This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as (...) compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developing by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an African Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process. (shrink)

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.Some commentators and ethics documents claim that physicians, whether acting as care givers (...) or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”. (shrink)

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.Some commentators and ethics documents claim that physicians, whether acting as care givers (...) or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”. (shrink)

In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research questionnaire, which is an adaptation of the How I Think questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review (...) of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability. Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement, cynicism, and professional decision-making in research. The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity. (shrink)

In Brazil, social science research ethics is a field still under construction and subject to intense dispute. The aim of this paper is to discuss how accepted principles of biomedical research ethics can be incorporated into the ethical review of social sciences, particularly open interviews, ethnographic research, and participant observation. The paper uses a case study—the ethnographic documentary "Severina's Story"—as the basis for analysis of the methodological and ethical issues raised in social science research. To promote ethical social science research, (...) based on principles such as human rights and the protection of vulnerable populations, institutional review boards must be sensitive to the epistemological and methodological particularities of all fields of human subjects research. (shrink)

In Brazil, social science research ethics is a field still under construction and subject to intense dispute. The aim of this paper is to discuss how accepted principles of biomedical research ethics can be incorporated into the ethical review of social sciences, particularly open interviews, ethnographic research, and participant observation. The paper uses a case study—the ethnographic documentary "Severina's Story"—as the basis for analysis of the methodological and ethical issues raised in social science research. To promote ethical social science research, (...) based on principles such as human rights and the protection of vulnerable populations, institutional review boards must be sensitive to the epistemological and methodological particularities of all fields of human subjects research. (shrink)