Determining if Renewal is Required

Please consider the following questions when determining if a Renewal Application or Closure Report must be submitted.  If you have any questions, please contact the IRB Office.

1) Will future research activities involve obtaining data through intervention or interaction with human subjects?

2) Will future research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to the subjects.  This includes any lists of participants that have not yet been destroyed.

3) Will future research activities include analyzing identifiable private information about living individuals?

PLEASE NOTE: If you answered yes to any of these 3 questions, a Renewal Application must be submitted for your research project.

If you answered no to all of the above questions, a Renewal Application is not required and a Closure Report must be submitted.  A protocol is eligible for closure if:

a) data collection is complete

b) there is no more participant contact (including follow-up interviews, calls, surveys)

c) the only research activity remaining is data analysis of de-identified data.

Closure Report Guidance

A Closure Report must be filed within 30 days of IRB Approved protocol completion.  The IRB does not recommend allowing IRB Approved protocols expire or to be administratively closed by the IRB Office as this does not bring proper completion to the protocol history.

When to Submit Renewal Applications

Human subject research projects are approved for no more than one year.  The IRB recommends that Renewal Applications be submitted to the IRB Office forty-five (45) days in advance of the Expiration Date of the protocol.  This will allow appropriate time for review, administrative modifications and approval prior to protocol expiration.

For non-exempt research that was approved through expedited review, a renewal application should be submitted no later than 45 days prior to the last day of that one-year approval period.  (For example, an application approved on June 30, 2007 would expire on June 30, 2008; a renewal application will be due at the IRB no later than May 15, 2008.)  For non-exempt research that was approved through Full Board review, a renewal application should be submitted by the application deadline for the IRB meeting scheduled for the month before the application expires.  Please check the IRB Full Board Review meeting dates that are posted on the IRB website

Human subject protocols that have been determined by the IRB to be Exempt projects do not require continuing review as they are exempt from the requirements set forth in the Code of Federal Regulations [45CFR46].  If you have any question about renewal applications, please contact the IRB Office at 301-405-7326 or email irb@umd.edu.

Harm to Participants

If it is in the best interest of individual subjects to continue participating in interventions or interactions for research which has recently expired and a Renewal Application is pending, the Principal Investigator should submit a request to the IRB Office for those research subjects to continue participating.  The request should include a description of the potential harm if the subjects do not continue participating in the research.

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