Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor…

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted…

Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method's increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of…

Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project ("Informed Consent"). Accordingly, information and consent represent a complex procedure, and the participant concerned "must receive comprehensible oral and written…

The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of…

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The…

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients' attitudes towards participating in a…

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied…

There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of "risk parity": if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of "ex ante" risk in…

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that…

With the ongoing and expanding use of willed bodies in medical education and research, there has been a concomitant rise in the need for willed bodies and an increase in the means of supplying these bodies. A relatively recent development to enlarge this supply has been the growth of for-profit willed body companies ("body brokers") in…

Video ethics in educational research involving children is a recent topic that has arisen since the increase in the use of visual mediums in research (such as photovoice and video) especially with the development of new and ubiquitous internet technologies and social media. This paper emerged as an expressed concerned by a group of scholars…

School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent…

Background: Medical research on children has increased in the last 20 years. International ethical regulations for conducting clinical research on children may not pertain to Muslim communities where religious beliefs play a big role in decision-making process. Methods: The aim of this paper was to illustrate the origins of bioethics principles in…