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ANNUAL CONTINUATIONS AND RENEWALS The IRB is responsible for the continuing review of research to ensure that the rights and welfare of human participants are being protected. Special attention will be paid to determine whether new information or unanticipated risks were discovered during the research. All expedited and full board approved human subject protocols at UMBC are approved for a total of five years. A protocol is initially approved for a period of up to 12 months. Four (4) continuations or renewals may be requested, each for a period of up to 12 additional months. Continuing review of research previously approved by the IRB at a convened meeting may be performed by the IRB where, at the time of renewal, the research: is permanently closed to the enrollment of new subjects, all subjects have completed all research related interventions, and the research remains active only for long-term follow-up of subjects; had no subjects ever enrolled and no additional risks were identified; where the remaining research activities are limited to data analysis. OR the research, where the IRB has determined and documented at a convened meeting, involves no greater than minimal risk and no additional risks have been identified. Expedited Review Procedure - http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm). The Human and Animal Protections Research Office will send the principal investigator an Annual Continuation Report Reminder in advance to the expiration of approval for a protocol approved via expedited review. The principal investigator, however, is responsible for timely submission of a continuation request. The request and all supportive materials must be submitted to the Human and Animal Protections Research Office at least four (4) weeks prior to the current protocol end date. Click on the below to download: NOTE: A protocol period lapses when no continuation request has been submitted prior to the expiration date. As such, no protocol activity may continue, including contact with participants and the use and analysis of collected data. If this occurs, the protocol will be administratively closed by the IRB; investigators listed on this protocol will not have new submissions reviewed until a closure report is received. The process for submitting a new protocol is required to resume project activities. 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. Exempt Protocols Under the Exempt category, the principal investigator is not required to submit a renewal request. If for any reason the status of the protocol changes and it is believed that the protocol is no longer exempt from IRB review and approval, please contact the Human and Animal Protections Research Office (HARPO@umbc.edu). |
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Last updated 04/28/2008 |
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