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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

Research Ethics Board

: : Authority
: : Membership
: : Number of Institutional REBs
: : REB Administration

Authority

The REB has the authority to approve, disapprove, propose modifications to, or terminate any proposed or ongoing research involving human subjects conducted within, or by members of, the institution. An institution can authorize its REB to accept the review decision of other REBs constituted under the TCPS if it so wishes.

Each institution must provide resources to allow for the financial and administrative independence of its REB. It must respect decisions made by the REB. An institution cannot overturn a negative REB decision, although it can refuse to allow research the REB has approved to proceed.

Recommended reading
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>> Article 1.2 Authority of the REB

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Membership

The TCPS requires that REBs consist of at least five members, including both men and women, of whom at least:

  • two members have broad expertise in the methods or areas of research that are covered by the REB;
  • one member is knowledgeable in ethics;
  • one representative comes from the community that the REB serves.

REBs that review biomedical research are required to have a member knowledgeable in the relevant law. Non-biomedical REBs are advised to include one member with legal knowledge. The institution's legal counsel should not be a member of the REB.

REB membership should be broad enough to reflect the community or society in which the REB functions and from which research subjects may be recruited. Should the REB decide that additional expertise is required for the ethics review of a specific proposal, ad hoc members may be nominated for the duration of the review.

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>> Article 1.3 Membership of the REB

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Number of Institutional REBs

The TCPS allows large institutions to have a number of co-ordinated REBs, usually covering different areas of research. Small institutions, or those with small workloads, may share an REB with other institutions.

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>> Article 1.4 Number of REBs Within an
Institution and Relationships Among REBs

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REB Administration

The TCPS outlines a number of administrative procedures used by REBs:

  • REBs need to meet regularly. They must hold face-to-face meetings to discuss research proposals that are not delegated to expedited REB review;

  • REBs must prepare and maintain minutes of all REB meetings;

  • REBs must reach a decision on whether to approve a project and allow the research to proceed. The REB decision is usually preceded by extensive discussion of ethical concerns and possible modifications to the research proposal. Sometimes the researcher will be invited to be present (but the researcher must be absent when the REB is making its decision). The researcher must be given an opportunity to reply before a REB makes a final decision not to approve proposed research;

  • Researchers may request, and REBs must provide, reconsideration of REB decisions.

  • A mechanism must be available to researchers to appeal REB decisions when through discussion and reconsideration between researchers and the REB an agreement cannot be reached. Ad hoc appeal boards are not permitted. Membership and procedures of appeal boards must meet the same requirements as a REB. By a formal letter of agreement, institutions can decide to use each other's REBs as appeal boards. The three agencies do not hear appeals;

  • An REB member who has personal involvement in a research project under review must not be present when the REB is making its decision, due to actual, potential or perceived conflict of interest.

Although the administrative operation of each institutional REB conforms to the TCPS, an REB develops its own set of procedures. Researchers may benefit from consulting with a REB about institution-specific procedures before submitting a proposal for review.

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>> Article 1.7 Meetings and Attendance
>> Article 1.8 Record Keeping
>> Article 1.9 Decision-making
>> Article 1.10 Reconsideration
>> Article 1.11 Appeals
>> Article 1.12 Conflicts of Interest

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Last Modified: 2009-09-01 Top of Page Important Notices