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2.9 Closure of On-Going Research

1.0 Purpose

The purpose of this policy is to describe the process of closing an on-going human research study, and to describe the Organization’s requirements of investigators when studies are closed.

2.0 Policy

It is the policy of the Organization that all research activities must cease when a research study has closed.

3.0 Definitions

  • 3.1. Closure of a study means that the research study is completed, and all research interventions have ceased. Completion may occur:
    • 3.1.1. When the aims of the study have been satisfied.
    • 3.1.2. As a decision by the investigator before study aims have been met (for example, due to lack of funds, poor accrual, departure of an investigator, demonstration of lack or efficacy or futility).
    • 3.1.3. As a decision by the sponsor or the granting agency.
    • 3.1.4. By the IRB or ORA if the investigator has failed to respond to the “Approval Expired” notification from the ORA that a study has expired, as per HRPP policy 2.7 (Continuing Review of Research).
  • 3.2. Expiration means that approval is no longer valid because required continuing review has not received full approval by the IRB by the expiration date, per HRPP policy 2.7 (Continuing Review of Research). Approval expiration is not study suspension.
  • 3.3. Suspension means that the research study is stopped, as a result of a directive of the IRB at a convened meeting, or a directive of the IRB Executive Chair (in consultation with the IO as appropriate), as per HRPP policy 8.6 (IRB Study Hold, Suspension and Termination). Suspension is usually temporary.
  • 3.4. Termination means that the research study is stopped, as a result of a directive by the IRB at a convened meeting, or by the Organization, per HRPP policy 8.6 (IRB Study Hold, Suspension and Termination). Termination is permanent.

4.0 Procedures

  • 4.1. When a study is closed, all research activities must cease. The investigator may not conduct any further research activities (including collection of existing or additional identifiable private information, or new analysis of existing identifiable private information), or allow any other person or organization to conduct any further research activities.
  • 4.2. The investigator is responsible for notifying the IRB when a study is closed by him/her, or by the sponsor or the granting agency.
  • 4.3. When a study is closed the investigator is responsible for revising the study status on ClinicalTrials.gov, and posting study results as appropriate, as per HRPP policy 1.29 (ClinicalTrials.gov Reporting).
  • 4.4. After the effective date of the Revised Rule, when a study is closed the investigator is responsible for posting the consent forms on ClinicalTrials.gov as required.
  • 4.5. If a study is closed by the IRB or ORA (per section 3.1.4 above), the investigator may request reactivation, with adequate justification, within two months from the date of completion. Reactivation after the two month grace period requires submission of a new IRB application.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL JANUARY 12, 2018

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