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Any proposed DTP genomic research would need to comply with the specific requirements of Chapter 3.3 to be satisfactorily addressed for ethical approval. 1.2 The National Health and Medical Research Council has the issue of Direct to Customer Genetic Testing under consideration and has published thr...

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Vydané v:The Journal of law, medicine & ethics Ročník 47; číslo 4; s. 582 - 704
Hlavní autori: Zawati, Ma'n H., Chalmers, Don, Dallari, Sueli G., de Neiva Borba, Marina, Pinkesz, Miriam, Joly, Yann, Chen, Haidan, Hartlev, Mette, Leitsalu, Liis, Soini, Sirpa, Rial-Sebbag, Emmanuelle, Hoppe, Nils, Garani-Papadatos, Tina, Vidalis, Panagiotis, Srinivas, Krishna Ravi, Siegal, Gil, Negri, Stefania, Hatanaka, Ryoko, Al-Hussaini, Maysa, Al-Tabba', Amal, Motta-Murgía, Lourdes, Moran, Laura Estela Torres, Hendriks, Aart, Nnamuchi, Obiajulu, Isasi, Rosario, Krekora-Zajac, Dorota, Sadoun, Eman, Ho, Calvin, Andanda, Pamela, Lee, Won Bok, Nicolás, Pilar, Mattsson, Titti, Talanova, Vladislava, Dosch, Alexandre, Sprumont, Dominique, Fan, Chien-Te, Hung, Tzu-Hsun, Kaye, Jane, Phillips, Andelka, Gowans, Heather, Shah, Nisha, Hazel, James W.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Los Angeles, CA SAGE Publications 01.12.2019
Cambridge University Press
Wiley
Predmet:
Aboriginal Australians
Biological Specimen Banks
Biomedical Research / ethics
Biomedical Research / legislation & jurisprudence
Confidentiality / legislation & jurisprudence
Consent
Cultural heritage
Direct-To-Consumer Screening and Testing / legislation & jurisprudence
Ethics Committees, Research / legislation & jurisprudence
Genetic testing
Genetic Testing / legislation & jurisprudence
Genomics
Hazardous Substances
Health
Humans
Internationality / legislation & jurisprudence
Internet
Juridik
Laboratories
Law
Life Sciences
Medical research
Minority & ethnic groups
Patient Selection
Policy Making
Research design
Research ethics
Research Personnel / psychology
Research Report
Researchers
Samhällsvetenskap
Social Sciences
Surveys and Questionnaires
Australia
ISSN:1073-1105, 1748-720X, 1748-720X
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Shrnutí:Any proposed DTP genomic research would need to comply with the specific requirements of Chapter 3.3 to be satisfactorily addressed for ethical approval. 1.2 The National Health and Medical Research Council has the issue of Direct to Customer Genetic Testing under consideration and has published three relevant information documents.1 1.3 The Commonwealth Australia Government, Department of Health has issued guidance for the Provision of Direct-to-Consumer Genetic Tests: Guiding Principles for Providers.2 The Australian Genomics Health Alliance (AGHA) published a news page on Understanding Direct-to-Consumer Genetic Testing, with information on clinical-grade testing.3 2. There is an over-riding requirement to respect “beliefs, customs and cultural heritage, and local laws” of all participants in other countries.5 The Australian HREC would require approval from the research ethics review body in the other country, where there is one.6 Where there are no “ethics approval processes” in the overseas country, research participants must be “accorded no less respect than [the] National Statement requires,”7 as well as these specific elements for Research generally in Chapter 3.1 and Genomic Research, in particular, as set out in Chapter 3.3.8 As far as is necessary to satisfy the requirements of paragraphs 1.10 to 1.13, the design and conduct of the research should reflect continuing consultation with the local participant population and the communities to which they belong.9 The Australian researcher conducting DTP genomic research in another country must also comply with the Australian Code for the Responsible Conduct of Research, 2018.10 4. Please consider the perspectives of the public, research participants, socially-defined groups (e.g., indigenous or minority populations), researchers, and other professional or government entities. Specific issues with specific research participants, such as socially-defined groups, including as examples indigenous or minority populations, would be critical components of the research design and ethical approval processes.
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ISSN:1073-1105
1748-720X
1748-720X
DOI:10.1177/1073110519897736