Nut Koonrungsesomboon1,2, Saranyapin Potikanond3, Mingkwan Na Takuathung3, Wutigri Nimlamool3, Juntra Karbwang4. 1. Department of Pharmacology, Faculty of Medicine, Chiang Mai University, 110 Intawaroros Road, Sriphoom, Muang, Chiang Mai, 50200, Thailand. nkoonrung@gmail.com. 2. Musculoskeletal Science and Translational Research (MSTR), Chiang Mai University, Chiang Mai, Thailand. nkoonrung@gmail.com. 3. Department of Pharmacology, Faculty of Medicine, Chiang Mai University, 110 Intawaroros Road, Sriphoom, Muang, Chiang Mai, 50200, Thailand. 4. Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan.
Abstract
PURPOSE: The present study aimed to determine the extent of information that healthy volunteers need in an informed consent form (ICF) to support their decision whether to participate in a bioequivalence study, a type of clinical studies involving the testing of pharmacokinetic equivalence of a generic drug with a brand-name drug in volunteer subjects. METHODS: This cross-sectional, descriptive study determined the perspectives of individuals who used to participate in bioequivalence studies, using an electronic-based questionnaire. A 5-point modified Likert scale was used to indicate the importance of each element of the ICF content, with an anchored rating scale from 1 (not important) to 5 (very important) for each item. RESULTS: Of 300 questionnaires distributed, all (100%) were returned. The respondents considered most items to be necessary for their decision, with the score ranging from 3.25 to 4.60 (mean overall score = 4.16 ± 0.30). The four top-rated items were the "major foreseeable risk" (4.60 ± 0.72), "participant's responsibility during participation" (4.52 ± 0.72), "confidentiality and the limit of confidentiality" (4.52 ± 0.82), and "all possible adverse effects of the drug" (4.47 ± 0.74), while the relatively less concerned items were related to general information. CONCLUSIONS: Most elements of the ICF content required were considered as important by the previously experienced volunteers in bioequivalence studies, notwithstanding that some elements were perceived as more important than others. The data from this study could be used to better tailor relevant information in an ICF to the needs of research participants in bioequivalence studies.
PURPOSE: The present study aimed to determine the extent of information that healthy volunteers need in an informed consent form (ICF) to support their decision whether to participate in a bioequivalence study, a type of clinical studies involving the testing of pharmacokinetic equivalence of a generic drug with a brand-name drug in volunteer subjects. METHODS: This cross-sectional, descriptive study determined the perspectives of individuals who used to participate in bioequivalence studies, using an electronic-based questionnaire. A 5-point modified Likert scale was used to indicate the importance of each element of the ICF content, with an anchored rating scale from 1 (not important) to 5 (very important) for each item. RESULTS: Of 300 questionnaires distributed, all (100%) were returned. The respondents considered most items to be necessary for their decision, with the score ranging from 3.25 to 4.60 (mean overall score = 4.16 ± 0.30). The four top-rated items were the "major foreseeable risk" (4.60 ± 0.72), "participant's responsibility during participation" (4.52 ± 0.72), "confidentiality and the limit of confidentiality" (4.52 ± 0.82), and "all possible adverse effects of the drug" (4.47 ± 0.74), while the relatively less concerned items were related to general information. CONCLUSIONS: Most elements of the ICF content required were considered as important by the previously experienced volunteers in bioequivalence studies, notwithstanding that some elements were perceived as more important than others. The data from this study could be used to better tailor relevant information in an ICF to the needs of research participants in bioequivalence studies.
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