โ Scribed by Roni M. Keller; Jonathan Cohen; Marika Fraser; David Bernstein; Richard M. Rosenfeld
No coin nor oath required. For personal study only.
Objective: Ethical considerations in the conduct and reporting of biomedical research include privacy, confidentiality, and protection of subjects. We sought to compare the degree and completeness of reporting of ethical review in otolaryngology and other disciplines. Design: Cross-sectional survey of six biomedical journals linked to national associations, representing the disciplines of otolaryngology, surgery, pediatrics, internal medicine, family practice, and plastic and reconstructive surgery. Methods: We reviewed all clinical research articles from 2002-2008 and abstracted data using a standardized form. Data included type of study, study support or funding, IRB approval (stated explicitly, in general terms, or not at all), ethics committee approval (stated explicitly, in general terms, or not at all), methods of informed consent, type of data collected, level of patient interaction with the investigators, location of study, and mention of the declaration of Helsinki. Results: A total of 10, 327 articles, of which 6875 (68%) were clinical research. Annals of Internal Medicine (75.3%), Pediatrics (67.4%) and Annals of Family Practice (60.5%) were the journals most likely to have ethical reporting. Otolaryngology-Head and Neck Surgery (45.1%), Journal of the American College of Surgeons (39.1%), and Plastic and Reconstructive Surgery (15.1%) were least likely to have any ethical reporting. Case reports were the study design least likely to have any reporting (94%). Risk factors for lack of ethics reporting included international studies, non-funded studies, pre-existing data, and no direct patient contact.
The results of our study highlight deficiencies in reporting of ethical review, and identify areas for future improvement.
A total of 10, 327 articles were found of which 6, 875 (67%) were clinical research. Fifty-five percent of the articles were written in the United States, Twenty-seven percent of articles had not for profit funding or grant support. Eight percent had for profit (industry) support. Thirty-two percent had any type of funding.
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