Gene editing of human embryos is not contrary to human rights law: A reply to Drabiak.

In an article in this journal, Katherine Drabiak argues that green lighting genome editing of human embryos is contrary to "fundamental human rights law." According to the author, genome editing of human embryos violates what we should recognize as a fundamental human right to inherit a genome without deliberate manipulation. In this reply article, we assess Drabiak's legal analysis and show methodological and substantive flaws. Methodologically, her analysis omits the key international legal instruments that form the so-called International Bill of Rights and thus fails to provide a full and accurate account of the fundamental international human rights standards. Substantively, Drabiak invokes, as a basis for prohibiting gene editing of human embryos, a legal standard (the rights and integrity of the future child) that is unknown to international law. Contrary to Drabiak's account, genome editing of human embryos is not prohibited under international law. Indeed, the right to health and the right to benefit from scientific progress may be interpreted as the basis of a legal duty to provide equality of access to germline gene editing, once determined it is beneficial and safe to use.

The Legalisation of Gamete Donation in Italy.

Since 2004, the regulation of assisted reproduction in Italy has undergone substantial reform as an effect of key judicial intervention. Limitations on embryo production, screening and transfer, the prohibition against engaging in preimplantation genetic diagnosis (PGD) and embryo selection, and the ban on gamete donation have all been removed by courts. In this article, I discuss how judicial intervention has improved the ability of Italian couples to access assisted reproduction technologies (ARTs), and how the expansion of reproductive rights is, however, still incomplete. In particular, I discuss the challenges in implementing the liberalisation of gamete donation, and identify the practical, political and cultural reasons for limited access to gamete donation. I also discuss the future of the prohibitions and restrictions that still exist in Law 40/2004.

Anticipation in the biosciences and the human right to science.

Anticipation entails contemplating the beneficial and harmful impacts of scientific and technological progress. Anticipation has a long history in science, technology, and innovation policy partly due to future impacts of scientific progress being inescapable. The link between anticipation, an undertheorized concept, and human rights law is yet to be fully explored. This paper links anticipation to the rights to science, a lesser-studied human right codified in the International Covenant on Economic, Social, and Cultural Rights. The paper argues that the normative content of the right includes anticipation entitlements and duties. Combining the entitlements and duties with anticipation typologies leads to identifying three forms of anticipation that governments (and, in some cases, scientists) must carry out: beneficial, responsible, and participatory anticipation. The paper concludes by identifying three ways in which further conceptual work can enrich human-rights-based anticipation.

Is significant mandibular advancement possible after the peak of puberty? Dento-osseous palatal expansion and the STM4 technique (Skeletal Therapy Manni Telescopic Herbst 4 miniscrews): A case report.

INTRODUCTION: Treatment of skeletal class II growing patients often requires the use of functional appliances, aimed at promoting mandibular advancement. Among these, Herbst appliance is recommended for its effectiveness, efficiency, and reduced need for compliance. Despite its skeletal favourable effects, well-known dental compensations can occur, especially when the appliance is not used close to the pubertal peak: upper incisors retroclination, lower incisors proclination, upper molars distalization and lower molars mesialization could reduce the overjet needed for a proper mandibular advancement. To counteract these unfavourable effects skeletal anchorage could be crucial. AIM: The aim of this case report is to describe and evaluate the effects of using a skeletally anchored Herbst appliance in an 18-year-old (CVM5) male patient with skeletal Class II malocclusion and a convex profile. TREATMENT PROTOCOL: The treatment started with a tooth-bone-borne palatal expansion, then the upper arch was bonded with pre-adjusted ceramic brackets. After 2months, a Manni Telescopic Herbst (MTH) supported by 4 miniscrews (two in the maxilla and two in the mandible) was applied. To avoid anchorage loss, TADs were connected with elastic chains to the arches. Nine months later, the Herbst was removed, the lower teeth were bonded and the patient wore class 2 elastics to stabilise the occlusion. RESULTS AND CONCLUSIONS: After 24months the treatment goal was achieved with a considerable improvement of the profile and a clinically significant mandibular advancement (Pogonion moved forward 7mm). A one-year follow-up lateral X-rays showed a good stability of the result.

Evaluation of the Co-Go-Me angle as a predictor in Class II patients treated with Herbst appliance and skeletal anchorage: a retrospective cohort study.

Introduction: A condylion-gonion-menton (Co-Go-Me) angle threshold of 125.5° has been introduced as a predictive parameter of cephalometric mandibular response in the orthopedic treatment of growing Class II patients with functional appliances, despite some contradictions in the literature. Considering the lack of studies evaluating the role of skeletal anchorage, this study aims to reassess the threshold of 125.5° in the Co-Go-Me angle as a useful predictor in growing skeletal Class II patients treated with acrylic splint Herbst appliance and two mini-screws in the lower arch (STM2). Methods: Thirty-five consecutively treated patients (20 males, 15 females; mean age, 11.37 years) with mandibular retrusion were classified into two groups according to their Co-Go-Me baseline values (Group 1, <125.5°; Group 2, >125.5°). The STM2 protocol involved the use of the MTH Herbst appliance with an acrylic splint in the lower arch and two interradicular mini-screws as anchorage reinforcement. Cephalometric analysis was performed by the same operator for each patient at baseline (T0) and at the end of the Herbst phase (T1). The effects of time and group on the variables were assessed by a repeated-measures analysis of variance. The primary research outcome was the difference between the groups in terms of mandibular responsiveness to treatment referred to as the relative difference (T1-T0) in Co_Gn. Results: The mean duration of the treatment was 9.5 months. No statistically significant differences between groups were detected at baseline, except from the expected SN/GoMe° (p < 0.001) and Co-Go mm (p = 0.028). No statistically significant changes between groups, which were caused by the treatment, were found considering the mandibular sagittal and vertical skeletal parameters. Similarly, no statistically significant differences were found in the dental changes between the high-angle and low-angle patients, apart from the upper molar sagittal position (p = 0.013). Discussion and conclusions: The 125.5° threshold in the Co-Go-Me value was not a reliable predictive parameter for the mandibular response in growing patients treated with the MTH Herbst appliance and lower skeletal anchorage. Due to its effective control in the sagittal and vertical planes, the STM2 technique might be an appropriate protocol to use in treating skeletal Class II patients, regardless of the growth pattern.

Ethical norms and the international governance of genetic databases and biobanks: findings from an international study.

This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers' use of samples obtained from biobanks; (3) what constitutes "collective consent" to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices.

Regulating assisted reproduction in Italy: a 5-year assessment.

In 2004, the Italian parliament comprehensively regulated medically assisted reproduction. Law 40/2004 has outlawed several techniques and tightly compressed the freedom of research in the area of human reproduction and regenerative medicine. This article analyses the post-2004 political, bioethical and legal debate on assisted reproduction in Italy. The analysis is grounded on empirical evidence on fertilisation outcomes released in 2007 and 2008 by the Italian government, on recent amendments related to the regulation of preimplantation genetic diagnosis and on the debates on the status of spare embryos as for their availability for scientific researches. The analysis shows that Law 40/2004 has failed to improve the access of infertile couples to assisted reproduction techniques and keeps supporting practices that the other jurisdictions have rejected because they are unwise from a clinical standpoint. Moreover, Law 40/2004 created severe limitations to scientific researches in the fields of medical embryology, gynaecology and regenerative medicine. With the political support of some Italian political parties and the Catholic Church, Law 40/2004 disregards the expectations of the majority of Italian citizens, international guidelines of good clinical practice, international codes of medical ethics, the interests of infertile couples and the social and economic relevance of biomedical research.

The Human Right to Science and the Regulation of Human Germline Engineering.

There is currently no international consensus on how human germline engineering should be regulated. Existing national legislation fails to provide the governance framework necessary to regulate germline engineering in the CRISPR era. This is an obstacle to scientific and clinical advancements and inconsistent with human rights requirements. To move forward, we suggest that the human right to science is an ideal starting point for building consensus, at the national and international levels, on governing principles that promote responsible scientific and technological advancements. Regulatory frameworks must recognize the international nature of modern germline genome engineering research, the need for shared governance rather than tech-locked prohibitions, and the fact that humans are not their germline.

Limitations on human rights: are they justifiable to reduce the burden of TB in the era of MDR- and XDR-TB?

Tuberculosis, in all its forms, poses a serious, demonstrable threat to the health of countless individuals as well as to health as a public good. MDR-TB and, in particular, the emergence of XDR-TB, have re-opened the debate on the importance, and nature, of treatment supervision for basic TB control and the management of drug-resistant TB. Enforcing compulsory measures regarding TB patients raises questions of respect for human rights. Yet, international law provides for rights-limiting principles, which would justify enforcing compulsory measures against TB patients who refuse to have diagnostic procedures or who refuse to be monitored and treated once disease is confirmed. This article analyzes under what circumstances compulsory measures for TB patients may be enforced under international law. Compulsory measures for TB patients may, in fact, be justified on legal grounds provided that these measures are foreseen in the law, that they are used as a last resort, and that safeguards are in place to protect affected individuals. The deadly nature of the disease, its epidemiology, the high case fatality rate, and the speed at which the disease leads to death when associated with HIV are proven.

Increasing both the public health potential of basic research and the scientist satisfaction. An international survey of bio-scientists.

Basic scientific research generates knowledge that has intrinsic value which is independent of future applications. Basic research may also lead to practical benefits, such as a new drug or diagnostic method. Building on our previous study of basic biomedical and biological researchers at Harvard, we present findings from a new survey of similar scientists from three countries. The goal of this study was to design policies to enhance both the public health potential and the work satisfaction and test scientists' attitudes towards these factors. The present survey asked about the scientists' motivations, goals and perspectives along with their attitudes concerning  policies designed to increase both the practical (i.e. public health) benefits of basic research as well as their own personal satisfaction. Close to 900 basic investigators responded to the survey; results corroborate the main findings from the previous survey of Harvard scientists. In addition, we find that most bioscientists disfavor present policies that require a discussion of the public health potential of their proposals in grants but generally favor softer policies aimed at increasing the quality of work and the potential practical benefits of basic research. In particular, bioscientists are generally supportive of those policies entailing the organization of more meetings between scientists and the general public, the organization of more academic discussion about the role of scientists in the society, and the implementation of a "basic bibliography" for each new approved drug.

Publications in PubMed on Ebola and the 2014 outbreak.

In this research note we examine the biomedical publication output about Ebola in 2014. We show that the volume of publications has dramatically increased in the past year. In 2014 there have been over 888 publications with 'ebola' or 'ebolavirus' in the title, approximately 13 times the volume of publication of 2013. The rise reflects an impressive growth starting in the month of August, concomitant with or following the surge in infections, deaths and coverage in news and social media. Though non-research articles have been the major contributors to this growth, there has been a substantial increase in original research articles too, including many papers of basic science. The United States has been the country with the highest number of research articles, followed by Canada and the United Kingdom. We present a comprehensive set of charts and facts that, by describing the volumes and nature of publications in 2014, show how the scientific community has responded to the Ebola outbreak and how it might respond to future similar global threats and media events. This information will assist scholars and policymakers in their efforts to improve scientific research policies with the goal of maximizing both public health and knowledge advancement.

Countries' Biomedical Publications and Attraction Scores. A PubMed-based assessment.

Studying publication volumes at the country level is key to understanding and improving a country's research system. PubMed is a public search engine of publications in all life sciences areas. Here, we show how this search engine can be used to assess the outputs of life science-related research by country. We have measured the numbers of publications during different time periods based on the country of affiliation of the first authors. Moreover, we have designed scores, which we have named Attraction Scores, to appraise the relative focus either toward particular types of studies, such as clinical trials or reviews, or toward specific research areas, such as public health and pharmacogenomics, or toward specific topics, for instance embryonic stem cells; we have also investigated a possible use of these Attraction Scores in connection with regulatory policies. We have weighed the statistics against general indicators such as country populations and gross domestic products (GDP). During the 5-year period 2008-2012, the United States was the country with the highest number of publications and Denmark the one with the highest number of publications per capita. Among the 40 countries with the highest GDPs, Israel had the highest publications-to-GDP ratio. Among the 20 countries with the most publications, Japan had the highest Attraction Score for induced pluripotent stem (iPS) cells and Italy the highest proportion of review publications. More than 50% of publications in English were from countries in which English is not the primary language. We show an assorted and extensive collection of rankings and charts that will inform scholars and policymakers in studying and improving the research systems both at the national and international level.

Policies to increase the social value of science and the scientist satisfaction. An exploratory survey among Harvard bioscientists.

Basic research in the biomedical field generates both knowledge that has a value per se regardless of its possible practical outcome and knowledge that has the potential to produce more practical benefits. Policies can increase the benefit potential to society of basic biomedical research by offering various kinds of incentives to basic researchers. In this paper we argue that soft incentives or "nudges" are particularly promising. However, to be well designed, these incentives must take into account the motivations, goals and views of the basic scientists. In the paper we present the results of an investigation that involved more than 300 scientists at Harvard Medical School and affiliated institutes. The results of this study suggest that some soft incentives could be valuable tools to increase the transformative value of fundamental investigations without affecting the spirit of the basic research and scientists' work satisfaction. After discussing the findings, we discuss a few examples of nudges for basic researchers in the biomedical fields.

Italy enacts new law on medically assisted reproduction.

In 2004, the Italian Parliament enacted a law regulating medically assisted reproduction. Although the law recognizes as legal certain assisted reproduction techniques, several other procedures are implicitly or expressly banned: oocyte and sperm donation, using embryos for the scientific research purposes and reproductive cloning. In this article, I outline the new legal framework, pointing out some of the shortcomings of its provisions, such as the failure to define what an 'embryo' is, the contradictions between this law and the law on abortion, the opportunity for Italian couples to circumvent some of the prohibitions by resorting to 'reproductive tourism', and the central role that physicians play in the new legal framework.