REB Application Process & Reporting
Application Process
Any Research Ethics Board (REB) Member can review your draft work and identify potential difficulties that could be easily fixed before an application is submitted.
Applications for research ethics review are accepted at any time during the academic year.
Ethical approval must be received PRIOR to the collection of data (including pilot studies).
- The appropriate application form from the list below:
- Research Ethics Project Application
- Course-Based Student Project Application
- Submit one for each course/assignment
- All Project Documents, including:
- Research instruments
- Recruitment documents
- Informed consent forms
- Debriefing protocols
- Documents from other REBs
- Permission letters
Application Timelines
Most applications are reviewed as they are submitted. When no modifications or clarifications are required, the review process may take up to 15 business days; if modifications or clarifications are requested, the process may take longer. Modifications or clarifications will be communicated through the Vice-Chair of the REB.
Note: Proposed projects that involve more than minimal risk will be subject to a Full Board Review at the earliest convenience of the REB.
Approved Projects
When a project is approved, the Vice-Chair forwards a copy Certificate of Ethical Approval.
Approved research projects are subjected to ongoing ethical review. The Principal Researcher is responsible for:
- notifying the REB of any significant changes to the research protocol of the approved project;
- notifying the REB of any breaches to the research protocol or any unintended negative events encountered during data collection; and
- Submitting an Annual Status Report at the project's completion, or for every year it is active.
Note: 1) and 2) may require the submission of a new/revised Project Application form.
Denied Projects
When a project is denied - the Principal Researcher has the option to appeal; as per the Research Involving Humans policy & procedure.
Reporting
Reporting of Unexpected/Adverse Events
According to the TCPS 2 (2022), “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 a research project (e.g., a participant in an exercise study falling off equipment)
- Equipment failure during an experimental session resulting 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
- notify the Chair of the REB with the details of the event and submit an Adverse Event Report no more than 48 hours after initial notification.
Reporting requirements for initial and follow-up of adverse events
Researchers must report only those adverse events that are considered unanticipated problems in the Adverse Event Report.
- Researchers 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 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:
- The 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.
Annual Status Reports
RDP REB approved research is subject to continuing research ethics review from the date of initial approval throughout the life of the project; to ensure 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 (2022), Red Deer Polytechnic'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.
The Annual Status Report form are emailed out mid-April. If you prefer to complete the Annual Status Report earlier, please contact us.