As per article 8.4 of the TCPS 2 (2018), when conducting research outside the jurisdiction of their home institution, whether at a site or abroad, or in Canada, researchers shall provide their home REBs with the:
The level of foreseeable risk posed to participants by their involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it will occur, whether to participants or third parties.
The TCPS 2 (2018) describes minimal risk research as "research in which the probability and magnitude of possible harms implied by participation in the research are no greater that those encountered by participants in those aspects of their everyday life that relate to the research" (Article 2, para. 9).
Consider individual as well as group vulnerabilities (e.g. pre-existing conditions, cognitive/emotional factors, legal status, socioeconomic factors, etc.)
Free and informed consent is an ongoing process that starts with the researcher's first contact with the individual and continues until the study's completion. Although written consent is most common, the REB understands that some disciplines and cultures do not use written consent.
It is the quality of the consent process, not the format, that is most important. Any verbal exchange about the study, the consent form, and all documentation given to participants should provide adequate and full information for the participant to make a free and informed decision about their participation.
I will ensure that all procedures under the project will be conducted in accordance with the NAIT REB's approved protocol and consent process, the Tri-Council Poly Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2018), and all relevant NAIT, provincial, national and international policies and regulations that govern research involving human participants.
Recruitment of participants will not begin until all appropriate institutes have provided their approval.
Adverse events: I will respond to such an event immediately and report it to the REB after no longer than one business day.
Modifications: Deviations from the initially approved protocol, which alter the risks to participants and are implemented without research ethics approval, constitute a violation of the TCPS 2. Any deviations from the project as originally approved will be submitted for approval prior to implementation.
Yearly renewal: Protocols are approved for one year, after which approval is suspended. If necessary, I will submit a Renewal Request 30 days prior to expiry to extend the research ethics approval.
Non-compliance: I understand that the REB is obligated to report any cases in which a research protocol does not hold a valid Certificate of Ethical Acceptability.
NAIT REB Approval Documents: I will retain a copy of the NAIT REB Ethics Certificate for Research Involving Humans for my records.