This policy describes when studies that have been approved by an IRB should be closed.
- The University of Wisconsin-Madison requires study teams to submit a final report (i.e., closure report) to the IRB to formally close a non-exempt research study within 30 days of study close out or approval of a 5 year replacement application.
- Research study closure can occur if all of the following conditions are met.
- Enrollment at all sites under UW-Madison IRB purview is closed.
- Research-related interventions and/or participant follow-up at sites under UW-Madison IRB purview is/are completed.
- Data or images under UW-Madison IRB purview are de-identified (i.e., there is no personally identifiable information, including through a code).
- Biological specimens under analysis or being housed in a repository under UW-Madison IRB purview are de-identified (i.e., there is no personally identifiable information, including through a code).
- If identifiable biological specimens are being maintained, the study cannot be closed unless they have all been transferred to a separate repository that has ongoing IRB oversight.
- Data analysis or manuscript preparation that requires the use of or access to directly identifiable or coded data is completed.
- The external study sponsor (if any) has agreed that activities involving human participants at sites under UW-Madison purview are complete and has provided permission to close the study with the IRB.
- If the UW-Madison has ceded (deferred) IRB oversight of a study involving human participants to another institution (e.g., WIRB, NCI CIRB), the study team is still expected to submit a closure report to the UW-Madison IRB that agreed to cede the study.
- When a study is formally closed, the UW-Madison study team is responsible for:
- Retaining study records in accordance with the longest period of time specified in the UW-Madison policies on Scientific Misconduct and Data Stewardship, Access and Retention, federal regulations, or other applicable regulations, policies, and contractual language.
- Continuing to provide confidentiality protection and honor all commitments made to participants and in the IRB applications, including communication of research results, specified conditions of sharing research data, recordings, images, and specimens, and financial obligations.
- Ensuring that any applicable ClinicalTrials.gov records are updated as appropriate.
- The reanalysis of identifiable participant data (this includes coded data) for a new research question requires review by an IRB.
- Study teams must consult with the office of the IRB that reviewed the original study prior to use of data, specimens, recordings, or images from a closed research study, whether by the original investigator or other investigators, as this may constitute new human participants research requiring IRB exemption or approval.
- If research teams plan on sharing images, data, recordings, or specimens with individuals or entities not previously described in the IRB application, they must consult with the office of the committee that reviewed the original study to help ensure that the conditions under which the IRB approved the collection and use continue to be met.
- If the Principal Investigator (PI) is terminating his or her employment with the UW-Madison or no longer fulfills the criteria to serve as PI, he or she must notify the IRB of this change in status.
- This notification must occur at least 14 calendar days prior to the effective date of the relevant change in status and they must do one of the following:
- Close the study with the appropriate UW-Madison IRB and cease activities involving human participants.
- Transfer the study to another UW-Madison researcher through the submission of a change of protocol.
- Request transfer of research outside of UW-Madison and close the study with the appropriate UW-Madison IRB.
- UW-Madison IRBs may require the closure and re-submission of any study, in any of the following situations.
- No research activities have begun or no participants have been enrolled within 3 calendar years from the date of the IRB approval of an initial review application.
- The IRB application and/or protocol needs to be updated to meet current IRB and regulatory standards.
- A study or protocol appears to have changed substantially from the IRB’s original assessment of it.
- The study team has not provided a response to any IRB query for 90 days.
Adopted By: Cross-Campus Human Research Protection Program Advisory (HRPP) Committee
Adoption Date: March 26, 2015
Copyright © 2015 University of Wisconsin System Board of Regents
- Policy on Data Stewardship, Access, and Retention
- Lab Close-Out Checklist
- Principal Investigator Status for UW-Madison Studies Involving Human Participants
- Procedure for Dealing with Misconduct in Scholarly Research
- Reporting Research Misconduct
- End of a Study
- How to Close Studies
- Protocol Closure Guidance
- Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
- Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support