If The Reb Determines That The Targeted Population And Prospective Participants Have The Capacity To Decide For Themselves To Participate In This Study, Must The Reb Also Require That The Researcher Seek The Authorization Of A Parent Or Authorized Third P (2023)

FAQs

Should researchers seek REB review prior to initiating community engagement? ›

This research includes in-depth interviews with individuals living in First Nations, Inuit and Métis territories, as well as the collection of blood and saliva samples, which will be used to perform genomic analyses. Researchers should initiate community engagement prior to seeking REB review.

Research that may be reviewed by the REB through a delegated review procedure normally includes research activities that present no more than minimal risk to human subjects, and minor changes in approved research.

Importantly, when authorization for participation was granted by an authorized third party and a participant acquires or regains decision-making capacity during the course of the research, the researcher shall promptly seek the participant's consent as a condition of continuing participation.

-TCPS 2 advocates a proportionate approach to REB review. In practice, this means that the REB as a whole, and each REB member, is required to consider the foreseeable risks, ethical implications and potential benefits of each research proposal in their evaluation of its ethical acceptability.

For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject's participation; a detailed description of ...

As stated in TCPS 2, REB review is required for "research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals" (Article 2.1 (b))(emphasis added).

Research that relies exclusively on public information that meets the definition and criteria in Article 2.2 (publicly available and protected by law, or in the public domain with no expectation of privacy) does not require REB review.

REB review is not required for research involving the observation of people in public places where: It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups; Individuals or groups targeted for observation have no reasonable expectation of privacy; and.

§ 46.111 Criteria for IRB approval of research.

In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).

For example, REB members are in a conflict of interest when their own research projects are under review by their REB, when they are a co-investigator, or when they are in a supervisory or mentoring relationship with a graduate student applicant.

What are two of the most important ethical concerns that arise when research is conducted with people in low and middle income countries? ›

Research sponsored by wealthy countries and conducted in relatively poor countries is beset by ethical issues, including double standards of care, cultural differences in informed consent, and exploitation of foreign research participants, which should be analyzed against the backdrop of poverty and limited health ...

REB mandate and reporting

The Health Canada-PHAC REB serves as an independent ethics review board to help ensure that all proposed or ongoing research involving human participants or communities carried out by, funded by, or otherwise under the auspices of Health Canada or PHAC, meets the highest ethical standards.

Any research project involving the direct collection of information from human subjects must be declared to the REB. This includes any investigation that necessitates a consultation with persons for the purpose of obtaining research data, whether personal or otherwise.

Research does not require REB review when it relies exclusively on information that is: Publicly available through a mechanism set out by legislation or regulation and that is protected by law; or. In the public domain and the individuals to whom the information refers have no reasonable expectation of privacy.

Research that relies exclusively on public information that meets the definition and criteria in Article 2.2 (publicly available and protected by law, or in the public domain with no expectation of privacy) does not require REB review.

Any clinical or behavioural study that involves human participants requires ethics review and approval to ensure that the research meets federal ethical requirements and protects the welfare of study participants.