Benson P R, Roth L H, Winslade W J
Soc Sci Med. 1985;20(12):1331-41. doi: 10.1016/0277-9536(85)90388-0.
Preliminary findings from an investigation of informed consent processes in four psychiatric research projects (two being carried out at a university medical center and two at a public psychiatric hospital) are reported. Study methods include the systematic observation of investigator/subject information disclosure sessions using audio and videotape, as well as the use of standardized interaction rating forms and subject understanding interviews. In an attempt to determine if subjects' understanding of research can be improved through increased subject education, several modes of information disclosure are compared. Partial results from the public psychiatric hospital portion of the investigation suggest low subject understanding in many areas with subjects often demonstrating difficulty differentiating between treatment and biomedical research. Subjects' problematic understanding of research purposes and methodology was compounded by investigator disclosures which often emphasized the therapeutic, personalistic and nonresearch-oriented aspects of the project. Nevertheless, even when information disclosures were significantly improved, subject understanding in many cases continued to be low--suggesting that additional factors aside from the quality of investigator disclosure are involved in psychiatric subjects' comprehension and understanding of research. The implication of these findings for informed consent, regulation of biomedical research and the protection of human subjects are discussed.
报告了对四个精神病学研究项目（两个在大学医学中心开展，两个在公立精神病医院开展）知情同意过程调查的初步结果。研究方法包括使用音频和视频对研究者/受试者信息披露环节进行系统观察，以及使用标准化互动评级表和受试者理解访谈。为了确定是否可以通过加强受试者教育来提高他们对研究的理解，对几种信息披露模式进行了比较。调查中公立精神病医院部分的部分结果表明，受试者在许多方面理解程度较低，他们常常难以区分治疗和生物医学研究。研究者的披露往往强调项目的治疗、个人化和非研究导向方面，这使得受试者对研究目的和方法的理解出现问题。然而，即使信息披露有了显著改善，在许多情况下受试者的理解仍然很低——这表明除了研究者披露的质量之外，还有其他因素影响精神病学受试者对研究的理解。讨论了这些发现对知情同意、生物医学研究监管和人类受试者保护的意义。
