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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

Progress Check

1. According to the TCPS, which of the following types of research require ethics review? (Select all that apply)

All research that involves living human subjects, except when the research is based exclusively on publicly available documentation.

Research involving human remains, cadavers, tissue, biological fluids, embryos or foetuses.

Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available documentation.

Quality assurance studies, performance reviews or testing within normal educational requirements.


2. Of the following, which best describes what Research Ethics Boards (REBs) have the authority to do?

Approve or disapprove any proposed or ongoing research involving human subjects conducted within, or by members of, the institution.

Approve or propose modifications to any proposed or ongoing research involving human subjects conducted within, or by members of, the institution.

Approve, disapprove, propose modifications to, or terminate any proposed or ongoing research involving human subjects conducted within, or by members of, the institution.


3. Which of the following statements about Research Ethics Boards (REB) are TRUE? (Select all that apply)

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.

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

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.

At least two members with broad expertise in research covered by the REB.

At least three members knowledgeable in ethics.

At least one representative from the community.

Biomedical REBs must include a member with legal knowledge.

The institution's legal counsel should be a member of the REB.


4. What does the TCPS say about appeals? (Select all that apply)

All appeals are handled by the appeal boards set up by the Research Agencies.

Institutions should permit review of a Research Ethics Board decision by an appeal board, provided that the board is within the same institution and its membership and procedures meet the requirements of the TCPS.

Institutions may create an ad hoc appeal board.

Institutions can decide to use each other's Research Ethics Boards as an appeal board, with the proviso of a formal letter of agreement.


5. Why is the concept of "minimal risk" important in the TCPS?

The TCPS does not define the standard of "minimal risk".

It is only applicable to bio-medical 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.


6. What does the TCPS say about the requirement for scholarly review?

Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the Research Ethics Board to undergo scholarly review.

All research requires scholarly review.

Research Ethics Boards are only concerned with ethics reviews.


7. What is meant by the concept of "a proportionate approach" to ethics assessment?

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 potentially harmful and ethically challenging research.

Research that poses more than minimal risk must undergo an ethics assessment by two Research Ethics Boards.

Research within the range of minimal risk does not require Research Ethics Board review.


8. Which of the following research projects could undergo expedited Research Ethics Board (REB) review? (Select all that apply)

Research protocols that involve no more than minimal risk.

Annual renewals of approved projects in which there has been little or no change in the ongoing research.

Research involving review of patient records by hospital personnel.

Confirmation that the modifications requested by the REB as a condition for approval have been met.

Research protocols that involve no more than moderate risk.


9. What does the TCPS say about review procedures for ongoing research?

The TCPS requires continuing ethics review of all on-going research projects. The frequency and extent of the review is proportionate to the degree of risk to which the research subjects are exposed. At a minimum, the researcher submits an annual report and notifies the Research Ethics Board when the research is complete.

The TCPS requires continuing ethics review of all on-going research projects, except for research within the range of minimal risk. At a minimum, the research submits a bi-annual report and notifies the Research Ethics Board when the research is complete.

The TCPS requires continuing ethics review of all on-going research projects. The frequency and extent of the review is proportionate to the number of research subjects involved. At a minimum, the researcher submits an annual report and notifies the Research Ethics Board when the research is complete.


10. What special considerations are applicable to multi-centred research?

International research must only undergo Research Ethics Board review in the country of origin.

The Research Ethics Board from the institution where the study has originated will conduct the ethical review, and therefore does not need to be done at other centres.

When submitting a proposal for multi-centred research, the researcher may wish to distinguish between core elements of the research -- which cannot be altered without invalidating the pooling of data from the participating institutions -- and those elements that can be altered to comply with local requirements without invalidating the research project.

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Last Modified: 2009-09-02 Top of Page Important Notices