PLoS Medicine. 2008, 372 (9649): 1555-1562. This information was subsequently used by many local researchers in their MalariaGEN ethics application. Ethical issues in human genomics research in developing countries Jantina de Vries1,2*, Susan J Bull1,2, Ogobara Doumbo3, Muntaser Ibrahim4, Odile Mercereau-Puijalon5, Dominic Kwiatkowski2,6 and Michael Parker1 Abstract Background: Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. 2008, 5 (9): e192-10.1371/journal.pmed.0050192. Nat Rev Genet. 4-Year PhD Programme Orview from Sanger's website. 10.1038/415673a. Ethical issues in medical genetics arise from (a) new and previously unknown information on individual and familial genetic heritage and (b) new knowledge in manipulating genetic traits associated with disorder or disease or for enhancement. 0000036039 00000 n The fact that collaborative genomics research in lower income countries involves the establishment of large and diverse scientific networks bringing together diverse and interdependent forms of expertise and institutions in higher and lower income countries, means that responsibility for the ethical dimensions of such research is inevitably shared. This article is published under license to BioMed Central Ltd. 0000037620 00000 n 0000036921 00000 n 0 Where personal identifiers are removed from genomic datasets there may arguably be limited risk of participant identification. 0000038730 00000 n 0000039876 00000 n 10.1086/381709. Parker M: When is research on patient records without consent ethical?. There may be a need to take this kind of issue seriously when designing consent processes for genomics. To do this, we consider the ethical, legal, and social aspect of genomics research in our work, including these key issues. Global Forum for Health Research: The 10/90 report on health research 2003-2004. Will the number of false positives or false negatives cause more harm than … A balance may need to be struck between the ethical implications of collecting many thousands of new samples against the ethics of using archived samples with less than ideal consent. It typically consists of specifications of the following elements: the exact work to be done on the materials; the conditions of storage of the materials, including for instance details on building access and security; the people that are to work with the samples, typically the heads of research groups and all the members of their group; an agreement about data sharing and collaboration in analysis; procedures for agreeing on any other work that is not covered in the current MTA. 10.1016/j.tig.2009.09.012. After genotyping or sequencing is completed, GWA studies are strongly reliant on bioinformatics and computational technology and infrastructure, but not all these need to be present at the site where analysis is conducted. 2004, Geneva: Global Forum for Health Research. 2008, 9 (5): 406-411. 2007, 8 (1): 11-10.1186/1472-6939-8-11. 2009, 35 (3): 189-193. We thank our many colleagues who helped to us to identify and address the ethical issues in the MalariaGEN Consortium. RCPA | HEALTH GENOMICS SURVEY 2017 | FINAL REPORT – MAY 2019 • A total of 1,181,923 tests were reported. Where researchers are engaged in the collection of large numbers of samples, it is vital that they are also in a position to analyse research results, and to use their contribution for career development. Drawing from the examples of direct-to-consumer DNA testing and ancient DNA research, Alondra Nelson, president of the Social Science Research Council and a professor at the Institute for Advanced Study in Princeton, who is a Hastings Center fellow, considered … These technical questions raise important ethical questions: When should a test be made available? There are strong scientific and ethical arguments for sharing genomic data as the full scientific value of a GWA study may not be realised unless it is analysed by different methods and combined with other datasets. Eur J Hum Genet. Information produced by genomic research has, for example, the potential to be informative about people other than the research participant. jeopardising the health of others (the duty of. 2009, 84 (2): 251-258. Issues in Genetic Testing Another issue for any genetics test — prenatal or later in life — is its accuracy, as well as the number of false positives and false negatives it produces. Retrouvez Ethical Challenges in Genomics Research: A Guide to Understanding Ethics in Context et des millions de livres en stock sur Amazon.fr. The Ethox Centre, Department of Public Health and Primary Care, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK, Jantina de Vries, Susan J Bull & Michael Parker, The Wellcome Trust Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK, Jantina de Vries, Susan J Bull & Dominic Kwiatkowski, Malaria Research and Training Centre, Faculty of Medicine, Pharmacy and Odonto-Stomatology, University of Bamako, PO Box: 1805, Point G, Bamako, Mali, Institute for Endemic Diseases, University of Khartoum, Medical Campus, Qasser Street, PO Box 102, Sudan, Institut Pasteur, Unité d'Immunologie Moléculaire des Parasites, 28 Rue du Dr Roux, 75724, Paris, Cedex, 15, France, Wellcome Trust Sanger Institute, Hinxton, Cambridge, CB10 1SA, UK, You can also search for this author in Legal and Ethical Issues in Genomics: Informed Consent, Part 2 6:52. Questions therefore arise about how decisions about the re-use of such samples should be made and who should be making them. 2005, Princeton and Oxford: Princeton University Press. 281 0 obj <>stream A prerequisite, however, is that such a repository can easily and securely be accessed at a distance, and that tools exist that allow for relevant data to be extracted and/or analysed when necessary. Rabinow P: French DNA trouble in purgatory. 0000002713 00000 n It also requires the processes through which consent is obtained to be locally appropriate . What will link international genomics research projects, though, are the more general principles of justice, ownership and the fair distribution of resources. It is important to remember, however, that whereas MTAs can play a significant role in organising the legal responsibilities in the research process, they cannot accommodate all the above challenges. 10.1086/430707. 0000005704 00000 n The Journal of Infectious Diseases. 10.1136/jme.2005.012492. Legal and Ethical Issues in Genomics: Informed Consent and Human Subject Research, Part 3 8:29. Examples include Genome-Wide Association studies (GWAS) and, more recently, projects that make use of next-generation sequencing. Notwithstanding its importance, the actual achievement of successful and appropriate community engagement presents a number of practical and ethical challenges. 10.1038/35052543. Along with its many benefits, genomic-based personalized medicine comes with legal and ethical considerations, including genetic discrimination and privacy of health information. 2009, 25 (11): 489-494. Keywords Wellcome Trust Sanger Institute (WTSI) 19th June 2019 . 10.1111/j.1471-8731.2004.00066.x. IRB: Ethics and Human Research. startxref 2010, 11 (1): 13-10.1186/1472-6939-11-13. The relatively recent development of genomics means that it is unlikely that consent to studies conducted a few years earlier would have included it. 10.2471/BLT.06.029843. The MalariaGEN Network has sought to address some of these challenges through the collaborative development of an informed consent template and guidelines for informed consent http://www.malariagen.net/home/ethics/consentpolicies.php. The main points raised concerned: how to ensure that participants give valid (informed) consent; justifications for the export of samples and specification of the procedures for sample return or destruction at the end of the project; ensuring the appropriate recognition of local investigators' contributions and capacity development; ensuring that genomic data will not be used to harm populations or countries; and ways of assigning benefits to the country or community that donated the samples. In MalariaGEN, the export of samples was found to be a particular stumbling block for ethics committees. Some ethical problems of medical genetics, e.g., abortion after prenatal diagnosis, choices about alternatives in assisted reproduction, and the status of the human embryo in genetic research, are highly debatable and, at this time in history, are issues beyond the reach of moral consensus among nations. 0000004176 00000 n Policy Issues in Genomics Policy Issues in Genomics NHGRI is committed to driving the responsible use of genomics in society in order to advance knowledge and ensure that genomics benefits the health of all humans. 10.1038/nrg2760. Ellison GTH, Jones IR: Social identities and the 'new genetics': scientific and social consequences. Lairumbi GM, Molyneux S, Snow RW, Marsh K, Peshu N, English M: Promoting the social value of research in Kenya: Examining the practical aspects of collaborative partnerships using an ethical framework. PLoS Genet. The review of genomic studies is challenging: the science is difficult to comprehend , the studies are hypothesis-generating rather than hypothesis-testing, use very large sample numbers [59, 60], and generate very large amounts of data that can be analysed many times for different purposes. 0000011155 00000 n Thus, genomic methodology may offer excellent opportunities for real and sustainable involvement from researchers in lower income countries (See Case 3). 2004, 59 (12): 2547-2559. 0000004570 00000 n Wendler D, Pace C, Talisuna AO, Maiso F, Grady C, Emanuel E: Research on Stored Biological Samples: The Views of Ugandans. Given the urgent need to alleviate the disease burden for people living in lower income countries, and the tremendous opportunity to redress wider issues of global injustice and inequality, the need to tackle and resolve the ethical challenges surrounding GWA studies is as important as it is acute. A majority are unaware of the progress made in routine and exotic genetics, and most are caught off guard by each new technology. An overview of study sites can be found on the project website, http://www.malariagen.net. It emphasizes that genomics has the potential to offer great benefit to public health on a global scale, notes the present ambiguity in international agreements on intellectual property rights on the legal status of genetic … 0000008627 00000 n 2008, 9 (2): 152-156. Nat Rev Genet. Daniels N: Just Health: Meeting Health Needs Fairly. Heeney C, Hawkins N, De Vries J, Boddington P, Kaye J: Assessing the Privacy Risks of Data Sharing in Genomics. They underline the need for education and research on ethical aspects of new genomic technologies. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. 0000037453 00000 n Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics … Wilcken B(1). 10.1016/S0140-6736(08)61631-1. They participated in several data analysis workshops and were also invited to the annual MalariaGEN meetings where they presented site-specific analyses. MTAs are an important means of protecting the interests of the researchers collecting and supplying samples. J Med Ethics. 10.1038/nature03342. 2008, 17 (2): 147-149. 2006, 63 (4): 1109-1120. For example, whereas the infrastructure for genotyping and whole genome analysis is usually based in higher income countries, the patients affected by the diseases are based in lower income countries. Noté /5. However, in order to ensure that all research sites are capable of conducting site-specific analyses, the following need to be considered: Central Data Repository: Genomic data files are large and require very significant computational resources for confidential storage. Necessary for local analyses are. Chokshi DA, Parker M, Kwiatkowski DP: Data Sharing and Intellectual Property in a Genomic Epidemiology Network: Policies for Large-Scale Research Collaboration. Also, regular meeting opportunities to discuss particular challenges, as well as a mentoring scheme to support junior researchers may be considered. 2008. xref Particularly important factors in deciding to regulate data access were the potential for genomic data associated with ethnicity to lead to ethnic stigmatisation and the importance of ensuring that future data uses are compliant with the purposes for which the samples were collected. Journal of Biomedical Informatics. They comprised 660,150 genetic/ genomic tests (constitutional – 545,029; cancer – 115,121); maternal serum screening (146,719); newborn bloodspot screening (307,770), and biochemical genetic diagnostic tests (67,284). 2008, New York: Cambridge University Press. 2005, 434: 214-217. It also requires a trusted body to maintain and share the data. Mascalzoni D, Hicks A, Pramstaller P, Wjst M: Informed Consent in the Genomics Era. Kaye J, Boddington P, de Vries J, Hawkins N, Melham K: Ethical implications of the use of whole genome methods in medical research. 10.1016/j.ajhg.2009.01.018. On the other hand, the genomic study requires the collection of blood samples from healthy children as well. Title: Ethical Issues in Genomics Research 1 Ethical Issues in Genomics Research. Clinical Infectious Diseases. Second, the network recognised the need to enable all contributing researchers to analyse their own data before it was made publicly available and incorporated this into the MalariaGEN Data Release Policy http://www.malariagen.net/home/downloads/16.pdf. Driven both by recognition of the need for locally relevant health research in lower income countries, and by awareness of the potential for exploitation in contexts of vulnerability and inequality , collaborative partnership and social value have been proposed as benchmarks against which the ethics of research in lower income countries should be measured [22, 23]. Where genomics research focuses on diseases affecting populations with lower average income and literacy levels, it tends to take place in collaborations between researchers from higher and lower income countries. Many applications of genomic technologies raise ethical issues. 0000009143 00000 n 0000037183 00000 n Following consultation, it was agreed that access to MalariaGEN datasets would be mediated via an independent data-access committee and that researchers would be granted access to genotyping data and to a limited amount of clinical and demographic data only after signing a legally-binding data-access agreement which placed restrictions on the acceptable uses to which MalariaGEN data can be put . Jantina de Vries. In the context of such diversity, identifying common ground where researchers can share experiences and insights is inevitably challenging. J.A. In addition to establishing means of developing consensus about ethical issues to be addressed in their research, networks need to determine how best to tailor the implementation of ethical principles to individual research sites. Trends in Genetics. 0000005014 00000 n It includes concerns about: privacy and whether anonymity can be guaranteed ; data security ; the implications of collecting and storing vast amounts of data and its uncertain future use; the implications of data release for populations and for family members of participants ; the need to strike a proper balance between research and protection ; the development of appropriate governance mechanisms ; the implications for trust, consent and autonomy [45, 66]; commercialisation; and the ethical importance of the sustainability of databases. genomics have accelerated the timing of some ethical, social, and legal issues, but, because of the slow pace of under-standing, neither broadly nor dramatically. Glasziou P, Chalmers I: Ethics review roulette: what can we learn?. Research Group Institute of Society Ethics and the Life Sciences, Ethical and social issues in screening for genetic disease New Engl J Med 286: (1972) 1129-1132 27. 2006, 84 (5): 382-387. Identity and Governance in an Age of Genomics. 2009, 10 (1): 13-10.1186/1472-6939-10-13. 0000038619 00000 n 0000005311 00000 n Over the past 5 years, GWAS have proven very valuable in identifying regions of the genome that affect resistance or susceptibility to a wide range of common diseases, although the method provides simply a starting point, and a range of other approaches will be required in future to fully characterise and understand the complex genetic determinants of human health and disease. Another key reason for adopting a managed approach to data release was the view that an ethical data release policy must also be combined with adequate protections for researchers in lower income countries. Some suggestions have been made about how to explain key terms of genomic studies , but the extent to which such abstractions effectively explain the risks and benefits involved remains yet to be seen. 0000007781 00000 n 0000039264 00000 n Many applications of genomic technologies raise ethical issues. One way in which this approach has benefitted the Network is in providing assistance during ethics review. Only in one site did researchers decide to re-consent participants whose samples were collected many years ago, but this was mainly because the research design of the particular sub-study required taking additional samples. 0000005558 00000 n 2005, 365: 1487-1498. Current ethical issues in genomics Richard gave a workshop on "Current ethical issues in genomics" to doctoral students at the Sanger Institute. 2003, 25 (2): 1-10. There is more than enough ethical mud in genetics of 1998 to keep physicians, lawyers, scientists and bioethicists on guard. MP and SB receive funding from a Wellcome Trust Enhancement Award in Biomedical Ethics (087285/Z/08/Z). 2010. The American Journal of Human Genetics. Nat Rev Genet. 0000013318 00000 n Resnik DB: The Distribution of Biomedical Research Resources and International Justice. Nature. This Report addresses the important ethical, legal, social and health issues raised by the patenting of DNA sequences--not only for the industrialized world, but also for developing countries. There are good ethical reasons for encouraging medical research on diseases affecting populations with lower average income and literacy levels. Foster MW, Sharp RR: Share and share alike: deciding how to distribute the scientific and social benefits of genomic data. In addition, where genomics research takes place in the context of resource inequalities between research partners, the concentration of samples and resources in particular partner sites raises questions about fairness, ethical oversight, benefit sharing, and long-term development of capacity at all research sites. %%EOF Dr. Gene E. Robinson. Malin B, Sweeney L: How (not) to protect genomic data privacy in a distributed network: using trail re-identification to evaluate and design anonymity protection systems. Nat Rev Genet. responsibility to prevent harm or avoid seriously. volume 12, Article number: 5 (2011) Particular challenges with regard to consent were how to collect consent in emergency situations, and how to explain the rationale for collecting samples from healthy children. The collection of both types of samples raised issues with regard to consent. 2001, 19 (5): 166-171. 2009, 6 (11): e1000143-10.1371/journal.pmed.1000143. Third, the network sought to develop software that allows the remote analysis of genomic data - meaning that MalariaGEN researchers anywhere in the world could analyse data without the need to invest in expensive in-house infrastructure for data analysis and storage. 2004, 4 (1): 42-57. Genomics is a fast-moving field and new technological opportunities are developed monthly. But one size does not fit all and the development of appropriate responses to these ethical issues will need to be conducted on a case by case basis. Yet recent and emergent developments in genetics and genomics are posing challenges to these conventional ethical paradigms. Tekola F, Bull S, Farsides B, Newport M, Adeyemo A, Rotimi C, Davey G: Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. A key bottleneck, however, is the ability to work with genomic data. Richardson SS: Revisiting Race in a chapter in a chapter in context... 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