Intellectual Property,Access to Medicines,and Health: New Research Horizons

In this introduction, we review the literature on intellectual property rights and access to medicines, identifying two distinct generations of research. The first generation analyzes the origins of new intellectual property rules, in particular the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the significance of TRIPS to developing countries. The second generation examines national-level experiences, as countries adjust their laws and practices to conform to TRIPS. Based on the insights provided by the articles in the special issue, we contribute to the second generation by considering a pair of overarching sets of issues. First, we highlight the domestic political challenges that affect how countries go about implementing their new obligations under TRIPS. We argue that alliances and coalitions are necessary to underpin the use of policy instruments designed to conform to TRIPS while taking into account local conditions and needs, and we present insights that allow us to understand why alliances and coalitions are difficult to construct and sustain in this area. Second, we explain why policies that many countries adopt in response to TRIPS often do not generate their desired or intended outcomes. In the last section of the introduction, we review the articles that appear in this special issue.     

Spotlight on research integrity: international insights on strengthening research culture in the forensic sciences and beyond

The Singapore Statement on Research Integrity, articulated during the 2nd World Conference on Research Integrity in 2010, encompasses principles that apply to all research endeavours, including the various disciplines that comprise the field of forensic science Singapore Statement on Research Integrity (2010) (https://wcrif.org/guidance/singapore-statement). Cases of research misconduct and breaches of research integrity in any field undermine the trustworthiness of research and make it difficult if not impossible for others to rely upon and replicate research results. Moreover, problems in the research environment, whether in the academic, public, or private sector, can include bullying and harassment, discrimination, abuse of power and corruption, as well as competitive pressures related to employment and status.     

Evaluating Bioinformatic Pipeline Performance for Forensic Microbiome Analysis*,†,‡

Microbial communities have potential evidential utility for forensic applications. However, bioinformatic analysis of high-throughput sequencing data varies widely among laboratories. These differences can potentially affect microbial community composition and downstream analyses. To illustrate the importance of standardizing methodology, we compared analyses of postmortem microbiome samples using several bioinformatic pipelines, varying minimum library size or minimum number of sequences per sample, and sample size. Using the same input sequence data, we found that three open-source bioinformatic pipelines, MG-RAST, mothur, and QIIME2, had significant differences in relative abundance, alpha-diversity, and beta-diversity, despite the same input data. Increasing minimum library size and sample size increased the number of low-abundant and infrequent taxa detected. Our results show that bioinformatic pipeline and parameter choice affect results in important ways. Given the growing potential application of forensic microbiology to the criminal justice system, continued research on standardizing computational methodology will be important for downstream applications.     

Sample Mining and Data Mining: Combined Real-Time and Retrospective Approaches for the Identification of Emerging Novel Psychoactive Substances

Novel psychoactive substances (NPS) are synthetic drugs that pose serious public health and safety concerns. A multitude of NPS have been identified in the United States, often implicated in forensic investigations. The most common and effective manner for identifying NPS is by use of mass spectrometry and the true utility lies within nontargeted acquisition techniques. During this study, a liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) assay was developed, validated, and implemented for forensic toxicology testing. A SCIEX TripleTOF™ 5600 + with SWATH^® acquisition was used. Resulting data were compared against an extensive library database containing more than 800 compounds. The LC-QTOF-MS assay was applied to the reanalysis of biological sample extracts to discover emergent NPS. More than 3,000 sample extracts were analyzed, and more than 20 emerging NPS were detected for the first time. Among these were isopropyl-U-47700, 3,4-methylenedioxy-U-47700, fluorofuranylfentanyl, N-methyl norfentanyl, 2F-deschloroketamine, 3,4-methylenedioxy-alpha-PHP, eutylone, and N-ethyl hexedrone.     

Postmortem Changes of Female External Genitalia and Their Importance in Suspected Sexual Abuse

Examination of the female external genitalia to assess for sexual abuse is performed in living individuals, and the interpretation of the findings is based on evidence-based studies. However, in the deceased, no such studies are available, and postmortem changes could present as suspicious findings that can be mistaken for trauma. Patches of discoloration in the hymen were reported previously in one case as hypostasis (i.e., livor and lividity), and based on this finding, it was listed as a finding that is not associated with trauma. This was a retrospective study that was conducted in the Center of Forensic and Legal Medicine in Dammam, Saudi Arabia over a 4-year period. The study included 30 deceased women in whom photographic documentation of their external genitalia was assessed for postmortem changes. The postmortem interval ranged from less than 24 h to more than 100 days, and the ages of these deceased women were in the 20–40 year-old age group. In cases where the hymen, vagina, and/or fossa navicularis were clearly visible, none of these areas showed any hypostatic discoloration. A comparison between antemortem and postmortem appearance of the hymen in one case clearly showed the absence of hypostatic changes in the hymen. In conclusion, any discoloration of the external genitalia that is detected in a female decedent requires serious consideration.     

Civilian Forensic Technician and Sworn Police Officer Job-Related Stress

Forensic Technicians provide crime scene investigation services and are exposed to stressful violent crimes, motor vehicle accidents, biological or chemical hazards, and other appalling imagery. Forensic Technicians would likely experience physical and psychological stress after exposure to trauma, and security vulnerabilities similar to Sworn Police Officers. The perceived availability of mental health resources, job-related physical, psychological stress, and traumatic experiences of both Forensic Technicians and Sworn Police Officers from California law enforcement agencies were investigated using a self-reported survey. Responses were evaluated for any significant differences in the perceived stress, job-related physical stress, and resulting psychological impact affecting the participants. The survey contained a mix of True/False, Circle/Check the Appropriate Box, or Likert Scale (1–5) responses. The results were evaluated statistically and discussed. Results indicated Sworn Police Officers and Forensic Technicians have different on-duty stress levels, but similar off-duty stress levels. Nearly two-thirds of 54 job-related stressors were not significantly different between the two occupations. However, Forensic Technicians reported more adverse effects in 17 physical and psychological job-related activities compared with Sworn Police Officers. Forensic Technicians reported lower awareness levels and availability of agency mental health support services than were reported by Sworn Police Officers. This study reports for the first time an unexpected outcome that perceived and job-related psychological stress is greater for Forensic Technicians than Sworn Police Officers. Possible reasons for this disparity will be discussed as well as stress management tools that should be implemented to reduce health risk factors for both career professionals as well as increase public safety.