Controlled access under review : improving the governance of genomic data access

In parallel with massive genomic data production, data sharing practices have rapidly expanded over the last decade. To ensure authorized access to data, access review by data access committees (DACs) has been utilized as one potential solution. Here we discuss core elements to be integrated into the fabric of access review by both established and emerging DACs in order to foster fair, efficient, and responsible access to datasets. We particularly highlight the fact that the access review process could be adversely influenced by the potential conflicts of interest of data producers, particularly when they are directly involved in DACs management. Therefore, in structuring DACs and access procedures, possible data withholding by data producers should receive thorough attention

Return of individual research results from genomic research: A systematic review of stakeholder perspectives.

Funder: Franca FundFunder: Canada Research Chair in Law and MedicineFunder: Canada Institute of Health ResearchFunder: Genome QuebecFunder: Genome CanadaFunder: Can-SHARE ConnectFunder: CIHRDespite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders' perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants

GA4GH: International policies and standards for data sharing across genomic research and healthcare.

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits

Variant data sharing by clinical laboratories through public databases : consent, privacy and further contact for research policies

Access to detailed variant data is key to inform and verify the interpretation of genomic data. Clinical laboratories can play a significant role in sharing patients' data through public variant databases. To facilitate data sharing, various public databases, such as ClinVar and DECIPHER have been established, which accept data submission from laboratories, clinicians, researchers, and patients. Despite clear benefits to sharing, questions may arise about the adequate form of consent to be obtained from patients when sharing data from their clinical tests through public databases. In this paper, we provide an overview and critical analysis of the relevant consent policies of the major public databases, and of the consent forms of clinical laboratories that share variant data via ClinVar

Registered access: authorizing data access

The Global Alliance for Genomics and Health (GA4GH) proposes a data access policy model-"registered access"-to increase and improve access to data requiring an agreement to basic terms and conditions, such as the use of DNA sequence and health data in research. A registered access policy would enable a range of categories of users to gain access, starting with researchers and clinical care professionals. It would also facilitate general use and reuse of data but within the bounds of consent restrictions and other ethical obligations. In piloting registered access with the Scientific Demonstration data sharing projects of GA4GH, we provide additional ethics, policy and technical guidance to facilitate the implementation of this access model in an international setting.SOMD is supported by the Canadian Institutes of Health Research (EP1-120608; EP1-120609; CEE-151618), Genome Quebec, Genome Canada, the Government of Canada, the Ministère de l’Économie, Innovation et Exportation du Québec (Can-SHARE grant 141210), and the Canada Research Chair in Law and Medicine. ML, IL, JT, and TN are supported by the ELIXIR, the research infrastructure for life-science data, and the H2020 ELIXIR-EXCELERATE grant 676559. IL and GK are supported by the European Molecular Biology Laboratory; MS by Research Foundation Flanders (FWO); MH by NIH/NHGRI 5U41HG002371-15; SW by NIH/NHGRI R00HG008175; S Beck by the National Institute for Health Research UCLH Biomedical Research Centre (BRC369/CN/SB/101310); S Brenner by NIH/NHGRI U41 HG007346; BMK by the Canada Research Chair in Law and Medicine; and PF by WT201535/Z/16/Z and the European Molecular Biology Laboratory

Registered access : a ‘Triple-A’ approach

We propose a standard model for a novel data access tier - registered access - to facilitate access to data that cannot be published in open access archives owing to ethical and legal risk. Based on an analysis of applicable research ethics and other legal and administrative frameworks, we discuss the general characteristics of this Registered Access Model, which would comprise a three-stage approval process: Authentication, Attestation and Authorization. We are piloting registered access with the Demonstration Projects of the Global Alliance for Genomics and Health for which it may provide a suitable mechanism for access to certain data types and to different types of data users

Legal aspects of genetic databases for international biomedical research: the example of the International Cancer Genome Consortium (ICGC).

There is a noticeable lack of international regulation on personal data exchange and management in research. This article sheds light in this area by describing how the International Cancer Genome Consortium is developing policies and procedures to address the ethical and legal issues raised by the international transfer of data and results. These policies and procedures aim, first and most importantly, to safeguard the interests of the research participants and other involved stakeholders and, secondly, to facilitate the sharing of data and results to realize greater benefits from this kind of internationally collaborative genetic research.link_to_subscribed_fulltex

Registered access: a ‘Triple-A’ approach

We propose a standard model for a novel data access tier – registered access – to facilitate access to data that cannot be published in open access archives owing to ethical and legal risk. Based on an analysis of applicable research ethics and other legal and administrative frameworks, we discuss the general characteristics of this Registered Access Model, which would comprise a three-stage approval process: Authentication, Attestation and Authorization. We are piloting registered access with the Demonstration Projects of the Global Alliance for Genomics and Health for which it may provide a suitable mechanism for access to certain data types and to different types of data users