You are here

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

It is the principal investigator's responsibility to submit a schedule continuing review application before the expiration of the IRB approval of an active project and in ample time for IRB review.

IRB Scheduled Continuing Review (SCR)

The IRB Scheduled Continuing Review 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, including the number of subjects enrolled, to the IRB and either:

  • Initiate the IRB review for the renewal of approval prior to the study's expiration date, or
  • Terminate the study upon the completion of the research and the closure of the study  

Because of it's multiple uses, the form may be referred to by the following terms: Continuing Review (CR)Scheduled Continuing Review (SCR), or Termination Application

SCR Requirements 

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.  The SCR is used to request an update to the approval period for the study upon IRB review.  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

If the study's 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 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. 

IRB Review 

Per federal regulations outlined in 45 CFR 46.109(e), the IRB must conduct a continuing review of federally-supported research at least once per year.  For research that is not federally-supported, U-M policy allows for the review period to be extended to two years (see HRPP Demonstration for details).  When an SCR is submitted, the IRB reviews the:

The IRB may recommend modifications or updates to a study upon continuing review. An SCR 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.

References and Resources

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)