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Academy News: July 2006Scientific research: be aware of ethical considerations involved Recently the stem cell research community was rocked by allegations of fraud and the subsequent retractions of several seminal articles in the field. This unfortunate occurrence reminds us to always be aware of the ethical considerations involved in scientific research. A recent forum in Science discussed several of the issues surrounding this scandal.1 While there are many issues raised in this case, one of the most illuminating was the state of medical ethics knowledge in South Korea. Apparently 85% of “over 900 biotechnology researchers” had no awareness of the Declaration of Helsinki. Even more concerning, “42% did not know about Institutional Review Boards.” To perform ethically competent research, the investigator must understand these basic tenets of biomedical ethos. This ethics article will highlight the basic codes that direct ethically appropriate human subject research. The current ethical framework in which scientific research takes place has its beginnings in the 17th century. Critical to the system were the development of trust and integrity. To build this trust and to help ensure the integrity, Boyle and others in the Royal Society of London created a system that would allow for reproduction and/or witnessing of experimental data. The integrity of the person transmitting the data to the scientific community was probably the most important element of the system.1 Those who were known to be trustworthy and to have provided reproducible and accurate data in the past were far more likely to be trusted in the future. This system was the foundation of our current system, where authors take responsibility for their work. Journals publish peer-reviewed articles that are written in such a manner as to allow for reproduction of the experiments with similar data being generated. However, the atrocities of the Nazi regime led to the development of the first real ethical code for medical research: the Nuremberg Code.2 There were two primary functions of this code. First, the idea of consent was developed, including the need for the subject to have “sufficient knowledge and comprehension … to make an understanding and enlightened decision” and the ability to withdraw consent during the course of the study. Second, the code stresses only investigations based on prior non-human experiments that are expected to “yield fruitful results” and do not place the subject in undue risk may be performed by a “scientifically qualified” person. The Declaration of Helsinki from 1964, as amended through 2004, expanded greatly upon the ethical basis of the Nuremberg Code.3 Included within its confines are the ideas of treating all subjects with dignity, and to perform research only “if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.” However, what the Declaration of Helsinki is probably most known for is the requirement for an independent committee to oversee the “design and performance of each experimental procedure.” This committee, which we now know as an Institutional Review Board, has the right to monitor trials, must be informed of adverse events in the study, and must receive a full disclosure from the investigators. Finally, the Declaration of Helsinki raises significant objections, although not absolute, to the use of placebo-controlled trials, arguing for the use of current therapy as a comparator. In 1979 the United States issued The Belmont Report, which further expanded on the ethical considerations involved in human subject research.4 The core issues involved in this report are the broad ethical principles of:
Respect for persons involves not only informed consent, and withdrawal of such, but also includes “respect for the immature and the incapacitated.” The idea of doing no harm to subjects is included in the concept of beneficence, however, this principle also emphasizes the need to “maximize possible benefits and minimize possible harms.” Justice deals with the ideas of “‘fairness of distribution’ or ‘what is deserved’.” A good example of a violation of the ethical principle of justice would be the Tuskegee syphilis study, where “disadvantaged, rural black men were used to study a disease that was by no means confined to that population.” These three reports provide the basis for our understanding of ethically appropriate human-subject research. Each builds upon the other and gives researchers the guidance they need to perform research that will not only benefit society, but also the subjects involved in the studies as well. Understanding the ethical underpinnings of scientific research may not prevent fraud from occurring, but it will help to ensure that researchers will not inadvertently expose themselves or their subjects to unethical behavior. As such, all researchers, both human-subject researchers and non-human subject investigators, bench or clinical, should make themselves well aware of these documents so that the integrity of scientific research remains intact. Web references are included with this column. In this manner we can hope to keep the trust that society has placed in us to further medical and scientific knowledge. References
The AAAAI Ethics/Conflict of Interest Committee provides these discussions as a way to open a dialogue on the various ethical issues that confront our specialty on a daily basis. These issues are often quite complex and do not have simple “right” or “wrong” solutions. The articles are meant as a way to highlight the various issues that are involved in these ethical dilemmas. They should not be viewed as the committee’s or the AAAAI’s particular stance on an issue.
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