We read with interest the paper by Nelson et al on local media influence on opting out from an exception from informed consent. According to the authors, researchers make great efforts to inform and consult the community about emergency research and waiver of consent, but without known evidence of effectiveness. These requirements for public disclosure and community consultation are unique to the United States. We would like to provide an international perspective on this topic.

We appreciate the international perspective offered by Dr. Kierzek et al. The regulations surrounding exception from informed consent research in the United States are designed to protect patients, yet they have been inconsistently interpreted and implemented. These inconsistencies challenge researchers in maintaining public/patient trust, as well as in conducting high-quality research. Researchers and institutional review board members have observed that stringent regulations pose a barrier to conducting research. Although the study we published was particular to the Portland, OR, Resuscitation Outcomes Consortium site, the differences in regulatory body approach to the study and the requirements for community consultation and public notification varied widely among the 8 US Resuscitation Outcomes Consortium sites, representing differing institutional review board interpretations of the same regulations. Some sites conducted extensive public disclosure campaigns and had hundreds of opt-out requests, whereas others had far less stringent requirements and relatively small numbers of opt-out requests. The variation in approaches among Resuscitation Outcomes Consortium sites has been previously published. The international regulatory differences have also been apparent in comparing US and Canadian site timelines for implementing these studies.

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