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Human Subjects Division (HSD)

Announcements

Now Available - Research Non-Compliance: Researcher Overview

Mar 25, 2011 at 2:21pm
HSD has developed a new policy and procedure to formally describe to researchers the process by which problems that occur in their research projects (which may or may not represent non-compliance) will be handled by HSD staff and the IRB. An accompanying document, Research Non-Compliance: Researcher Overview, includes HSD's policy, definitions of non-compliance, and clarifications about the timeframe (10 days) for required reporting of research problems to the IRB. Consistent with current practice, problems that occur in research will continue to be reported to the IRB using the Report of Other Problems (ROOP) form. The ROOP is used to report events such as protocol deviations or violations, which are types of non-compliance, as well as unanticipated problems. The Research Non-Compliance: Researcher Overview provides important information about how these reports are assessed by HSD staff and the IRB and how the assessment will be communicated to the researcher. A new instruction included in the procedure is . . . Problems/events that occur in research that are out of the control of the researcher/staff do not need to be reported to the IRB unless that problem/event posed an increased risk to the subject(s). You may still be required to report these events to your study sponsor or others. Examples of events out of the control of the researcher/staff include but are not limited to:
  • A lab losing a blood sample IF this lost sample did not pose a risk to the subject’s safety or well-being.
  • A subject who fails to come in for their required study visit by the specified time because their car wouldn’t start if the missed visit did not pose a risk to the subject’s safety or well-being.
Please note that, also consistent with current practice, adverse events (i.e. reports of actual or potential physical injury/harm to a subject or others) will continue to be reported using the Adverse Event form. Please direct any questions about the new policy and procedure to wbrown3@uw.edu.