Ethics of DNA research on human remains: five globally applicable guidelines.

We are a group of archaeologists, anthropologists, curators and geneticists representing diverse global communities and 31 countries. All of us met in a virtual workshop dedicated to ethics in ancient DNA research held in November 2020. There was widespread agreement that globally applicable ethical guidelines are needed, but that recent recommendations grounded in discussion about research on human remains from North America are not always generalizable worldwide. Here we propose the following globally applicable guidelines, taking into consideration diverse contexts. These hold that: (1) researchers must ensure that all regulations were followed in the places where they work and from which the human remains derived; (2) researchers must prepare a detailed plan prior to beginning any study; (3) researchers must minimize damage to human remains; (4) researchers must ensure that data are made available following publication to allow critical re-examination of scientific findings; and (5) researchers must engage with other stakeholders from the beginning of a study and ensure respect and sensitivity to stakeholder perspectives. We commit to adhering to these guidelines and expect they will promote a high ethical standard in DNA research on human remains going forward.

Classical and Molecular Genetic Research on General Cognitive Ability.

Arguably, no psychological variable has received more attention from behavioral geneticists than what has been called "general cognitive ability" (as well as "general intelligence" or "g"), and for good reason. GCA has a rich correlational network, implying that it may play an important role in multiple domains of functioning. GCA is highly correlated with various indicators of educational attainment, yet its predictive utility is not limited to academic achievement. It is also correlated with work performance, navigating the complexities of everyday life, the absence of various social pathologies (such as criminal convictions), and even health and mortality. Although the causal basis for these associations is not always known, it is nonetheless the case that research on GCA has the potential to provide insights into the origins of a wide range of important social outcomes. In this essay, our discussion of why GCA is considered a fundamentally important dimension of behavior on which humans differ is followed by a look at behavioral genetics research on CGA. We summarize behavioral genetics research that has sought to identify and quantify the total contributions of genetic and environmental factors to individual differences in GCA as well as molecular genetic research that has sought to identify genetic variants that underlie inherited effects.

Synthetic biology: Novel approaches for microbiology

In the past twenty years, molecular genetics has created powerful tools for genetic manipulation of living organisms. Whole genome sequencing has provided necessary information to assess knowledge on gene function and protein networks. In addition, new tools permit to modify organisms to perform desired tasks. Gene function analysis is speed up by novel approaches that couple both high throughput data generation and mining. Synthetic biology is an emerging field that uses tools for generating novel gene networks, whole genome synthesis and engineering. New applications in biotechnological, pharmaceutical and biomedical research are envisioned for synthetic biology. In recent years these new strategies have opened up the possibilities to study gene and genome editing, creation of novel tools for functional studies in virus, parasites and pathogenic bacteria. There is also the possibility to re-design organisms to generate vaccine subunits or produce new pharmaceuticals to combat multi-drug resistant pathogens. In this review we provide our opinion on the applicability of synthetic biology strategies for functional studies of pathogenic organisms and some applications such as genome editing and gene network studies to further comprehend virulence factors and determinants in pathogenic organisms. We also discuss what we consider important ethical issues for this field of molecular biology, especially for potential misuse of the new technologies (AU)

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Biocontainment in gain-of-function infectious disease research.

The discussion of H5N1 influenza virus gain-of-function research has focused chiefly on its risk-to-benefit ratio. Another key component of risk is the level of containment employed. Work is more expensive and less efficient when pursued at biosafety level 4 (BSL-4) than at BSL-3 or at BSL-3 as modified for work with agricultural pathogens (BSL-3-Ag). However, here too a risk-to-benefit ratio analysis is applicable. BSL-4 procedures mandate daily inspection of facilities and equipment, monitoring of personnel for signs and symptoms of disease, and logs of dates and times that personnel, equipment, supplies, and samples enter and exit containment. These measures are not required at BSL-3 or BSL-3-Ag. Given the implications of inadvertent or deliberate release of high-threat pathogens with pandemic potential, it is imperative that the World Health Organization establish strict criteria for biocontainment that can be fairly applied in the developing world, as well as in more economically developed countries.

The lessons of Asilomar and the H5N1 "affair".

In mid-1974, soon after the first recombinant DNA molecules were replicated in Escherichia coli, scientists called for, and observed, a voluntary moratorium on certain experiments. One goal of the moratorium was to hold a conference (Asilomar) to evaluate the risks, if any, of this new technology. The Asilomar conference concluded that recombinant DNA research should proceed but under strict guidelines. The furor surrounding the recent genetic manipulation of the transmissibility of avian influenza virus H5N1 led to a short-term moratorium that has been extended indefinitely. The question is how long should the moratorium remain in place, or should it be permanent? Voltaire observed, "History never repeats itself; man always does." I believe the parallels of Asilomar can be applied to the problem facing biomedical science today. We should move forward to establish standardized guidelines, using common sense and scientific creativity. The onus of responsibility falls on the individual scientist and involves the education of a new generation of scientists into the social and ethical implications of genetic engineering in a new age of genomics and synthetic biology. In addition, scientists who work with infectious agents must deal not only with biosafety but also, alas, with bioterrorism. The H5N1 "affair" is not a question of freedom of inquiry or the dissemination of scientific research; it is a question of the social responsibility of science and scientists to ensure that the public understands why this work is beneficial and worthwhile.

The pause on Avian H5N1 influenza virus transmission research should be ended.

A voluntary 60-day pause on avian H5N1 influenza virus transmission research was announced in January 2012 by the international community of influenza scientists engaged in this work to provide time to explain the benefits of such work and the risk mitigation measures in place. Subsequently, the pause was extended to allow for time for review of the biosafety and biosecurity conditions. After almost 8 months, these conditions have been met in some countries and are close to being met in others. Because H5N1 virus transmission studies are essential for pandemic preparedness, researchers who have approval from their governments and institutions to conduct this research safely under appropriate biosecurity conditions should resume this important work.

Research on highly pathogenic H5N1 influenza virus: the way forward.

The voluntary moratorium on gain-of-function research related to the transmissibility of highly pathogenic H5N1 influenza virus should continue, pending the resolution of critical policy questions concerning the rationale for performing such experiments and how best to report their results. The potential benefits and risks of these experiments must be discussed and understood by multiple stakeholders, including the general public, and all decisions regarding such research must be made in a transparent manner.

Rethinking biosafety in research on potential pandemic pathogens.

If accidentally released, mammalian-transmissible influenza A/H5N1 viruses could pose a greater threat to public health than possibly any other infectious agent currently under study in laboratories, because of such viruses' likely combination of transmissibility and virulence to humans. We advocate explicit risk-benefit assessments before work on such pathogens is permitted or funded, improvement of biosafety practices and enforcement, and harmonization of criteria for permitting such experiments across government agencies, as well as internationally. Such potential pandemic pathogens, as they have been called, jeopardize not only laboratory workers and their contacts, but also the wider population, who should be involved in assessments of when such risks are acceptable in the service of scientific knowledge that may itself bear major public health benefits.

Is there anything unique in the ethics of synthetic biology?

Synthetic biology does not create any ethical dilemmas that have not already been raised in the development of practices such as genetic screening, genetic engineering, and other interventions in the evolutionary processes. The issue is, nevertheless, ethically serious. Two different angles are examined: the philosophical legitimacy of human intervention in the shaping of human nature, and the more pragmatic (though by no means less important) question of the risks involved in such a novel line of research. As for the first, the claim made here is that in principle there is no constraint in human intervention in the world, since ultimately the source of any value lies in human interests, welfare, and values. This is an approach that is opposite to Habermas's. As for the practical problem of risk, research in synthetic biology calls for particular caution, since in at least the first stages of a new research or program, there is no social regulation, and society is wholly dependent on the scientist's ethical integrity.

Ethical and regulatory challenges posed by synthetic biology.

Synthetic biology is a relatively new science with tremendous potential to change how we view and know the life sciences, but like many developing technologies, it has provoked ethical concerns from the scientific community and the public and confronts demands for new regulatory measures. The concerns raised involve the danger of "dual use," in which results for improving human well-being and the environment may be misappropriated for bioterror. To counteract these dangers, many governments, but the United States and Israel in particular, have introduced new laws and redoubled measures for biosafety and biosecurity. In the United States, the recent H5N1 results achieved by two groups of NIH-funded investigators highlighted the dilemma of balancing the risk of dual-use research and the freedom of science. In Israel, concern for unconventional terrorism is long-standing, and the country is constantly engaged in improving biosecurity and biodefense measures. In 2008, the Israeli parliament passed the Regulation of Research into Biological Disease Agents Law, a legislative framework for safeguarding research into biological disease agents. This article summarizes and analyzes the current state of affairs in the United States and Israel, ethical attitudes, and regulatory responses to synthetic biology.

Researcher responsibilities and genetic counseling for pure-bred dog populations.

Breeders of dogs have ethical responsibilities regarding the testing and management of genetic disease. Molecular genetics researchers have their own responsibilities, highlighted in this article. Laboratories offering commercial genetic testing should have proper sample identification and quality control, official test result certificates, clear explanations of test results and reasonably priced testing fees. Providing test results to a publicly-accessible genetic health registry allows breeders and the public to search for health-tested parents to reduce the risk of producing or purchasing affected offspring. Counseling on the testing and elimination of defective genes must consider the effects of genetic selection on the population. Recommendations to breed quality carriers to normal-testing dogs and replacing them with quality normal-testing offspring will help to preserve breeding lines and breed genetic diversity.

Molecular medicine and concepts of disease: the ethical value of a conceptual analysis of emerging biomedical technologies.

Although it is now generally acknowledged that new biomedical technologies often produce new definitions and sometimes even new concepts of disease, this observation is rarely used in research that anticipates potential ethical issues in emerging technologies. This article argues that it is useful to start with an analysis of implied concepts of disease when anticipating ethical issues of biomedical technologies. It shows, moreover, that it is possible to do so at an early stage, i.e. when a technology is only just emerging. The specific case analysed here is that of 'molecular medicine'. This group of emerging technologies combines a 'cascade model' of disease processes with a 'personal pattern' model of bodily functioning. Whereas the ethical implications of the first are partly familiar from earlier--albeit controversial--forms of preventive and predictive medicine, those of the second are quite novel and potentially far-reaching.