Changes to, or non-compliance with the research protocol without prior approval from the Sponsor or the approving HREC that may (or has the potential to) impact or have a significant effect on the participants right to safety, welfare, privacy and/or on the integrity of the data. Deviations may result from the action of a researcher, research staff and/or the participant.
Examples of a protocol deviations:
- Failure to follow the HREC approved recruitment strategy, the use of unapproved recruitment materials or recruitment methods;
- Failure to obtain valid informed consent or complete study screening processes according to the approved protocol;
- Loss of laptop computer or portable storage devices that contained identifiable, private information about participants;
- Distribution of incorrect or study medication, dose or the use of expired study medications;
- Not following inclusion/exclusion criteria;
- A rescheduled study visits or follow up visit, failure to collect an ancillary self-report questionnaire;
- Subject’s refusal to complete scheduled research activities;
- Failure to provide medical assistance, support or complete safety follow up to participants who request assistance;
- Changes to the research methodology, data collection methods, plan for disseminating the research results without prior approval from the sponsor or approving HREC.
Protocol deviation reports must be submitted for ethical review if the deviation from HREC-approved procedures, ICH-GCP, or the clinical trial protocol potentially impacts the health and wellbeing of trial participants or affects the reliability and robustness of the data generated. In these instances, a Protocol Deviation Report Form must be submitted as soon as possible or within 72 hours of becoming aware of the event where a:
- UNSW HREC or HREAP has reviewed and provided ethical approval for a research project;
- Ethical approval for an external research project has been received and the protocol deviation resulted from an action of a UNSW researcher, UNSW research staff and/or the participant recruited at a site that UNSW is responsible for or where UNSW is the sponsor of the research project.
Protocol deviation reports are submitted using the iRECS Portal.