What information and the extent of information research participants need in informed consent forms: a multi-country survey

Autor: Kim H. Ooi, Mei M. Tew, Murnilina Abdul Malek, Mohammad Hakimi, Edlyn B. Jimenez, Leh H. Teng, Mohd F. A. Jamil, Ahmad Hamim Sadewa, Sattian Kollanthavelu, Wasanthi Subasingha, Jebananthy Anandaselvam Pradeepan, Pavithra Janarsan, Panduka Karunanayake, Fatihah Mahmud, Liyana Ahamad Fouzi, Beng Z. Chan, Siti M. Ali, Chih-Shung Wong, Ju F. Tay, Paul P. Kumaran, Melvyn Y. C. Chin, Shalini Sri Ranganathan, Ragini Kulkarni, Nilakshi Samaranayake, Suman Kanungo, Nurain Mohd Noor, Manori Gamage, Subhash Yadav, Kwanchanok Yimtae, Madarina Julia, Jacinto Blas V. Mantaring, Phanthipha Wongwai, Wei H. Lim, Shoen C. Chiew, Cristina E. Torres, Madawa Chandratilake, Aisyah Ali, Renu Wickremasinghe, Maisarah Noor, Nut Koonrungsesomboon, C.A. Wanigatunge, Jayanie Weeratna, Narwani Hussin, Eti Nurwening Sholikhah, Xin J. Lim, Sivasangari Subramaniam, Irene Gitek, Kian K. Kong, Elanngovan Nagandran, Juntra Karbwang, Peter S. K. Tok, Ranjith Kumarasiri, K. Muhunthan, Thipaporn Tharavanij, Roli Mathur, Tri Wibawa, Bing-Ling Kueh, Nadirah Sulaiman, Gurpreet Kaur
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: BMC Medical Ethics, Vol 19, Iss 1, Pp 1-11 (2018)
ISSN: 1472-6939
Popis: Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. 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.
BMC Medical Ethics, 19(1), art.no.79; 2018
Databáze: OpenAIRE
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