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.     

Client preferences for informed consent information

Thirty-five current therapy clients, 47 former clients, and 42 college students with no therapy experience rated 27 items in terms of importance for inclusion in informed consent discussions. The current and former client samples rated information about inappropriate therapeutic techniques, confidentiality, and the risks of alternative treatments as most important, and information about the personal characteristics of the therapist and the therapist's degree as least important. The results of this study provide evidence for differential informed consent disclosure practices.     

Enhancing the informed consent process: a conceptual overview

Concern about limitations in the ability to give valid informed consent among certain groups of individuals has led to increased interest in defining, measuring, and enhancing consent-related decision-making. In this overview, we summarize issues related to the definition of decision-making capacity, discuss methods that have been used to assess decision-making abilities and other aspects of informed consent, and briefly describe studies that aim to understand variation in different elements of informed consent. We then review strategies that have been used with the intent of improving aspects of the informed consent process. Finally, we provide an outline of areas that are in need of future studies in order to reach the ultimate goal of preserving as much autonomy as possible in at-risk populations, while still achieving valuable research and treatment goals.     

Senile dementia and informed consent

Senile dementia in the elderly is a prevalent condition which requires ongoing medical treatment. This disease causes a deterioration of cognitive processes and, consequently, it is likely to impair the capacities required to give informed consent to needed medical care. However, a diagnosis of senile dementia does not necessarily indicate that the afflicted individual is incompetent. The means of assessing competency in dementia patients and their likely impairments according to five standards is described in this paper. Recommendations for obtaining consent from the competent dementia patient are made and mechanisms for providing special protection to the incompetent patient in the consent process are discussed.     

Managed care and informed consent

Arguments for efficiency in health care delivery have been used to support some level of withholding of information about available treatment options from patients in managed care systems. To the extent that such arguments prevail, they may necessitate changes in the established understanding of and commitment to informed consent and the disclosure of information to patients.     

Altruistic discourse in the informed consent process for childhood cancer clinical trials

Scholars have debated the role that altruistic considerations play--and should play--in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) "the future" and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.     

The practice of empathy as a prerequisite for informed consent

The patient-physician relationship, as formulated in the traditional biomedical model of medicine, is inherently flawed. In entering this relationship, most patients seek simply to be delivered from illness back to normal psychosocial functioning. The physician, however, almost invariably responds with a purely biologic approach to diagnosis and treatment that often does not effectively address the patient's needs. This precludes the opportunity for a consensus between them, and may in fact lead to the physician manipulating the patient's decisions about the course of therapy. The relationship should be reshaped within a new scientific model of patient care that combines the biomedical analysis of disease with an empathic understanding of the patient's illness experience. Truly informed consent is viewed as a natural outcome of the application of this more comprehensive framework.     

Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry

This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.     

Women in labor: some issues about informed consent

Women wishing hospital admission for childbirth are asked to sign very general pre-admission consent forms. The use of such forms suggests that women in labor are considered incompetent to give informed consent. This paper explores some of the problems with advance directives and general consent, and argues that since women in labor are not generally incompetent, it is not appropriate to require this kind of consent of them.