Background The use of lengthy, detailed, and complex informed consent forms 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 to 5. Results Of the 2484 questionnaires distributed, 2113 were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making. Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF. 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. (shrink)

The aim of the study was to develop a new comprehensive reading assessment battery for multi-ethnic and multilingual learners in Malaysia. Using this assessment battery, we examined the reliability, validity, and dimensionality of the factors associated with reading difficulties/disabilities in the Malay language, a highly transparent alphabetic orthography. In order to further evaluate the reading assessment battery, we compared results from the assessment battery with those obtained from the Malaysian national screening instrument. In the study, 866 Grade 1 children from (...) multi-ethnic and multilingual backgrounds from 11 government primary schools participated. The reading assessment battery comprised 13 assessments, namely, reading comprehension, spelling, listening comprehension, letter name knowledge, letter name fluency, rapid automatized naming, word reading accuracy, word reading efficiency, oral reading fluency, expressive vocabulary, receptive vocabulary, elision, and phonological memory. High reliability and validity were found for the assessments. An exploratory factor analysis yielded three main constructs: phonological-decoding, sublexical-fluency, and vocabulary-memory. Phonological-decoding was found to be the most reliable construct that distinguished between at-risk and non-at-risk children. Identifying these underlying factors will be useful for detecting children at-risk for developing reading difficulties in the Malay language. In addition, these results highlight the importance of including a range of reading and reading-related measures for the early diagnosis of reading difficulties in this highly transparent orthography. (shrink)