Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.     

Substantive due process after Gonzales v. Carhart

This Article begins in Part I with a doctrinal evaluation of the status of Washington v. Glucksberg ten years after that decision was handed down. Discussion begins with consideration of the Roberts Court's recent decision in Gonzales v. Carhart and then turns to the subject of Justice Kennedy's views in particular on substantive due process. In Part II, the Article goes on to consider whether the Glucksberg test for substantive due process decision making is correct in light of the original meaning of the Fourteenth Amendment.The Article concludes in Parts II and III that Glucksberg is right to confine substantive due process rights recognition to recognition only of those rights that are deeply rooted in history and tradition.     

Bromadiolone poisoning: LC-MS method and pharmacokinetic data

Abstract:  Poisoning with superwarfarins, like bromadiolone, is a growing public health problem, and the mortality is high. Pharmacokinetic data on bromadiolone in humans are however scarce, and there are no reports following repeated exposures to bromadiolone. We have developed a method for quantification of bromadiolone in whole blood, using liquid chromatography–mass spectrometry (LC-MS). The analytical method is reported. Limit of detection was 0.005 mg/L and limit of quantification was 0.01 mg/L. The concentrations of bromadiolone in whole blood and plasma in serial samples from a 62-year-old woman were measured. The half-life of bromadiolone in blood was estimated to be about 6 days in the initial phase of elimination and about 10–13 days in the terminal phase. The mean plasma/blood ratio of bromadiolone was 1.7 ± 0.6. Stability testing of bromadiolone in whole blood samples after two cycles of freeze and thaw revealed that bromadiolone concentrations decreased.     

Rechtsfragen der Bestellung der Mitglieder der Volksanwaltschaft

Nach der Bundesverfassung sind die Mitglieder der Volksanwaltschaft von den drei mandatsstärksten Parteien zu nominieren. Der Beitrag untersucht das Bestellungsverfahren der Volksanwaltschaft, wenn mehr als drei Parteien infolge gleicher Mandatsstärke ein Nominierungsrecht beanspruchen.     

A novel histological technique for distinguishing between epithelial cells in forensic casework

There are a number of forensic cases in which the identification of the epithelial cell type from which DNA originated would provide important probative evidence. This study aimed to develop a technique using histological staining of fixed cells to distinguish between skin, buccal and vaginal epithelium. First, 11 different stains were screened on formalin-fixed, wax-embedded cells from five women. Samples were analysed qualitatively by examining staining patterns (colour) and morphology (absence or presence of nuclei). Three of the staining methods – Dane's, Csaba's and Ayoub-Shklar – were successful in distinguishing skin epithelial cells from buccal and vaginal. Second, cells were smeared directly onto slides, fixed with one of five fixatives and stained with one of the three stains mentioned above. Methanol fixation, coupled with the Dane's staining method, specific to keratin, was the only technique that distinguished between all three cell types. Skin cells stained magenta, red and orange and lacked nuclei; buccal cells stained predominantly orange–pink with red nuclei; while vaginal cells stained bright orange with orange nuclei and a blue extracellular hue. This staining pattern in vaginal cells was consistent in samples collected from 50 women aged between 18 and 67. Identification of cell type from unlabelled micrographs by 10 trained observers showed a mean success rate of 95%. The results of this study demonstrate that histological staining may provide forensic scientists with a technique for distinguishing between skin, buccal and vaginal epithelial cells and thus would enable more conclusive analyses when investigating sexual assault cases.     

Interrogation of short tandem repeats using fluorescent probes and melting curve analysis: A step towards rapid DNA identity screening

Current forensic DNA profiling methods rely on the analysis of samples at specialised laboratories with an average turnaround time of several days. The ability to rapidly determine a partial profile of short tandem repeats at the point-of-arrest would be of great benefit to police forces around the world, for example enabling a suspect to be rapidly included or excluded from an investigation. We have developed a homogeneous PCR method for the interrogation of STR loci utilising fluorescent oligonucleotide probes and melting curve analysis. Alleles of the D18S51, TH01 and D8S1179 loci were differentiated and identified on the basis of target length and probe melting temperature. Assay performance was evaluated by comparing melting peak data with the AmpFlSTR^® SGM Plus^® system. The method is compatible with direct analysis of unpurified buccal swab samples, enabling a partial STR profile to be generated within 1 h.     

Chemico-toxicological study of fluoxetine

Selected aspects of chemico-toxicological analysis of the tranquillizer drug fluoxetine are described. Optimal conditions for fluoxetin extraction from internal organs and biological fluids (blood, urine) are specified and methods proposed for its detection and quantitation including TLC, UV SPM, and HPLC. The proposed methods were verified using laboratory animals and materials for expert examination.