Lapse in Approval

Continuation Review and Lapse in Approval

I. PURPOSE/BACKGROUND

This policy refers to the federal requirement1 of the IRB to conduct a continuing review of all research, and the responsibility of the investigator to submit the continuing review application to the IRB.

During the continuation review, the IRB considers all new information provided by the investigator, and determines whether it results in a change to the risk/benefit ratio of the research study. This review is a significant part of the IRB’s duty to continuously monitor a study.

The IRB reviews the recruitment process, the informed consent process, and the continuing safety of the subjects. Federal regulations require the continuing review to be performed at least annually, but may also be performed at intervals specified by the IRB depending on the risk level associated with a research study. For multi-year research, the investigator is responsible for submitting the continuation application prior to the expiration date of the current IRB approval in order for the IRB to make these determinations.

II. POLICY

The investigator must provide his or her application for continuing review to the IRB by the required date. If the investigator fails to do so, and the research has expired before the annual review approval has been issued by the IRB, all research must stop. No human subject activity may take place on or after the research expiration date unless the IRB finds it is in the best interest of individual subjects to continue participation in research interventions or interactions.

III. PROCEDURE FOR POLICY

Continuing Review Submission

An expiration reminder letter will be sent to the investigator sixty and thirty days before study expiration. The investigators are asked to submit the following documents to the IRB at least 30 days before the expiration date:

  • A Continuation Review including:
    1. number of subjects enrolled
    2. adverse reactions
    3. protocol violations
    4. proposed changes
    5. confirmation on informed consent process
    6. subjects not completing the study
    7. description of preliminary results
    8. brief description of the research project
  • The revised informed consent document
  • The last five signed consents and HIPAA research authorizations

Once all continuing review materials are received, a determination is made whether the continuing review is eligible for expedited review2 or if it should be scheduled for full-board review. If the review is to be a full-board review, the continuing review will be scheduled for review at the first regular meeting within 30 days prior to the study expiration date.

Lapse in Approval

If an investigator has failed to provide continuing review information to the IRB by the required date, and the research has expired before the annual review approval has been issued by the IRB, all research must stop. The investigator will be sent a notice that the research has expired and that no human subjects activity, including enrollment or recruitment, may take place on or after the expiration date. The investigator will have 10 working days from the date of the expiration notice to obtain continuing review approval for the research, or it will be administratively closed by the IRB and the Dean/department chair will be notified of the non-compliance.

If the study is closed by the IRB, the investigator must submit a new project application via the electronic submission system for IRB review and approval if he or she would like to re-open the project. A memo to the IRB must be included with the new submission with the following information:

  • the circumstances that led to the protocol closure;
  • reasons why the investigator feels the research should be re-opened;
  • corrective action the investigator has taken in order to avoid study expiration and closure in the future.

A lapse in approval represents significant non-compliance and is referred to the IRB for determination of serious or continuing non-compliance. Such a determination may be reported to federal regulatory agencies such as the OHRP and FDA, sponsors, and institutional officials. The HSPPO Quality Improvement Program Compliance Auditors may also conduct audits on lapsed research to determine if there was any study activity conducted within the lapsed period.

Safety of Subjects During Lapse in Approval

During a lapse in approval, research activity may continue for currently enrolled subjects only if the IRB finds that it is in the best interest of individual subjects to continue participating in the research. In order for the IRB to make this determination, the principal investigator must submit to the IRB a written list of research subjects for whom stopping the research would cause harm, and the reason. An IRB Chair will review and determine who may continue in the research, and which procedures will be allowed to continue.

IV. REFERENCES

1. 45 CFR part 46.109(e)
2. 45 CFR part 46.110

Subject:IRB Policy and ProcedureApproved:
Author:
Human Subjects Protection Program
First Effective Date: 4/1/2014Revision Date:
Approved by:
Laura D. Clark, MD,
Chair Biomedical IRB
Signature:
Laura D. Clark, MD,
Chair Biomedical IRB
Date Signed:
04/01/2014