Policy experts advocate mutual recognition for reviews of international research data intensive ;
genomic research has great potential to improve human health and medicine. But for the millions of data points that are collected through the efforts of large-scale sequencing to be truly valuable, they must be analyzed together and sharing across institutions and jurisdictions. This poses many challenges, including navigation processes-complex ethical approval at multiple sites and in multiple jurisdictions.
In an article Policy Forum published this week in the journal Science , members of equivalence (ERE) Task Force Ethics Review of the Global Alliance for Genomics and Health (GA4GH) Regulatory and ethics Working Group discussed this challenge and ways to cope, particularly through ad hoc models to achieve ethical review “mutual recognition” worldwide.
“As more data sharing and research becomes increasingly connected and collaborative structures national government research are beginning to address the need for harmonization of procedures and standards between ethics committees research (CER). for example, a REC alone is needed to pass an internal multi-site project genomics research in the UK, “said Edward Dove, a doctoral student at the University of Edinburgh School of Law in the UK, Coordinator of the task Force ERE, and lead author. “However, these reforms government or regulations do not apply when data are shared internationally. At the international level, the challenges are many and remain unresolved. Multiple and often duplicated, ethics approvals are needed, without any evidence that these benefits participants, science or society. “
A first step
As a first step towards mutual recognition between ethics committees, the Task Force ERE met in Switzerland in June 2015 to identify and develop assessment models ethics are used throughout the world as well as ethical assessment methods that allow more efficient distribution of genomic and clinical data for research. Funded by the Public Population Project in Genomics and Society (P3G), the Wellcome Trust and the Foundation Brocher, those attending the meeting were experts in ethics of Australia, Belgium, Canada, the Netherlands, the United Kingdom, USA ., and South Africa. Through discussions based on the theory and practical experience, participants identified three models of mutual recognition: reciprocity, the delegation and the federation. In many cases, some combination of the three is conducted, leading to an ad hoc, mix and match approach.
Current models for reform have multiple variations and come with advantages and disadvantages, which are outlined in the article. For example, reciprocity allows flexible criteria review, but can be time at the initial stage of implementation. Federation, while reducing costs and duplication of multiple CER, is difficult to implement because of problems in getting several jurisdictions agreement on policy and standards.
Symposium to be held in Montreal
“Ultimately, what we need is an international organization that has the support of the authorities and to enable multi-stakeholder ethical review the system of mutual recognition for intensive international research data,” said Bartha Knoppers , director of the Center for Genomics and Policy at McGill University, President of the P3G in Montreal, and Chairman of the Working Group on Regulation and Ethics GA4GH. In the meantime, however, the special models described in the document provide a framework to guide current initiatives of international data exchange.
Knoppers added that “GA4GH has a fundamental role to work with regulatory authorities at regional, national and international levels.” To this end, the Task Force will hold a ERE second symposium to be held in Montreal in May 2016 researchers, industry members, ethicists, legislators and regulators around the world will meet to extend the work begun in 2015.
This article was originally published on medicalxpress, Read the original article
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