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Welcome & Instructions
About the Tutorial for the TCPS
Introducing the TCPS
Section 1: Ethics Review
Section Overview
Ethics Context
Research Requiring Review
Research Ethics Board
Review Process
Case Studies
Progress Check
Section 2: Free and Informed Consent
Section 3: Privacy and Confidentiality
Section 4: Conflict of Interest
Section 5: Inclusion in Research
Conclusion
Glossary
Acknowledgements
Finish
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Tutorial: Ethical Conduct of Research involving Humans: Section 1: Ethics Review

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

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:

  • 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.
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>> Balancing Harms and Benefits
>> Minimizing Harm
>>
Maximizing Benefit

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Minimal Risk

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.


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>> Minimal Risk

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Scholarly Review

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.

Recommended reading
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>> Article 1.5 Scholarly Review as Part of Ethics Review

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Proportionate Approach to Ethics Assessment

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.

Recommended reading
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>> Article 1.6 A Proportionate Approach to Ethics Assessment


Ongoing Research

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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>> Article 1.13 Review Procedures for Ongoing Research


Special Considerations: Multi-Centred Research and Research in Other Jurisdictions or Countries

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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>> Review of Multi-Centred Research
>> Article 1.14 Review of Research in Other Jurisdictions or Countries


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Last Modified: 2009-09-03 Top of Page Important Notices