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: : Analysis, Balance, and Distribution of Harms and Benefits
The ethics review process considers the risk of the harm and the benefits of the research, and who will incur them. This comparison of harms and benefits is a matter of judgement, as many factors are considered that can rarely be directly measured against each other.
The TCPS requires that:
Research within the range of minimal risk entails, from the perspective of the research subject, no greater probability and magnitude of possible harms than those encountered by the subject in aspects of his or her everyday life related to the research.
Research involving more than minimal risk requires greater scrutiny in ethics review and greater provision for protection of research subjects than research within the range of minimal risk.
Scholarly review consists of evaluation of the academic or scientific merits of the research. It should not be driven by other considerations, including those that may compromise academic freedom.
The TCPS requires that all research meet basic design standards. For
a research project posing more than minimal
risk, the design must be valid and capable of answering the research
questions that are being asked in the study. The extent of scholarly review
for research within the range of minimal risk varies, and depends on the
type of research being carried out. For example, research in the humanities
and social sciences that poses, at most, minimal risks, shall not normally
be required by the REB to be peer reviewed. The scholarship of a research
protocol may be assessed by a number of organizations, including the research
sponsors and research institutions, as well as the REB.
The TCPS requires that REBs adopt a proportionate approach to ethics review. This approach is based on the guiding principle that the more potentially invasive or harmful the research, the more care should be taken in its review. Research within the range of minimal risk requires less intensive scrutiny than does potentially harmful and ethically challenging research.
The institution may allow different levels of ethics review for different research:
Full REB review is the default requirement for all research involving
human subjects, but an institution may decide to authorize other levels
of review. If other levels of review are permitted, the results of such
reviews must be reported to the full REB.
The TCPS requires continuing ethics review of all ongoing research projects. The frequency and extent of the review is proportionate to the degree of risk to which the research subjects are exposed. The researcher proposes the continuing review process to the REB for approval. At a minimum, the researcher submits an annual report and notifies the REB when the research is complete. The REB may also require more frequent monitoring and reports as a condition of approval.
In multi-centred research, where several REBs consider the same proposal, the researcher may indicate to the REB which elements of the research cannot be changed without affecting the pooling of data from other institutions and those that can be altered to comply with local requirements. REBs may coordinate their review of multi-centred projects and communicate any concerns they may have with other REBs reviewing the same project.
Because an institution is responsible for research activities undertaken by its researchers regardless of where the research is conducted, research is reviewed by the institution where the researcher is employed as well as by any institution or authority at the location where the research will be carried out.