Kamisato Ayako, Hong Hyunsoo, Okubo Suguru
The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Ritsumeikan University, Kyoto, Japan.
Asian Bioeth Rev. 2023 Mar 30;15(4):397-416. doi: 10.1007/s41649-023-00247-4. eCollection 2023 Oct.
One of the ethical principles of medical research involving human subjects is obtaining proper informed consent (IC). However, if the participants' actual awareness of medical research terminology is lower than the researchers' prediction of that awareness, it may cause difficulty obtaining proper IC. Therefore, this study aims to clarify the presence of "perception gaps" and then discuss IC-related issues and measures based on the insights obtained. We conducted two online surveys: a "public survey" to understand the Japanese public's awareness of 11 medical research terms and a "physicians' survey" to investigate physicians' predictions regarding public awareness. In the "public survey," for each term, respondents were instructed to select their situation from "understand," "have heard," or "have never heard." In the "physicians' survey," respondents were asked to estimate the proportions of the general public who would "have understood," "have heard," or "have never heard" by using an 11-step scale. We analyzed separately in two age groups to understand the age-related difference. We received 1002 valid responses for the "public survey" and 275 for the "physicians' survey." Of the public respondents, more than 80% had never heard of terms such as , , , , or . Concurrently, physicians overestimated general public awareness of the terms , , , and (in the ). The results revealed the perception gap between the general public and physicians which raise serious concerns about obtaining proper IC from clinical research participants.
The online version contains supplementary material available at 10.1007/s41649-023-00247-4.
涉及人类受试者的医学研究伦理原则之一是获得适当的知情同意（IC）。然而，如果参与者对医学研究术语的实际认知低于研究人员对该认知的预测，可能会导致难以获得适当的知情同意。因此，本研究旨在阐明“认知差距”的存在，然后根据所获得的见解讨论与知情同意相关的问题和措施。我们进行了两项在线调查：一项“公众调查”以了解日本公众对11个医学研究术语的认知，以及一项“医生调查”以调查医生对公众认知的预测。在“公众调查”中，对于每个术语，受访者被要求从“理解”、“听说过”或“从未听说过”中选择自己的情况。在“医生调查”中，要求受访者使用11级量表估计公众中会“理解”、“听说过”或“从未听说过”的比例。我们按两个年龄组分别进行分析以了解年龄相关差异。“公众调查”收到1002份有效回复，“医生调查”收到275份有效回复。在公众受访者中，超过80%的人从未听说过诸如 、 、 、 或 等术语。同时，医生高估了公众对 、 、 和 （在 中）这些术语的认知。结果揭示了公众与医生之间的认知差距，这引发了对从临床研究参与者处获得适当知情同意的严重担忧。
在线版本包含可在10.1007/s41649-023-00247-4获取的补充材料。
