Routine HIV testing of hospital patients and pregnant women: informed consent in the real world

The Centers for Disease Control and Prevention (CDC) has recommended that HIV testing be routinely offered to certain patients in hospitals with a high prevalence of HIV infection and on all pregnant women. The CDC does not, however, offer implementation level guidelines for obtaining informed consent. We provide a moral justification for requiring informed consent for HIV testing and propose guidelines for securing such consent. In particular we argue that genuine informed consent can be secured without elaborate counseling, such as that currently used at Counseling and Testing Sites, provided that sufficient written notice is given to the patients before testing and that they are specifically asked for permission.     

Participants' understanding of the process of psychological research: informed consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41% were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

The fair transaction model of informed consent: an alternative to autonomous authorization

The doctrine of informed consent in bioethics has relied on the view that consent is valid when it represents a patient or research subject's autonomous authorization. In this article we challenge this reigning conception of the validity of informed consent in clinical research, focusing in particular on the problem of the therapeutic misconception. We argue that the autonomous authorization model of informed consent suffers from four defects: (1) it fails to do justice to the relevance of risk-benefit considerations in shaping the criteria for the validity of consent, (2) it compromises the interests of subjects by preventing them from consenting to research participation with less than substantial understanding when doing so would likely be consistent with their preferences and beneficial to them or at least be unlikely to cause them harm, (3) it jeopardizes the interests of investigators by denying them fair notice regarding when the consent of research subjects can be considered valid and thus make it permissible for them to be enrolled in research, and (4) it threatens the reasonable limits on the responsibility of investigators to assure the adequacy of subjects' understanding of what research participation involves. In place of the autonomous authorization model, we present and defend a fair transaction model of informed consent, which better reflects the values served by consent.     

Routine screening: informed consent, stigma and the waning of HIV exceptionalism

The Centers for Disease Control and Prevention (CDC) recently recommended that HIV screening should become routine for all adults in the United States. Implicit in the CDC proposal is the notion that pre-test counseling would be more limited than at present, and that written informed consent to screening would no longer be required. If widely implemented, routine testing would mark a tremendous shift in the US HIV screening strategy. There are a number of considerations used to determine what screening tests should be routine, and HIV fits the bill in almost every regard. Yet the stigma associated with HIV infection remains, making the CDC's recommendation highly controversial. Will minimizing requirements for pre-test counseling and special written informed consent lead to unexpected or unwanted HIV testing, or do these stringent counseling and consent requirements needlessly scare people away? Will widespread and routine testing be associated with declining stigmatization, or will it drive some patients away from seeking desperately needed health care? These are high stakes questions, and we're about to find out the answers.     

Patients' interpretations of verbal expressions of probability: implications for securing informed consent to medical interventions

Physicians often use verbal expressions of probability to characterize their uncertainty about outcomes and the risks or side effects of proposed therapies. However, there is an extensive literature that documents the inherent vagueness of such expressions. Because of the potential importance of probability terms to physician-patient communication and decision-making, we asked patients to tell us the odds they thought applicable to the term "rare," as used by their physician to discuss the likelihood of an adverse outcome from surgery. Patients were randomly assigned to one of three outcome groups: death, severe heart attack, or severe pneumonia. Demographic data were elicited from each subject, as were indicators of present health status, medical history for certain diseases and surgery, and life expectancy. Linear regression and ANOVA analyses of the responses indicate that patient age, education level, perceived health status, and recency of experience with disease and medical care influence patients' numeric interpretations. We discuss the implications of these results.     

论知情同意的中国本土化--中国文化视野中的知情同意走向

知情同意原产于西方,移植到中国后被"家文化"、"功利论"、"简单化"等中华传统文化彻底改造过以后,浓缩成了手术前一味要求病人家属或单位领导签字的行为模式,远离了知情同意的主旨,但曾一度非理性地普遍流行.现在,又出现了一种照搬欧美知情同意的倾向,在一线医务人员中引发了诸多困惑和不满.在实施知情同意时,离开中华文化语境,或者在本土化中化掉其本质的做法,都是不可行的.正确的取向只能是立足于中国当代医学实践,以正在形成中的中国现代文化去整合西方知情同意的本质、理念和规范,构建成一套适合中国国情的知情同意机制.     

Increasingly informed consent: discussing distinct aspects of psychotherapy at different points in time

Psychologists are ethically obligated to obtain informed consent to psychotherapy "as early as is feasible" (American Psychological Association, 2002, p.1072). However, the range of topics to be addressed includes both information that may be immediately and uniformly applicable to most clients via policy or rule, as well as information that is not immediately presentable because it varies widely across clients or emerges over time. In this study, licensed psychologists were surveyed regarding the earliest feasible point at which they could provide information regarding specific aspects of psychotherapy. Results indicate that, although psychologists believe that they are capable of presenting some information, such as payment and confidentiality policies, at the outset, they believe that a discussion of more substantive issues, such as psychotherapy duration, goals, orientation, and activities, can take place only after some therapy has transpired. Implications are discussed regarding the process and event models of informed consent.     

"There is no evidence to suggest...": changing the way we judge information for disclosure in the informed consent process

Feminist health activists and medical researchers frequently disagree on the adequacy of the informed consent processes in clinical trials. I argue for an informed consent process that reflects the central importance of patient-participant autonomy. Such a standard may raise concerns for medical researchers about their capacity to control the quantity and quality of the information they disclose to potential participants. These difficulties might be addressed by presenting potential participants with differently sized disclosure packages.     

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.