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Once the HSRB has approved a project, it must be carried out as planned. Any changes in subject population, recruitment plans, research procedures, measures/instruments, study location, consent process, or major research personnel must be approved by the HSRB prior to implementation. You must submit a Modification Form to the HSRB via IRBNet.org. Enacting changes without prior approval constitutes a protocol violation.
Minor changes are handled by administrative action or expedited review. Changes that affect the risk/benefit ration may require full board review. Implementation of the change must wait for the HSRB's approval.
Adverse events are unexpected problems whose nature, severity, and frequency are not described in the information provided to the HSRB or to subjects. Examples include unexpected complications for a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events must be reported to the HSRB within 10 working days of the event. The RPI is responsible for completing and submitting an "adverse event report" to
The HSRB office. The report must discuss:
Researchers must maintain a file of all documents concerning the use of human subjects in research for at least three (3) years. The documents that researchers must have on file are as follows:
Original signed consent forms must be kept in a secure location within Metropolitan State University property and separate from all other research and correspondence files. HSRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include suspension of funding, fines, and exclusion from future funding.