Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an…

Consent is one necessary foundation for ethical research and it's one of the research ethics committee's major roles to ensure that the consent process meets acceptable standards. Although on Oxford 'A' REC (an NHS Research Ethics Committee based in the UK) we've been impressed by the thought and work put into this aspect of research ethics, we've…

Artificial placentas (APs) are technologies that mimic the human placenta to treat extremely preterm infants. Being an invasive and risky technology, it will raise important ethical questions for human trials. Hence, in this Topic Piece we provide a blueprint of further issues to investigate. First, counselling will have the double role of…

In today's online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in…

Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford 'A' Research Ethics Committee we've found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision…

We draw on three illustrative vignettes to examine how REBs manage participants' agency in the context of qualitative research. We ask: Who owns a participant's consent? Central to informed consent is the principle of "Respect for Persons," which privileges the autonomy of individuals to make decisions about what happens (or not) to…

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…

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the…

The growing importance of researching online activities, such as cyber-deviance and cyber-crime, as well as the use of online tools (e.g. questionnaires, games, and other interactive tools) has created new ethical and legal challenges for researchers, which can be even more complicated when researching adolescents. In this article, we highlight…

Dynamic consent is increasingly recommended for longitudinal and biobanking research; however, the value of investing in such systems is unclear. We undertook a rapid review of the benefits and challenges of implementing dynamic consent by searching five databases (Ovid Medline, Ovid Embase, Scopus, Web of Science, Cumulative Index to Nursing and…

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…

The last decade has seen a rise in big data approaches, including in the humanities, whereby large quantities of data are collected and analysed. In this paper, we discuss long-form audio recordings that result from individuals wearing a recording device for many hours. Linguists, psychologists and anthropologists can use them, for example, to…

The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19…

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…

Learning about research ethics and research integrity is greatly facilitated by case studies, which illuminate, ground and personalise abstract questions. This paper argues that fiction can provide similar learning experiences, incarnating ethical dilemmas through a medium that is highly accessible yet sophisticated in its depictions of how…