Science ethics as a bureaucratic problem: IRBs,Rules, and Failures of control

“Institutionalized science ethics” refers to the statutory, professional and institution-based ethical standards that guide and constrain scientists' research work. The primary institution responsible for implementing institutionalized science ethics is the Institutional Review Board. We examine the limitations of IRBs and institutionalized science ethics, using bureaucratic theory and, especially, theory related to the development and enactment of rules. We suggest that due to the very character of rules-based systems, improvements in IRB outcomes are unlikely to be achieved through either more or better rules or even by bureaucratic reform. Instead, we suggest that improvements in human subject protection can best be advanced through increased participation. Ours is not a call for more participation by the general public but participation, via “Participant Review Boards” of persons who are eligible, by the protocols of the research in question, to serve as subjects. This provides a level of legitimacy and face validity that cannot be obtained by IRB affiliates, even by “external representatives.” In making these points, we review a recent science ethics controversy, the KKI/Johns Hopkins lead paint study. In spite of being approved by IRBs, the study resulted in a civil lawsuit that reached the Maryland Court of Appeals. The case illustrates the limits of institutionalized science ethics and the bureaucracies created for their enactment. The case also underscores the complex and equivocal nature of the ethical guidelines established under the National Research Act. We are grateful to – for providing helpful comments on an earlier draft.     

Oral abuse of fentanyl patches (Duragesic): seven case reports

In order to increase the understanding regarding the oral abuse and potential toxicity of fentanyl patches seven cases were identified over a 3-year period where fentanyl, either alone or in combination with other factors, contributed to death following the oral abuse of Duragesic patches. The decedents comprised three females and four males with ages ranging from 20 to 51 years. Postmortem blood fentanyl concentrations were determined in all cases and ranged from 7 to 97 ng/mL. Two deaths were classified as a fentanyl overdose, three deaths were classified as a fentanyl and ethanol overdose, one death was considered a mixed drug intoxication and the remaining death was determined to be a combination of fentanyl and medical causes. These cases represent the largest reported series of deaths following the oral administration of transdermal fentanyl patches and provide detailed information on the potential for the abuse of transdermal Duragesic patches via this route. The postmortem blood fentanyl concentrations detected for each of the decedents demonstrate the potentially fatal blood concentrations that can arise after this relatively rare route of administration.     

Frontal sinus accuracy in identification as measured by false positives in kin groups

The aims of this study were to verify if frontal sinuses can uniquely identify individuals belonging to family groups using Cameriere methods and to test if kinship can affect the proportion of erroneous identifications. For this purpose, we compared the proportion of false-positive identifications in a sample of 99 individuals within 20 families with a control sample of 98 other individuals without kinship. The results show that the combined use of SOR and the Yoshino code number allows personal identification with a small probability of false positives (p < 10(-6)), even when kinship is taken into account. The present research confirms the importance of studying anthropological frameworks for identification, which leads to reliable methods and allows for both quick and economic procedures.     

Validation of an Abbreviated Version of the Structured Interview of Reported Symptoms in Outpatient Psychiatric and Community Settings

This study examined the effectiveness of an abbreviated version of the Structured Interview of Reported Symptoms (SIRS-A) in identifying malingered mental illness. The SIRS-A is comprised of 69 items drawn from the SIRS (R. Rogers et al. 1992, SIRS: Structured Interview of Reported Symptoms: Professional Manual. Odessa, FL: Psychological Assessment Resources, Inc.), substantially reducing the administration time. A simulation design was used with three samples; 87 psychiatric outpatients who responded honestly were compared to 29 community-dwelling adults and 24 psychiatric patients instructed to malinger psychopathology. The SIRS-A generated sensitivity comparable to or exceeding that of the SIRS normative data, but specificity was poorer; many genuinely impaired patients were misclassified as malingering. Although these findings suggest the SIRS-A may be an effective means to assess malingering in psychiatric populations, further research assessing the reasons for the elevated false positive rates is necessary.     

Injustice and arousal

Central to equity and distributive justice theories is the assumption that reward inequities produce feelings of distress and that such feelings motivate efforts to reduce the perceived injustice. Physiological arousal under such conditions would provide direct evidence of injustice distress. To date, no such evidence exists. In the present study, a skin conductance measure was obtained for subjects receiving either just or unjust allocations in a pay-forwork setting. As expected, heightened arousal occurred (relative to baseline levels) in underpay and overpay conditions, with no such effect in a just-pay condition. It was also predicted and found that heart rate—more an index of somatic activity than distress—did not discriminate among experimental conditions. The implications of these results for theoretical development and applied research are discussed.     

New South Wales

New South Wales easily retained its reputation as the State of commotion. Politicians and administrators during the past twelve months have lived through interesting times. Things are out in the open, at least. A rich and varied range of inquiries has been tackling problems which have remained hidden for decades. Hard items on the agenda of administrative reform are at last receiving attention. Courts and parliamentary procedures are being revitalized. The next great uproar will occur when the long-awaited Freedom of Information Act arrives and provides ordinary members of the public with their own tickets of admission to the political and administrative arena.     

Stability and Change in U.S. Grand Strategy

Since the Global War on Terror (more recently termed the Long War) emerged as the centerpiece of U.S. grand strategy in 2001, the post–Cold War U.S. debate has narrowed significantly. Essentially three alternative strategies now compete for pride of place. Two are variants of a “primacy” strategy; one is a variant of “restraint,” sometimes termed “offshore balancing.” All three strategies take globalization as a given and as a positive development. None specifically connects U.S. military power to globalization. To the extent that globalization can be argued to have negative consequences, restraint offers a different remedy than either version of primacy. This article offers a brief characterization of globalization and speculates on its positive and negative results. The three grand strategies that remain visible in the U.S. public policy debate, and their suggested remedies, are then discussed. Finally, the U.S. military strengths and weaknesses are evaluated in order to gauge which strategy's remedies are most feasible.