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| Introduction to research ethics: past and present ethical codes of research | Dan Perju Dumbravă *, Cristina Gavrilovici **
* MD, PhD, Institute of Forensic Medicine, Cluj, danperjud@yahoo.com
** MD, MA, University of Medicine and Pharmacy "Gr.T.Popa" Iasi
| Abstract
For many years research on human beings has been performed with little attention on moral rules, mostly to serve the benefit of the research community. History has shown us that research cannot be neutral, although several codes of ethics have been set in place in order to protect human subjects: the Nuremberg Code, the Declaration of Helsinki, Belmont Report. This paper is an essay meant to compare these three codes of research ethics, highlighting the aspects that we appreciate the most, and concluding with the choice of one that we consider the most suitable for the respect of human subjects and human dignity.
Key words: research ethics, Nuremberg Code, Declaration of Helsinki, Belmont Report
Justice has been one of the major ethical principles when conducting research on human subjects. All the major codes and regulations have been developed as a result of lack of protection for human subjects, as a misrepresentation of the risks and benefits or simply as an ignorance of moral principles that a researcher should undertake before a scientific "exploration" is actually implemented. The history has shown us unhappy examples of human rights violation. Consequently, today the universal research arena is highly regulated with different codes and guidelines that are continuously revised and adapted to accommodate the complexity of problems in a pluralistic society, shaped by scientific, political and cultural values. Nationally and internationally there are pressures to subordinate the interests of the subject to those of the science and society.
For the past 50 years the main sources of guidance on the ethical conduct of clinical research have been the Nuremberg Code, Declaration of Helsinki, Belmont Report and many other similar acts. However, these documents have been produced as a response to specific events, thus lacking sometimes specificity or applicability to other situations. Generally speaking, Nuremberg Code was part of the legal decision condemning the atrocities of the Nazi doctors and thus focused on the need for consent; the Declaration of Helsinki was developed to correct the omissions from the Nuremberg Code and so focuses on risk ? benefit ratio and external review; the Belmont Report meant to provide broad principles, in response to research abuses such as Tuskegee. There are differences in these codes but they are alike in their insistence that patient autonomy be respected and supported, in their concern for the rights of individual patients and research subjects above scientific and societal goals.
An eloquent question in this context would be: what makes a research involving human subjects ethical? The answer that most researchers, bioethicists and Institutional Review Board (IRB) members would probably offer is "informed consent". This is the oldest recognized ethical problem that the past had dealed with and the main point of the Nuremberg code. Beside this old fundamental "ABC" for all research, other ethical guidelines include the need of a social or scientific value, animal experimentation validity, subjects' "freedom" to withdraw from the study, the researcher's "duty" to terminate a study if it turns to harm people and general statements regarding the protection of human subjects. This last point has been the subject of thoroughly critiques, since it doesn't bring too much specificity in the description of "special" populations nor a good apprehension on the "risks" issues.
Because of its link with the horrors of World War II and the use of prisoners in Nazi concentration camps for medical experimentation, debate continues today about the authority of the Code, its applicability to modern medical research, and even its authorship. The judges at Nuremberg, although they realized the importance of Hippocratic ethics and the maxim "primum non nocere", recognized that more was necessary to protect human research subjects (Shuster E., 1997)
Although we do agree that the main weakness is its ambiguous and indistinct character we wouldn't extensively criticize it, since it has the attribute of being the first code of practice for research, opening for the first time the door to moral standards for research with human beings. It also has been called "the most important document in the history of the ethics of medical research" (Shuster, 1997). Scrutinizing and reproving the Nuremberg Code is like condemning Hippocratic Oath for not being adequate enough for today's medicine. "Do not harm" from the Hippocratic Oath is no longer a sound medical principle but the Oath has the value of being the most ancient proponent of medical ethics, under which the future physician becomes a catalyst through whom God works to preserve life and health. Even today Germans attitude, quite reluctant when it comes with human experimentation, remained influenced by guilt over the abuse of medical research in the Nazi era.
Approximately 20 years later, as a result of scientific advances in medical field that brought into light new ethical dilemmas, Helsinki Declaration, expanded the standards of care with more explicit "ideals" of research and new principles. I could distinguish five main advantages of this code of scientific conduct uncovered by Nuremberg Code: identifying vulnerable population and potential subsequent coercion, the need of external review, special ethical issues when conducting international research, ethical issue related with publication and special issues related with clinical research combined with medical care.
For the first time some vulnerable populations (children, mentally ill) were defined and along with this, the relationship between vulnerability and coercion. Furthermore, strength (even in comparison with upcoming regulations) resides on the fact that it is emphasized that coercion can be effective even with non ? vulnerable populations (e.g. the economically disadvantaged or simply the persons who cannot refuse due to a particular relationship with the principal investigator). Research on other "exposed" or susceptible groups like pregnant women or prisoners have not yet been regarded as morally problematic (but later on under CIOMS regulations).
The importance of external review (by an ethic committee or IRB) comes not only from the need to ensure that ethical principles are respected but also as a safeguard against conflicts of interest, especially when funding profits or institutional affiliation purposes come into play. I would link this requisite for scrutinization, with research publication and requirements to adopt ethical guidelines for publications (both for researchers and editors). I do consider that this is the major strength of Helsinki Declaration. By publication, the designs, methods and results are openly shared within scientific community and to public attention; publication can bring scientific reward or reproof; and finally medicine's advances cannot be presented and represented but by means of publication.
Science has an international character; it comes under tough international competition and global struggle for knowledge achievements. Helsinki Declaration has the merit of bringing into the light for the first time that there might be particular ethical, legal and regulatory requirements for research on human subjects from other countries. Although I do not believe that people are equal, human rights should be defended in the entire world. To what extent is ethical to conduct a non therapeutic study on sick subjects or a therapeutic one on subjects suffering from other disease have raised several controversial debates and constituted the start point of many forthcoming revisions of Helsinki Declaration.
The distinction between therapeutic and non-therapeutic has been thoroughly criticized and considered illogical by Levine (2000), who, regardless the fact that he considers the whole Declaration a flawed document carefully explain that by making this net distinction it rules out all research in the field of pathogenesis, pathophysiology and epidemiology. We do agree that a rigid distinction between these two categories of research cannot be drawn since at least some of the components of every research protocol are non therapeutic. On the other hand, the same like the Nuremberg Code situation, the Helsinki Declaration by classifying the research as explained above attempted to reveal that some research might involve more than a minimal risk without clear or reasonable benefit for the subject. It is still unclear how much the altruism should weight when assessing the voluntariness of participation into such a study and since a psychological evaluation of each subject is not feasible, the whole problem comes back to the value of informed consent.
The distinction between Biomedical and behavioral vs. therapeutic research has been maintained also in Belmont Report. However this new code does not emphasize on the "structure" of research and consequent ethical implication but mainly clarification of the ethical principles particularly applied in research. It brings more of a philosophical flavor than a list of policies. It incorporates the actual description of the moral guidelines (autonomy, beneficence, justice), and how this fit into the research domain.
Beneficence is not understood as a "charity" act, but in terms of responsibility to secure the well-beings of the subjects. The ideal principle that Belmont Report intrinsically assumes is that one should not injure regardless the benefits, but also disclaims that this is impractical since avoiding harm requires knowing what is harmful.
Beside the reinforcement of the risk ? benefit ratio, this Report introduce the idea of longer term benefits and risks that may result from the improvement of the knowledge or development of the novel medical procedure. There are psychological harm, physical harm, legal harm, social harm and economic harm and corresponding benefits. While risks are assessed in terms of probabilities, benefits are estimated as positive values related to health or welfare.
The justice principle is the hardest to explain, maybe because it is so difficult to accomplish. It is easier to define injustice and Belmont Report condemns the injustice that arises from social, racial, sexual and cultural biases.
In summary, The Nuremberg Code focusing on the human rights of research subjects has changed forever the way both physicians and the public view the proper conduct of medical research on human subjects. The Declaration of Helsinki focuses on the obligations of physician-investigators to research subject, Belmont report does not include several issues that have been stipulated in Helsinki Declaration (publication ethics, the use of placebo, international research ethics etc) but it has the value of illustrating and clarifying what is the principlism, how should it be inserted into research and why do we need principle to conduct our research life. Helsinki Declaration has been revised several times due to rapid advances of medicine, raising new unsolved ethical dilemmas. As long as the science will be a perpetuum mobile we cannot expect any code of guidelines to be perfectly adapted in research community. This is why we prefer Belmont Report (even with its inherent limitations): the minimal moral fundamentals should first be understood and then applied.
References
[1] Levine RJ., Some recent developments in the International guidelines on the ethics of research involving human subjects, Annals of the New York Academy of Science, 918: 170-8, 2000
[2] Shuster E., Fifty years later: the significance of the Nuremberg code, N Engl J Med, 337, 1440, 1997
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