Abstract.Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the pro-

Background The prevalence of written “action plans” (APs) among emergency department (ED) patients with acute asthma is unknown. Objective To determine the prevalence of APs among ED patients, to describe the demographic and clinical profile of patients with and without APs, and to examine the appropriateness of response to an asthma exacerbation scenario. Methods Using a standard protocol, 49 North American EDs performed a prospective cohort study involving interviews of 1,756 patients, ages 2–54, with acute asthma. Among children only, a random sample was contacted two years after the index ED visit to assess current AP status and parents’ self-management knowledge. Results The overall prevalence of APs was 32% (95% confidence interval [CI], 30%–34%), and was higher among children than adults (34% vs. 26%, respectively; p = 0.001). Patients with APs had worse measures of chronic asthma severity (p < 0.05) and were more likely to be hospitalized (multivariate odds ratio, 1.5; 95%CI, 1.1–2.1). After 2 years, most children with an AP at the index ED visit still had one but only 20% of those without an AP had obtained one; moreover, many of the APs appeared inadequate. Parents of children with a current AP performed slightly better on the asthma scenario, but both groups overestimated their asthma knowledge. Conclusion The prevalence of APs among ED patients with acute asthma is unacceptably low, and many of these APs appear inadequate. “Confounding by severity” will complicate any non-randomized analysis of the potential impact of APs on asthma outcomes in ED patients.

Abstract. In recent years, industry has become an important source of funding for biomedical research. Industry-sponsored clinical trials are a particular source of controversy. In light of recent developments, the authors reevaluate the 1995 SAEM guidelines for investigator involvement in industry-sponsored clinical trials. The authors divide industry-funded clinical trials into two categories: investigator-initiated and industry-initiated, and discuss the differences between them. They examine several areas of ethical debate, including exclusivity contracts between a principal investigator and a corporate sponsor, the size of per-patient reimbursements for recruiting patients into clinical trials, and authorship criteria. Finally, the authors oppose the assumption that industry-sponsored research is automatically biased, and suggest that multiple levels of review will help to uncover bias, whatever the source. Once mutual respect for ethical guidelines and practices are established, collaboration between emergency medicine researchers and industry should be encouraged.