Flashcards
TCPS 2
Cards in this deck (18)
- 1Can the law influence the conduct of research?The law may influence the conduct of research, particularly in relation to competence to provide free and informed consent, privacy and confidentiality.
- 2Name a specific law that may govern the conduct of research.Canadian Charter of Rights and Freedoms Privacy Act,
Personal Information Protection and Electronic Documents Act,
provincial legislation such as the Civil Code of Quebec,
personal data protection legislation,
age of majority legislation. - 3May the REB member knowledgeable in the law provide legal opinion to the REB?He or she does not provide legal opinions. The member knowledgeable in law alerts the REB to legal issues and their implications.
- 4In Canada, which body ensure that principles of ethics are applied to research involving human subjects.Research Ethics Boards (REBs)
- 5What is an REB?A REB is a multidisciplinary committee established by an institution to undertake the ethics review of research projects affiliated with that institution. The REB ensures that ethical principles of the TCPS are applied to research involving human subjects.
- 6What kinds of studies need not undergo REB review?While quality assurance studies, performance reviews, or testing within normal educational requirements do not normally require REB review, there may be circumstances where these activities overlap with research. In such cases, the activities would be expected to undergo ethics review.
- 7REBs do not review research that isbased exclusively on publicly available documentation.
REBs review research involving humans as subjects of research.
A researcher should seek the opinion of the REB should there be any doubt concerning the need for REB review of a research with or on humans. - 8Can an institution refuse to allow research the REB has approved to proceed?An institution cannot overturn a negative REB decision, although it can refuse to allow research the REB has approved to proceed. It must respect decisions made by the REB.
- 9The TCPS requires that REBs consist ofat 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. - 10The institution's legal counsel should be a member of the REB. True or False?False.
The institution's legal counsel should not be a member of the REB. - 11Should the REB decide that additional expertise is required for the ethics review of a specific proposal, what may be done?ad hoc members may be nominated for the duration of the review.
- 12Scholarly review consists ofevaluation of the academic or scientific merits of the research. It should not be driven by other considerations, including those that may compromise academic freedom.
- 13What are the levels of ethics review?Full review
Expedited review
Departmental review - 14Full REB review:A face-to-face meeting of REB members is required to undertake ethics review of research proposals involving greater than minimal risk;
- 15Expedited 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;
- 16Departmental review:A department may undertake the ethics review of undergraduate projects carried out within formal course requirements.
- 17The TCPS requires continuing ethics review of all ongoing research projects. The frequency and extent of the review isproportionate 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.
- 18In multi-centred research, where several REBs consider the same proposal, the researcher may indicate to the REB which elements of the researchcannot 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.
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- Professional Clinical Research Topics (Clinical Research) Flashcards on TCPS 2, created by A M on 11/08/2015.
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- A M
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