Enforcing informed consent requirements: form or substance?
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Biomedical subjects
Publications and source records attributed to R R Faden.
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In September 1986, the Baltimore Huntington's Disease Project initiated a voluntary program of presymptomatic genetic testing for Huntington's Disease (HD). Forty-seven persons at 50% risk for HD attended one of two educational sessions designed to educate them about the test. At the beginning and end of each session, subjects completed the Affect Adjective Checklist and a set of questions assessing knowledge about and attitude toward presymptomatic testing. As a result of attending an educational session, subjects learned more about presymptomatic testing, and their attitude towards finding out whether they had the marker for the HD gene became more favorable. Fewer people requested genetic testing than expected. Those who later chose to undergo genetic testing had a more favorable attitude at both the beginning and at the end of the educational session. The significance of these data for genetic counselors is discussed.
Information collected by the National Gay Rights Advocates in 1986 and by the authors in the spring of 1987 was used to determine the extent to which the states currently regulate the practices of the health insurance industry specific to acquired immunodeficiency syndrome (AIDS). Of the 10 states reporting the greatest number of AIDS cases, six prohibit insurers form denying coverage to group policy applicants because of human immunodeficiency virus (HIV) infection. These findings refer only to the status of state regulatory activity specific to AIDS.
Health communications campaigns are a major strategy used by governments to promote health. This article discusses key issues in the ethics of health communications campaigns, including the compatibility of health campaigns with the principle of respect for autonomy and how conflicts with this principle can be justified. Five potential justifications for state-sponsored health communications campaigns are reviewed: the public's health as an independent value; collective efficiency and majoritarian preferences; third party or state's interests; harm to the health of others; and countering the short-term contingencies of a market.
We studied the attitudes of 490 pregnant women toward the abortion of defective fetuses. Three hundred of these women were participating in a prenatal screening program for neural tube defects. Although theoretical accounts of the effects of behavior on attitude would suggest that participation in a screening program would affect abortion attitudes, evidence in support of such an association was weak. The overwhelming majority of women, regardless of whether they had participated in the screening program, believed that women are justified in having an abortion in the face of fetal abnormality. There was a sharp increase in the number of screening program participants who said they would have an abortion when the probability of the fetus being affected with a neural tube defect rose from 95 per cent to 100 per cent.
We investigated the knowledge of pregnant women participating in a maternal serum alphafetoprotein (MSAFP) screening program for the detection of neural tube defects (NTDs) in the fetus. Women participating in the screening program scored higher on two knowledge tests than a comparison group of pregnant women who were not offered screening. However, there were substantial gaps in the knowledge base of women in the program, as measured by one of the tests. Women did not misinterpret a negative test result to mean that the test had identified a potential problem with the fetus; instead, there is a suggestion that they tended to interpret a negative result too positively, as an assurance that the baby was healthy in all respects.
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It is generally agreed that patients have a right to be adequately informed. However, little is known about the extent to which doctors and patients agree about information that should be disclosed. We studied what patients want to know, as contrasted with what physicians report actually disclosing, in a population of physicians who treat seizures and patients or parents of patients who have this disorder. In general, it was found that patients or parents of patients who have this disorder. In general, it was found that patients prefer far more detailed disclosures than physicians routinely offer and that the two groups have widely different beliefs about the consequences of detailed disclosures. Patients and parents preferred extensive disclosures, particularly regarding risks and alternative therapy. Physicians were likely to disclose only risks with a relatively high probability of occurrence and they provided little information about alternative therapies. Patients and parents were also much more likely than physicians to believe that the final decision concerning therapy should rest with the patient. The data suggest that a better empirical understanding of the consequences of detailed disclosures may help resolve differences of opinion regarding how much information should be provided to patients.
There is currently substantial disagreement about the kind of information that must be disclosed in obtaining an informed consent. This study examined physicians' interpretations of the demands of two alternative legal standards for disclosure, as well as a third standard intended to capture their normative sense of what should be disclosed to patients. Other factors which might affect disclosure practices of physicians were also studied. The findings raise questions about the extent to which a legal standard for disclosure can have an impact on medical practice; the data suggest that doctors currently disclose what they think patients want to be told. However, it appears that physicians substantially underestimate the amount of information patients wish to receive.
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Informed consent is a significant ethical as well as medicolegal issue. Both aspects are summarized in this article, which focuses on the major unresolved problems raised by legal and moral analyses of informed consent. The discussion stresses the effects of the doctrine of informed consent on medical practice, with particular reference to problems encountered in the neurological health field.
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The concept of voluntariness is central to an understanding of ethical considerations in two aspects of public health education practice: (1) the selection of appropriate interventions, and (2) the selection of appropriate targets for such interventions. The position is taken that most mass communications programs in public health education are persuasive as well as informative in intent. It is argued that the impact of such programs on voluntariness can be analyzed with regard to the rationality and resistibility of the persuasive appeals involved. Considerations of justice, as well as voluntariness and liberty, are reviewed in the discussion of appropriate targets for intervention. The issue of victim-blaming in public health education is explored, and conditions under which behavioral public health programs may be morally justifiable are suggested.
Traditionally, informed consent has been handled by the physician in a one-to-one interchange with the patient. As standards for adequate disclosure become more rigid and demands on physician time increase, however, the physician-patient model may cease to be practical. This study evaluated four alterative disclosure models: a formal discussion, a videotape, a pamphlet, and an informal discussion, each designed and executed by a team of health educators. Study results suggest that the informed consent process is little affected by disclosure medium and that it may be possible to strive for cost-efficiency in disclosure without compromising the quality of the consent obtained. Based on these results, a two-part disclosure process is proposed which allocates certain aspects of the disclosure to the treating physician, others to health education.
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Persons with a history of a sexual transmitted disease (STD) are at increased risk for infection with human immunodeficiency virus (HIV). The extent to which women with a previous history of a STD report currently practicing protective behaviors against STD transmission is examined. Specifically, whether having experienced one or more previous episodes of an STD was related to current STD/HIV preventive practices was studied. Of the study group, 36% had at least one prior STD episode. Results of bivariate analysis show no relationship between previous STDs and current STD/HIV preventive practices: 47% of women with no previous STD episode, 64% of women with 1 previous episode, and 46% of women with 2 or more previous STD episodes reported currently practicing moderate to high levels of STD/HIV prevention methods. To adjust for potentially confounding variables, logistic regression analyses were also performed. The logistic regression model included age, alcohol use with sex, drug use with sex, marital status, and perceived risk of becoming infected with an STD in the next year. Results from the logistic regression analyses also showed no relationship between prior STD episode and current level of preventive practices against STD/HIV. Variables found to be significantly associated with level of STD/HIV preventive practices were marital status, age, and drug use with sex. These findings suggest that greater advantage should be taken of the opportunities presented when women are diagnosed with an STD to teach individuals at risk of acquiring STDs or HIV to practice risk-reduction behaviors.