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Important Points in this Case Study
The protocol review process seeks to maintain an appropriate balance between the achievement of valuable research results, on the one hand, and the protection of human participants, on the other. It is important that both objectives be realized.
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Where a research project poses no more than minimal risk to human subjects, i.e., no more than they would otherwise experience in day-to-day life, regulations allow for a more efficient protocol review process. Certain categories of "minimal risk" projects may qualify for an expedited review, while other categories may be exempt from the requirement for review.
In addition, where the project poses no more than minimal risk to participants, the requirement for informed consent may be waived.
Those decisions are made by the Administrative Panel, on the basis of the project design and the information provided by the researchers.
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