Review Process
: : Analysis, Balance, and Distribution of Harms and Benefits
: : Minimal Risk
: : Scholarly Review
: : Proportionate Approach to Ethics Assessment
: : Ongoing Research
: : Special Considerations: Multi-Centred Research and Research
in
Other Jurisdictions or Countries
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Analysis, Balance,
and Distribution of Harms and Benefits
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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:
- foreseeable harms should not outweigh anticipated benefits;
- research subjects must not be subjected to unnecessary risks of harm;
- the socially beneficial aims of the research cannot be achieved without
the participation of humans;
- the benefits associated with the research are made as great as possible
and the risks are minimized.
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.
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Proportionate Approach
to Ethics Assessment
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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: A face-to-face meeting of REB members is required
to undertake ethics review of research proposals involving greater than
minimal risk;
- Expedited REB review: An individual or subgroup of the REB may undertake
ethics review of research proposals within the range of minimal risk.
Expedited review may also be used for some annual renewals of approved
projects, for some research involving health record review and for
confirmation that the modifications requested by the REB as a condition
for approval have been met;
- Departmental review: A department may undertake the ethics review
of undergraduate projects carried out within formal course requirements.
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.
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Special Considerations:
Multi-Centred Research and Research in Other Jurisdictions or Countries
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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.
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