Nut Koonrungsesomboon1,2, Thipaporn Tharavanij3, Kittichet Phiphatpatthamaamphan3, Ratha-Korn Vilaichone3, Sudsayam Manuwong4, Parichat Curry4, Sith Siramolpiwat3, Thanachai Punchaipornpon3, Supakit Kanitnate5, Nattapol Tammachote5, Rodsarin Yamprasert6, Waipoj Chanvimalueng7, Ruchirat Kaewkumpai6, Soiphet Netanong6, Peerapong Kitipawong3, Paskorn Sritipsukho8,9, Juntra Karbwang10. 1. Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. 2. Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. 3. Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand. 4. Department of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand. 5. Department of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand. 6. Center of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand. 7. Department of Otolaryngology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand. 8. Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand. 9. Center of Excellence in Applied Epidemiology, Thammasat University, Pathum Thani, 12121, Thailand. 10. Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. karbwangj@nagasaki-u.ac.jp.
Abstract
PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
RCT Entities:
PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
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