Medical research What is it?
What is medical research? Medicine has been called the most scientific of the humanities and the most humane of the sciences (Pellegrino & Thomasma 1981) This reference to science has resonance for the practice of medicine as a whole but is especially true in the context of medical research
What is medical research? Any broad definition of science and the scientific method would refer to the making of systematic observations and measurements, the process of experimentation, the formulation and testing of hypotheses and their modification in the light of new observations Understanding the application of science to medicine can be contentious, particularly when a distinction has to be made between innovative medical practice, medical audit and clinical research
What is medical research? Innovative practice Audit Medical research The distinction between these rests on the intent
Innovative practice Medical practice focuses exclusively on the benefit to the individual patient and is not directed at producing knowledge that may become generally applicable, although broad benefit may emerge from accumulated clinical experience and subsequent formal experiment Innovative practice, for example was the use of bismuth compounds for resistant peptic ulcers before the role of Helicobacter pylori was understood
Innovative practice The physicians who initially used bismuth could be seen to act in an innovative manner (and in accord with the ethical principle of beneficence) The USA Belmont Commission defined practice as interventions that are designed solely to enhance the wellbeing of an individual patient or client and that have a reasonable expectation of success
Audit Audit is a systematic examination designed to determine the degree to which an action or set of actions achieves predetermined objectives The ethical issues for individual patients are those required for the delivery of a normal standard of care
Audit The audit process does, however, bring the added dimension of an endeavour to avoid harm (consistent with the principle of nonmaleficence) and improve service (the principle of beneficence) for patients who will thereafter pass through the selected system Thus audit is also an exercise that seeks to maximise welfare for future patients and would be consistent with the aims of the utilitarian ethic
Medical research The primary intention of medical research is to uncover facts and make new conclusions that can be used to the advantage of patients in general; the important distinction is that participating patients may or may not benefit in the process Medical research was defined in the Belmont Report as being designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
Medical research The moral issues that arise are quite different from those of innovative practice or audit, and they are specially challenging. Necessarily, research of this type utilises the tools of science and scientific enquiry, including experimentation, observation and measurement
The moral justification for medical research The contribution of research to the community is supported by Declaration of Helsinki which states, It is the duty of the physician to promote and safeguard the health of the people (Introduction, 2) and Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects (Introduction, 4)
The moral justification for medical research The same notion is echoed by Council for International Organisations of Medical Sciences with the words The ethical justification of biomedical research involving human subjects is the prospect of discovering new ways of benefiting people's health (Guideline, 1) The pursuit of clinical research to alleviate suffering is rooted in the moral obligation to care
CAM The term, complementary and alternative medicine (CAM) covers a number of widely varied diagnostic and therapeutic practices that operate according to a diversity of underlying principles but possess the common feature that their rationales do not rest on conventional scientific understanding
CAM Many are long-established, e.g. traditional herbal medicines, acupuncture, homeopathy, and their practitioners would argue that the ethical justification for their activity relies not in research-based evidence but in ancient wisdom and the experience of benefit to individual patients accumulated over years
CAM Modern clinical trial methodology allows satisfactory comparisons of CAM with conventional therapies and offers the opportunity progressively to establish what position CAM might have in patient care (Ernst 2001)
Scientific issues Is there a question to answer (using humans)? Uncertainty principle (equipoise, strong and weak) Risk-benefit (therapeutic and nontherapeutic) What chance of a clear outcome (design, facilities, availability of subjects)? Can the results be generalised? Will patient care be better?
Investigator issues Dual responsibility, physician and investigator Potential conflicts of interest
Research subject issues Consent to participate from the potentially vulnerable subject Consent to remain in a trial Randomisation (patient preference trials) Placebo use Confidentiality Privacy