METHODS: National principal investigators from 30 countries were asked if the original PIS/ICF was edited in their countries and, if so, to share with us the one used to recruit participants. We assessed whether the 25 different elements of information from the good clinical practice guidelines and the Declaration of Helsinki were present in, deficiently described, or absent from the PIS/ICFs.
RESULTS: Nineteen national principal investigators responded: eight (Argentina, Brazil, Ethiopia, Georgia, Iran, Lebanon, Lithuania, and Malaysia) stated that no edits were introduced to the original PIS/ICF; eight (Canada, Colombia, Philippines, India, Ireland, Pakistan, Portugal, and Switzerland) added some elements of information in the national PIS/ICF; and three (Italy, Peru, and Spain) reported not participating in the trial. None of the elements included in the original PIS/ICF were omitted from the edited PIS/IFC. Six elements of information were omitted and five deficiently described in the original PIS/ICF. The number of elements omitted from the edited PIS/ICFs varied (range = 2-5). Nine PIS/ICFs incompletely described or omitted the informing of study participants about the study results, while five deficiently described or omitted the anticipated expenses for trial participation. Information concerning whom to contact for more information or in case of injury was deficient in six PIS/ICFs. Unlike the original PIS/ICF, all edited PIS/ICFs informed participants about the existence of compensation or treatment for any injury related to the trial.
CONCLUSIONS: WHO should consider adding three of the omitted elements in PIS/ICFs of future multinational similar trials.
METHODS: We performed a scoping review using three broad concepts: population (stateless population, migrants, refugees, asylum seekers, internally displaced people), issues (healthcare and ethics), and context (11 countries in SEA). Three databases (PubMed, CINAHL, and Web of Science) were searched from 2000 until May 2023 over a period of four months (February 2023 to May 2023). Other relevant publications were identified through citation searches, and six bioethics journals were hand searched. All searches were conducted in English, and relevant publications were screened against the inclusion and exclusion criteria. Data were subsequently imported into NVivo 14, and thematic analysis was conducted.
RESULTS: We identified 18 papers with substantial bioethical analysis. Ethical concepts that guide the analysis were 'capability, agency, dignity', 'vulnerability', 'precarity, complicity, and structural violence' (n=7). Ethical issues were discussed from the perspective of research ethics (n=9), clinical ethics (n=1) and public health ethics (n=1). All publications are from researchers based in Singapore, Thailand, and Malaysia. Research gaps identified include the need for more research involving migrant children, research from migrant-sending countries, studies on quality of migrant healthcare, participatory health research, and research with internal migrants.
CONCLUSIONS: More empirical research is necessary to better understand the ethical issues that exist in the domains of research, clinical care, and public health. Critical examination of the interplay between migration, health and ethics with consideration of the diverse factors and contexts involved is crucial for the advancement of migration health ethics in SEA.