The efficacy of modern medicine depends very largely on scientific research into the causes of disease, innovative therapies, and methods of organizing and delivering healthcare services. Interestingly, modern bioethics can also be considered to have developed from the articulation of standards for the ethical conduct of medical research. Discussion of the ethics of research in the aftermath of the violations of human life and dignity not only in the Third Reich and Imperial Japan but also in the Western liberal democracies before and after the World War II provoked more general discussions of the ethical basis of medical care. For instance, modern discussions of the role of patient autonomy in bioethics owe much to the analysis of this concept in the Belmont Report of 1979 (p. 195), which was concerned with the protection of human subjects of research.
Until relatively recently, medical research was considered to be an area of special ethical risk, involving, as it often did, exposing patients to risks of harm that could be serious, and that could involve doctors in treating their people more as “research subjects” than as patients who should under no circumstances be harmed. This way of thinking about research ethics remains important. However, more recent thinking about research ethics has pointed out that patients can be harmed by exposing them to untested or unevaluated medical interventions, and that there is far more continuity between research ethics and “ordinary” bioethics than had been thought. In addition, debate is currently continuing about whether very strongly protective (perhaps “risk averse”) approaches to patient welfare undermine attempts to improve population health overall by blocking the sharing of data and by making certain kinds of research with children or members of other vulnerable groups unnecessarily difficult. At the same time, there is growing public concern over whether medical research is always as disinterested and beneficial as most of its practitioners would hope: controversy continues over conflict of interest in research, underreporting or misreporting of research findings, and the commercialization of medical research.
This section reviews the main areas of medical research ethics that affect working clinicians today. The opening chapter (Ch. 25) surveys the principal issues. Chapter 26 considers the boundary between innovation in medicine and surgery and formal research. While medical practice is modified piecemeal all the time, both to respond to specific features of individual patients’ needs and to respond to innovative ideas of individual practitioners, formal research imposes specific requirements on doctors and may be quite tightly regulated. When does an innovation become a research project? Should ethical standards for innovation be different from those for research? The following (Chapter 27 and 28) concern the two most important forms of clinical research: clinical trials and epidemiology, respectively. Each describes the main ethical issues in each form of research methodology. Chapter moves on to discuss the dual role of physician and researcher: do doctors who involve their patients in research projects face a conflict of roles and of moral obligations? Or can enrolling your patients in research projects be seen as entirely consistent with the requirements of “ordinary” bioethics? Chapter 30considers another kind of conflict of role or conflict of interest. Do doctors who conduct research have obligations to the public or to their patients that conflict with their obligations to the sponsors of their research? How should such conflicts be minimized and regulated? The final chapter in this section (Ch. 31) concerns a form of research that is of growing importance, embryo research. Can such research be considered simply immoral? Whose interests need to be considered? Should the state intervene to regulate such research?
There are many types of research that could not be covered in the space available. Nor have we been able to give more than a passing mention to some of the wider issues of scientific integrity, the relationship between medical research and evidence-based medicine, the impact of medical innovation on public health, and the global health context of research. Nonetheless, this section sets out the chief issues of current importance, and the general principles that can be applied to these related problems.
Several of these other topics are taken up in Sections 4, 6, and 8 .