Please use this identifier to cite or link to this item: http://cmuir.cmu.ac.th/jspui/handle/6653943832/62795
Title: What information and the extent of information research participants need in informed consent forms: A multi-country survey
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
Keywords: Medicine
Nursing
Social Sciences
Issue Date: 15-Sep-2018
Abstract: © 2018 The Author(s). 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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85053378779&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/62795
ISSN: 14726939
Appears in Collections:CMUL: Journal Articles

Files in This Item:
There are no files associated with this item.


Items in CMUIR are protected by copyright, with all rights reserved, unless otherwise indicated.