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The purpose of an IRB review is to assure, both in advance and
by periodic review, that
appropriate steps are taken to protect the rights and welfare of humans
participating as subjects in a research study. To accomplish this
purpose, IRBs review research protocols and related materials (e.g.,
informed consent documents and investigator brochures) to ensure
protection of the rights and
welfare of human subjects of research. The chief objectives of every
IRB protocol review are to assess the scientific merit of the research
and its methods, to promote fully informed and voluntary participation
by prospective subjects who are themselves capable of making such
choices (or, if that is not possible, informed permission given by a
suitable proxy) and to maximize the safety of subjects once they are
enrolled in the project
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