BACKGROUND: Participants' understanding of clinical trials is important in informed consent. However, little is known about what information participants really want to know. AIMS: To demonstrate the existence of a discrepancy between participants' understanding and their desire to know. METHODS: The participants in clinical trials at Seoul National University Hospital were surveyed. The survey consisted of 11 statements based on the essential elements of informed consent. The participants gave two responses to each statement on a five-point Likert scale to rate their subjective understanding and desire to know, respectively. Information discrepancy was defined as the difference between these two ratings: if understanding exceeded desire to know for a particular item, it was defined as 'over-informed'; if desire to know exceeded understanding for a particular item, it was defined as 'under-informed'. RESULTS: Participants reported good understanding of 'voluntariness', 'duration', 'study involves research' and poor understanding of 'confidentiality', 'compensation', 'benefits', 'procedures' and 'risks or discomforts'. For 'risks or discomforts', 'who to contact', 'voluntariness', 'duration' and 'procedures', participants reported high desire to know compared with 'confidentiality', 'purpose', 'study involves research' and 'benefits'. The elements 'study involves research', 'voluntariness', 'duration', 'purpose' and 'who to contact' were over-informed, while 'compensation', 'risks or discomforts', 'procedures', 'confidentiality' and 'benefits' were under-informed. Participants over 50 years of age, those without a college education and those whose participation was less voluntary were relatively less informed about the clinical trials. CONCLUSIONS: An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved.
BACKGROUND:Participants' understanding of clinical trials is important in informed consent. However, little is known about what information participants really want to know. AIMS: To demonstrate the existence of a discrepancy between participants' understanding and their desire to know. METHODS: The participants in clinical trials at Seoul National University Hospital were surveyed. The survey consisted of 11 statements based on the essential elements of informed consent. The participants gave two responses to each statement on a five-point Likert scale to rate their subjective understanding and desire to know, respectively. Information discrepancy was defined as the difference between these two ratings: if understanding exceeded desire to know for a particular item, it was defined as 'over-informed'; if desire to know exceeded understanding for a particular item, it was defined as 'under-informed'. RESULTS:Participants reported good understanding of 'voluntariness', 'duration', 'study involves research' and poor understanding of 'confidentiality', 'compensation', 'benefits', 'procedures' and 'risks or discomforts'. For 'risks or discomforts', 'who to contact', 'voluntariness', 'duration' and 'procedures', participants reported high desire to know compared with 'confidentiality', 'purpose', 'study involves research' and 'benefits'. The elements 'study involves research', 'voluntariness', 'duration', 'purpose' and 'who to contact' were over-informed, while 'compensation', 'risks or discomforts', 'procedures', 'confidentiality' and 'benefits' were under-informed. Participants over 50 years of age, those without a college education and those whose participation was less voluntary were relatively less informed about the clinical trials. CONCLUSIONS: An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved.
Authors: Teodora Alexa-Stratulat; Marius Neagu; Anca-Iulia Neagu; Ioana Dana Alexa; Beatrice Gabriela Ioan Journal: Dev World Bioeth Date: 2018-06-22 Impact factor: 2.294
Authors: Juntra Karbwang; Nut Koonrungsesomboon; Cristina E Torres; Edlyn B Jimenez; Gurpreet Kaur; Roli Mathur; Eti N Sholikhah; Chandanie Wanigatunge; Chih-Shung Wong; Kwanchanok Yimtae; Murnilina Abdul Malek; Liyana Ahamad Fouzi; Aisyah Ali; Beng Z Chan; Madawa Chandratilake; Shoen C Chiew; Melvyn Y C Chin; Manori Gamage; Irene Gitek; Mohammad Hakimi; Narwani Hussin; Mohd F A Jamil; Pavithra Janarsan; Madarina Julia; Suman Kanungo; Panduka Karunanayake; Sattian Kollanthavelu; Kian K Kong; Bing-Ling Kueh; Ragini Kulkarni; Paul P Kumaran; Ranjith Kumarasiri; Wei H Lim; Xin J Lim; Fatihah Mahmud; Jacinto B V Mantaring; Siti M Md Ali; Nurain Mohd Noor; Kopalasuntharam Muhunthan; Elanngovan Nagandran; Maisarah Noor; Kim H Ooi; Jebananthy A Pradeepan; Ahmad H Sadewa; Nilakshi Samaranayake; Shalini Sri Ranganathan; Wasanthi Subasingha; Sivasangari Subramaniam; Nadirah Sulaiman; Ju F Tay; Leh H Teng; Mei M Tew; Thipaporn Tharavanij; Peter S K Tok; Jayanie Weeratna; Tri Wibawa; Renu Wickremasinghe; Phanthipha Wongwai; Subhash Yadav Journal: BMC Med Ethics Date: 2018-09-15 Impact factor: 2.652