Ethics Case Study

Human Experiments and Informed Consent

In the quest for the ultimate face lift doctors in Manhattan conducted a study in which they preformed two different operations, one on each half of the face, to see which came out better. The study involved 21 patients whose average age was 59, who went to Manhattan Eye, Ear, and Throat Hospital in 1992 and 1993 for face-lifts. On one-half of the face, surgeons cut the skin at the hairline and pulled it back and up. They pulled and tightened the underlying muscle but did not cut it. In the second, more aggressive procedure, another set of surgeons cut beneath skin and tissue from the side of the face toward the nose, cut and pulled the underlying muscle back and upward. The latter procedure carries a higher risk that nerves will be accidentally cut and the face partly paralyzed. The surgeons were seeking to resolve a 20-year debate about which procedure is more effective. They say there is little if any noticeable difference in the two sides of the patients' faces. However, the study checked the patients only once, one year after the procedures. The great ethical debate in this study was a case of informed consent and study approval. The surgeons neither informed the patients of the experiment nor did they give the patients consent forms explaining in detail the procedures along with the risks they faced. In 1996, the surgeons who conducted the experiment published their findings in a medical journal.

After the story surfaced, someone alerted the division of the federal government that regulates experiments preformed on humans. This in turn sparked an official investigation into the operations and the ways the surgeons went about conducting them. The study's authors say that they did not seek committee approval or give detailed consent forms because neither was necessary. They felt that since the two procedures were well established, the study was not a human experiment [1]. The law on the other hand suggests other wise. Under Federal law, a human experiment is defined simply as an investigation that uses people's bodies and is not required for the direct diagnosis, prevention, or treatment of a patient's condition [6].

When proposing research that will involve human subjects, several ethical issues must be taken into account. First, the main concern of the investigator should be the safety of the research participant. The investigator must obtain informed consent from each participant and it must be obtained in writing. They must also specify how confidentiality concerns will be approached. The investigator should consider how unfavorable events will be handled such as who will provide care for a participant harmed during the study and who will pay for the care. Lastly, before enrolling patients in the study, the investigator should be aware if a new treatment is being tested against the currently accepted treatment and they should be truly unsure of which method is better [2].

In 1974, Congress passed the National Research Act and established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It required that all research receive prior review and approval from an Institutional Review Board. These Institutional Review Boards are local committees that determine whether certain standards are met to protect the human subjects before research may be preformed [3]. They are made up of physicians, ethicists, clergy, lawyers, and people from the community. In 1978, The National Commission developed a report, which identified basic ethical principles in biomedical and behavioral research involving human subjects. Along with the principles guidelines were developed to ensure that the research is conducted in accordance with those principles. The Belmont Report identified three main concepts by which to evaluate the ethics of research: respect for persons, beneficence, and justice [3]. These concepts have been the subject of much analysis and criticism. Although they do not cover the entirety of ethical analysis, they do propose an exceptional starting point from which to evaluate the process of, the motives for, and the social impact of research. Respect for persons states the importance of recognizing persons as their own decision makers and protects those who are unable to make decisions for themselves. This principle brings about the need to obtain informed consent. The concept of beneficence asserts the importance of protecting the welfare of human subjects by minimizing possible risks. Justice refers to an equal distribution of risks and benefits of the research. No group shall be exposed excessively to risks of research or denied its benefits. Researchers must also ensure that no one particular group is favored due to class, economic status, or race unless warranted by the research objectives. It is the Institutional Review Boards responsibility to implement these concepts [4]. As mandated by congress, The Belmont Report also distinguishes the boundaries between practice and research. Practice is described as "interventions