An evaluation of "informed consent" with volunteer prisoner subjects.
"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent. (+info)
Randomisation and resource allocation: a missed opportunity for evaluating health care and social interventions.
Equipoise is widely regarded to be an essential prerequisite for the ethical conduct of a randomised controlled trial. There are some circumstances however, under which it is acceptable to conduct a randomised controlled trial (RCT) in the absence of equipoise. Limited access to the preferred intervention is one such circumstance. In this paper we present an example of a randomised trial in which access to the preferred intervention, preschool education, was severely limited by resource constraints. The ethical issues that arise when conducting randomised trials in health care are considered in the context of trials of social interventions. In health, education and social welfare, effective interventions are frequently limited due to budgetary constraints. Explicit acknowledgement of the need to ration interventions, and the use of random allocation to do this even in the absence of equipoise, would facilitate learning more about the effects of these interventions. (+info)
Extending the boundaries of the Declaration of Helsinki: a case study of an unethical experiment in a non-medical setting.
To examine the ethical issues involved in governmental decisions with potential health risks, we review the history of the decision to raise the interurban speed limit in Israel in light of its impact on road death and injury. In 1993, the Israeli Ministry of Transportation initiated an "experiment" to raise the interurban speed limit from 90 to 100 kph. The "experiment" did not include a protocol and did not specify cut-off points for early termination in the case of adverse results. After the raise in the speed limit, the death toll on interurban roads rose as a result of a sudden increase in speeds and case fatality rates. The committee's decision is a case study in unfettered human experimentation and public health risks when the setting is non-medical and lacks a defined ethical framework. The case study states the case for extending Helsinki type safeguards to experimentation in non-medical settings. (+info)
Ethics that exclude: the role of ethics committees in lesbian and gay health research in South Africa.
Prevailing state and institutional ideologies regarding race/ethnicity, gender, and sexuality help to shape, and are influenced by, research priorities. Research ethics committees perform a gatekeeper role in this process. In this commentary, we describe efforts to obtain approval from the ethics committee of a large medical institution for research into the treatment of homosexual persons by health professionals in the South African military during the apartheid era. The committee questioned the "scientific validity" of the study, viewing it as having a "political" rather than a "scientific" purpose. They objected to the framing of the research topic within a human rights discourse and appeared to be concerned that the research might lead to action against health professionals who committed human rights abuses against lesbians and gay men during apartheid. The process illustrates the ways in which heterosexism, and concerns to protect the practice of health professionals from scrutiny, may influence the decisions of ethics committees. Ethics that exclude research on lesbian and gay health cannot be in the public interest. Ethics committees must be challenged to examine the ways in which institutionalized ideologies influence their decision making. (+info)
Covert video surveillance continues to provoke debate.
When the editor invites comment on a response to an analysis of a criticism of a protocol already defended by the author in this journal, the issue is clearly contentious. I will comment briefly on Thomas's paper in this issue of the journal, and look at points of agreement as well as dissent. (+info)
Covert video surveillance -- a response to Professor Southall and Dr. Samuels.
In their reply to my recent paper on Munchausen's syndrome by proxy, Professor Southall and Dr. Samuels concede that some things may be learned from my observations. They do not attend to the main argument of the paper, however, that the proportion of research interest in their use of covert video surveillance merits consideration of the research protocol by an independent research ethics committee. It will not do simply to assert that the use of this technology for the purposes outlined in their accounts is not research. I formulated arguments based on facts divulged in those published accounts for regarding their work as containing a considerable proportion of research activity. Unfortunately their reply did not address these arguments. Until such points are adequately answered the protection of patients calls for satisfactory judgments to be made on certain important issues which any research ethics committee would be obliged to consider in an evaluation of their activities. I suggest that some of these features will create more difficulties for approval of such a protocol than others. (+info)
Human facial expressions as adaptations: Evolutionary questions in facial expression research.
The importance of the face in social interaction and social intelligence is widely recognized in anthropology. Yet the adaptive functions of human facial expression remain largely unknown. An evolutionary model of human facial expression as behavioral adaptation can be constructed, given the current knowledge of the phenotypic variation, ecological contexts, and fitness consequences of facial behavior. Studies of facial expression are available, but results are not typically framed in an evolutionary perspective. This review identifies the relevant physical phenomena of facial expression and integrates the study of this behavior with the anthropological study of communication and sociality in general. Anthropological issues with relevance to the evolutionary study of facial expression include: facial expressions as coordinated, stereotyped behavioral phenotypes, the unique contexts and functions of different facial expressions, the relationship of facial expression to speech, the value of facial expressions as signals, and the relationship of facial expression to social intelligence in humans and in nonhuman primates. Human smiling is used as an example of adaptation, and testable hypotheses concerning the human smile, as well as other expressions, are proposed. (+info)