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…

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 Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing…

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…

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…

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article,…

Individuals who register as body donors do so for various reasons, with aiding medical science a common motivation. Despite awareness of several key reasons for donation, there are few in-depth explorations of these motivations to contextualize persons' reasons for donating. This study undertakes a mixed-method exploration of motivations for body…

The COVID-19 pandemic has brought unprecedented, major challenges to the ethical conduct of research including challenges for the rapid and robust ethical review of biomedical research. The Indian Council of Medical Research's "National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic"…

Background: Adults with intellectual disabilities and/or autism are often excluded from participating in health and healthcare research. Understanding study information, which is an important aspect of demonstrating capacity to give informed consent, can be a particular challenge. This study surveyed clinical researchers to discover: (i) their…

This year the world commemorates the beginning of the tragic USPHS syphilis experiments that occurred in Tuskegee, Alabama from 1932 to 1972. In light of this sobering anniversary, this article will briefly examine four studies: the already mentioned USPHS syphilis studies in Tuskegee, the Nazi Holocaust Experiments and the resulting Doctors'…