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

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.

Mass testing of healthcare workers for COVID-19-A single institution experience in Sabah, East Malaysia.

Approximately 1.29 million COVID-19 cases involving healthcare workers (HCWs) have been reported globally, leading to several hospitals conducting mass testing for early detection of infected HCWs. This study was conducted to report our experience and findings from the mass testing of HCWs from a public hospital in Sabah, Malaysia. The mass testing was conducted from 1st March 2020 to 30th June 2020, and involved self-reported data and laboratory results of 2089 HCWs. All HCWs who took at least two nasopharyngeal swabs for COVID-19 testing at two different time intervals during the study period were included. Throughout the mass testing period, various strategies such as practices of the new norm, daily temperature and symptom checking, wearing of appropriate personal protective equipment (PPE), identification of high-risk areas and travel declaration of staffs were within the hospital for prevention of COVID-19 transmission. We observed a small percentage of COVID-19 infected HCWs (n = 19, 0.91%) from the mass testing. Both symptomatic and asymptomatic COVID-19 HCWs were almost equal in number. A majority of those infected were nurses (n = 16, 0.77%) who had contact exposure to COVID-19 positive person or person under investigation (PUI) (n = 15, 0.72%). Four of the COVID-19 infected HCWs (n = 4/19, 21.05%) had no contact exposure. These HCWs were not identified through contact tracing. Fortunately, they were detected during the mass testing and were isolated promptly. In conclusion, mass testing of HCWs helped in early identification of COVID-19 infected HCWs not identified through contact tracing. Strategies such as stratified mass testing, strict compliance to new norm, appropriate PPE usage and identification of high-risk area were effective in the prevention of COVID-19 infection among HCWs.