@article{oai:nagasaki-u.repo.nii.ac.jp:00001360, author = {Karbwang, Juntra and Koonrungsesomboon, Nut and Torres, Cristina E. and Jimenez, Edlyn B. and Kaur, Gurpreet and Mathur, Roli and Sholikhah, Eti N. and Wanigatunge, Chandanie and Wong, Chih-Shung and Yimtae, Kwanchanok and Abdul, Malek Murnilina and Ahamad, Fouzi Liyana and Ali, Aisyah and Chan, Beng Z. and Chandratilake, Madawa and Chiew, Shoen C. and Chin, Melvyn Y. C. and Gamage, Manori and Gitek, Irene and Hakimi, Mohammad and Hussin, Narwani and Jamil, Mohd F. A. and Janarsan, Pavithra and Julia, Madarina and Kanungo, Suman and Karunanayake, Panduka and Kollanthavelu, Sattian and Kong, Kian K. and Kueh, Bing-Ling and Kulkarni, Ragini and Kumaran, Paul P. and Kumarasiri, Ranjith and Lim, Wei H. and Lim, Xin J. and Mahmud, Fatihah and Mantaring, Jacinto B. V. and Md, Ali Siti M. and Mohd, Noor Nurain and Muhunthan, Kopalasuntharam and Nagandran, Elanngovan and Noor, Maisarah and Ooi, Kim H. and Pradeepan, Jebananthy A. and Sadewa, Ahmad H. and Samaranayake, Nilakshi and Sri, Ranganathan Shalini and Subasingha, Wasanthi and Subramaniam, Sivasangari and Sulaiman, Nadirah and Tay, Ju F. and Teng, Leh H. and Tew, Mei M. and Tharavanij, Thipaporn and Tok, Peter S. K. and Weeratna, Jayanie and Wibawa, Tri and Wickremasinghe, Renu and Wongwai, Phanthipha and Yadav, Subhash}, issue = {1}, journal = {BMC Medical Ethics}, month = {Sep}, note = {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}, title = {What information and the extent of information research participants need in informed consent forms: a multi-country survey}, volume = {19}, year = {2018} }