Risk perception and risk attitude in informed consent

Journal of Family Medicine and Primary Care, 2021

International Health, 2012

The use of Informed consent (IC) became a prerequisite for research in response to abuses of human subjects during the last half-century, yet participant's comprehension of presented information is rarely explored. Major ethical concerns arise when information offered is not well comprehended by research participants. It is therefore a fundamental concern for all researchers to ensure that there is good comprehension of informed consent information in biomedical researches hence the current study endeavored to evaluate the comprehension of information for informed consent by Hemato-Oncology study participants. A descriptive cross sectional study design was used where systematic and convenience sampling techniques were used to sample the mothers who had assented to the study and research assistants involved in recruiting (recruiters) respectively. Two sets of semi-structured questionnaires were administered to 201 mothers and 6 recruiters, separately. Data from mothers and recruiters was collected for a period of one month and analyzed using descriptive and non-parametric correlation technique of multiple correspondence analysis (MCA). The response rate was 187 (93%) and 6 (100%) for the mothers and research assistants respectively. The mean age of the mothers was 28 ± 2.24 years with most having either secondary 89 (48%) or college education 67 (36%). Their preferred language of communication was English 165 (88%) or Kiswahili 22 (12%). The mean comprehension index of IC contents by the mothers was 73.27% (Std. Dev: 28.72%). Recruiters who had more than one year experience in research used ≥ 30 min in IC process compared to ≥ 1 hour for those who had been in research for less than one year. Low comprehension levels were found among older mothers (≥ 35 years) and those with primary education, however, comprehension was higher in participants who considered the consent form to be of appropriate length 181 (97), written in an easy to understand language 173 (96) and preferably written in English 165 (88%). The level of comprehension among the mothers on IC contents was relatively high with a few recording low comprehension. Age, education level, language of transmission, length and readability of the consent form as well as recruiter experiences were all found to influence comprehension of IC information.

Ergonomics, 1999

People are frequently asked to make commitment s by signing contract s, consent forms and other legal documents. Although it is prudent to read these forms carefully, people sometimes do not do so. The present research sought to assess some of the factors related to the usability of legal documents. In study 1, participants reported that they had signed a variety of legal documents that they did not fully read or under stand. They also identified characteristics that hinder understanding and offered suggestions for improvement. In study 2, another group of participants rated those characteristics and confirmed the first study' s findings. Study 3 measured the effects of three different resear ch parti cipati on consent forms: conventional 'legalistic', improved , and one-line (control). Results showed that the improved form significantly enhanced comprehension compared to the conventional form and both were higher than the control. Even though comprehension with the conventional legalistic consent form was poor, all but one person signed it, agreeing to parti cipate in a potentially risky activity. However , given the improved form, participants tended to take advant age of a stated option of doin g a less risky activity. Study 4 found th at consent form comprehen sion was greater when: (a) the form a ppeared to be more informal as compared to more official looking; (b) there was less time pressure compared to greater time pressure; and (c) there was an accompanying oral recitation of the consent form. Implications of these results are discussed.

Journal of Patient Safety, 2016

Objective This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making. Methods Sixty interviews in personal interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information, and open-ended questions to determine reactions, clarity of information, and suggestions for improvement. Results Although 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes toward inclusion of risk information, and the recognized importance of physician-patient conversations. Conclusions This study provides evidence from the patient perspective tha...

Ethics & …, 2005

We examined participants' reading and recall of informed consent documents presented via paper or computer. Within each presentation medium, we presented the document as a continuous or paginated document to simulate common computer and paper presentation formats. Participants took slightly longer to read paginated and computer informed consent documents and recalled slightly more information from the paginated documents. We concluded that obtaining informed consent online is not substantially different than obtaining it via paper presentation. We also provide suggestions for improving informed consent-in both face-to-face and online experiments.