Morality, ethics, norms and research misconduct.

Sir,

We read with great interest the recent article “Ethical issues in biomedical research and publication” by Shah.[1] Although this article offers a great deal of valuable information, there are three areas for discussion we would like to elaborate upon.

First, there are indeed big differences amongst descriptive ethics (morals), normative/prescriptive ethics and analytic ethics (metaethics).[2] The World Medical Association (WMA) defined “morality” as the value dimension of human decision-making and behaviour. Morals are concepts involving nouns such as ‘rights’, ‘responsibilities’ and ‘virtues’; and adjectives such as ‘good’ and ‘bad’ (or ‘evil′), ‘right’ and ‘wrong’, ‘just’ and ‘unjust’. “Ethics” is the study of morality – it involves careful and systematic reflection on moral decisions and behaviour and helps achieving a correct analysis of situations. Hence, “ethics” is a matter of knowing, whereas “morality” is a matter of doing. Ethics provides rational criteria for people to decide or behave in some ways rather than others, and it may not be associated with learning and life experiences. Morality is formed or shaped by the rules or instructions given by those with authority or role models, whether or not people agree with them. Simply speaking, morals are unarguable, but ethics is and has always been debatable.[3]

The term “norm”, as cited by Shah.[1] should also be used with caution, because it can be interpreted in different senses. For example, “norm” is defined by Georges Canguilhem, a French Neo-Aristotelian philosopher and physician, as not being statistical, however, instead, to be associated with normativity that is the ability of a living organism to adapt with activity and flexibility to changing circumstances.[4] The Canguilhem's norm is therefore totally different from the Shah's norms because research ethics is not adaptation ability of humans, but standards for humans, especially for physicians and researchers. In other words, the Canguilhem's norm is the personal adjustment of humans (physicians and investigators) to adapt with the ethical standards, and is not the standards themselves.

Ethical standards make science and medicine divergent from ethics. Scientific progress has grown exponentially over the past decades, and has created disparity between countries and regions (so-called “vertical advancement”). In contrast, ethics has no border across countries, regions or cultures, and is or should be all the same (so-called “horizontal advancement”). The WMA states that, “In most countries, there are laws that specify how physicians are required to deal with ethical issues in patient care and research. The medical licensing and regulatory authorities can and do punish physicians for ethical violations. However, ethics and law are not identical. Quite often ethics prescribes higher standards of behaviour than does the law, and occasionally ethics requires that physicians disobey laws that demand unethical behaviour. Moreover, laws differ significantly from one country to another, while ethics is applicable in every country and culture”.[3]

The second concern is about research misconduct. The Royal College of Physicians of Edinburgh has provided the definition of “research misconduct” as any behaviour by a researcher, whether intentional or not, that fails to scrupulously respect high scientific and ethical standards.[56] Research misconduct can be categorised into 8 types: Fabrication, falsification, plagiarism, problematic data presentation or analysis, failure of human subject protection, inappropriate claims of authorship, duplicated publication, and undisclosed conflicts of interest. These can result in patient injury, deterioration of the patient-physician relationship, loss of public trust in biomedical research, as well as pollution and degradation of the medical literature.[6] Details on research misconduct were extensively reviewed by Gilbert and Denison[5] and Pitak-Arnnop et al.[6]

Lastly, Shah[1] pointed out that “..misconduct is a very rare occurrence in research and there is no evidence that science has become ethically corrupt. The rate of misconduct has been estimated to be as low as 0.01% to as high as 1% of researchers per year.” Apart from the absence of a reference, this statement can be misleading because the misconduct rate seems to be underestimated.

A possible cause of the underestimated rate of research misconduct is the journals themselves, such as journal's guidelines for authors, and journal's mechanisms for upholding research and publication ethics.[6-10] Sorinola et al.[11] reported that instructions to authors of 249 biomedical journals were limited and inconsistent. Only one-sixth of those journals required patient's consent in case reports. Ethical guidance to authors of 124 high-impact journals was found to be less than ideal.[12] Our recent study revealed that ethical issues in the instructions to authors of most journals within 3 different surgical specialities—otolaryngology, plastic surgery, and oral-maxillofacial surgery—were incomplete, regardless of speciality and impact factor.[9]

A recent survey showed that many journal editors tended to disregard research ethical problems.[13] Once scientific fraud occurs, many journals fail to take immediate action to tackle the problem, especially when senior researchers are involved. A number of editors are unfamiliar with handling such situations, and some are unaware of potential ethical problems that may arise.[1314] These findings further support the study results by Nath et al.[15] and Steen[16] that retraction of articles due to unintentional error was more common than retraction due to scientific misconduct. To us, the low rate of scientific misconduct, as cited by Shah,[1] is not good news. This may require a greater effort of the journals to police the research malpractice.

For more details on research and publication ethics, we refer the interested readers to our recent publications.[6-1017-22]