TCPS 2: CORE-2023 module Questions and Answers

TCPS 2: CORE -2023 module Questions and Answers In the TCPS 2, three complementary core principles serve as the guide to ethical research involving human participants: - Answer - Respect for Persons Concern for Welfare Justice Respect for Persons - Answer - recognizing the intrinsic value of each individual and their autonomy. In the context of research, it means recognizing that participants should only subject themselves to the risks of participation in research as a matter o f choice, based on the information they need or request to understand those risks, as well as the purpose and potential benefits of the research. It means respecting their values and their choices to decide whether to participate, or to continue to partic ipate, in research. It also means putting in place additional measures to protect those who lack the capacity to make their own decisions. Concern for welfare - Answer - avoiding exposing participants to unnecessary risks. This requires consideration of t he physical, mental, and spiritual health of participants, as well as their physical, economic and social circumstances. To achieve the most favourable balance of foreseeable risks and potential benefits, researchers and REBs must understand the impact of those risks on a person in the prospective participant's circumstances, and on the group to which they belong Justice - Answer - dual obligation to treat persons as well as groups and communities: 1) fairly and 2) equitably. TCPS 2 provides guidance fo r - Answer - the ethical conduct of research involving human participants. For researchers in Canada - Answer - compliance with the TCPS 2 is a condition of Agency funding and a requirement for all research conducted under the auspices of an eligible institution Where the TCPS 2 applies, it does regardless of - Answer - Who carries out the research; What the source of funding is, if any; and Where the research is conducted. TCPS 2 defines research as - Answer - an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation disciplined inquiry - Answer - inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community Human participants - Answer - those individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s) Research involving human participants, as defined in the TCPS 2, requires - Answer - review and approval by a REB. The TCPS 2 definition of human participant includes - Answer - human biological materials from living and deceased individuals what does not require REB review - Answer - Activities t hat use techniques or methods similar to those used in research, but do not have a research purpose do not require REB review because they do not fall within the TCPS 2 definition of research. For research to be ethical - Answer - the potential benefits of the research should outweigh the foreseeable risks to participants. REBs should assess the risks by - Answer - considering only those risks that are attributable to the research. When assessing the potential benefits, they should consider only those for p articipants, their community, and society. how to determine the appropriate level of ethics review that is required - Answer - REBs should distinguish between minimal risk research and research that is greater than minimal risk in order Researchers have a duty to - Answer - avoid, minimize, or eliminate unnecessary research -attributable risks. Minimal risk research - Answer - research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research. incidental finding - Answer - a discovery about research participants or prospective participants that is made in the course of research, but is outside the ob jectives of the research study