SOP #32 Study Closure

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 32
Effective Date: 10/8/2021

Policy

When all research-related interventions or interactions with human subjects have been completed, and all data collection and/or utilization/analysis of identifiable private information, for any purpose, have been concluded, then the research may be considered as completed and the application may be closed. The Principal Investigator should not close an IRB application as long as the investigator is utilizing individually identifiable private information collected as part of the research.

Purpose

To provide guidance to investigators regarding criteria for closure of an IRB application and to describe the closure processes.  Federal regulations require the IRB to maintain oversight of research involving human subjects at a frequency appropriate to the level of risk to participants and in accordance with federal regulations (45 CFR 46.109(e)and(f) and 21 CFR 56.109(f)). IRB oversight is required until a project no longer involves human participants, as defined by federal regulations. Some research requires formal continuing review and reapproval; others may undergo abbreviated review via status check (see, CSS IRB SOP #20 Continuing Review of Approved Research). This SOP describes circumstances under which the IRB needs to oversee research, and when such review can end, and the project formally closed to IRB oversight.

Definitions

IRBNet: The electronic IRB management system.

Human Subject (DHHS): A living individual about whom an investigator (whether professional or student) conducting research:

  1. obtains information or biospecimens through intervention or interaction with the individuals, and uses, studies, or analyzes the information or biospecimens; or
  2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Human Subject (FDA): An individual who is or becomes a participant in research, either as a recipient of the test article or as a control and/or an individual on whose specimen a device is used. Under the FDA regulations and guidance, a human subject may include individuals whose de-identified tissue specimens are used in in vitro diagnostic medical device research.

Private Information: Includes information about data or behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information, which has been provided for specific purposes by an individual, and the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable in order to be considered information to constitute research involving no subjects. This may include identifiable private information obtained from a primary subject about a third party.

Final Report: A report the Principal Investigator may elect to submit to the IRB to serve as a final record of any pertinent activity since the last continuing review report and to record research project completion.

Relying Institution: The institution that has assigned an external IRB to serve as the Reviewing IRB under an IRB Authorization Agreement.  (See, CSS IRB SOP #19 Cooperative Research Authorization Agreements and Sample Agreements.)

Procedure

As long as human subjects research is ongoing, including analysis of collected data that contains identifiable private information or identifiable biospecimens, the study must maintain IRB approval or exemption.  When CSS’s IRB oversight includes at least one Relying Institution, the CSS investigators may not submit a request for study closure until human subjects research activities are complete at each Relying Institution.  (See, CSS IRB SOP #19.)

The closure of a protocol is a change in the status of an approved research activity from active to closed. Protocol closure must be reported to the IRB by the Investigator. The Closure Date establishes the record-keeping period of 3-years (or more, as applicable) post closure, and allows the IRB to collect pertinent information as needed, as well as close its files.  These procedures apply to all human subject research reviewed by the IRB, and exempt research.

Studies may be closed when the involvement of human subjects ceases (interventions, interactions, observations, and the gathering, use, study, and analysis of identifiable private information, including specimens, are all complete).

A research project no longer involves human participants when:

  • Investigators have finished obtaining data through interaction or intervention with participants, and
  • All information about the participants has been completely de-identified or destroyed.
  • Examples:
    • When the only remaining activity of a research project involves the analysis of data sets without any individual participant identifiers.
    • All “keys” linking any ID codes back to the identities of individual participants have been destroyed, aggregation of any possible indirect identifiers has occurred, etc.
    • Note: Data sets with ID codes or other methods of indirect identification require IRB oversight until it is no longer possible to link the data to the identities of the individual participants.

IRB oversight is no longer required, and studies should be closed in the following circumstances:

  • In rare cases of data that cannot be completely de-identified (e.g. video recordings), IRB oversight may end when all use of the data for research purposes is complete and data is securely archived for storage in a manner that assures confidentiality.
  • If data and corresponding oversight are transferred to an established repository.

Studies are administratively closed:

  • When IRB approval lapses, or
  • If the PI or Supervising Investigator has left CSS and oversight is not transferred to an eligible principal investigator.

Once a project is closed, IRB approval is no longer active. No human subjects research activities may take place after the date of closure. Investigators and supervising investigators are notified by IRBNet upon closure due to a lapse in approval.

Investigator Responsibilities

Investigators must retain research records pertaining to a research protocol for a period of three (3) years after the closure date. (See, CSS IRB SOP #03 IRB Records.) If other regulations and policies apply to a particular protocol, the protocol is retained in accordance with the longest applicable record retention requirements (e.g., a minimum of six (6) years for research covered by HIPAA). Such research records include, but are not limited to, signed informed consent forms, the approved protocol, and correspondence with the IRB.

Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by the CSS IRB, the Department of Health and Human Services, the Food and Drug Administration (FDA), and research sponsors.

Investigators may submit study closures to the IRB on a Study Closure Report found on IRBNet.  Once a research protocol has been closed, Investigators may keep the data they collected, including identifiable private data, in a manner consistent with the IRB approved protocol and subject consent. Investigators must continue to honor any confidentiality protections of the data.

However, investigators may not conduct any additional analysis of identifiable data without applying for IRB approval or exemption. Investigators must continue to protect the confidentiality of the data as described to the IRB and honor any other commitments that were agreed to as part of the approved research including, for example, future use of data or specimens, provision of research results to subjects, and provision of any outstanding payments or compensation.

Additionally, if an Investigator becomes aware of risks to subjects from their participation in the research for which the subjects have not been informed, the investigator must notify the IRB via the submission of an Unanticipated Problem and/or Adverse Event Report.

Investigators who leave the Institution must deposit their research records with their Department Head prior to their departure from the institution.

IRB Responsibility

The IRB Chair or designee is responsible for reviewing study closure reports, typically by expedited review, and either approve the closure of the study or request additional information or confirmation of facts from the investigator.

Reopening a Study After Closure

Investigators may reopen a study following a lapse in approval by submitting an amendment for continuing review in IRBNet. If a long period of time has passed since closure, an application for a new study may be required. In most cases, investigators who wish to re-open projects that have been administratively closed due to departure of principal investigator or supervising investigator must submit a new IRB application for review. Exceptions may be granted at the discretion of the IRB Chair when there are no concerns about adequate supervision, protection of human subjects, etc.

If after an IRB application is closed, the investigator seeks to engage in an activity such that the criteria for closure would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.

Resources

45 CFR § 46.103

21 CFR 56.103

45 CFR § 46.108

21 CFR 56.108

45 CFR § 46.109

21 CFR 56.109

Purdue Standard Operating Procedures https://www.irb.purdue.edu/sops/ Allina Health HRPP/IRB SOPs -

https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-resea rch-administration-home/hrpp-irb-sop-manual.pdf?la=en&hash=50A1A5F7B07CC65A86FB9F9B3471800 3

UCLA Research Administration Study Closure -

https://ora.research.ucla.edu/OHRPP/Documents/Policy/11/Study_Closure.pdf Mayo Study Closure -

https://www.mayo.edu/research/documents/11-closure-of-irb-appspdf/doc-10027256 Children’s Hospital of Philadelphia (CHOP) IRB SOP Study Closure -

https://irb.research.chop.edu/sites/default/files/documents/irbsop405_studyclosure_012219.pdf Iowa State Study Closure https://www.compliance.iastate.edu/sites/default/files/imported/irb/guide/docs/study-closure.pdf

This is a new policy per the 2018 Common Rule Requirements

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