First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless

The 21st-century translational science campaign could lead to an increase in first-in-human (FIH) trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: (1) the requirement for adequate preclinical research; (2) study design safeguards; and (3) choice of subject population. I also examine specific ethical considerations relevant to the three subject populations (healthy volunteers, seriously ill patients lacking standard treatment options, and stable patients) involved in FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials.     

A Website Content Analysis of Women’s Resources and Sexual Assault Literature on College Campuses

In an effort to examine how higher education institutions have provided women with resources to handle issues that disproportionately affect them, this study assessed the availability of women’s resource centers on college campuses within the United States, with a particular focus on sexual assault-related resources. A website content analysis was conducted, through which we coded to assess ease of use, clarity, and comprehensiveness of the programs and information made available to women. Although many universities had sexual assault literature, few had women’s resource centers. In addition, the quality of literature and programs varied greatly among the universities. Future research should attempt to explain organizational differences in college responses to the call for resources, as well as examine women’s experiences with resources on campus. Portions of this research were presented at the 2006 meetings of the American Society of Criminology in Los Angeles, CA and at the 2006 meetings of the Midwest Sociological Society in Omaha, NE.

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Off-Label Prescribing: A Call for Heightened Professional and Government Oversight

Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing.     

The relationship between job status,interviewing experience,gender, and police officers' adherence to open‐ended questions

Purpose. The current study examined whether several factors related to the job and demographic profile of police officers are associated with adherence to best‐practice guidelines when interviewing children. Method. One hundred and seventy‐eight police officers completed a standardized (simulated) interview regarding an allegation of abuse by a 5‐year‐old child. Immediately prior to this interview, details were obtained from the officers' regarding their job status, gender, interview experience, the timing and nature of prior training/supervision, and experience outside the policing profession with young children. Results. The results showed that timing of training was the only factor that related to interview performance. The proportion of open‐ended questions among participants who completed their interviewer training course less than 1 month prior to the simulated interview was better than those who completed the training earlier. Interestingly, the performance of the latter group was identical to that of a group of participants who had not yet received any formal interview training. The implications of the findings are discussed, along with directions for future research.     

Witnesses in the special court for Sierra Leone: The importance of the witness–lawyer relationship

This study is concerned with the relationship between witnesses testifying in the Special Court for Sierra Leone and their legal teams. Other research conducted with witnesses in international war crimes tribunals suggests that this relationship has a significant impact on the experience of such witnesses. A structured interview was administered to 171 witnesses who had testified in the Special Court for Sierra Leone. Witnesses generally felt their lawyers' attitude towards them was extremely good. Emotional support and good preparation for testifying seem to be particularly important predictors of witnesses' relationship with their lawyers, as does the level of respect they felt they received from court staff. However, communication between witnesses and their legal teams after the testimony is over did not have a significant impact on witnesses' evaluations of their lawyers' attitude towards them.     

The political economy of local government financialization and the role of policy diffusion

By analyzing why English local governments have made extensive use of long-term market loans with embedded derivatives, this paper seeks to contribute to the growing literature on local government financialization. Using an original, large-N panel dataset for the period from 1998 to 2014, we show that the configuration of the local political economy is an important driver of financialization processes: a Labour Party majority as well as fiscal and economic stress make it more likely that councils adopt risky financial instruments. As the use of financial innovations has also diffused geographically, policy diffusion impacts local governments as well. Highlighting the conditional effect of finance sector power, which only increases the use of financial innovations in very large councils, as well as the temporal dimension of fiscal and economic stress, we create ample avenues for further research.     

Flatter world and thicker walls? Blogs, censorship and civic discourse in China

The Internet simply because it exists in China will not bring democracy to China. It is a tool, not a cause of political change. So far, the Chinese government has succeeded through censorship and regulation in blocking activists from using the Internet as an effective political tool. Likewise, blogs may be a catalyst for long-term political change because they are helping to enlarge the space for collaboration and conversation on subjects not directly related to political activism or regime change. However their role in China is more likely to involve political evolution—not revolution.     

Anthropological analyses of 30 insertion/deletion autosomal markers in five major ethnic groups of Pakistan

We investigated the forensic efficacy of the 30 insertion/deletion (Indel) markers included in the Qiagen Investigator® DIPplex kit in 529 Pakistani individuals from five major subpopulations in Pakistan (Punjabi, Pashtun, Sindhi, Saraiki, and Baloch). In the Sindhi population, the distribution of HLD81 and HLD97 alleles deviated from Hardy-Weinberg equilibrium after Bonferroni correction. The combined match probability ranged from 2.0E-12 (Pashtun and Baloch) to 1.0E-12 (Sindhi), and the mean paternity exclusion power varied from 0.995 (Punjabi, Sindhi, and Saraiki) to 0.996 (Pashtun and Baloch). The high combined power of discrimination (0.999 999 999 999 97) and low combined match probability (1.7E-12) for all subpopulations studied support the utility of the 30 Indel markers for forensic identification in the studied subpopulations. The allele frequencies of the Indel markers in the Pakistani subpopulations were compared with those from 18 other populations. The results show that the populations clustered according to geography. The subpopulations investigated in this work showed a close genetic relationship with others from Pakistan, as well as with South Central Asian and Middle Eastern populations. The results suggest that the Investigator^® DIPplex kit can be useful as a supplementary tool for human identification in the five Pakistani subpopulations investigated in this study.Supplemental data for this article is available online at https://doi.org/10.1080/20961790.2021.1933366 .