BackgroundTo investigate the factors related to approval after review by an Institutional Review Board, the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision frequency. (...) The revision frequency and total review time influenced the efficiency of review.ResultsThe latent variable of reviewing was the most important factor mediating the PIs and vulnerability to IRB review approval. The local PIs moderated with genetic study and revision frequency had an impact on the review process and mediated non-approval.ConclusionsBetter guidance of the investigators and reviewers might improve the efficiency with which IRBs function. (shrink)

Neuromarketing is an emerging field in which academic and industry research scientists employ neuroscience techniques to study marketing practices and consumer behavior. The use of neuroscience techniques, it is argued, facilitates a more direct understanding of how brain states and other physiological mechanisms are related to consumer behavior and decision making. Herein, we will articulate common ethical concerns with neuromarketing as currently practiced, focusing on the potential risks to consumers and the ethical decisions faced by companies. We argue that the (...) most frequently raised concerns—threats to consumer autonomy, privacy, and control—do not rise to meaningful ethical issues given the current capabilities and implementation of neuromarketing research. But, we identify how potentially serious ethical issues may emerge from neuromarketing research practices in industry, which are largely proprietary and opaque. We identify steps that can mitigate associated ethical risks and thus reduce the threats to consumers. We conclude that neuromarketing has clear potential for positive impact on society and consumers, a fact rarely considered in the discussion on the ethics of neuromarketing. (shrink)

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions (...) on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself. (shrink)

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” has raised legitimate concerns about the integrity of the IRB process. One author has described a multicenter trial as being withdrawn from consideration at one institution when rejection was imminent, in order to avoid informing other IRBs reviewing (...) the protocol of the study's rejection. This practice and IRB shopping seem at odds with the spirit, if not the “letter,” of the regulations. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. (shrink)

It is not unusual for researchers in ethnography (and sometimes Institutional Review Boards) to assume that research of “public” behavior is morally unproblematic. I examine an historical case of ethnographic research and the sustained moral outrage to the research expressed by the subjects of that research. I suggest that the moral outrage was legitimate and articulate some of the ethical issues underlying that outrage. I argue that morally problematic Ethnographic research of public behavior can derive from research practice that includes (...) a tendency to collapse the distinction between harm and moral wrong, a failure to take account of recent work on ethical issues in privacy; failure to appreciate the deception involved in ethnographers’ failure to reveal their role as researchers to subjects and finally a failure to appropriately weigh the moral significance of issues of invasion of privacy and inflicted insight in both the research process and subsequent publication of research. (shrink)

These CQ Sources were compiled by Bette Anton.