What information and the extent of information research participants need in informed consent forms: a multi-country survey.
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Karbwang Juntra, Koonrungsesomboon Nut, Torres Cristina E, Jimenez Edlyn B, Kaur Gurpreet, Mathur Roli, Sholikhah Eti N, Wanigatunge Chandanie, Wong Chih-Shung, Yimtae Kwanchanok, Abdul Malek Murnilina, Ahamad Fouzi Liyana, Ali Aisyah, Chan Beng Z, Chandratilake Madawa, Chiew Shoen C, Chin Melvyn Y C, Gamage Manori, Gitek Irene, Hakimi Mohammad, Hussin Narwani, Jamil Mohd F A, Janarsan Pavithra, Julia Madarina, Kanungo Suman, Karunanayake Panduka, Kollanthavelu Sattian, Kong Kian K, Kueh Bing-Ling, Kulkarni Ragini, Kumaran Paul P, Kumarasiri Ranjith, Lim Wei H, Lim Xin J, Mahmud Fatihah, Mantaring Jacinto B V, Md Ali Siti M, Mohd Noor Nurain, Muhunthan Kopalasuntharam, Nagandran Elanngovan, Noor Maisarah, Ooi Kim H, Pradeepan Jebananthy A, Sadewa Ahmad H, Samaranayake Nilakshi, Sri Ranganathan Shalini, Subasingha Wasanthi, Subramaniam Sivasangari, Sulaiman Nadirah, Tay Ju F, Teng Leh H, Tew Mei M, Tharavanij Thipaporn, Tok Peter S K, Weeratna Jayanie, Wibawa Tri, Wickremasinghe Renu, Wongwai Phanthipha, Yadav Subhash, FERCAP Multi-Country Research Team
Аннотация
METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).
RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).
CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.