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IRB STUDY CLOSURE: WHO, WHEN, AND HOW

WHO. Study Closure is to be requested by the principal investigatorIf the principal investigator authorizes another person to sign as the PI's designee, the designee's signature is accepted on the Study Closure form.. WHEN . Circumstances for Closure: (as found in VCU IRB WPP

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IRB STUDY CLOSURE: WHO, WHEN, AND HOW

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    1. IRB STUDY CLOSURE: WHO, WHEN, AND HOW? Susan Kimbrough Assistant Director Office of Research Subjects Protection Virginia Commonwealth University

    2. WHO Study Closure is to be requested by the principal investigator If the principal investigator authorizes another person to sign as the PIs designee, the designees signature is accepted on the Study Closure form.

    3. WHEN Circumstances for Closure: (as found in VCU IRB WPP #X-4) VCU IRB oversight may end ONLY if both of the following two conditions are met: No further interaction/intervention with the subject (or access to the subjects personally identifiable information) for the purpose of research data collection. AND (a) All data analysis involving the research site(s), under the VCU IRB approval, is complete (with data and/or samples de-identified and will remain de- identified). OR (b) Data has been de-identified, with no codes or keys that would allow for the potential of identifying individuals in the future. This typically applies to multi-center research where de-identified data is provided to the sponsor and the sponsor authorizes VCU IRB closure.

    4. There is one additional circumstance for closure When the PI leaves VCU and chooses not to request a change in PI

    5. Reminders

    6. Exempt Studies No Expiration Date No Continuing Review Once approved, these studies only return to the IRB for Amendments or potentially for Unanticipated Events Without submission of a Study Closure, the study has the potential to stay open indefinitely Submission of Study Closure is often overlooked with these studies

    7. Exempt Studies (cont) On a yearly basis, a report is run of all Exempt studies open more than 3 years Reminder sent to PI that a study is still open; update is requested regarding the current status of the study In April 2008, a report was run of all Exempt studies approved prior to 2005 Inquiries were sent out on 295 Exempt studies (*higher than usual as no report was run for 2007) Of the 295 studies . . . 226 could have been officially Closed! Many of these studies had long been completed (including student research projects). However, they had not been officially closed by submitting a Study Closure form. These yearly inquiries can serve as a reminder that a study is still open with the IRB

    8. Expedited and Full Board Studies Studies have an approval period of no more than 365 days. Expiration dates are listed on the approval letters. Continuing review notices are sent out prior to the study expiration Continuing Review Form Includes a question, Is your project completed? If YES, submit Study Closure Form Continuing Review Form can serve as a reminder that a study is still open with the IRB

    9. Expiration Notices Failure to submit either a Study Closure or Continuing Review prior to the expiration date results in the Expiration of the study Reports are run on a weekly basis to check for expired studies Expiration Notices are sent to PIs These notices can sometimes serve as a reminder that a study had not been officially closed with the IRB

    10. PI Leaving VCU Per regulations a study must have an IRB approved Principal Investigator PRIOR to leaving VCU, the PI needs to either: Submit a request to change the PI (review and approval required prior to the PIs separation from VCU) OR Submit a Study Closure Form Otherwise, we will need to contact the PIs Chair regarding the status of the study

    11. PI Leaving VCU (cont) What Happens to the Data? VCU Office of Research Policy on Research Data (http://www.research.vcu.edu/p_and_g/data.htm) VCU retains ownership of the research data A written agreement can be put into place between the Chairperson and investigator for the future use of the data Oversight and dispute resolution for this policy comes under the Vice President for Research

    12. Office of Research Policy on Research Data (cont) Retention of Research Data Research data disclosed or referenced in publications must be retained a minimum of 5 years (or as otherwise defined by state regulations or agreement) Research data resulting from sponsored programs are to be retained by the University for a minimum of 5 years after submission of the final Report on the Research project, unless a longer retention period is specified by the sponsor

    13. HOW Study Closure Form Found on the Office of Research Subjects Protection website, under Forms, at (http://www.research.vcu.edu/irb/index.htm) Study Closure Form contains a link to WPP #X-4 for guidance regarding circumstances/conditions under which VCU IRB oversight may end; and therefore, a study may close. Form needs to be submitted prior to the expiration date of the study.

    14. Following Study Closure: (as found in VCU IRB WPP #X-4) If the PI finds that future correspondence or interaction with the subjects of the study is necessary (for research data collection), the PI is to immediately inform the IRB. The PI may request that the IRB re-open the study by continuing review or request a new initial review

    15. Useful Links VCU IRB Written Policies and Procedures - http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm VCU Study Closure Form - http://www.research.vcu.edu/forms/vcuirb.htm VCU Office of Research Policy on Research Data - http://www.research.vcu.edu/p_and_g/data.htm

    16. Unrelated tidbits of useful information worth mentioning: Use the most up-to-date versions of all forms and templates (Research Plan/ICF) Always refer to our website for the most recent forms Do not copy a form you have in your files it most likely has been updated Do not use the auto date feature for the version date in the footer We accept the previous version of forms for 30 days following the posting of a new version

    17. More unrelated tidbits Revisions to study documents (i.e. Research Plan, ICF, advertisement, letters to subjects, etc) Always update the Version # and/or date in the footer of the document if the document is being revised (Do not use the auto-date feature) Do not update the Version # and/or date in the footer of the document if the document is not being revised

    18. Thank you! For questions, please feel free to contact me at sdkimbrough@vcu.edu or 827-1533

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