Country Reports

Abstract

There has been little, if any, discussion of the issue as of now b. There has been discussion among researchers, but little discussion among policy makers c. There has been discussion among both researchers and policy makers d. I am not sure -or other answer 1.1 In Australia, genomic research would require ethics approval like any other human research. DTP research would also attract the general requirements for approving human research, including minimizing risk and ensuring consent (Chapter 2.1-2.3 National Statement). In addition, there are specific requirements for Genomic Research in the National Statement in Chapter 3.3. 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. Assume that a researcher in your country wants to conduct DTP genomic research with participants in your country and that such research is subject to IRB/REC review. Please describe the conditions for IRB/ REC approval, if it could be approved at all.

Returning individual research results in international direct-to-participant genomic research: results from a 31-country study

“…The countries taking this position were Australia, Brazil, Denmark, India, Peru, Qatar, South Africa, Spain, and Switzerland. While Australian researchers are “required to consider” [ 10 ] whether to return research results, for example, Brazil’s Guidelines for Ethical Analysis of Human Genetic Research Projects requires the universal return of individual results unless a participant has explicitly declined to receive them [ 10 ]. In Peru, regulations specify that both individual and aggregate results must be returned.…”

“…In Peru, regulations specify that both individual and aggregate results must be returned. Other provisions underline the importance of community benefit sharing [ 10 ]. Swiss law similarly provides a right “to be informed of results relating [to health]” and specifies that the communication of results must be carried out in a manner appropriate to the circumstance [ 10 ].…”

“…Other provisions underline the importance of community benefit sharing [ 10 ]. Swiss law similarly provides a right “to be informed of results relating [to health]” and specifies that the communication of results must be carried out in a manner appropriate to the circumstance [ 10 ]. In Denmark, rules on the return of results are governed by an Executive order of the Ministry of Health, which specifies that researchers must inform participants if important information about their health is discovered.…”

“…In July 2019, the research team met to compile findings and develop recommendations. Our principal findings and completed expert reports were published in the Journal of Law, Medicine & Ethics in the winter of 2019 [ 10 , 11 ]. While the findings reflect the views of leading experts in the regulation of genomic science, others in the surveyed countries might have reached different conclusions.…”

International Coordination of Research Ethics Review: An Adequacy Model

“…International research projects are typically subject to oversight from multiple IRBs-one at each participating site or country. In a 31-country survey of ethicolegal experts (hereafter: the "Country Reports"), Rothstein et al found that international DTP genomic research predominantly requires ethics reviews in both the researcher's country, as well as in each country where participants are recruited [1,3]. This survey explored requirements applying to international DTP genomic research, including IRB review, informed consent, local collaborators, restrictions on cross-border sample and data transfers, and rules specific to human genetic research.…”