Ethical process in human research published in thoracic surgery journals.
ABSTRACT 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.
- [Show abstract] [Hide abstract]
ABSTRACT: The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results.Journal Of Clinical Periodontology 02/2012; 39 Suppl 12:81-107. · 3.69 Impact Factor
Article: Ethical issues in surgical research.[Show abstract] [Hide abstract]
ABSTRACT: Higher standards of evidence for surgical procedures are likely to be demanded in the future by health insurance providers. Consequently, more formal and rigorous surgical research, including RCTs, will become more prevalent. Facing the ethical challenges of surgical research requires understanding of the ethically significant differences between surgical practice and research and the ways in which the ethical standards appropriate for the design and conduct of clinical research differ from the ethics of clinical care.Canadian journal of surgery. Journal canadien de chirurgie 04/2010; 53(2):133-6. · 1.63 Impact Factor
Article: Ethical issues in cardiac surgery.[Show abstract] [Hide abstract]
ABSTRACT: While ethical behavior has always been part of cardiac surgical practice, ethical deliberation has only recently become an important component of cardiac surgical practice. Issues such as informed consent, conflict of interest and professional self-regulation, among many others, have increasingly attracted the attention of cardiac surgeons. This article covers several broad topics of interest to cardiac surgeons and cardiologists and discusses several other topics more briefly. There is much uncertainty regarding what the future holds for cardiac surgical practice, research and culture and we also discuss the background of ethical issues to serve as a platform for envisioning what is to come.Future Cardiology 05/2012; 8(3):451-65.