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Risk In Emergency Research Using A Waiver Of/Exception From Consent: Implications Of A Structured Approach For Institutional Review Board Review, Andrew Mcrae, Stacy Ackroyd-Stolarz, Charles Weijer
Risk In Emergency Research Using A Waiver Of/Exception From Consent: Implications Of A Structured Approach For Institutional Review Board Review, Andrew Mcrae, Stacy Ackroyd-Stolarz, Charles Weijer
Charles Weijer
OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold.
METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study …