Research is increasingly recognised as a key component of medical curricula, offering a range of benefits including development of skills in evidence-based medicine. The literature indicates that experienced academic supervision or mentoring is important in any research activity and positively influences research output. The aim of this project was to investigate the human research ethics experiences and knowledge of three groups: medical students, and university academic staff and clinicians eligible to supervise medical student research projects; at two Australian universities. Training (...) in research ethics was low amongst academic staff and clinicians eligible to supervise medical student research. Only two-thirds of academic staff and students and less than half of clinicians surveyed indicated that specific patient consent was required for a doctor to include patient medical records within a research publication. There was limited awareness of requirements for participant information and consent forms amongst all groups. In the case of clinical trials, fewer clinicians and students than academics indicated there was a requirement to obtain consent. Awareness of the ethics committee focus on respect was low across all groups. This project has identified significant gaps in human research ethics understanding among medical students, and university academic staff and clinicians. The incorporation of research within medical curricula provides the impetus for medical schools and their institutions to ensure that academic staff and clinicians who are eligible and qualified to supervise students’ research projects are appropriately trained in human research ethics. (shrink)

Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who conducted clinical trials with (...) rural subjects. The interviews provided a way to examine the influence of budgetary factors when deciding to conduct a clinical study, how information about the budget and the purpose of the study is conveyed to research participants, and the potential willingness of clinicians and coordinators to enroll in the kinds of studies they offer. The findings suggest that clinical trial research in rural communities may challenge clinicians’ abilities to balance the needs of the patient with the needs of the research enterprise. Few respondents seemed to recognize the traditionally recognized hazards of a dual relationship, specifically the moral risks of trying to attend to the interests of both patient and industry. It seems important to re-examine how we protect human subjects and what such protection should look like as research becomes part of the way medical care is provided, even in very rural areas. (shrink)

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' (...) clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them. (shrink)