Ongoing Review / Annual Status Report
Annual Status Reports are due: June 15
Red Deer College Research Ethics Board (REB) approved research is subject to continuing research ethics review from the date of initial REB approval throughout the life of the project; continuing REB review ensures that all stages of a research project are ethically acceptable in accordance with the principles of the Research Involving Humans Policy.
The Principal Researcher is responsible for maintaining REB Ethical Clearance for active research studies involving human participants. As per the TCPS2 (2014), RDC’s Research Involving Humans policy (article 2.1), and in accordance with current best practices, studies with ethics clearance from the REB must be renewed at least once per year. It is at the discretion of the REB to require renewals more often, if need be, appropriate to the degree of risk within the study.
We have moved the Annual Status Report process online this year. You can access the form by clicking the link above. If you have difficulties accessing this form, please contact ethics [at] rdc [dot] ab [dot] ca and an alternative format form will be provided.
REPORTING OF UNEXPECTED / ADVERSE EVENTS
According to the TCPS2 (2014) Ethical Conduct for Research Involving Humans, “Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participant’s welfare.”
Adverse Events are defined as occurrences with an undesirable outcome for the participant. The following are examples of adverse events that must be reported:
- Negative, physical, or allergic reactions to drugs administered in a study
- Physical consequences from dietary manipulations (e.g., fainting)
- Negative physical reactions in volunteers who have chronic diseases (e.g., heart conditions, etc.)
- Unexpected accidents that occur during the course of a research project (e.g., a participant in an exercise study falling off an exercise bike or treadmill)
- Equipment failure during an experimental session should also be reported if it resulted in harm to a participant
- Participants showing signs of emotional upset in conjunction with or following interviews or other tasks associated with participation
- Any release, even inadvertent, of research participants' identities or personal information
- Partial or complete data loss
To report an adverse event, the researcher must first notify the Chair of the REB with the details of the event as soon as possible but no later than 48 hours after the event. This notification should be followed as soon as possible to a maximum of 48 hours by the completion and submission of an Adverse Event Report.
Reporting requirements for initial and follow-up of adverse events:
- Researcher must report only those adverse events that are considered unanticipated problems. Adverse events are reported using the Adverse Event Report.
- Researcher must submit follow up notification of all adverse events if the participant's condition worsened and/or relationship of the adverse event to the study treatment has changed or at the time of resolution.
- A summary list of adverse events or other incidents, experiences, outcomes that are deemed unanticipated problems and their REB report dates must also be included at the time of Annual Review.
- Regardless of whether the adverse event is determined to be an unanticipated problem, the researcher must ensure the adverse event is reported to the study sponsor or grant agency, as sponsors are responsible for submitting safety information to applicable regulatory authorities (e.g., Health Canada, FDA) in accordance with regulatory requirements.
Once the Chair receives notice of an Adverse Event:
- Chair will call the Board together to review the Adverse Events Report and the original application. The Board meeting will be held within 2 business days of notification. A minimum of 3 Board members in addition to the Chair must attend the meeting.
- Following the meeting, the Chair will provide feedback and direction to the researcher within 1 business day of the Board meeting.
The researcher is then responsible for follow-up and/or resolution within five business days of the Board response.
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Main Phone: 403.342.3400
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Email: inquire [at] rdc [dot] ab [dot] ca
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Red Deer, Alberta | T4N 5H5