Medical Research & Ethics Medical Research and Essay

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Medical Research & Ethics

Medical Research and Ethics

Conflict between Medical Research & Ethics

Conflict between Medical Research & Ethics: Case of Tuskegee Syphilis

Each day medical providers and researchers make decisions about what information is necessary to disclose to patients and under what circumstances they should make disclosures. In the clinical setting, the negative implications of a poorly considered disclosure decision can involve simple problems such as a patient being unaware that a medication may cause nausea. However, some disclosure decisions can have more serious consequences such as a patient undergoing intensive treatment without sufficient knowledge of their poor prognosis. ( L. Carroll, 2001) In the research setting, the result of nondisclosure can range from a subject not understanding their time commitment of trial participation to more extreme consequences -- such as a subject participating in research without being aware of life-threatening risks.( James H. Jones, 1993)

The current essay is an opinion paper about the disclosure of critical information to the patients and their ethical implication regarding patient consent, benefit and management. The author will analyze the well-known case of Tuskegee Syphilis in this context.

Disclosure as an Obligation in Medicine

During the 1960s, a dramatic shift toward patient right's began to surface. One of the areas identified as needing reform by providers involved providing honest disclosure to patients about their medical diagnosis and treatment options. Patient's began to challenge the medical community -- both in the court of law and in the court of public opinion -- about whether the provider was actually in the best position to make treatment decisions on behalf of their patients. Many health care professionals argued that disclosure of a poor diagnosis would be harmful to the patient's physical and psychological well-being.

The transition from a culture of nondisclosure toward one that relies heavily upon informed consent can be traced back to several landmark legal cases. The precedent for voluntary consent originated as early as 1914 when the case of Schlorendorff v. New York Hospital used the language of "self-determination" to justify imposing an obligation to obtain patient consent. (Jessica Berg, 2001) In his opinion, Justice Benjamin Cardoza wrote that, "Every human being of adult years and sound mind has a right to determine what shall be done with his own body."

In doing so, this case commenced an important step toward the eventual inclusion of disclosure as a requirement for a patient to voluntarily consent to treatment. At this time the term "informed consent" had not been used, but the court indicated that some basic form of consent should be obtained from the patient before treatment is rendered.

Taskegee Syphilis Case

In 1972, the New York Times reported on a research study being conducted in Tuskegee, Alabama where subjects diagnosed with syphilis were left untreated so that researchers could document what natural effects of syphilis on the human body. Between 1932 and 1972, the study enrolled four hundred subjects who were diagnosed with syphilis and two hundred subjects who were used as the control group. Those diagnosed with syphilis were never told of their diagnosis, but were promised transportation, hot lunches, free medical care (except for syphilis) and free burial once autopsies were conducted. The subjects of this study, predominantly poor and uneducated African-American's, were never told of their condition and never offered treatment for their disease -- even when it was discovered in the 1940s that penicillin could treat syphilis. (Robert, 2003) In fact, it had not been disclosed to the subjects that they were even participating in a research study since they were told that they had "bad blood" and needed occasional medical exams (Susan Reverby, 2000)

Patient Consent

Disclosure is also a unique consideration because it involves making a decision about whether to communicate specific information. It is impossible to disclose everything as such an attempt would overload human communication. As a result of practicality, every individual must make decisions about what she or he will disclose. Disclosure decisions may be motivated by considering either the discloser or receiver's perspective of the information in question.

On the other hand, disclosure is better understood as a prima facie obligation that is generally required, but may allow for exceptional situations of nondisclosure. (Fritz Steele, 1975) According to one author discussing business ethics, every act of disclosure gives another person an opportunity to learn, take action or obtain control that was previously held only by the discloser.

Because disclosure can have such a profound effect on human relationships, justifications are often given for decisions of nondisclosure.

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Three common reasons that are often cited for maintaining lower levels of disclosure include: whether the discloser will be rejected or harmed by the information, whether the receiver will be angered or harmed by the information and finally, the loss of control once a disclosure has been made Discerning which information should be disclosed is particularly important for health care professionals who must weigh not only factual information, but probabilities and whether these are certain or significant enough to disclose. The type of information that may be provided by health care providers can be life altering and may be more sensitive in nature than other areas of human communication.

Benefits to Patient, Society and Medical Professionals

The Tuskegee research was sponsored by the Public Health Service (PHS) which had continued to approve and fund the study for three decades. In 1966 an employee of PHS requested that the research be reviewed for moral concerns and a meeting by officials from the PHS Center for Disease Control determined that the research was justified. Only when the New York Times exposed the study to the public did the PHS recognize the devastation that their study had caused. A panel by the Department of Health convened immediately and judged the study unethical from its beginning and recommended its immediate end. The report also called for compensation for the surviving victims of the research and recommended that a national oversight board be developed to regulate research at institutions receiving federal funding. (Albert, 1995) The injustice recognized in the Tuskegee trial continues to serve as a powerful example of the devastation that can occur when information is not disclosed to research subjects.

After the Tuskegee experiment, Congress passed the National Research Act requiring that all research funded by the Department of Health, Education & Welfare be reviewed by Institutional Review Boards (Charles M. McCarthy, 1995) In another alteration of the FDA regulations, the procedures and policies were established for IRB oversight.While revisions have continued to be made to protect special populations, these guidelines along with those developed by the National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research (which was created by the National Research Act) continue to be the standards used to monitor current research experiments and are required from any research who receives federal funding.

Finally, the National Research Act created the National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research (Charles M, 1995). The commission was tasked to develop the basic ethical principle in conducting medical research. In its report the commission identified three basic principles underlying the ethical conduct of human research. 119 The Commission determined that ethical research must be founded on clear and informed consent. The type of information that the Belmont Report states should be specifically disclosed to subjects involves information about research procedures, purposes, risks, benefits and alternatives

The Institutional Compliance and Ethics

Despite the significant consequences of disclosure decisions for patients, subjects and medical professionals, no comprehensive ethical analysis has been developed in specific detail for how to approach disclosure decisions. While the issue of disclosure is one that is touched on within normative ethics -- such as truth telling or informed consent -- the ethical aspects surrounding disclosure decisions deserve consideration of their own. ( Karen Coulson, 2005)

The obligation to disclose material information should be given separate consideration from truth-telling which is held by some to be a moral absolute and by others to be a strongly held prima facie obligation in which there are few, if any, exceptions that justify lying.( S.P. Collis, 2005)

The central ethical question surrounding disclosure that will be addressed involves how to weigh the right of a patient to be given certain information against a competing interest by a provider, researcher or other stakeholders (including the patient themselves). These situations, which have tended to surface more in recent years due to the growing relationship of health care and industry, are highly complex and require much reflection before a decision about disclosure is made. ( Jerome Kassirer, 1998) It is widely acknowledged that nondisclosure may be acceptable under conditions where information may pose a psychological threat of detriment to the patient and is medically contraindicated

The obligation to disclose material information, particularly in the context of informed consent, is strongly held in the medical setting as a way of respecting patient's right to determine their treatment path. (James H. Jones, 1993).....

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