The Academy of Medicine of Malaysia College of Paediatrics acknowledges the role of children in research and this position statement explores the ethical considerations in obtaining assent from minors in the Malaysian context. It highlights the importance in respecting children's agency and navigating cultural complexities. The College proposes flexibility in the minimum age for assent of at least nine years old, while emphasising the need for a tailored assent procedure. Addressing language and cultural diversities and expanding local empirical research on a formal assent process are some building blocks in developing a standardised nationwide process in obtaining assent from children.
The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; non-institution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity.
The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.
There are three major issues of ethical concern related to epilepsy care in the developing world. First, is it ethical for a developing country to channel its limited resources from direct epilepsy care to research? The main considerations in addressing this question are the particular research questions to be addressed and whether such research will bring direct benefits to the local community. Second, in a country with limited resources, when does ignoring the high treatment gap become an ethical issue? This question is of particular concern when the community has enough resources to afford treatment for its poor, yet is not providing such care because of gross wastage and misallocation of the national resources. Third, do countries with plentiful resources have an ethical responsibility to help relieve the high epilepsy treatment gap of poor countries? Indeed, we believe that reasonable health care is a basic human right, and that human rights transcend national boundaries. Although health care is usually the responsibility of the nation-state, many modern states in the developing world are arbitrary creations of colonization. There is often a long process from the establishment of a political-legal state to a mature functional nation. During the long process of nation building, help from neighboring countries is often required.
Visual recording of human subjects is commonly used in biomedical disciplines for clinical, research, legal, academic and even personal purposes. Guidelines on practice standards of biomedical recording have been issued by certain health authorities, associations and journals, but none of the literature discusses this from an Islamic perspective. This article begins with a discussion on the general rules associated with visual recording in Islam, followed by modesty issues in biomedical recording and issues of informed consent and confidentiality. In order to be deemed ethical from the Islamic perspective, all the aforementioned criteria must conform to, or not contradict, Islamic teaching.
Published data and studies on research misconduct, which focuses on researchers in Malaysia, is still lacking, therefore, we decided that this was an area for investigation. This study provides qualitative results for the examined issues through series of in-depth interviews with 21 researchers and lecturers in various universities in Malaysia. The aims of this study were to investigate the researchers' opinions and perceptions regarding what they considered to be research misconduct, their experience with such misconduct, and the factors that contribute to research misconduct. Our findings suggest that the most common research misconducts that are currently being witnessed in Malaysian universities are plagiarism and authorship disputes, however, researchers seldom report incidents of research misconduct because it takes too much time, effort and work to report them, and some are just afraid of repercussions when they do report it. This suggests possible loopholes in the monitoring system, which may allow some researchers to bypass it and engage in misconduct. This study also highlights the structural and individual factors as the most influential factors when it comes to research misconduct besides organizational, situational and cultural factors. Finally, this study highlights the concerns of all participants regarding the 'publish or perish' pressure that they believe would lead to a hostile working environment, thus enhancing research misconduct, as researchers tend to think about their own performance rather than that of whole team or faculty. Consequently this weakens the interpersonal relationships among researchers, which may compromise the teaching and supervision of junior researchers and research students.