Searight H R, Miller C K
Deaconess Family Medicine Residency Program, St. Louis, MO 63139, USA.
J Am Board Fam Pract. 1996 Jan-Feb;9(1):14-22.
Federal regulations require that research subjects provide informed consent for their participation in biomedical research. Before giving consent, subjects are presented with information about study procedures, risks, benefits, and alternatives. Although investigators have assessed subjects' retention of consent material, little is known about how participants view methodologic dimensions of biomedical research, such as placebos and randomization, or the distinction between medical treatment in a research protocol versus personal health care. These issues were examined with a qualitative interview study.
Research interviews were conducted with 14 subjects who had recently completed their participation in one of two drug trial studies. The interviews were tape-recorded and transcribed. The transcripts were analyzed and coded for thematic content.
Participants showed a thorough understanding of important study elements, such as randomization and placebos. They described primarily altruistic motives for participating in the drug trial. There was evidence that subjects might not make a clear distinction between personal medical care and treatment in a research protocol.
Participants viewed their involvement in research very positively. They understood most important methodologic dimensions. The findings, however, suggest that the consent process should include greater attention to the distinction between research and clinical practice.
联邦法规要求研究对象为参与生物医学研究提供知情同意。在给予同意之前，会向研究对象提供有关研究程序、风险、益处及替代方案的信息。尽管研究人员已评估研究对象对同意材料的记忆情况，但对于参与者如何看待生物医学研究的方法学维度，如安慰剂和随机分组，或研究方案中的医学治疗与个人医疗保健之间的区别，却知之甚少。通过一项定性访谈研究对这些问题进行了探讨。
对14名近期完成两项药物试验研究之一的参与者进行了研究访谈。访谈进行了录音和转录。对转录文本进行分析并按主题内容编码。
参与者对随机分组和安慰剂等重要研究要素有透彻的理解。他们描述了参与药物试验主要是出于利他动机。有证据表明，研究对象可能无法明确区分个人医疗保健与研究方案中的治疗。
参与者对自己参与研究持非常积极的看法。他们理解了最重要的方法学维度。然而，研究结果表明，同意过程应更加关注研究与临床实践之间的区别。
