Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, 3584 CG, PO Box 85500, Utrecht 3508 GA, The Netherlands.
Department of Health Technology Assessment, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, 3584 CG, PO Box 85500, Utrecht 3508 GA, The Netherlands.
J Clin Epidemiol. 2015 Sep;68(9):1108-14. doi: 10.1016/j.jclinepi.2015.03.013. Epub 2015 Mar 27.
The Ottawa Statement is the first guidance document for the ethical and scientific conduct of cluster-randomized trials (CRTs). However, not all recommendations are straightforward to implement. In this paper we will reflect in particular on the recommendation on identifying human research subjects and the issue to what extent the randomization process should be disclosed if there is a risk of contamination.
The Ottawa Statement was thoroughly evaluated within a multidisciplinary research team, consisting amongst others of epidemiologists and ethicists.
Patients in a CRT may also be considered as research subjects if they are indirectly affected by the studied interventions in a CRT. Second, health care workers are research subjects in CRTs but have a different moral status compared with ordinary research participants. This different status has implications for withdrawal and the choice of the primary objective. Third, modified informed consent for CRTs may be obtained when researchers can demonstrate that disclosure of the randomization process would affect the validity of a CRT.
Recommendations of the Ottawa Statement on identifying the research subject and providing informed consent can and should be refined.
渥太华声明是首个关于群组随机试验（CRT）的伦理和科学实施的指导文件。然而，并非所有建议都易于实施。在本文中，我们将特别反思关于确定人类研究对象的建议，以及在存在污染风险的情况下，随机化过程应在何种程度上披露的问题。
渥太华声明在一个多学科研究团队中进行了彻底评估，该团队成员包括流行病学家和伦理学家等。
如果 CRT 中研究的干预措施间接地影响到患者，那么患者也可以被视为 CRT 的研究对象。其次，在 CRT 中，卫生保健工作者也是研究对象，但与普通研究参与者的道德地位不同。这种不同的地位对退出和主要目标的选择有影响。第三，当研究人员能够证明披露随机化过程会影响 CRT 的有效性时，可以获得 CRT 的修改后知情同意书。
渥太华声明中关于确定研究对象和提供知情同意的建议可以并且应该得到改进。
