Interrelationships among Native Peoples, Genetic Research, and the Landscape: Need for Further Research into Ethical, Legal, and Social Issues

To understand the impacts of development on native peoples requires an understanding of how their genetic make-up is implicated in their relationship with their landscapes. This is an area ripe for more research. The ASLME project on DNA Fingerprinting and Civil Liberties proposed improvements to the ethical and legal safeguards for the collection and storage of DNA-derived genetic information. Native peoples have proposed a similar examination of the ethical and legal issues related to the collection and storage of their genetic information obtained via family histories and genealogies.     

Genomic research and incidental findings.

The Human Genome Project showed that there is significant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental findings create legal, ethical, and financial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental findings need to be established in the study design and reviewed and approved by the Institutional Review Board.     

The advent of DNA databanks: implications for information privacy

Genetic identification tests -- better known as DNA profiling -- currently allow criminal investigators to connect suspects to physical samples retrieved from a victim or the scene of a crime. A controversial yet acclaimed expansion of DNA analysis is the creation of a massive databank of genetic codes. This Note explores the privacy concerns arising out of the collection and retention of extremely personal information in a central database. The potential for unauthorized access by those not investigating a particular crime compels the implementation of national standards and stringent security measures.     

The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

Population genetic studies: is there an emerging legal obligation to share benefits?

It appears that large-scale population genetic studies are the necessary next step in genomics research. Such studies promise to provide correlative data to permit researchers to understand the etiology of a vast array of complex human diseases. Simultaneously, such studies are increasingly seen as yet another mechanism for the developed world to benefit at the expense of the developing world. In fact, a recent World Health Organization Report suggests that "without explicit attention at the international level, the initial technological fruits of genomics are likely to consist primarily of therapeutic and diagnostic applications for conditions affecting large populations in rich countries." (World Health Organization, Genomics and World Health, 2002). In developed and developing countries alike, there are concerns that the pharmaceutical industry stands to gain at the expense of the population(s) from which population genetic data are derived. In light of the current interest concerning ongoing population genetic studies and an increasing interest by many countries, Canada included, in embarking on large-scale population genetic research, it is appropriate to consider the concept of benefit-sharing as a potential mechanism to assuage these concerns. It is the author's position that by virtue of common law equitable principles and developing norms in international law, including the Human Genome Organization Statement on Benefit-Sharing, that there are principled legal and ethical reasons to compel the sharing of benefits that accrue from the commercialization of the resulting data. Using the United Nations Convention on Biological Diversity and the Bonn Guidelines as a model, I suggest that appropriate benefit-sharing mechanisms have been considered in the context of non-human biological materials and that these same mechanisms may be applicable in the context of international and intra-national population genetic studies.     

Ethics and AIDS: a summary of the law and a critical analysis of the individual physician's ethical duty to treat

Persons afflicted with acquired immune deficiency syndrome (AIDS) or its preceding medical conditions face a potential problem with assured access to basic threshold medical care. Subject to certain limitations, there is no guarantee that a physician will fulfill the health care needs of any population of patients. Individuals with AIDS, thus, have a considerable interest in the development of a duty on behalf of physicians to provide treatment. This Note first highlights the limits of the legal duty to treat. It then examines the theoretical impetus propelling an ethical duty to treat. The Note concludes that the grounds for imposing an ethical duty on physicians are too weak to support that result, but the creation of an AIDS-specific legal duty is a viable alternative.     

Criminal DNA databases: the European situation

In the last 5 years, a number of European countries have successfully introduced national databases holding the DNA profiles from suspected and convicted criminal offenders as well as from biological stain materials from unsolved crime cases. At present, DNA databases are fully or partially in operation in the UK, The Netherlands, Austria, Germany, Finland, Norway, Denmark, Switzerland and Sweden. Furthermore, in the other European countries, specific legislation will be enacted soon, or the introduction of such databases is being discussed to initiate a legislative process. Numerous differences exist regarding the criteria for a criminal offender to be included in the database, the storage periods and the possibility to remove database records, the possibility to keep reference samples from the offenders as long as their respective records are being held, and the role of judges in the process of entering a database record or to perform a database search. Nevertheless, harmonization has been achieved regarding the DNA information stored in national databases, and a European standard set of genetic systems has been recommended which is included either in part or completely in the DNA profiles of offenders and crime stains for all European databases. This facilitates the exchange of information from database records to allow the investigation of crime cases across national borders.     

"Biological identikit": Development of a SNPs-panel for the analysis of forensic DNA phenotyping and ancestry

Personal identification in mass disasters and in crimes is essential for humanitarian, ethical and legal reasons. In these contexts, when individuals cannot be identified by standard forensic DNA analysis, the Forensic DNA Phenotyping and the analysis of the biogeographical ancestry could help. The aim of this study was to evaluate the potential of a new panel of 891 SNPs in predicting phenotypic traits and biogeographical origin to create a “biological identikit”. In addition to fresh biological material, old evidence found at the crime scene or extracted and long-term stored DNA were tested with 41 SNPs for phenotyping and 850 SNPs for ancestry. All the SNPs were successfully incorporated into a single two-step multiplex PCR reaction using the IonAmpliSeq ™ Library Plus and applied for massive parallel sequencing with the Ion S5 platform using up to 0.05 ng/µL of DNA. The analysis of the results was carried out with an in-house predictive algorithm and consulting 20 population databases. By comparing the results obtained with identikit or video-photographic surveys, it was possible to predict phenotype and ancestry with an accuracy greater than 90%. While these new markers cannot identify a specific individual, they can be a valuable investigative tool.     

Forensic databases,a perspective from the penitentiary centers of Spain

Scientific and technological progress in the field of forensic genetics is very useful in the resolution of criminal cases, but it entails the need for a deep ethical reflection, as the individual Fundamental Rights may be violated.This project aims to collect and compare the opinion of prisoners and prison officials on what characteristics the country's forensic database should have. In this context, 210 subjects were surveyed, 101 of them prisoners and the rest prison officials, from three different Spanish penitentiary centers.Among the results obtained, most prisoners and officials consider the national DNA database to be useful, and additionally, a 40% of the participants would support the integration of the profiles of the entire population. 64% considered it ethical to use the DNA profiles of the database as a tool for familial searching. Despite this, half of the respondents are concerned about the future uses of the DNA database.Integrating the opinion of these analyzed groups with other relevant judicial, scientific and ethical convictions, ensures the regulation between security and individual’s Human Rights.     

国际通信法:界域、主体及架构

国际通信法是现代国际法专业化发展的产物,其界域包括两类通信领域的国际事务:一是国际通信活动的规制,二是通信制度的国际协调;其主体具有鲜明的多元化特征,被国际通信法赋予国际人格并参加国际通信法律关系的实体,不仅有国家和政府间国际组织,还有法人和个人。国际通信法是一个庞大的法律体系,其规范具有普遍性、区域性和双边性三个不同层次,分属国际电信联盟、万国邮政联盟、世界贸易组织等众多国际体制,归于国际通信通道法、国际通信服务法和国际通信行为法三个不同板块,由此形成了国际通信法的立体网络架构。我国通信事业的发展非常迅速,但有关通信的立法相对滞后。因此,有必要熟悉通信领域的国际规则,加强国际通信法的研究。     

International Legal Rulings on Lustration Policies in Central and Eastern Europe: Rule of Law in Historical Context

The transitional justice literature highlights various trade-offs involved in the choice and implementation of lustration as a transitional justice measure in Central and Eastern Europe. This article examines how international legal body rulings on lustration laws have interpreted rule-of-law versus justice concerns. The European Court of Human Rights and the International Labour Organization have explored possible information problems, due process violations, employment discrimination issues, and bureaucratic loyalty concerns within the context of lustration. Three findings emerge from their legal rulings. First, contrary to popular notions, international legal bodies are not antilustration. The institutions are engaging with questions regarding the fair implementation, not the legality, of lustration laws. Second, the prioritizing of justice concerns during the transition efforts is highlighted as a way to lay a strong democratic foundation. Third, the organizations have emphasized the importance of placing rule of law in historical context, thereby situating post-Communist societies within other posttotalitarian regime-building narratives.     

Governing Genetic Databases: Challenges Facing Research Regulation and Practice

This paper reports on the initial findings of an interdisciplinary research project on the governance of human genetic databases in England and Wales. The number of biosample and information collections has expanded, yet considerable legal uncertainty surrounds their definition, collection, storage, management, and use which could inhibit research and clinical practice, while failing to protect the rights and interests of all stakeholders. We report some initial findings from the legal research and identify major challenges associated with defining 'genetic databases'. We identify a wide range of relevant instruments and regulatory actors, and suggest that none adequately addresses the challenges posed by contemporary research techniques or the'corporeal'and'informational'materials used in the genetic databases context. This preliminary analysis seriously questions the efficacy of the current regulatory framework and concludes that developing an appropriate governance framework for the creation, maintenance, and use of genetic databases requires the bringing together of legal analysis with good quality empirical evidence.     

The ethical, legal and social implications of umbilical cord blood banking: learning important lessons from the protection of human genetic information

Internationally networked umbilical cord blood banks hold great promise for better clinical outcomes, but also raise a host of potential ethical and legal concerns. There is now significant accumulated experience in Australia and overseas with regard to the establishment of human genetic research databases and tissue collections, popularly known as "biobanks". For example, clear lessons emerge from the controversies that surrounded, stalled or derailed the establishment of some early biobanks, such as Iceland's deCODE, Autogen's Tonga database, a proposed biobank in Newfoundland, Canada, and the proposed Taiwan biobank. More recent efforts in the United Kingdom, Japan, Quebec and Tasmania have been relatively more successful in generating public support, recognising the critical need for openness and transparency, and ample public education and debate, in order to build community acceptance and legitimacy. Strong attention must be paid to ensuring that other concerns--about privacy, discrimination, informed consent, governance, security, commercial fairness and financial probity--are addressed in structural terms and monitored thereafter, in order to maintain public confidence and avoid a backlash that inevitably would imperil such research. Once lost, credibility is very difficult to restore.     

A Communitarian Approach: A Viewpoint on the Study of the Legal, Ethical and Policy Considerations Raised by DNA Tests and Databases

A communitarian approach is applied to DNA testing and databases. It concerns itself both with individual rights and the common good. It finds that DNA testing, although it is highly intrusive, often advances both individual rights (for instance, helps exonerate suspects) and the common good (for example, acts as a deterrent). However given its high level of intrusiveness and the insufficient level of oversight provided by existing checks and balances, the author argues for a national civil review board to provide still more accountability.     

WHEN PARENTS CAN CHOOSE TO HAVE THE “PERFECT” CHILD: WHY FERTILITY CLINICS SHOULD BE REQUIRED TO REPORT PREIMPLANTATION GENETIC DIAGNOSIS DATA

Preimplantation Genetic Diagnosis (PGD) is a procedure used to screen embryos for certain genetic conditions before implantation via in vitro fertilization (IVF) so the desired embryos can be chosen for implantation. The procedure was originally used to prevent the birth of children with deadly genetic disorders, but it is now used for more controversial reasons, such as to select for sex. Limited information is available regarding how PGD is used in the United States and there are many ethical concerns surrounding the practice of PGD, most notably that it could lead to the creation of designer babies and eugenic practices. This Note proposes amending a federal act to require fertility clinics to report PGD data through an existing web‐based system. This data can then be used by policymakers to federally regulate PGD practices.     

The EDNAP mitochondrial DNA population database (EMPOP) collaborative exercises: organisation, results and perspectives

This paper presents an overview of the organisation and the results of the collaborative exercises (CE) of the European DNA Profiling (EDNAP) Group's mitochondrial DNA population database project (EMPOP). The aim of the collaborative exercises was to determine whether uniformity of mtDNA sequencing results could be achieved among different laboratories. These were asked to sequence either the complete mtDNA control region or the two hypervariable regions HVI (16024-16365) and HVII (73-340) from DNA extracts, buccal swabs or bloodstains, proceeding in accordance with the protocol and strategies used in each individual laboratory. The results of the collaborative exercises were employed to identify possible sources of errors that could arise during the analysis and interpretation of mtDNA profiles. These findings were taken as a basis to tentatively make suitable arrangements for the construction of a high quality mtDNA database. One hundred fifty mtDNA profiles were submitted to the evaluating laboratory, and disaccording profiles were classified into four groups corresponding to the source of error: clerical errors, sample mix-ups, contaminations and discrepancies with respect to the mtDNA nomenclature. Overall, 14 disaccording haplotypes (16 individual errors) were observed. The errors included 10 clerical errors, 3 interpretation problems, 2 cases of sample mix-up and 1 case of point heteroplasmic mixture, where the 2 sequencing reactions brought inconsistent base calls. This corresponds to an error rate of 10.7% in a virtual mtDNA database consisting of the collaborative exercise results. However, this estimate is still conservative compared to conclusions drawn by authors of meanwhile numerous publications critically reviewing published mtDNA population databases. Our results and earlier published concerns strongly emphasize the need for appropriate safety regulations when mtDNA profiles are compiled for database purposes in order to accomplish the high standard required for mtDNA databases that are used in the forensic context.     

Evaluation of skin-related variants in African ancestry populations and their role in personal identification

Pigment-related genetic variants point out their role in personal identification as they can be considered predictors suitable for Forensic DNA Phenotyping (FDP) and mounting evidence suggest also their bio-geographic inferential power for gaining information about the individual geographical origin. As they could be regarded as AIMs (Ancestry Informative Markers) they are powerful tools for inferring genetic composition of admixed population. Despite the huge range of skin tones across our species, little is known about genetic basis in global population and particularly our knowledge is less precise for those showing a complex historical and genomic background. The current research aims to explore the allelic status in several SNPs mapped in selected genes known to be involved in skin pigmentation: OCA2, HERC2, SLC45A2, SLC24A5 and two intergenic regions between BEND7/PRPF18 and EIF2S2/ASIP. The genetic evaluation has been performed on selected African and African derived populations: Fon, Dendi, Bariba and Berba communities from Benin, and Afroecuadorians. Data integration has been made up merging genotypic results with available information from major biological data warehouse as Phase 3–1000 Genomes Project or International HapMap Project in order to obtain a selected populations panel useful for their use as inferential model training set to test the likelihood of correct assignment to geographically differentiated human groups. The proposed variants panel seems to properly interpret the geographic variation and some new interesting evidence could be pointed out in African mixed populations, that seem to be differentially distributed if the total panel is considered. Understanding human pigmentation architecture can provide fundamental insight into genetic interaction of complex traits and the relationship between environmental adaptation and population history. In addition, the results support the use of phenotypic inference along with bio-geographical ancestry information as valid auxiliary tools in personal identification.     

Family Ties: The Use of DNA Offender Databases to Catch Offenders'' Kin

The authors examine the scientific possibility and the legal and ethical implications of using DNA forensic technology, through partial matches to DNA from crime scenes, to turn into suspects the relatives of people whose DNA profiles are in forensic databases.     

Attitudes towards police use of consumer/private DNA databases in investigations

Consumer DNA products, such as databases that allow the public to explore familial relationships, have recently been used by police to assist in investigations. This has moved the collection of DNA used in criminal investigations away from the limitations of criminal databases and has opened up ethical concerns regarding privacy and consent. This study explored public attitudes and support towards police use of consumer DNA databases in investigations to assess whether different crime types or moral and attitude alignments influenced the level of public support of police using these consumer products. An international survey of 438 adults, using theory and scales pertaining specifically to retributive punishment and attitudes towards law, courts and police, found that moral alignment and attitudes did influence the level of public acceptability towards police usage of these techniques and that support did vary based on crime type. This research found that higher levels of public support was given for the most serious case types explored (sexual assault and homicide). Participant support for police access to private DNA databases by case type was as follows; 83.5% for sexual assault, 83.2% for homicide, 85.2% for identifying unidentified human remains, 62.8% for robbery and 58.9% for illicit drug related cases. Small to medium effects sizes were observed for these results. Although these findings provided context towards public attitudes, further research specific to international attitude differences and variance between serious crime types and public acceptability could further develop these findings.     

The emergence of biobanks in the legal landscape: towards a new model of governance

Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizens?