<p>To move Alzheimer Disease (AD) research forward it is essential to collect data from large cohorts, but also make such data available to the global research community. We describe the creation of an open science dataset from the PREVENT-AD (PResymptomatic EValuation of Experimental or Novel Treatments for AD) cohort, composed of cognitively unimpaired older individuals with a parental or multiple-sibling history of AD. From 2011 to 2017, 386 participants were enrolled (mean age 63 years old ± 5) for sustained investigation among whom 349 have retrospectively agreed to share their data openly. Repositories are findable through the unified interface of the Canadian Open Neuroscience Platform and contain up to five years of longitudinal imaging data, cerebral fluid biochemistry, neurosensory capacities, cognitive, genetic, and medical information. Imaging data can be accessed openly at <a href="https://openpreventad.loris.ca" target="_blank">https://openpreventad.loris.ca</a> while most of the other information, sensitive by nature, is accessible by qualified researchers at <a href="https://registeredpreventad.loris.ca" target="_blank">https://registeredpreventad.loris.ca</a>. In addition to being a living resource for continued data acquisition, PREVENT-AD offers opportunities to facilitate understanding of AD pathogenesis.</p>
A systematic way of recording data use conditions that are based on consent permissions as found in the datasets of the main public genome archives (NCBI dbGaP and EMBL-EBI/CRG EGA).
While modern genomics research often adheres to community norms emphasizing open data sharing, many genomics institutes and projects have recently nuanced such norms with a corpus of data release policies. In particular, publication moratoria and data retention policies have been enacted to ‘reward’ data producers and ensure data quality control. Given the novelty of these policies, this article seeks to identify and analyse the main features of data retention and publication moratoria policies of major genomics institutes and projects around the world. We find that as more collaborative genomics projects are created, and further genomic research discoveries are announced, the need for more sophisticated yet practical and effective policies will increase. Reward systems should be implemented that recognize contributions from data producers and acknowledge the need to remain dedicated to the goals of open data sharing. To this end, in addition to the current choices of employing data retention or publication moratoria policies, alternative models that would be easier to implement or less demanding on open science should also be considered.
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.
In this letter to the editor, we respond to the recent publication by Philibert et al. Methylation array data can simultaneously identify individuals and convey protected health information: an unrecognized ethical concern (Clinical Epigenetics 2014, 6:28). Further discussion of the issues raised by the risk of re-identification of epigenetic methylation data is needed, and a more nuanced approach should be taken with respect to its implications for data sharing policy than the one provided.
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.
In the past decade, there has been a surge in the number of sensitive human genomic and health datasets available to researchers via Data Access Agreements (DAAs) and managed by Data Access Committees (DACs). As this form of sharing increases, so do the challenges of achieving a reasonable level of data protection, particularly in the context of international data sharing. Here, we consider how excessive variation across DAAs can hinder these goals, and suggest a core set of clauses that could prove useful in future attempts to harmonize data governance.
Large-scale epigenome mapping by the NIH Roadmap Epigenomics Project, the ENCODE Consortium and the International Human Epigenome Consortium (IHEC) produces genome-wide DNA methylation data at one base-pair resolution. We examine how such data can be made open-access while balancing appropriate interpretation and genomic privacy. We propose guidelines for data release that both reduce ambiguity in the interpretation of open-access data and limit immediate access to genetic variation data that are made available through controlled access.
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