Revelations from the Tuskegee syphilis experiment forced the medical community to enact policies to prevent such a tragedy from repeating itself. Consequently, the Belmont Principles and Declaration of Helsinki were created in order to establish a universal code of ethics for research involving human subjects. Both the Belmont Principle and Declaration of Helsinki emphasize that the well-being of research subjects triumphs over any research goals. Although these documents were created in order to simplify and unify medical ethics, their simplicity allowed for continued debate. In the editorial “The Ethics of Clinical Research in the Third World,” Marcia Angell argues that the current shift towards the privatization of clinical trials has diminished …show more content…
Streamlining medical ethics to a universal system lowers the risk of abuse. To prevent abuse of power, all the goals of research must be “secondary to the well-being of the participants” (Angell 847). The investigator’s responsibility is to provide the best quality possible for the subjects even at the expense of scientific progress. Angell highlights the difference between the best possible care and the best available care. She claims that treatment of subjects by following the local standard of care when a better treatment exists is unethical. Context, or the feasibility of the treatment in a specific region should be ignored. Angell defines the role of a research subject as a patient rather than a vessel for knowledge. Angell alludes to the Tuskegee trial in her criticism of current clinical study practices in the third world. She criticizes studies that use placebo groups because they sacrifice the well-being of the subject for efficiency. As a result, “we have not come very far from Tuskegee” (Angell 849). These studies are only possible in Third World countries because of the “asymmetry in knowledge and authority between researchers and their subjects (Angell 847). This disparity between subject and investigator strips the subject of autonomy and renders him dependent on the investigator in matters of decision-making. The bypassing of the …show more content…
Therefore, Varmus and Sather assert that the use of placebo groups in trials in Third World countries ethical. Varmus and Sather define an unethical trial as one that deprives people of “known, effective, [and] affordable intervention” (Varmus, Sather 1003). Individuals in Third World countries deserve the opportunity to enroll in studies (autonomy) that address their needs (justice). Current HIV treatment for women and children is not feasible in Third World because it is too expensive for both the patient and the healthcare infrastructure in those countries. Studies using placebo groups best address this problem because of its higher potential for producing vital knowledge. These studies qualify under the principle of beneficence because it is ultimately useful. Varmus and Sather argue that a study without a placebo is unlikely to provide results, and thus fails to benefit subjects. Even though these trials are likely to be approved in the U.S. and most developed nations, it would be unjust to deprive those in the Third World these opportunities; citizens in Third World Countries have the right to participate in research that can potentially benefit them. Context matters; ethical principles must mold to the subjects’ socioeconomic
The author explains how randomized clinical trials put physicians in ethically intolerable positions of choosing between the good of the patient and that of society. A kantian argument is formed when the author explains how the physician has the duty to tell the truth and not use the patient as a mere means to satisfy the needs of a majority. The well being of the patient is far more important than that of the society when it comes to treatment by personal physician, the Author suggests that there should be alternatives to randomized clinical trials to deal with observer bias and patient selection. The overall message of the article stresses the importance of a patient’s well being over the well being of a society because the physician has the duty to help the patient improve his/her health.
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
The first half of the 20th century was plagued by actions that are revealed to be unethical and frightening in today’s society. Poor medical practices during this time period were often overlooked. Many doctors, without advanced equipment or proper safety guidelines would perform procedures on living bodies to see what had happened to them. These experiments were often completed without informed consent. One of the most unethical studies that came from the 1900’s was the Tuskegee Syphilis Study, that took place in Macon County, Alabama.
Since the inception of this mode of research, peoples’ perception of what constitutes moral behavior towards patients and specifically harvesting cells from patients has changed. Over time, other doctors would take cells from patients without patient consent and use them for research. Coming from this, people began to think about how ethical this was, and especially if the potential for scientific or medical advances outweighs the injustices imposed by the lack of obtaining patient consent. One could argue that in the area of ethical behavior and medical advances, it might be necessary and acceptable to take cells or tissue samples without patient consent. And even though these cells and the research of these cells might not affect the patient, what advantages and disadvantages could come from obtaining or not obtaining patient consent?
Denise Dudzinski, PhD, MTS, Helene Starks, PhD, MPH, Nicole White, MD, MA (2009) ETHICS IN MEDICINE. Retrieved from: http://depts.washington.edu/bioethx/topics/pad.html
The study took advantage of an oppressed and vulnerable population that was in need of medical care. Some of the many ethical concerns of this experiment were the lack of informed consent, invasion of privacy, deception of participants, physical harm, mental harm, and a lack of gain versus harm. One ethical problem in this experiment was that the benefits did not outweigh the harm to participants. At the conclusion of the study there were virtually no benefits for the participants or to the treatment of syphilis. We now have
Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles that consider the ethical standards that should prevail in such circumstances. Should researchers be upheld to universal standards, or are the standards more applicable in a “local” sense, where the conditions and the constraints of the location provide the context for how the principles should be applied?
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
Within public health, the issue of paternalism has become a controversial topic. Questions about the ethics of public health are being asked. The role of ethics in medical practice is now receiving close scrutiny, so it is timely that ethical concepts, such as autonomy and paternalism, be re-examined in their applied context (Med J Aust. 1994). Clinically, patients are treated on a one on one basis, but public health’s obligation is toward the protection and promotion of an entire population’s health. So, based on this difference, the gaping questions targeting public health now becomes, under what conditions is it right to intervene and override an individuals’ autonomy? And if so, is the paternalistic intervention justified? Part of the concern
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
The declaration of Helsinki: in 1965, the world medical association (WMA) developed guidelines for ethical principles regarding human trials. It focused on protecting the rights of human subjects. It was the basis of ICH-GCP guideline...
In this diverse society we are confronted everyday with so many ethical choices in provision of healthcare for individuals. It becomes very difficult to find a guideline that would include a border perspective which might include individual’s beliefs and preference across the world. Due to these controversies, the four principles in biomedical ethic which includes autonomy, beneficence, non-maleficence and justice help us understand and explain which medical practices are ethical and acceptable. These principles are not only used to protect the rights of a patient but also the physician from being violated.
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.
McGee, Glenn and Arthur L. Caplan. "Medical Ethics." Microsoft® Encarta® 98 Encyclopedia. © 1993-1997: Microsoft Corporation. CD-ROM.