Reporting of ethical approval and informed consent in clinical research published in leading anesthesia journals

Paul S Myles, Nicole Tan
Anesthesiology 2003, 99 (5): 1209-13

BACKGROUND: Ethical conduct in human research in anesthesia includes approval by an institutional review board (IRB) or ethics committee and informed consent. Evidence of these is sometimes lacking in journal publications.

METHODS: The authors reviewed all publications involving human subjects in six leading anesthesia journals for the year 2001 (n = 1189). Rates of IRB approval and informed consent were examined and compared with potential predictors that included journal, type of publication, and patient demographics (age, sex, elective or emergency status). Rates were compared by use of chi-square and logistic regression.

RESULTS: The authors found that IRB approval was documented in 71% of publications and consent was obtained in 66% of publications. Significant variation in IRB approval and consent was found among journals (P < 0.0005) and according to type of publication (P < 0.0005). Because publication type affected rates of IRB approval and consent (trials > mechanistic studies > observational studies > case reports), an analysis restricted to prospective studies also found a significant difference in IRB approval and consent among journals (P < 0.0005).

CONCLUSIONS: This study suggests that rates of IRB approval and informed consent vary among publications in anesthesia journals. Clearer guidelines (and author adherence) for all types of publication are needed, both as a protection for research subjects and to maintain public trust in the process.

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