scholarly journals Legal problems related to transfer of genetic information in the case law: medical and research spheres

2020 ◽  
pp. 47-55
Author(s):  
Yulia Andreevna Melikhova
Keyword(s):  
Informed Consent ◽  
Genetic Information ◽  
Genetic Diseases ◽  
Genetic Research ◽  
Russian Literature ◽  
Case Law ◽  
The Subject ◽  
Voluntary Informed Consent ◽  
Attending Physician ◽  
To Receive

The subject of this article is the analysis of mainly foreign case law on the transfer of genetic information in the spheres of medicine and scientific research.. The author addresses the positions of courts on private issues such as: the responsibility of attending physician and third parties to inform relatives of a patient about the risks of genetic diseases, rights of relatives to access genetic information after a patient has died, acquisition of a voluntary informed consent for participating in research. Comparison is conducted on approaches of the courts in other regions and countries in reviewing similar cases. The novelty of the research lies in the choice of the topic and obtained conclusions. The author analyzes foreign case law on the transfer of genetic information in the medical and research spheres, which has not previously been a subject of separate study in the Russian literature. The conclusion is formulated on the absence of universal position of the courts on the question of understanding the content of genetic information, limits of the rights of relatives to receive genetic information of a patient. The courts are unanimous in their decisions (or the cases are isolated) on the matter that participation in genetic research must be preceded by a voluntary informed consent, which can be presumed and applies exclusively to the research agreed to. The participants do not have rights to results of the research, and the discovered genes cannot be patented by the researchers.

scholarly journals The preferences of potential stakeholders in psychiatric genomic research regarding consent procedures and information delivery

2019 ◽  
Vol 55 ◽  
pp. 29-35 ◽  
Author(s):  
Anna Sundby ◽  
Merete Watt Boolsen ◽  
Kristoffer Sølvsten Burgdorf ◽  
Henrik Ullum ◽  
Thomas Folkmann Hansen ◽  
...  
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Genetic Research ◽  
Genomic Research ◽  
Research Subjects ◽  
Cross Sectional ◽  
Telephone Consultation ◽  
Active Involvement ◽  
Consent Procedure ◽  
To Receive

AbstractBackground:Genomic sequencing plays an increasing role in genetic research, also in psychiatry. This raises challenges concerning the validity and type of the informed consent and the return of incidental findings. However, no solution currently exists on the best way to obtain the informed consent and deliver findings to research subjects.Aims:This study aims to explore the attitudes among potential stakeholders in psychiatric genomic research toward the consenting procedure and the delivery of incidental findings.Methods:We developed a cross-sectional web-based survey among five groups of stakeholders. A total of 2637 stakeholders responded: 241 persons with a mental disorder, 671 relatives, 1623 blood donors, 74 psychiatrists, and 28 clinical geneticists.Results:The stakeholders wanted active involvement as 92.7% preferred a specific consent and 85.1% wanted to receive information through a dynamic consent procedure. The majority of stakeholders preferred to receive genomic information related to serious or life-threatening health conditions through direct contact (69.5%) with a health professional, i.e. face-to-face consultation or telephone consultation (82.4%). Persons with mental disorders and relatives did not differ in their attitudes from the other stakeholder groups.Conclusion:The findings illustrate that the stakeholders want to be more actively involved and consider consent as a reciprocal transaction between the involved subjects and the researchers in the project. The results highlight the importance of collaboration between researchers and clinical geneticists as the latter are trained, through their education and clinical experience, to return and explain genomic data to patients, relatives, and research subjects.

scholarly journals Privacy Protection and Genetic Research: Where Does the Public Interest Lie?

2014 ◽  
Vol 51 (3) ◽  
pp. 471 ◽  
Author(s):  
Ubaka Ogbogu ◽  
Sarah Burningham
Keyword(s):  
Public Interest ◽  
Genetic Information ◽  
Genetic Research ◽  
Case Law ◽  
Personal Health ◽  
Public Interests ◽  
Policy Regimes ◽  
The Public ◽  
Privacy Law ◽  
Individual Privacy

There is significant public interest in the outcomes of genetic research. However, there is also a great deal of concern that genetic research and associated realms will foster the use and disclosure of personal health and genetic information in ways that undermine protected privacy interests. This article proposes that a balance must be struck between legitimate public interests implicated in the collection, use, and disclosure of genetic information for research purposes. The article also explores the tension between the public interest in genetic research and the protection of individual privacy in relation to different policy regimes and reviews existing statutory rules, case law, and administrative decisions on the public interest exception in Canadian privacy law.

scholarly journals Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles

2015 ◽  
Vol 43 (3) ◽  
pp. 502-513 ◽  
Author(s):  
Laura M. Beskow ◽  
P. Pearl O'Rourke
Keyword(s):  
Genetic Information ◽  
Genetic Research ◽  
Family Members ◽  
Research Process ◽  
Secondary Users ◽  
Consent Forms ◽  
Research Results ◽  
Considerable Debate ◽  
The Subject ◽  
Genetic Results

Whether or not to offer individual genetic results to research participants has been the subject of considerable debate, yet consensus regarding what, when, and how to return remains elusive. Despite this lack of clarity, the discussion has moved to the offer of research results to family members of participants, including when the participant is deceased. Given the familial implications of genetic information, this extension is perhaps logical. But it raises concerns throughout the research process, including, for example, questions about disclosures and choices on consent forms, procedures for identifying and contacting family members, and how any such obligations might apply to secondary users of biospecimens and data.

scholarly journals Participant-Partners in Genetic Research: An Exome Study with Families of Children with Unexplained Medical Conditions (Preprint)

2017 ◽  
Author(s):  
Sara Huston Katsanis ◽  
Mollie A Minear ◽  
Azita Sadeghpour ◽  
Heidi Cope ◽  
Yezmin Perilla ◽  
...  
Keyword(s):  
Genetic Information ◽  
Research Team ◽  
Research Study ◽  
Genetic Research ◽  
Genomic Research ◽  
Active Engagement ◽  
Medical Conditions ◽  
Relevant Research ◽  
Research Results ◽  
To Receive

BACKGROUND Unlike aggregate research on groups of participants with a particular disorder, genomic research on discrete families’ rare conditions could result in data of use to families, their healthcare, as well as generating knowledge on the human genome. OBJECTIVE In a study of families seeking to rule in/out genetic causes for their children’s medical conditions via exome sequencing, we solicited their views on the importance of genomic information. Our aim was to learn the interests of parents in seeking genomic research data and to gauge their responsiveness and engagement with the research team. METHODS At enrollment, we offered participants options in the consent form for receiving potentially clinically relevant research results. We also offered an option of being a “partner” versus a “traditional” participant; partners could be re-contacted for research and study activities. We invited adult partners to complete a pre-exome survey, attend annual family forums, and participate in other inter-family interaction opportunities. RESULTS Of the 385 adults enrolled, 79% opted for “partnership” with the research team. Nearly all (99.2%) participants opted to receive research results pertaining to their children’s primary conditions. A majority indicated the desire to receive additional clinically relevant outside the scope of their children’s conditions (92.7%) and an interest in non-clinically relevant genetic information (82.7%). CONCLUSIONS Most participants chose partnership, including its rights and potential burdens; however, active engagement in study activities remained the exception. Not surprisingly, the overwhelming majority of participants—both partners and traditional—expected to receive all genetic information resulting from the research study.

scholarly journals 3409 The Power of Phenotypic Extremes in Detecting Novel Genetic Modifiers of Hemophilia

2019 ◽  
Vol 3 (s1) ◽  
pp. 23-24
Author(s):  
Ohad Shimshon Bentur ◽  
Barry S. Coller
Keyword(s):  
Informed Consent ◽  
Genetic Information ◽  
Genetic Modifier ◽  
Genetic Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Genetic Modifiers ◽  
Research Results ◽  
Study Participants ◽  
Actionable Variants

OBJECTIVES/SPECIFIC AIMS: 1. To identify novel genetic modifiers that result in a mild bleeding phenotype in patients with FVIII <1%. 2. To examine the feasibility of a practice model that incorporates the principles and methods for both obtaining consent for NGS and returning individual research results from the sources described above. METHODS/STUDY POPULATION: 1. We plan a 3-step approach for identifying novel genetic modifiers of hemophilia: a. Obtain samples from individuals with an extremely mild bleeding phenotype: The study will be narrowed to patients with confirmed FVIII <1%, a null mutation in the gene for FVIII, and a mild bleeding phenotype according to a detailed bleeding history. b. Identify variants that modify phenotype: Whole exome sequencing will be performed, followed by a focused analysis of genes known or suspected to be involved in thrombosis and hemostasis and prediction of variant impact using algorithms that account for conservation and deleteriousness of all variants. c. Verify the impact of novel variants in independent samples: In silico (analyze genetic databases for suspected variants), in vivo (assess bleeding in animal models of hemophilia after introducing presumed modifier variants). 2. We will employ a model for obtaining informed consent and communicating individual genetic research results and results with potential clinical impact to research participants: a. The informed consent process will be performed after potential participants read a pamphlet entitled “Genetic Research at The Rockefeller University Hospital and Center for Clinical and Translational Science.” The pamphlet includes 16 questions that the potential participants are urged to ask the investigator, including, “What will you look for in my genetic information?”, “Will I receive results from this study?”. Potential participants will also be informed of the meaning of clinically actionable variants, either pathogenic variants related to phenotype or secondary (“incidental”) findings (i.e. variants unrelated to phenotype, the knowledge of which could lead to actions that may improve health). Participants who do not want to receive information about potentially actionable variants will be excluded from the study to avoid a situation where the investigator has clinically important information that cannot be shared with the participant. b. Genetic testing will be performed in a CLIA-certified lab to allow investigators to share the results with the study participants. c. Results will be reported to study participants according to a standard operating procedure (SOP) that classifies the report of variants according to the relation to phenotype and the pathogenic potential. d. Participant satisfaction with the informed consent process and the return of results will be assessed by a questionnaire for obtaining participants’ perceptions of their research experience, based on a standard set of validated research participation experiences measures (Kost RG et al, J Clin Transl Sci. 2018;2:31). RESULTS/ANTICIPATED RESULTS: Samples from individuals with severe null mutation hemophilia and a mild bleeding phenotype will be enriched in genetic modifier variants. After completing participation, participants will express satisfaction with the informed consent process and the results of the return of genetic information. DISCUSSION/SIGNIFICANCE OF IMPACT: Genetic risk assessment to predict bleeding risk has the potential to provide hemophilia patients with tailored therapy, allowing for very early initiation of treatment (prophylactic thrice weekly IV administration of FVIII) in patients with a high bleeding risk and deferring this costly and burdensome treatment in patients who are expected to be mild bleeders. Genetic modifier variants of hemophilia may be found to predict thrombosis in non-hemophiliac patients and profoundly impact the treatment of venous thrombosis. A structured process for obtaining consent for NGS and return of genetic results to study participants can protect them from uncertain genetic information. Moreover, this process will prevent a situation in which investigators have knowledge about clinically actionable variants but they are not allowed to report them to the participants or do not have a process for doing so. Sharing individual research results and results with clinical significance with participants of studies that involve whole exome sequencing can promote transparency and engagement of participants throughout the research enterprise.

scholarly journals Informed Consent for Genetics Research in Italy

2019 ◽  
Vol 6 (1) ◽  
pp. 6-12 ◽  
Author(s):  
Piergiorgio Fedeli ◽  
Nunzia Cannovo ◽  
Rosa Guarino ◽  
Vincenzo Graziano
Keyword(s):  
Genetic Information ◽  
Scientific Community ◽  
Genetic Research ◽  
Genetic Data ◽  
Health Utility ◽  
Family Risk ◽  
The Public ◽  
Genetics Research ◽  
The Subject ◽  
Freedom And Responsibility

Background:Genetic research has become an indispensable instrument for medical research, and the subjects involved have both divergent and convergent interests.Objective:The possibility of having more detailed genetic information undoubtedly offers benefits for the health of the subject, but could also pose risks and make the subject vulnerable to discrimination.The scientific community has viewed very favorably the public health utility of family history, in which data from a family whose members suffer from chronic pathologies is collected and filed, in order to develop a sort of "stratification of family risk."Even though in the last decade the scientific and juridical literature has contributed greatly to the topic of biobanks, the perplexities that continue to surround this theme give the idea that current ethical protocols on research are inadequate.Conclusion:Genetic data must be used not to exploit, but to serve the person. Freedom and responsibility must be the twin guiding lights for establishing parameters for the use of biological samples. An evaluation of how this technology impacts the various aspects of the future of society is urgently needed.

scholarly journals Law and regulation of retained organs: the ethical issues

Legal Studies ◽  
2002 ◽  
Vol 22 (4) ◽  
pp. 527-549 ◽  
Author(s):  
John Harris
Keyword(s):  
Informed Consent ◽  
Genetic Information ◽  
Ethical Issues ◽  
Genetic Privacy ◽  
Children's Hospital ◽  
Moral Importance ◽  
The World ◽  
Children’S Hospital ◽  
The Subject ◽  
Alder Hey

Organ retention has been with us for millennia. Walk into virtually any cathedral and many a church in Europe and you will find an array of retained organs or tissue, allegedly originally the property of assorted saints, or even of God, and almost certainly collected without proper informed consent and retained in less than secure conditions. In our own time the complexities of organ collection, retention and use have proliferated. The events at Alder Hey Children's Hospital and the debates about the ethics of biobanking all over the world have dramatically highlighted the complexity, the difficulty and the moral importance of these issues. Some of these issues have to do with the question of who can give permission for or consent to such removal and retention. Other issues involve consideration of whose rights or interests are engaged when cadaver organs and tissue are removed and retained, just what in particular is the nature, extent and force of those rights or interests, and how they are to be balanced against other moral considerations. These questions are the subject of this paper. We will not, however, here be concerned with the issues of genetic privacy, the security of genetic information.

INFLUENCE OF OFFICE BLEACHING SYSTEMS ON THE RESISTANCE OF HARD TOOTH TISSUES

2020 ◽  
pp. 119-125
Author(s):  
Magsumova O.A. ◽  
Postnikov M.A. ◽  
Ryskina E.A. ◽  
Tkach T.M. ◽  
Polkanova V.A.
Keyword(s):  
Informed Consent ◽  
Oral Fluid ◽  
Personal Data ◽  
Acid Resistance ◽  
Non Invasive ◽  
Hard Tissues ◽  
Voluntary Informed Consent

One of the non-invasive methods for treating discoloration of hard tooth tissues is teeth whitening. The aim of this work is to assess the dynamics of changes in the acid resistance of enamel and hard tissues of teeth and the rate of its remineralization after the procedure of office teeth whitening. The study involved 123 patients aged 18 to 35 years with discoloration of various origins, with the color of hard tooth tissues on the Vita Classic A2 scale and darker. Before performing the office, teeth whitening procedure, all patients gave their written voluntary informed consent to participate in this study, as well as consent to the processing of personal data. Depending on the chosen method of office teeth whitening, patients were divided into 3 groups. The resistance of hard tooth tissues was judged based on the determination of TOER and CASRE tests. These indicators were determined at various times (5 days before the office teeth whitening procedure, 5 days after it, after 14, 30 days and 6 months). Regardless of the chosen whitening system, the office teeth whitening procedure is accompanied by a decrease in the enamel's resistance to acids and a decrease in the rate of its remineralization. The remineralizing function of oral fluid promotes the positive dynamics of the studied parameters after 14 days and after 30 days values increased due to the appointment of remineralizing therapy to all patients in 2 weeks after the teeth whitening procedure. After 6 months, all patients had high enamel resistance and the rate of its remineralization.

A. Rudalyov. 4 shots (A. Zhuchkova)

2019 ◽  
pp. 272-277
Author(s):  
Anna V. Zhuchkova
Keyword(s):  
Russian Literature ◽  
Theoretical Research ◽  
New Realism ◽  
The Press ◽  
The Subject

The review considers A. Rudalyov’s book 4 Shots [ 4 vystrela ], devoted to the ‘new realism’, a trend in 2000s Russian literature, and more specifically, works of four ‘new realists’: Z. Prilepin, R. Senchin, S. Shargunov, and G. Sadulaev. The reviewer criticizes the author for an incomplete and biased presentation of ‘new realism’, which had been a focus of intense discussions among literary critics and scholars for over a decade. The same flaw blights the descriptions of the four chapters’ respective protagonists: Prilepin, Senchin, Shargunov, and Sadulaev. Rudalyov ended up writing a panegyric, albeit with very sparse language, mainly by repetition of flattering epithets from the press. He failed, however, to address the discussion of the ‘new realism’ by critics or supply a review of literary theoretical research on the subject. Therefore, the reviewer finds the book lacking in any historical-literary and philological value.

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