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 interventional study, prospective clinical study, cohort study, Phase I clinical trial, or double-blind study. Concurrently, physicians overestimated general public awareness of the terms placebo, cohort study, double-blind study, and randomized clinical trial (in the group of people under 60). The results revealed the perception gap between the general public and physicians which raise serious concerns about obtaining proper IC from clinical research participants. (shrink)

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in (...) Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place. (shrink)