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Continuing Review Process

Using the U-M IRB System

To log on to eResearch Regulatory Management System (eRRM):  www.eresearch.umich.edu

For eRRM information, see the Regulatory Management website

For system instructions to submit an IRB continuing review, see Resources below

Image alerting reader of new information

 

As of January 21, 2019, the effective date of the revised Common Rule, scheduled continuing review will no longer be required for most studies reviewed by IRB-HSB.  Learn more below!

IRB Scheduled Continuing Review (SCR)

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

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

Blue info iconUnder 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 January 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-up clinical data from procedures that subjects would undergo as part of clinical care.

​The IRB may require 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) management.
  • The research will be conducted internationally or at non-UM sites
  • An amendment or incident report reveals new findings that require additional oversight
  • The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance

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

SCR Requirements 

At U-M the continuing review process is called 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 study team to:

  • Report the 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's 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 manner for IRB review. 

Lapse in IRB Approval

A human subjects study must retain active IRB approval until the study team has completed the work (e.g., all papers submitted and analyses completed) on the research, or until the data has been completely deidentified, including the destruction of any keys or codes linking the data to subject identifiers. If the study requires continuing review and the approval period expires (i.e., lapses), all research activity must stop until IRB approval is re-established.  This means no new subjects may be enrolled in the study, no data may be collected, 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 (3) months, the Prinicpal Investigator (PI) or study team may submit an SCR to initiate an IRB review for approval.  If greater than three months, the IRB may require a new application.  The IRB has the authority to require a full re-review of the study in cases of lapsed approvals. 

Terminating a Study at SCR

 Image showing the Termination Report submission option in eRRM

Principal Investigators have the option to terminate the study at the time of Scheduled Continuing Review (SCR) if the study is complete (e.g., activity limited to data analysis).  The SCR process will direct the PI (or Faculty Advisor for studies where a student serves as the PI) to complete a Termination Report in eRRM to close the project

 

References and Resources

  • Creating a Scheduled Continuing Review (SCR) (PDF) eResearch Regulatory Management (eRRM) system instructions to submit a request for a continuing review of an approved study to the IRB for re-approval.  Provided by ITS.
  • Creating a Termination Report (PDF) eResearch Regulatory Management (eRRM) system instructions to submit a request to terminate (close) an approved study.  Provided by ITS.

Questions?

For questions regarding IRB continuing review requirements (e.g., policy, procedure, science), contact:

IRB Health Sciences and Behavioral Sciences
Phone: (734) 936-0933
Fax: (734) 936-1852
irbhsbs@umich.edu

For help using eResearch Regulatory Management, contact:

ITS Service Center
(734) 764-HELP (764-4357)
4HELP@umich.edu 
online service request (login required)