Ethical issues in medical statistics

ABSTRACT

Medical statistics [biostatistics], as a vital essential part of modem life, does raise some fundamental ethical issues. Surprisingly, this aspect seems to have been totally ignored by books on medical ethics. This paper discusses how the statistical aspects affect the ethics. The relation between biostatistics and medical research is explored. All stages of a medical research exercise are vulnerable to statistical mismanagement which might lead to misuse of patients by exposing them to unjustified risk and inconvenience; the misuse of resources including the researchers' time, which could be better employed on more valuable activities; and the consequences of publishing misleading results, which may include carrying out unnecessary further work. These are specific and highly undesirable outcomes. Failure to guard against these is surely as unethical as using experimental methods that offend against moral principles, such as failing to obtain full informed consent from subjects. Raising statistical standards of medical researches and publications serves as a safeguard to observe the element of ethics. This can be achieved by widespread teaching of medical statistics at all levels, involvement of biostatisticians as active participants of any medical researches and ethical committees. Ethical issues in medical statistics require wider and more open debate. Those involved in medical research need to involve the whole medical profession. Indeed, moral philosophers, theologians, and other professional groups have an important contribution to make