Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine

Objective: To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. Data Sources and Data Extraction: One-year retrospective re view of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRE, method of consent, design of research, and interventions involved in the study. Data Synthesis: Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRE review and informed consent approval. IRE approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRE approval and informed consent between research conducted in the United States (n = 71, 57%) or outside the United States (n = 92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p<.05). All studies (23) supported by the pharmaceutical industry were fully approved. Conclusions: Many published studies in critical care lack IRE approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.