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

BMC Medical Ethics
Juntra KarbwangFERCAP Multi-Country Research Team

Abstract

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. 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). 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 conce...Continue Reading

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Aug 21, 2019·European Journal of Clinical Pharmacology·Nut KoonrungsesomboonJuntra Karbwang
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Jan 19, 2021·The American Journal of Bioethics : AJOB·Joseph Millum, Danielle Bromwich
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