Namely, children presenting at the hospital were often severely ill and required immediate medical assistance. Social Science & Medicine. Even today, only a small proportion of medical research focuses on the problems primarily affecting the world's poorest people . 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 … 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. J Med Ethics. 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. Parker M: When is research on patient records without consent ethical?. BMC Medical Ethics. Children are important participants in genetics research, and in genetics research involving children, IRBs must address the primary issues of privacy, confidentiality, informed consent, and the return of results. 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. Important issues such as ownership of samples and data and capacity to analyse genomic data need to be addressed for such studies to be successful. Social Science & Medicine. Within the context of MalariaGEN, we did not resolve ways of addressing these challenges. 0000006361 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 . Contributors Richard Milne. In practice, MalariaGEN researchers across the network engaged in some form of community engagement, but the majority of such initiatives were developed ad hoc by researchers in the absence of agreed-upon guidelines for best practice or even a toolkit for community engagement. 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. 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, New York: Cambridge University Press. A key challenge for genomics research conducted on populations with lower average income and literacy levels is how conditions can be created under which it is possible for researchers and research ethics committees to feel confident that samples and data will be used appropriately, and that the decision-making process for their use is sufficiently transparent. 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]. Abstract. Because GWA studies require access to sophisticated laboratories and large-scale genotyping facilities with attendant statistical expertise, most of which are currently only available in a few countries in the world, samples collected for GWA studies are often exported for processing, quality control and genotyping. 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. Some of these relate to the question of how the relevant community is to be identified and represented [24, 27]. 0000036255 00000 n 2004, 364: 1086-1091. They underline the need for education and research on ethical aspects of new genomic technologies. These technical questions raise important ethical questions: When should a test be made available? 2008, Sixth Revision, CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Author information: (1)Biochemical Genetics and Newborn Screening Departments, The Children's Hospital at Westmead, Sydney, New South Wales, Australia. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania. For more than two decades, the National Human Genome Research Institute has (NHGRI) has been committed to driving the responsible use of genomics in society in order to advance knowledge and ensure that genomics benefits the health of all populations. 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). 0000007965 00000 n The empirical literature that exists on community partnership tends to show that the achievement of these benchmarks may only really be possible in the context of effective and sustained community engagement and accountability [24–26]. 2008. 10.1038/nrg2124. Critical Public Health. 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. Trends in Genetics. 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. 0000005014 00000 n IRB: Ethics and Human Research. PPSI Committee Members. 2005, 77: 171-190. Bulletin of the World Health Organisation. 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. 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]. Identity and Governance in an Age of Genomics. PLoS Genet. Découvrez et achetez Ethical Challenges in Genomics Research. 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. 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. One way in which this approach has benefitted the Network is in providing assistance during ethics review. Particularly challenging is the fact that many of the potential harms and benefits of genomics research relate to populations rather than to individuals . 2009, 10: 331-335. Significant improvements in malaria treatment and prevention [54, 55] also mean that fewer samples are available for research on that disease. Will the number of false positives or false negatives cause more harm than … 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. Developing World Bioethics. 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. 0000038492 00000 n Some nations have made progress and made patenting human genes illegal, however there are still many places in the world that it is still legal. 2007, 33 (1): 35-38. In particular, the network should seek to support local analyses, for instance by making a data analyst available to all sites. 10.1016/S0140-6736(05)66420-3. Fairhead J, Leach M, Small M: Where techno-science meets poverty: Medical research and the economy of blood in The Gambia, West Africa. Papers reporting on the results of these studies are forthcoming. 0000017648 00000 n Through the execution of the Action Plan, the committee hopes to raise the community’s awareness of ethical and social issues that arise in the conduct of genetics and genomics research, and to help researchers navigate these issues. Retrouvez Ethical Challenges in Genomics Research: A Guide to Understanding Ethics in Context et des millions de livres en stock sur Amazon.fr. Most of the ethical discussions related to genome editing center around human germline because editing changes made in the germline would be passed down to future generations. 2004, 189: 930-937. 2005, 27 (2): 1-5. Researchers are able to analyse and publish analyses of their data increasingly seen as key! Y Chromosomes in Latter-Day Saints Founders and Comparison to Utah samples in the preference centre often have to rely on... The health of others ( the duty of mechanisms of disease have to on. 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