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Closing a protocol All expedited and full board approved human subject protocols at UMBC are approved for a total of five years. Prior to the end of the fifth year of the protocol, the Human and Animal Protections Research Office will send the investigator a notice of closure, stating the requirements for closing the protocol and submitting a new protocol for continuing the research project. Investigators, whose externally funded projects are not being renewed, may request a one-time, six month extension to complete data analysis and prepare a report for the funding agency. Requests must be made in writing to the IRB at least sixty (60) days prior to the termination of the project and submitted to the Human and Animal Protections Research Office. As the activities of a research project come to an end, the principal investigator is responsible for submitting a closure report, indicating any research findings and/or outcome of the project. A closure report is also required if the investigator is leaving the university. The investigator must sign the closure report. In cases where the investigator is a student, the faculty advisor must cosign the report. Attach copies of any results, reports, articles (etc.) deemed necessary to support the closure of the protocol and forward to the Human and Animal Protections Research Office. When is a protocol officially closed? The procedure differs depending upon whether the study is minimal risk or higher. In cases where the project is minimal risk or less, protocol closure may occur when data collection is completed, when basic data analyses are completed and when all contact with participants has ended. The basic data analyses should allow the investigator to conclude with reasonable certainty that there are no further impacts from the study on the participants. If the investigator has stated in the protocols or informed participants that identifying information, which could be linked to participants, this deletion must be made prior to closing a protocol. Note that a protocol closure does not affect an investigator's ability to write articles or publish. However, it does stop any ongoing or future contact between the investigator and participants. All linkages to participants should be destroyed. Should the investigator decide future contact is needed with the participants, or to collect additional data, he/she must notify the IRB. Students completing research for their thesis or dissertation must, upon completion of the project activities (as defined above), submit a closure report. Click on the below to download:
If a principal investigators does not respond to a continuation (renewal) request by the date the protocol is due to expire, the IRB, via the Human and Animal Protections Research Office, will administratively close the protocol. No protocol activity may continue, including contact with participants, the use of and/or the analysis of subject records and collected data. |
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Last updated 04/28/2008 |
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