Genetic Privacy Research Articles

Personalized Medicine in the U.S. and Germany: Awareness, Acceptance, Use and Preconditions for the Wide Implementation into the Medical Standard.

The aim of our research was to collect comprehensive data about the public and physician awareness, acceptance and use of Personalized Medicine (PM), as well as their opinions on PM reimbursement and genetic privacy protection in the U.S. and Germany. In order to give a better overview, we compared our survey results with the results from other studies and discussed Personalized Medicine preconditions for its wide implementation into the medical standard. For the data collection, using the same methodology, we performed several surveys in Pennsylvania (U.S.) and Bavaria (Germany). Physicians were contacted via letter, while public representatives in person. Survey results, analyzed by means of descriptive and non-parametric statistic methods, have shown that awareness, acceptance, use and opinions on PM aspects in Pennsylvania and Bavaria were not significantly different. In both states there were strong concerns about genetic privacy protection and no support of one genetic database. The costs for Personalized Medicine were expected to be covered by health insurances and governmental funds. Summarizing, we came to the conclusion that for PM wide implementation there will be need to adjust the healthcare reimbursement system, as well as adopt new laws which protect against genetic misuse and simultaneously enable voluntary data provision.

Judges’ views on evidence of genetic contributions to mental disorders in court

This preliminary analysis assesses how judges view the use of behavioral genetics evidence on genetic influences to mental disorders in court. Twenty-one semi-structured interviews, analyzed using constant comparative analysis, were conducted with California trial court judges. Most judges reported the beneficial effects of this evidence being presented in court, particularly as a mitigating factor for sentencing. Yet some judges viewed it as an aggravating factor and expressed concerns about genetic privacy. Judges described initial reactions to being potentially presented with evidence on genetic influences to mental disorders as apprehension, curiosity, and sympathy. Judges also reported putting significant trust in experts on these issues. Findings suggest some judges are skeptical of this evidence, but largely open to its presentation. Sympathetic reactions may result in mitigating attitudes of some judges. As judges significantly trust experts, some judges could also be overly trusting of genetic evidence and expert opinion on these issues.

The presence and future of the use of DNA-Information and the protection of genetic informational privacy: A comparative perspective

DNA-Information is used to solve a criminal case or to establish a match between the suspect of a particular criminal case and other unsolved crimes. However, DNA-Information on its own is not entirely reliable evidence as this scientific technology produces errors with a certain probability. The use of DNA-Information in criminal proceedings is in conflict with the protection of individual's genetic informational privacy. Although England and Wales, Germany and South Korea have different legal provisions on the use of DNA-Information, in all these legal orders there are similar problems. Therefore, there is a need for appropriate legislative criteria which balance the protection of individual's genetic informational privacy relating to DNA and the effectiveness of the criminal justice system in a society which employs all the available modern forensic technologies.

Increasing relevance of non-human genetics in Hungarian forensic practice

In step with the evolution of molecular genetics, the application of non-human biological traces is an intensively researched field in forensic sciences [1]. Recently it has been widely acknowledged that this extended possibility – with associated abilities and pitfalls – for forensic DNA examination can provide innovative results in criminal and civil casework as well as in connection with associative evidence.Depending on the specific species or types of traces, the final results can have very different criminalistics value (e.g., plants, dogs or microbiome of soil traces), but it is unquestionable that non-human DNA has an increasing role in forensic biological evidence [2–4].However, in contrast to the investigation of human DNA-traces, there currently exist no restrictions concerning DNA loci and privacy of genetic information, and a wide spectrum of genetic information and technologies may be applied. The field is developing with animal rights, international (e.g. CITES) conventions, national regulations and professional recommendations [5–7].The Hungarian forensic practice on animal DNA examination has been developing since 2000 [8]. The range of cases is sufficiently broad, and includes fatal accidents and animal attacks (case #1) as well as illegal trade cases (case #2). In case of degraded animal hair samples we used two sets of Canine STR markers with shortened amplicons, and species specific primers (Ursus sp.) for mitochondrial DNA analysis of mixed samples (case #2), respectively. The results supported the evaluation of individualization (case #1), confirming the species identification (case #2).

Biochemistry in an undergraduate writing‐intensive first‐year program: Seminar courses in drugs and bioethics

The College of the Holy Cross offers a universal first-year program called Montserrat, in which first-year students participate in a living-learning experience anchored by a yearlong seminar course. The seminar courses are part of a thematic cluster of four to eight courses; students in the cluster live together in a common dormitory and participate in shared co-curricular events designed to engage the entire cluster in intellectual discourse related to the theme. A two-semester seminar within the "Natural World" cluster was offered using biochemical principles as the underlying content. In the first semester, students were introduced to drug design, activity and abuse via student presentations and guided readings on ethnobotany, drug laws, drug use in religion, and prescription drug costs. In the second semester, students discussed primary readings in ethics followed by case study analyses of assisted reproduction technologies, informed consent, genetic privacy, performance enhancing drugs and genetically modified organisms. Student learning outcomes were evaluated via rubrics and a College-facilitated survey.

Genetic privacy and the use of archival human material in genetic studies – current perspectives

Genetic privacy and the use of archival human material in genetic studies – current perspectives

Astronaut twins study raises questions about genetic privacy

Astronaut twins study raises questions about genetic privacy

After Genetic Privacy: an Interview with Yaniv Erlich

After Genetic Privacy: an Interview with Yaniv Erlich

Normative framework for the protection against genetic discrimination in Serbia

The paper is devoted to a normative framework of protection against genetic discrimination in the legal system of the Republic of Serbia, contained in the Law on Patients Rights, as of 2013 and in the Law on Prevention and diagnostics of genetic disorders, genetically conditioned anomalies and rare diseases, as of 2015. The analysis has shown that the rules on protection of the genetic data and the use of genetic samples, which are crucially important for prevention of genetic discrimination, have not been harmonized with contemporary ethical and legal standards. The contents of the Article 9 of the Law on Prevention and diagnostics of genetic disorders, genetically conditioned anomalies and rare diseases reduces the scope and level of protection against genetic discrimination in relation to the protection, given by the General Antidiscrimination Law. The legal definition of the genetic discrimination notion is not comprehensive, clear or precise, either, so it causes confusions, which, additionally, make the application of anti-discrimination regulations more difficult. Having in mind the harmful effects caused by the genetic discrimination, there is a need to eliminate the observed normative failures in due time and enable people to enjoy the benefits, provided by genetic investigations, without the fear from discrimination. In order to prevent the genetic discrimination, it is necessary to work on both information providing and raising awareness about the genetic privacy and the genetic discrimination problem, but also on promotion of the social justice and development of sensibility for bioethical challenges brought by the new age

Newborn DNA Storage Raises Serious Privacy Concerns

Newborn DNA Storage Raises Serious Privacy Concerns

State responses to biotechnology.

This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990-2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justice, economic development, labor law, health and safety, privacy, and property rights). This analysis seeks to answer three questions regarding biotechnology legislation at the state level: who is acting (policy adoption), when is policy adopted (policy timing), and what is policy doing (policy content). Theoretical concerns examine state ideology (conservative or liberal), policy type (economic or moral), and the role of external events (federal law, news events, etc.) on state policy adoption. Findings suggest ideological patterns in adoption, timing, and content of biotech policy. Findings also suggest economic policies tend to be more uniform in content than moral policies, and findings also document a clear link between federal policy development, external events, and state policy response.

Storage and use of Newborn Screening Blood Specimens for Research: Assessing Public Opinion in Illinois.

Storage and use of residual dried blood spots (DBS) from newborn screening (NBS) for research purposes has been a topic of elevated interest following high profile disputes between genetic privacy advocacy groups and state NBS programs. Our objective was to assess public opinion in Illinois regarding storage and use of residual DBS for research. Five hundred twenty-six Illinois residents completed a survey assessing attitudes about research uses for DBS, storage length, and consent issues. Over 80 % of respondents expressed agreement with questions regarding research uses of DBS. Eighty-three percent of respondents were in favor of storage for at least one year with 44 % favoring indefinite storage. Respondents with higher educational attainment were more likely to support research use of DBS and less likely to desire contact for each future study (P < 0.05). Black respondents were less likely than white respondents to express agreement for the use of DBS for research or to favor long-term storage (P < 0.05). Support was high for storage and use of DBS in our sample. Consent was important and respondents wanted choices about participation. Forty-two percent of respondents were not aware of NBS prior to this survey, highlighting a need for greater education about this public health program. Trust in the public health service of NBS must be protected through transparency in the policy process.

Redefining genomic privacy: trust and empowerment.

Fulfilling the promise of the genetic revolution requires the analysis of large datasets containing information from thousands to millions of participants. However, sharing human genomic data requires protecting subjects from potential harm. Current models rely on de-identification techniques in which privacy versus data utility becomes a zero-sum game. Instead, we propose the use of trust-enabling techniques to create a solution in which researchers and participants both win. To do so we introduce three principles that facilitate trust in genetic research and outline one possible framework built upon those principles. Our hope is that such trust-centric frameworks provide a sustainable solution that reconciles genetic privacy with data sharing and facilitates genetic research.

Following the giant’s paces-governance issues and bioethical reflections in China

BackgroundChina has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus on bioethics developments in western countries, but also should pay attention to the situation in China. Under this era of rapid advancement in genomics, reassessing the conventionally accepted bioethical principles is strongly needed.DiscussionIn this paper, we will analyze the case of BGI in the context of the Chinese regulatory system in order to identify methods to regulate genetic research more effectively and to strengthen BGI’s role in international collaborative research projects. Three main issues concerning sample collection and samples/data management are addressed. Firstly, an ambiguous definition of research, which does not specifically include biosamples/data, when applied to genetic research, may cause confusion and leave loopholes in governance. Secondly, the current regulations do not provide sufficient guidelines on the details of what information to present to prospective subjects, and how to combine informed consent with strategies of re-consent, withdrawal and feedback from research. Finally, the existing regulations do not adequately address issues of genetic privacy and data protection.SummaryBioethical issues related to genetic research in China may be partially due to the nature of genetic research and partially stems from the strategy of simply adopting general international guidelines into the Chinese context without detailed considerations of the local needs. However, there are no perfect readymade ethical solutions for everyone; every country faces different open questions and challenges behind what appears to be unified guidelines. Given the importance of China in international genetic research, other countries ought to be concerned about the bioethical developments in China. China should also have a substantive discussion with the international community on bioethics issues.

Genetic data sharing and privacy.

Genetic data sharing and privacy.

Regulating Genetics

Over the past three decades, government regulation and funding of DNA testing has reshaped the use of genetic evidence across various fields, including criminal law, family law, and employment law. Courts have struggled with questions of when and whether to treat genetic evidence as implicating individual rights, policy trade-offs, or federalism problems. We identify two modes of genetic testing: identification testing, used to establish a person’s identity, and predictive testing, which seeks to predict outcomes for a person. Judges and lawmakers have often drawn a bright line at predictive testing, while allowing uninhibited identity testing. The U.S. Supreme Court in Maryland v. King, for example, held that entering arrestee DNA in databanks does not implicate substantial Fourth Amendment concerns, since police do not test for genetic predispositions “not relevant to identity.” We argue that policy implications of genetic testing laws cannot be so neatly demarked. For example, federal welfare laws require states to use DNA to establish paternity to collect child support from “deadbeat dads,” which may be relevant to identity, but also creates potentially destabilizing effects on families. We explore how genetic testing has been legally regulated across a variety of fields. We identify two dominant modes of regulatory action dealing with genetics: data-driven and ethics-based. Data-driven legislation is ostensibly focused on short-term benefits of gathering a population’s genetic information. Ethics-based legislation, in contrast, is concerned with long-term consequences, such as effects on privacy. We particularly critique data-driven legislation, and we argue that judges, legislators and scholars should focus squarely on the individual and government interests at stake. We set out a list of five factors that legal actors should consider when considering genetics regulation: (1) equality, (2) accuracy, (3) privacy, (4) finality, and (5) federalism. In particular, equality concerns permeate the short history of DNA regulation. In each of the areas explored, comparatively disadvantaged groups such as arrestees, convicts, juveniles, noncitizens, and welfare recipients, have received the most intrusive regulation and collection of their genetic evidence, while comparatively privileged persons benefit from enhanced genetic privacy. We conclude that the regulation of genetic evidence deserves far more careful legal scrutiny, since the ways that genetic evidence is deployed can profoundly affect constitutional rights and the structure of legal and social institutions.

Genetic information, non-discrimination, and privacy protections in genetic counseling practice.

The passage of the Genetic Information Non Discrimination Act (GINA) was hailed as a pivotal achievement that was expected to calm the fears of both patients and research participants about the potential misuse of genetic information. However, 6 years later, patient and provider awareness of legal protections at both the federal and state level remains discouragingly low, thereby, limiting their potential effectiveness. The increasing demand for genetic testing will expand the number of individuals and families who could benefit from obtaining accurate information about the privacy and anti-discriminatory protections that GINA and other laws extend. In this paper we describe legal protections that are applicable to individuals seeking genetic counseling, review the literature on patient and provider fears of genetic discrimination and examine their awareness and understandings of existing laws, and summarize how genetic counselors currently discuss genetic discrimination. We then present three genetic counseling cases to illustrate issues of genetic discrimination and provide relevant information on applicable legal protections. Genetic counselors have an unprecedented opportunity, as well as the professional responsibility, to disseminate accurate knowledge about existing legal protections to their patients. They can strengthen their effectiveness in this role by achieving a greater knowledge of current protections including being able to identify specific steps that can help protect genetic information.

Erratum: Routes for breaching and protecting genetic privacy

Nature Reviews Genetics 15, 409–421 (2014) In the above article, an incorrect citation was given in reference 107. The citation should have been: Ayday, E., Raisaro, J. L., McLaren, P. J., Fellay, J. & Hubaux, J.-P. Privacy-preserving computation of disease risk by using genomic, clinical, and environmental data.

Return of results from genomic sequencing: A policy discussion of secondary findings for cancer predisposition

Advances in DNA sequencing technology now allow for the rapid genome-wide identification of inherited and acquired genetic variants including those that have been identified as pathogenic alleles for a number of diseases including cancer. Whole genome and exome sequencing are increasingly becoming a part of both clinical practice and research studies. In 2013 the American College of Medical Genetics and Genomics (ACMG) recommended that results of pathogenic genetic variants in 56 genes, nearly half of which comprise cancer genes (including BRCA1, BRCA2, TP53, MLH1, MLH2, MSH6, PMS2, and APC), be returned to patients who have their genome sequenced independent of the purpose for the test. This recommendation has been highly controversial for several reasons, particularly the recommendation that individuals be returned secondary findings of disease causing variants for adult onset conditions regardless of age and without consideration of patient preferences. In addition, the policy regarding returning results of secondary findings from genomic sequencing studies in research settings is currently unclear. In response to these emerging ethical issues, the Washington University Brown School of Social Work in St. Louis, MO, United States hosted a policy forum entitled “First do no harm: Genetic privacy in the age of genomic sequencing” on February 25th, 2014. The forum included a panel of experts to discuss their views on ethical issues related to return of results in both the clinical and research settings. In this report, we highlight key issues related to return of results from genome sequencing tests that emerged during the forum.

Routes for breaching and protecting genetic privacy

We are entering an era of ubiquitous genetic information for research, clinical care and personal curiosity. Sharing these data sets is vital for progress in biomedical research. However, a growing concern is the ability to protect the genetic privacy of the data originators. Here, we present an overview of genetic privacy breaching strategies. We outline the principles of each technique, indicate the underlying assumptions, and assess their technological complexity and maturation. We then review potential mitigation methods for privacy-preserving dissemination of sensitive data and highlight different cases that are relevant to genetic applications.