*Forms are subject to change. Check for the latest forms on the Tulane IRB web site.Guidance on Study Closures

Tulane University Human Research Protection Program

Guidance on Study Closures

IMPORTANT NOTE: DO NOT close a study if any of the following 6 conditions apply. Such studies must remain active and continue to receive ongoing IRB review and approval and therefore, Continuing Review materials must be submitted appropriately.

  • Enrollment at any Tulane approved site is ongoing
  • Research-related interventions and/or follow-up at any Tulane approved sites are ongoing
  • Participant follow-up at any Tulane approved site is ongoing
  • Biological specimens containing personally identifiable information are being maintained in a repository that has been approved as a part of this study or upon which analysis or research is ongoing. If, however, specimens were transferred to a separate repository that has ongoing IRB approval, the study may be closed
  • Data analysis or manuscript preparation that involves the use or access to personally identifiable information is ongoing
  • If there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB

Study Closure Form Reporting Requirement

To allow for a substantive and meaningful review of research activities at the close of a study, the PI is required to submit a Study Closure Form for all the studies that were reviewed and approved by the IRB. This report updates the IRB on the conduct and outcomes of the study, which may need to be disclosed to the study participants or others.

PI Responsibilities

  • Submit the Study Closure Form:

The form must be submitted via IRBNet (irbnet.org) within 30 days of completion or termination of all research activity, even if the current approval period has expired

The PI need not wait for the end of the study approval period to submit a Study Closure Form

  • Store the research records the required length of time:

The records must be stored in accordance with Federal Regulations, Tulane HRPO policy, and any additional requirements stipulated by research sponsors

  • Subsequent use of data from closed research:

When using data from closed research, whether by the original investigator or other investigators, the research may constitute as human subjects research requiring IRB approval or an Exemption. For further information about storage of data for future use and about secondary uses of data, consult the HRPP Policies and Procedures

  • Continue to provide confidentiality protections:

Confidentiality of subjects data must continue to be protected when communicating research results and/or transmitting any financial obligations to subjects

  • If terminating employment or other association with Tulane University, the PI is obligated to either:
  • Close the study by submitting a Study Closure Form to the Tulane HRPO

Or

  • Transfer the protocol to another Tulane University Investigator (via an Amendment) who has taken the CITI Training Course. The original PI will remain responsible for the study until the Amendment has received IRB approval

IRB Responsibilities and Procedures

The Tulane University HRPO will review all Study Closure Forms and request further information, if needed.

The Tulane University HRPO may close projects without investigator approval in the following circumstances:

  • If it is determined that the PI is no longer affiliated with Tulane and an Amendment Form to change the PI or transfer the study was not submitted
  • If the approval period for the research has expired, all research activities must stop. The study is permanently closed after 30 days of expiration has passed and no Continuing Review materials have been submitted
  • If the PI has not responded to the HRPO or IRB’s request for revisions and/or clarifications within a timeframe determined

*In any of the situations above, the HRPO will notify the PI of the study closure

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Issued: 11/10/09 Last Reviewed: 08/01/13

Effective: 11/10/09 Last Revised: 08/01/13

Form #: 717