of research reviewed by the IRB-HSBS.

If the lapse is less than three (iii) months, the Prinicpal Investigator (PI) or report team may submit an SCR to initiate an IRB review for blessing.  If greater than three months, the IRB may require a new awarding.  The IRB has the authority to require a full re-review of the study in cases of lapsed approvals.

Terminating a Study at SCR

Principal Investigators accept the selection to terminate the study at the time of Scheduled Continuing Review (SCR) if the study is complete (due east.g., activity limited to data analysis).  The SCR procedure volition direct the PI (or Kinesthesia Advisor for studies where a student serves as the PI) to complete a Termination Written report in eRRM to shut the project

"No Continuing Review" Annual Touchpoint

For studies that qualify for no continuing review ("No CR"), reporting the project status helps the IRB to monitor the study'southward progress.  To facilitate this, anAnnual Touchpoint email is sent to the study team on the ceremony of the qualifying report'southward blessing date.
This system electronic mail acts as an annual reminder for study teams to take action, as needed, to update the status of their written report through the amendment, incident reporting, or termination processes. The U-M IRB Offices review the Annual Condition Study responses and IRB staff may contact investigators if boosted information or activity by the written report squad is needed.

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Source: https://research-compliance.umich.edu/continuing-review-process