Länsimies-Antikainen Helena, Pietilä Anna-Maija, Laitinen Tomi, Schwab Ursula, Rauramaa Rainer, Länsimies Esko
Department of Nursing Science, Kuopio University Hospital and University of Kuopio, Kuopio, Finland.
J Adv Nurs. 2007 Jul;59(2):146-54. doi: 10.1111/j.1365-2648.2007.04279.x. Epub 2007 Jun 3.
This paper is a report of a study to describe and analyse the use of informed consent in clinical research, from the point of view of voluntary adult research participants, in order to develop and test an interview schedule for the evaluation of informed consent.
Informed consent is one of the central ethical research principles in healthcare research, but empirical research on this topic is still scarce. To evaluate and develop the ethical quality of scientific research, there is a need to explore the meaning and implications of informed consent for research participants.
The data were collected in 2004 by interviews using an interview schedule created for this study by the first author and discussed in a multidisciplinary group. The response rate was 81%. The sample consisted of 32 patients with a metabolic syndrome who were participants in a project evaluating the effects of betaine on cardiovascular risk factors.
Participants stated that the key elements of informed consent are information, understanding and decision-making, and that competence is an essential factor in the reception and understanding of information and making an independent decision about participation. Our interview schedule was found to be useful in the investigation of informed consent.
This study strengthened the perception that more extensive research about research participants is needed.
本文报告一项研究，旨在从成年自愿参与研究的受试者角度描述和分析临床研究中知情同意的使用情况，以制定并测试一份用于评估知情同意的访谈提纲。
知情同意是医疗保健研究中的核心伦理研究原则之一，但关于这一主题的实证研究仍然匮乏。为了评估和提高科学研究的伦理质量，有必要探究知情同意对研究参与者的意义和影响。
2004年通过访谈收集数据，使用第一作者为本研究编制并在多学科小组中讨论过的访谈提纲。回应率为81%。样本包括32名患有代谢综合征的患者，他们是一项评估甜菜碱对心血管危险因素影响项目的参与者。
参与者表示，知情同意的关键要素是信息、理解和决策，而能力是接收和理解信息以及就是否参与做出独立决策的一个重要因素。我们发现访谈提纲在调查知情同意方面很有用。
本研究强化了这样一种观念，即需要对研究参与者进行更广泛的研究。
