Ethical Process in Human Research Published in Thoracic Surgery Journals

Medical University of South Carolina, Charleston, South Carolina, United States
The Annals of thoracic surgery (Impact Factor: 3.85). 08/2006; 82(1):6-11; discussion 11-2. DOI: 10.1016/j.athoracsur.2006.01.084
Source: PubMed


Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002.
We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852).
Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%).
There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

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    • "The US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research defines the research's objectives as “to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalize knowledge.”36(p41) Therefore, a case series is considered as a subset of human research, necessitating the strict adherence to the ethical requirements and peer review.40,41 "
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    ABSTRACT: Objectives: To review outcomes and complications of endoscope-assisted submandibular sialadenectomy (EASS) and to analyze this innovative technique with regard to ethical issues. Methods: We used a systematic review study design to identify clinical studies on EASS, published in English, French, German, and Thai. The last electronic search was conducted in September 2009. We checked the bibliographies of the identified articles, relevant local journals, and congress abstracts. Publications were further assessed and assigned their respective levels of evidence. We also investigated reporting on human subject protection, conflicts of interest, funding support, and commercial relationships. Results: Five case series reporting a total of 28 patients met the inclusion criteria. There was no need of recourse to open surgery. All of the authors claimed satisfactory cosmetic results. Complications were uncommon. However, no controlled trial was available, and outcome measures varied between studies. Human subject protection and funding sources were mentioned in only 2 articles. Commercial relationships and conflicts of interest could not be identified. Conclusions: All of the reports favor outcomes of EASS. However, their level of evidence is low, and the superiority of this procedure over the conventional surgery remains unknown. The success of this procedure should not be overemphasized in information for consent and mislead surgeons to begin it without adequate training and elaborate environment. The lack of ethical documentation creates a high degree of suspicion of the studies.
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    The Annals of thoracic surgery 11/2006; 82(4):1173-4. DOI:10.1016/j.athoracsur.2006.06.063 · 3.85 Impact Factor
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