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Policies & Procedures

Closure or Withdrawal


Purpose

The purpose is to outline the policies and procedures for closure or withdrawal of human research projects.

Definitions

Closure of a research project is an official action taken by the Institutional Review Board (IRB) or Exempt Review Committee (ERC) to finalize its IRBNet history and to set a date of destruction for all electronic and hard copy records maintained by the Office of Planning and Institutional Research (OPIE).

De-identification means the removal or separation of any and all identifiers, or any other unique items of individually identifying information, from records or specimens.

Identifiable means the identity of the subject is known or may be readily ascertained by the investigator or associated with the information.

Identifiers may include items such as (1) name; (2) address; (3) elements of dates related to an individual (e.g., date of birth); (4) email address; (5) numbers, such as telephone/fax, social security, medical record, health plan/beneficiary, certificate/license, vehicle identifiers (e.g., license plate),  accounts (e.g., bank/credit card), device ID/serial; (6) web URLs; (7) Internet Protocol (IP) addresses; (8) biometric identifiers (e.g., voice, fingerprints); (9) full face photographs or comparable images; (10) or any other unique identifying number, characteristics or codes not assigned by the investigator for coding purposes (e.g., Global Positioning System readings).

Withdrawal of a research project is a specific type of closure which is requested by a Principal Investigator (PI) or automatically made by the IRB or ERC under certain circumstances.

The conditions for closure and withdrawal are described below.

Note: When a Principal Investigator (PI) erroneously submits an IRBNet package and the package must be withdrawn, such a withdrawal will not affect the status of the entire project.

Policy

Research approved by the Institutional Review Board (IRB) or Exempt Review Committee (ERC) expires one year from the approval date.  By the end of an approval year, a project must either:

  • Officially close prior to or at the date of expiration; or
  • Receive continuing review and approval prior to the expiration date.


The PI, the IRB and/or the ERC may close approved projects. Procedures for closing a study fall into five categories:

  • Closure due to receipt of closure report;
  • Closure due to PI’s separation from the University;
  • Withdrawal due to PI’s non-response to IRB/ERC requests for modifications after initial review (6 months from last board or committee decision letter);
  • Closure after expired approval and PI’s non-response to requests for final status report or continuing review/renewal (See Continuing Review policy);
  • Withdrawal request initiated by PI.


The PI is responsible for promptly closing an approved study or requesting withdrawal of a submission if any of the following conditions exist:

  • Closure: All research/clinical investigation activities including recruitment, enrollment, data collection and analysis are complete;
  • Closure: Only data analysis remains, but all data are completely de-identified, and no identifying links or codes to the de-identified data exist;
  • Closure: The PI never initiated the study even though it was approved;
  • Closure: The PI plans to leave the University and intends to continue the research activities at another institution; or
  • Withdrawal: The PI is abandoning the project after it has received initial review, but before approval is granted.

Note: Some pieces of information that may not appear to be identifiable in and of themselves may be combined to create new data that could potentially identify a research subject (e.g., person over 85 in a singular zip code; combination of exact birth date within a zip code, etc.).

To close or withdraw a project, the PI must submit a closure report form to the IRB or ERC requesting the action and providing a description of the results or the reason for withdrawal.

If a PI is closing a project because the only remaining activities involve analysis of de-identified data, the PI must explain exactly how the data are no longer identifiable so that closure may be considered.

If a faculty, staff or student investigator separates from the institution while a project is still underway, but activities are limited to data analysis of de-identified data only, the PI must close the project, as Marywood University is no longer responsible for its oversight.

Procedures

Closure Due to PI’s Submission of Closure Report

  1. As a study nears its projected end date, IRBNet generates automated e-mail messages, which are sent to the PI at 90 days, 60 days, 30 days, and 10 days prior to expiration, as well as one day after. This reminder indicates the date of expiration.
  2. The PI completes the closure report and submits it to the appropriate board or committee through IRBNet.
  3. An OPIE staff member administratively reviews the submission. If questions arise, the staff member will contact the PI; otherwise, the project is marked as closed in the IRBNet system. The expiration date is erased from the system so as to stop auto reminders.
  4. Upon closure, an OPIE staff member codes the protocol records as closed in the appropriate database. The OPIE staff member moves the protocol file (IRB only) from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed. IRBNet purges records every January after the destruction date.
  5. If the PI is closing the project because the only activity which remains is analysis of de-identified data, the PI must explain exactly how the data are no longer identifiable so that closure may be considered.


Closure Due to PI’s Separation from University (Analysis of De-Identified Data Only) 

  1. The PI completes the closure report and submits it to the appropriate board or committee through IRBNet.
  2. An OPIE staff member administratively reviews the submission. If questions arise, the staff member will contact the PI; otherwise, the project is marked as closed in the IRBNet system. The expiration date is erased from the system so as to stop auto reminders.
  3. Upon closure, an OPIE staff member codes the protocol records as closed in the appropriate database. The OPIE staff member moves the protocol file (IRB only) from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed. IRBNet purges records every January after the destruction date.


Withdrawal Due to PI’s Non-Response to Requested Modifications

  1. If, after initial review, the PI fails to respond to the IRB or ERC’s request for additional information or modifications within a reasonable amount of time from the date of the last decision letter published in IRBNet (usually between 2-3 months), an OPIE staff member reminds the PI that the IRB/ERC never approved the study and had requested modifications to the submission.
  2. If the PI does not respond within six months of the published decision letter, an OPIE staff member attempts further contact, including via telephone. If a response is not received within 2 days of attempted contact, an OPIE staff member creates a “Special Project Package” in IRBNet so that the IRB or ERC can take an official action separate from the initial package’s action.
  3. An OPIE staff member administratively withdraws and permanently closes the project file immediately after the status is changed in IRBNet.
  4. Upon closure, an OPIE staff member codes the protocol records as closed in the appropriate database. The OPIE staff member moves the protocol file from the active filing cabinet (IRB only) and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed. IRBNet purges records every January after the destruction date.


Closure Due to Expired Approval and PI’s Non-Response to Requests for Closure Report or Continuing Review

  1. As an approved study nears its projected end date, IRBNet generates automated e-mail messages, which are sent to the PI at 90 days, 60 days, 30 days, and 10 days prior to expiration, as well as one day after. This reminder indicates the date of expiration. 
  2. If the PI does not respond after the fourth automated message is sent (10 days prior), an OPIE staff member notifies the PI by email.  If there’s still no response after two working days, the staff member places a follow-up telephone call.
  3. If there is no response as of the expiration date, an OPIE staff member creates a “Special Project Package” in IRBNet so that the IRB or ERC can take an official action separate from the last package’s action. The staff member permanently closes the project file.
  4. Upon closure, an OPIE staff member codes the protocol records as closed in the appropriate database. The OPIE staff member moves the protocol file (IRB only) from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed. IRBNet purges records every January after the destruction date.


PI Initiated Withdrawal

  1. If, after initial review has been conducted and a decision letter has been published, the PI decides that s/he no longer wishes to pursue approval and wants to abandon a project, s/he submits a closure report to the appropriate board or committee through IRBNet, marking withdrawal and the reason.
  2. An OPIE staff member administratively reviews the submission. The project is marked as withdrawn and closed in the IRBNet system.
  3. Upon closure, an OPIE staff member codes the protocol records as withdrawn and closed in the appropriate database. The OPIE staff member moves the protocol file (IRB only) from the active filing cabinet and stores it alphabetically by PI last name in the closed filing cabinet. Records are stored for the minimum time required by regulations and/or contracts, after which they are destroyed. IRBNet purges records every January after the destruction date.

 

      Related Policies

      • Approval of Research
      • Continuing Review
      • Mandatory Reporting
      • Records Retention
      • Separation of Principal Investigators
      • Suspension or Termination

       

      History

      07/19/2013 - Created
      10/24/2014 - Updated (De-identified Data)
      12/05/2014 - Updated (Clarification on De-identified Data Reporting for Closure)
      06/13/2017 - Corrected references to office name; updated formatting and related policies; updated procedures