Recombinant DNA research: actions under the guidelines--NIH. Notice of actions under NIH guidelines for research involving recombinant DNA molecules

This notice sets forth actions taken by the Director, National Institute of Allergy and infectious Diseases (NIAID), by authority of the Director. NIH, under the June 1983 NIH Guidelines for Research Involving Recombinant DNA Molecules (48 FR 24556).     

Office of Recombinant DNA Activities; recombinant DNA research: action under the guidelines. National Institutes of Health (NIH), PHS, DHHS. Notice of action under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

This notice sets forth an action to be taken by the Director, National Institutes of Health (NIH), under the NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR 34496, amended 59 FR 40170, 60 FR 20762, 61 FR 1482, 61 FR 10004, 62 FR 4782, 62 FR 53335, 62 FR 56196, 62 FR 59032, 63 FR 8052, 63 FR 26018).     

Medicare program: request for public comments on implementation of the Medicare+Choice program, and notice of timeframes for submission of applications for contracts--HCFA. Notice of intent to regulate; solicitation of comments

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice program. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with us. The BBA directs the Secretary to publish by June 1, 1998, regulations establishing standards for the Medicare+Choice program. We have already received comments and inquiries from the public on a number of issues associated with the Medicare+Choice program. This document solicits further public comments on issues related to implementation of the Medicare+Choice program. We intend to consider these comments as we develop an interim final rule to implement the Medicare+Choice program. This document also includes preliminary information regarding application procedures for organizations that intend to contract with us to participate in the Medicare+Choice program. This document also informs the public of a meeting to discuss the Medicare+Choice program.     

Duplex-specific nuclease (DSN): A method for the rehabilitation of low-copy number DNA profiles

A continual challenge in the field of forensic DNA analysis is the amplification and interpretation of degraded and low-copy number (LCN) DNA obtained from amounts of limited biological evidence. It has been well established that DNA profiles obtained from the amplification of low quality, degraded, and/or LCN DNA samples are often of limited value due to the frequent occurrence of preferential amplification during polymerase chain reaction (PCR). The by-products of preferential PCR amplification are often observed as inter- and intra-locus peak imbalance, allelic dropout, and/or locus dropout. These are all artifacts that are identified during the interpretation phase of analysis rather than by improving the quality of the DNA present. While it is theoretically possible to obtain a complete DNA profile from a single cell, in reality, profiles obtained from suboptimal amounts of DNA are difficult to interpret and frequently inconsistent when replicated. Inspired by advances in next-generation sequencing techniques, we propose a methodology for simultaneously normalizing the abundance of PCR products across all short tandem repeat (STR) loci using the DNA exonuclease, duplex-specific nuclease (DSN). DSN is an enzyme isolated from the hepatopancreas of Red King (Kamchatka) crab that possesses a strong affinity for digesting double stranded DNA (dsDNA) and has limited activity toward single stranded DNA (ssDNA). Degraded DNA known to display peak imbalance and allele dropout was amplified using AmpFlSTR^® Identifiler^® Plus for 28 cycles. Following amplification, samples were denatured at 99.9 °C for 5 min and incubated with one unit of DSN at 62 °C in a 28 μl volume for 1 min. Nuclease activity was terminated through the addition of equal volume of 10 mM EDTA and 95 °C incubation for 2 min. Following DSN treatment, 21 of 30 alleles within the known profile exhibited some improvement in peak height balance. The findings obtained support the potential use of DSN treatment as a method for normalizing STR profiles and improving the quality of data from degraded and low quantity DNA samples.     

Applying the Consolidated Standards of Reporting Trials (CONSORT) to studies of mental health provision for juvenile offenders: a research note

The degree of reporting transparency in randomised controlled trials (RCTs) is an important factor when the validity of any results is being considered. The use of the Consolidated Standards of Reporting Trials (CONSORT) guidelines has improved the reporting standards of RCTs in many healthcare journals, but these guidelines have yet to be adopted universally. In this study, we applied the CONSORT Statement to RCTs identified from a systematic review of mental health provisions for juvenile offenders. We assessed the number of CONSORT items reported in each trial and investigated the extent of endorsement by journal editors. The findings showed that some items were fully endorsed (e.g., the aim of the study) whereas other items, such as sample size estimations, were not presented in any of the trials. A minority of journals supported the use of the CONSORT Statement in their journals’ instructions for authors. The overall reporting standard for this sample of trials was, therefore, mixed. Comparisons with trials conducted in other disciplines are discussed, and suggestions for improving reporting standards are presented.

Reply to Mac Giolla and Ly (2019): On the reporting of Bayes factors in deception research

Bayes factors provide a continuous measure of evidence for one hypothesis (e.g., the null, H0) relative to another (e.g., the alternative, H1). Warmelink et al. (2019, Legal Criminol Psychol, 24, 258) reported Bayes factors alongside p‐values to draw inferences about whether the order of expected versus unexpected questions influenced the amount of details interviewees provided during an interview. Mac Giolla & Ly (2019) provided several recommendations to improve the reporting of Bayesian analyses and used Warmelink et al. (2019) as a concrete example. These included (I) not to over‐rely on cut‐offs when interpreting Bayes factors; (II) to rely less on Bayes factors, and switch to ‘nominal support’; and (III) to report the posterior distribution. This paper elaborates on their recommendations and provides two further suggestions for improvement. First, we recommend deception researchers report Robustness Regions to demonstrate the sensitivity of their conclusions to the model of H1 used. Second, we demonstrate a method that deception researchers can use to estimate, a priori, the sample size likely to be required to provide conclusive evidence.     

Fluorescent SSCP of overlapping fragments (FSSCP-OF): a highly sensitive method for the screening of mitochondrial DNA variation.

The mtDNA analysis (mtDNA) is increasingly being demanded for forensic purposes due to the fact that many times the use of standard nuclear marker fails to analyze degraded samples (such as bones) and specially for the analysis of hair shafts (a common sample in the crime scene). However, analysis of mtDNA sequencing implies a great lab effort when a high number of samples must be analyzed.The present work introduces a novel and reliable method for the screening of mtDNA variation in the first and second hypervariables (HV1 and HV2) regions which we have denominated fluorescent single strand conformation polymorphism (SSCP) of overlapping fragments (FSSCP-OF). FSSCP-OF is based on the basic theory of SSCP analysis and combines two complementary strategies: the use of PCR amplified overlapping fragments and fluorescent detection technology. The overlap region contains a high percentage (50%) of the d-loop mtDNA variation and for this reason, the probability to detect a polymorphic position by SSCP analysis is clearly increased in comparison to conventional SSCP methods due to the fact that the same polymorphic position is usually placed in a different "relative" position in the two overlapped fragments. The use of multicolor fluorescent technology allows also the multiplex amplification of overlapping fragment and its subsequent analysis in an automatic sequencer. We have analyzed 50 samples of unrelated individuals through the FSSCP-OF technique and we have found that using this methodology the probability to distinguish two samples with different sequences is close to 100%. FSSCP-OF has other important advantages with respect to previous screening methods, such as the automation and standardization of the protocols, which is of special interest for the forensic routine.     

The German Berufsgenossenschaften (institutions for statutory accident insurance and prevention): organisation, mandate and activities in the area of mental health

The present article first describes the institution of the German Berufsgenossenschaften (BGs, the institutions for statutory accident insurance and prevention) and their mandate. Besides rehabilitation and compensation, these comprise the prevention of occupational accidents and diseases, and work-related hazards. The main focus within the area of mental health is the prevention work, but rehabilitation and compensation within the German social insurance system in general, and with respect to mental health, will also be explained. Furthermore, the prevention-rehabilitation interface will be illustrated and the cooperation with the health insurance institutions will be described. In the second part, selected results of a survey regarding mental health and stress will be presented.     

The utility of mitochondrial DNA sequences for the identification of forensically important blowflies (Diptera: Calliphoridae) in southeastern Australia.

The applicability of mitochondrial DNA (mtDNA) sequencing was investigated for the identification of the following forensically important species of blowflies from southeastern Australia: Calliphora albifrontalis, C. augur, C. dubia, C. hilli hilli, C. maritima, C. stygia, C. vicina, Chrysomya rufifacies, Ch. varipes and Onesia tibialis. All breed in carrion except O. tibialis, which is an earthworm parasitoid. Emphasis was placed on Calliphora species because they predominate among the carrion-breeding blowfly fauna of southern Australia and their immatures are difficult to identify morphologically. A partial sequence of the mitochondrial COII gene was determined for all species and for COI for C. albifrontalis, C. augur, C. dubia and C. stygia only. Five other species of blowflies, Chrysomya albiceps, Ch. rufifacies, Protophormia terraenovae, Lucilia illustris and L. sericata, for which sequence data were already available, were also included. Analysis of the COI and COII sequences revealed abundant phylogenetically informative nucleotide substitutions that could identify blowfly species to species group. In contrast, because of the low level of sequence divergence of sister species, the data could not distinguish among taxa from the same species group, i.e. the species within the C. augur and C. stygia groups. The molecular data support the existing species group separation of the taxa within Calliphora. Because of the speed and accuracy of current nucleotide sequencing technology and the abundant apomorphic substitutions available from mtDNA sequences, this approach, with the analysis of additional taxa and genes, is likely to enable the reliable identification of carrion-breeding blowflies in Australia.     

The impact of Daubert: implications for testimony and research in forensic anthropology (and the use of frontal sinuses in personal identification)

This paper emphasizes the need for objectivity and standardized methodologies in the forensic sciences, particularly physical anthropology. To this end, a review of important events in scientific evidence admissibility law, particularly the standards set in the case of Daubert v. Merrell-Dow Pharmaceuticals, Inc., 1993, is presented. The method of confirming a putative identification by visual comparison of antemortem and postmortem frontal sinus radiographs is examined in light of current admissibility standards. The technique is revealed to have a number of shortcomings, including a lack of empirical testing, no estimates of potential error rates, no standards controlling the technique's operation, and no objective determination standards. These shortcomings may, in some instances, prevent resulting conclusions from being admissible evidence. It is suggested that some methods (including frontal sinus comparison) may require more rigorous testing in order to meet these new and stricter standards.     

Guidelines on International Protection: The application of Article 1A(2) of the 1951 Convention and/or 1967 Protocol relating to the Status of Refugees to victims of trafficking and persons at risk of being trafficked

UNHCR issues these Guidelines pursuant to its mandate, as containedin the 1950 Statute of the Office of the United Nations HighCommissioner for Refugees in conjunction with Article 35 ofthe 1951 Convention relating to the Status of Refugees and ArticleII of its 1967 Protocol. These Guidelines complement the UNHCRHandbook on Procedures and Criteria for Determining RefugeeStatus under the 1951 Convention and the 1967 Protocol relatingto the Status of Refugees (1979, re-edited, Geneva, January1992). They should additionally be read in conjunction withUNHCR's Guidelines on International Protection on gender-relatedpersecution within the context of Article 1A(2) of the 1951Convention and/or 1967 Protocol relating to the Status of Refugees(HCR/GIP/02/01) and on "membership of a particular social group"within the context of Article 1A(2) of the 1951 Convention and/orits 1967 Protocol relating to the Status of Refugees (HCR/GIP/02/02),both of 7 May 2002. These Guidelines are intended to provide interpretative legalguidance for governments, legal practitioners, decision-makersand the judiciary, as well as for UNHCR staff carrying out refugeestatus determination in the field.