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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 been or must be ceased. CompletionClosure 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 if subject accrual has been judged to be inadequate to achieve the scientific goals of the study
    • 3.1.5. By the ORA if the study remains in standard follow-up without additional research interventions or protocol dictated assessments.
    • 3.1.6. By the IRB or ORA if the investigator has failed to respond to the “Approval Expired” notification from the ORA that IRB approval for 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 Expiration means that approval is no longer valid because required continuing review has not received full approval by the IRB by the expiration date, per HRPP policy 2.7 (Continuing Review of Research).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 Closure for Indadequate Accrual

  • 4.1. Single site studies where UNMC/UNO/CHMC is the sole participant, or multi-institution studies where UNMC/UNO/CHMC is a participant but there is no external funding, may be closed by the IRB or ORA for low or no accrual.
    • 4.1.1. Low accrual is defined as less than 1/2 of expected accrual based on the total accrual divided by the estimated time to accrue subjects in initial IRB application.
  • 4.2. Studiers with low or no accrual after two review cycles will be required to provide explanation and a detailed plan to increase accrual. Plans to increase accrual might include, but are not limited to:
    • 4.2.1. additional sites
    • 4.2.2. additional investigators
    • 4.2.3. additional study personnel, such as coordinators
    • 4.2.4. expanded study populations or less restrictive inclusion or exclusion criteria
    • 4.2.5. augmented education/training of referring practitioners, as applicable
    • 4.2.6. new advertising
    • 4.2.7. extension of the expect time to achieve target accrual
      • 4.2.7.1. investigators must provide adequate justification that extension of the study accrual time will not affect the utility of the research results
    • 4.2.8. decrease in number of subjects
      • 4.2.6.1. reduction in number of subjects must not compromise the scientific integrity oif the study. Reduction in the number of approved subjects is primarily applicable to multi-institutional studies where overall study wide accrual is unchanged.
  • 4.3. Failure to accrue a minimum number of subjects by the next review cycle, without acceptable justification by the investigator will lead to closure of the study.
  • 4.4. The IRB may allow certain studies involving rare conditions to continue despite poor or no accrual, provided there is the prospect of direct benefit to subjects.

5.0 Closure of Studies in Standard Follow-Up

  • 5.1. Studies may remain in standard follow-up for no more than three review cycles, and then will be closed, unless:
    • 5.1.1. the study is collecting data in any form (such as survival); or
    • 5.1.2. the organization is contractually required to keep the study open; or
    • 5.1.3. the study includes a tissue bank at the organization (UNMC, UNO, CHMC or BMC); or
    • 5.1.4. the investigator can provide adequate justification for the study to remain open.
  • 5.2. If later access to study data is needed by investigators or sponsors, a Medical Records application should be submitted to access existing data

6.0 Closure Procedures

  • 4.6.1. 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.
  • 4.6.2. The investigator is responsible for notifying the IRB when a study is closed by him/her, or by the sponsor or the granting agency.
  • 4.6.3. 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).
  • 4.6.4. After the effective date of the Revised Rule, whenWhen a study is closed the investigator is responsible for posting the consent forms on ClinicalTrials.gov as required.
  • 4.6.5. If a study is closed by the IRB or ORA (per section 3.1.4 or 3.1.5. 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:

REVISED JANUARY 29, 2021

Added inadequate accrual as reason for closure by IRB (section 3.1.4) and criteria and process for closure (section 4); added prolonged time in standard follow-up as reason for closure by ORA (section 3.1.5) and criteria and process for closure (section 5).

INITIAL JANUARY 12, 2018

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