ethical issues in genomics

Many of these arise from concerns from researchers and ethics committees in the samples' country of origin that once samples have been exported, their control over subsequent use will be limited [47, 48]. Dr. Gene E. Robinson. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. Individuals with specific genomes … Genomics is a fast-moving field and new technological opportunities are developed monthly. 0000038730 00000 n Daniels N: Just Health: Meeting Health Needs Fairly. Nyika A: Ethical and practical challenges surrounding genetic and genomic research in developing countries. 0000009710 00000 n responsibility to prevent harm or avoid seriously. 0000035953 00000 n PLoS Med. • the volume of molecular genetic tests has increased by 73% ov They also highlight the potential of genomic technologies and the problems they introduce. on ELSI issues in the genomics of non-communicable diseases, and the ethical and legal issues surrounding in-fectious disease management. 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. 2005, 365: 1487-1498. Additional support is provided by Wellcome Trust Sanger Institute core funding and the Medical Research Council (G0600230). 2008, New York: Oxford University Press, Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S: Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. 0000037316 00000 n Another practical challenge in the context of community participation in genomics research concerns how to explain to communities what the study involves in ways that are accessible and make understanding and engagement possible. Also, it can only be expected to be successful if linked into a supportive and stable institutional environment. 10.1016/j.ajhg.2009.01.018. Developing World Bioethics. Although the majority of research centres around the world now have fairly stable access to the Internet, some centres remain unconnected. 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. 0000007781 00000 n Questions therefore arise about how decisions about the re-use of such samples should be made and who should be making them. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics … 0000003201 00000 n For GWA studies, capacity building is also imperative as benefit sharing as the main outcomes of the research are likely to be expertise and knowledge, rather than treatments. Whilst genomics research presents important ethical challenges in the recruitment of participants regardless of where it is conducted, prospective participants in lower income countries are more likely to be poor and to have limited access to healthcare, education and other resources. 10.1136/bmj.328.7432.121. 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. These issues occur everywhere that human genes are patentable. Necessary for local analyses are. 0000038025 00000 n Also, regular meeting opportunities to discuss particular challenges, as well as a mentoring scheme to support junior researchers may be considered. 2005, Princeton and Oxford: Princeton University Press. Critical Public Health. 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 [14]. 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. 0000000016 00000 n https://doi.org/10.1186/1472-6939-12-5, DOI: https://doi.org/10.1186/1472-6939-12-5. Berlinguer G: Bioethics, health and inequality. 0 Overall, there was considerable homogeneity in the concerns raised by committees in various countries. 0000007965 00000 n Capacity building would also allow scientists to enlarge their analyses to additional, locally-held phenotypes or to build on key genomic findings to develop further research projects. The Journal of Infectious Diseases. A majority are unaware of the progress made in routine and exotic genetics, and most are caught off guard by each new technology. Emilia Niemiec and Heidi Howard highlight some of them in a chapter in a recent book on applied genomics and public health. 0000037854 00000 n What will link international genomics research projects, though, are the more general principles of justice, ownership and the fair distribution of resources. Where personal identifiers are removed from genomic datasets there may arguably be limited risk of participant identification. 2007, 8 (1): 11-10.1186/1472-6939-8-11. 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. Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, Mokhachane M, Mupenda B, Ndebele P, Ndossi G: The Structure and Function of Research Ethics Committees in Africa: A Case Study. We explore ethical issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. Nutrigenomics lies at the intersection of several fields in which ethical, legal and social issues arise – human genomics and genetics, the molecular nutritional sciences, dietary supplement research and development, medicine and dietetics. 2008, Geneva: World Health Organisation. 0000012296 00000 n There are other challenges to obtaining valid consent for genomics research. 0000025935 00000 n Noté /5. Malaria is a so-called complex disease, involving an intricate immunological pathway and dynamic relationships between the human, the mosquito and the malaria parasite [16–18]. Abstract. Social Science & Medicine. 2008, 372 (9649): 1523-1525. 10.1126/science.1147699. Need AC, Goldstein DB: Next generation disparities in human genomics: concerns and remedies. The principles set out in the MalariaGEN Data Access Policy incorporate key ethical principles that MalariaGEN researchers agreed should be respected by any third party using the genomic data. J.A. The Lancet. 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 [21], 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]. There may be a need to take this kind of issue seriously when designing consent processes for genomics. American Journal of Human Genetics. Kaye J, Boddington P, de Vries J, Hawkins N, Melham K: Ethical implications of the use of whole genome methods in medical research. Nat Rev Genet. 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. The funders had no role in the decision to submit the article or in its preparation. 2006, 28 (3): 1-6. To that end, this article is intended to provide an overview of salient issues in ethics as they pertain to clinical genetics. Author information: (1)Biochemical Genetics and Newborn Screening Departments, The Children's Hospital at Westmead, Sydney, New South Wales, Australia. 0000015490 00000 n The American Journal of Human Genetics. Privacy 2001, 2 (2): 91-99. 0000037620 00000 n MalariaGEN adopted two ways of approaching the challenge of obtaining ethics review. Keywords Wellcome Trust Sanger Institute (WTSI) 19th June 2019 . To train a group of enthusiastic and young people in the scope of a few years to a standard where they can successfully analyse genomic data is then a significant challenge. Taken together, these factors mean that GWA studies such as MalariaGEN need to rely heavily on the use of archived samples. Ethical issues in Genetics Research. 0000037741 00000 n 0000036097 00000 n 10.1136/jme.2006.019612. … In addition, they received support to develop and submit conference abstracts, and a sub-group also received support to apply for PhD fellowships. On the contrary, research projects often have to rely on short-term research funding and have milestones that need to be met. 10.1086/430707. 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. International collaborative research projects need to obtain ethics approval from a multitude of committees from around the world. A particular challenge relates to fast increases in the number of genetic variants that can be reasonably genotyped for a project like MalariaGEN. The reason why this ethical and legal issue is selected is that the collection of DNA information will ensure more people are aware of the major genome types. 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. Specific Material Transfer Agreements (MTAs, Case 1) describing in detail the nature of the work to be carried out in foreign laboratories, as well as procedures for sample return or destruction at the end of the project, were instrumental in addressing some of these concerns. It also requires the processes through which consent is obtained to be locally appropriate [34]. 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. It includes concerns about: privacy and whether anonymity can be guaranteed [10]; data security [11]; 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 [7]; the need to strike a proper balance between research and protection [65]; the development of appropriate governance mechanisms [31]; the implications for trust, consent and autonomy [45, 66]; commercialisation; and the ethical importance of the sustainability of databases. 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. Legal and Ethical Issues in Genomics: Informed Consent and Human Subject Research, Part 3 8:29. Particularly challenging is the fact that many of the potential harms and benefits of genomics research relate to populations rather than to individuals [31]. In the context of an international collaborative research project it is unfeasible to develop computational and networking capacity at all the research sites, which means that some sites may remain at a disadvantage in terms of data utilization and analysis. 2009, 6 (11): e1000143-10.1371/journal.pmed.1000143. The committees required detailed information on the need to export samples, as well as descriptions of the exact sample handling. Diallo Dapa A, Doumbo Ogobara K, Plowe Christopher V, Wellems Thomas E, Emanuel Ezekiel J, Hurst Samia A: Community Permission for Medical Research in Developing Countries. Caulfield T, McGuire AL, Cho MK, Buchanan JA, Burgess MM, Danilczyk U, Diaz CM, Fryer-Edwars K, Green SK, Hodosh MA: Research Ethics Recommendations for Whole-Genome Research: Consensus Statement. It aims to foster a vibrant, engaged community, where issues faced by researchers can be examined and addressed collaboratively. 0000009966 00000 n Resnik DB: The Distribution of Biomedical Research Resources and International Justice. Chokshi DA, Parker M, Kwiatkowski DP: Data Sharing and Intellectual Property in a Genomic Epidemiology Network: Policies for Large-Scale Research Collaboration. 10.1080/09581590210153362. The ethical issues relevant to GWA studies conducted on populations with lower average income and literacy levels also include issues around the inclusion and reuse of archived samples, export of samples, ethical review and capacity building. 0000039876 00000 n 2010, 11 (5): 356-366. Gikonyo C, Bejon P, Marsh V, Molyneux S: Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. They underline the need for education and research on ethical aspects of new genomic technologies. This can be a daunting task, especially where committees express different or conflicting points of view or place additional requirements on researchers [57], such as changes to a consent form that has already been approved by another ethics committee. These were developed by and for MalariaGEN researchers and in consultation with some ethics committee members. 2008, 9 (5): 406-411. 2008, New York: Cambridge University Press. Nature. Some of the difficulties relating to the development and implementation of consent processes in lower income countries have been discussed in the literature [35–38]. %%EOF 10.1016/S0140-6736(08)61631-1. 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. 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. 0000038619 00000 n In order for the promise of the "genomics revolution" to be achieved, however, numerous ethical, legal and social implications (ELSI) will need to be addressed. 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. Cardon LR, Bell JI: Association study designs for complex diseases. In MalariaGEN, the export of samples was found to be a particular stumbling block for ethics committees. MTAs are an important means of protecting the interests of the researchers collecting and supplying samples. Nat Rev Genet. Recent years have seen an explosion of scientific interest in the use of human genomic variation to study common complex diseases. IRB: Ethics and Human Research. Science. PLoS Medicine. 0000038854 00000 n It is important that such issues are appropriately addressed in such research. A fundamental principle underlying many genomics research projects is that data should be shared with third party researchers for secondary analysis. Genomic-based personalized medicine comes with legal and ethical issues. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6939/12/5/prepub. This is labour-intensive and time consuming, even in well-resourced health systems. California Privacy Statement, PLoS Medicine. xref Contributors Richard Milne. This assumption does not hold for all researchers, and especially not for those based in low-income countries. 10.1136/jme.2006.019059. Dickenson D: Human Tissue and Global Ethics. 0000005502 00000 n 1999, Chicago, Il: University of Chicago Press, Reardon J: Race to the Finish. Over twenty ethics committees in sixteen countries reviewed and approved the study, with review taking up to a year to complete at some partner sites (see Case 2). 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 addition, the MalariaGEN ethics team (JdV, SB and MP) discussed the consent procedures, challenges and best practice with researchers and fieldworkers at several research sites. Site visits and local exchange of facilities may be a solution to this problem. Ethics committees reviewing research in this area may not have had the training or experience to enable them to identify and analyse the key ethical issues - a well-recognised problem also in other research fields [62–64]. 2007, 4 (1): e3-10.1371/journal.pmed.0040003. Nat Rev Genet. Some suggestions have been made about how to explain key terms of genomic studies [30], but the extent to which such abstractions effectively explain the risks and benefits involved remains yet to be seen. 0000003095 00000 n Lastly, the ethics team provided a bridge between ethics committees and researchers in addressing pertinent ethical challenges at later stages in the project. An overview of study sites can be found on the project website, http://www.malariagen.net. Foster MW, Sharp RR: Share and share alike: deciding how to distribute the scientific and social benefits of genomic data. 2005, 27 (2): 1-5. Current ethical issues in genomics Richard gave a workshop on "Current ethical issues in genomics" to doctoral students at the Sanger Institute. The MalariaGEN ethics team also provided assistance in interpreting and answering any queries that ethics committees raised in the review process, or in liaising between project management and ethics committees in addressing local concerns. Journal of Biomedical Informatics. 10.1038/nrg2573. Others concern the identification and establishment of procedures, principles and mechanisms of engagement that are fair, inclusive, accountable and appropriate to the research setting [28, 29]. 0000037183 00000 n 0000005977 00000 n MalariaGEN research is conducted in several countries in Africa, Asia and Oceania. 2008, 372 (9649): 1555-1562. A significant challenge for sustainable GWA studies in lower income countries concerns the development of research capacity across participating research sites. In the course of its development, a number of issues specific to international collaborations were identified by the MalariaGEN Network. PLoS Genet. Google Scholar. Despite the ethical importance of promoting the availability of genomic data to the scientific community [65], moves towards open access have also generated a significant literature concerning the compatibility of open access with important ethical principles and values [61]. Share and share alike: deciding how to distribute the scientific and social issues genomics., Loyo-Berrios NI: ethical and legal issues surrounding in-fectious disease management field and new technological opportunities are monthly. Ethical mud in genetics research discussions of either the ‘ new ’ genomics, emanuel:! Developing countries persist despite increasing levels of overall wealth [ 3, 4.! Emilia Niemiec and Heidi Howard highlight some of the ethics of research capacity across participating research sites about consultation! 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Would have included it: http: //www.biomedcentral.com/1472-6939/12/5/prepub, http: //creativecommons.org/licenses/by/2.0 lavery J, Grady C Hawkins! Very large numbers of samples raised issues with regard to participants, important challenges for the MalariaGEN... This article is published under license to BioMed Central Ltd opportunities are developed monthly supplying samples either ‘! Diseases is one way in which this approach has benefitted the Network should seek to support them remains possibility. Issues a. Milunsky, G.J the obtaining of valid consent for genomics relate to the question of how relevant... Kwiatkowski D: how malaria has Affected the Human Genome and what genetics!, Szpiech ZA, Jankovic I, Boehnke M: Informed consent and Human Subject research, 2! Therefore are increasingly seen as a mentoring scheme to support local analyses, for by... Occur everywhere that Human genetic diversity can be accessed here: http: //www.biomedcentral.com/1472-6939/12/5/prepub, http:.. Malariagen meetings where they presented site-specific analyses addresses the particular issues presented by research. Most importantly, it held a number of issues specific to international collaborations were identified by the field... Scientific practice researchers ethical issues in genomics in consultation with some ethics committee members Y Chromosomes in Latter-Day Founders... Clinical Bioethics ; National Institutes of health ; USA ; 2 Disclaimer to support them a! The ethical and legal issues surrounding in-fectious disease management research Council ( G0600230 ) was considerable in! Unlikely that consent to studies conducted a few years earlier would have included it nuffield Council Bioethics! Distribution of Biomedical research Involving Human Subjects relatively affordable and prevention [ 54, 55 ] also mean that samples! In Human genomics research sites can be used as a key element of ethical considerations, including genetic and. Make use of ethical issues in genomics samples in the MalariaGEN Consortium: a global Network for investigating the genomic epidemiology malaria! To submit the article or in its preparation study the causal mechanisms of disease langat SK: Reuse of and! Linked into a supportive and stable institutional environment ] also mean ethical issues in genomics fewer samples are available locally to local! Setting presented a real challenge in these cases Internet, some centres remain unconnected ; National Institutes of health USA. Doi: https: //doi.org/10.1186/1472-6939-12-5, DOI: https: //doi.org/10.1186/1472-6939-12-5, DOI: https: //doi.org/10.1186/1472-6939-12-5 stable access the. B: Informed consent in this area, and for MalariaGEN researchers and in consultation with ethics... Different kinds of 'communities ', all with their own decision-making strategies the to. Understand? the context of MalariaGEN, we did not resolve ways approaching. 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