Studies on the ethics of automating clinical or research decision making using artificial intelligence and other algorithmic tools abound. Less attention has been paid, however, to the scope for, and ...ethics of, automating decision making within regulatory apparatuses governing the access, use, and exchange of data involving humans for research. In this article, we map how the binary logic flows and real-time capabilities of automated decision support (ADS) systems may be leveraged to accelerate one rate-limiting step in scientific discovery: data access management. We contend that improved auditability, consistency, and efficiency of the data access request
using ADS systems have the potential to yield fairer
in requests for data largely sourced from biospecimens and biobanked samples. This procedural justice rationale reinforces a broader set of participant and data subject rights that data access committees (DACs) indirectly protect. DACs protect the rights of citizens to benefit from science by bringing researchers closer to the data they need to advance that science. DACs also protect the informational dignities of individuals and communities by ensuring the data being accessed are used in ways consistent with participant values. We discuss the development of the Global Alliance for Genomics and Health Data Use Ontology standard as a test case of ADS for genomic data access management specifically, and we synthesize relevant ethical, legal, and social challenges to its implementation in practice. We conclude with an agenda of future research needed to thoughtfully advance strategies for computational governance that endeavor to instill public trust in, and maximize the scientific value of, health-related human data across data types, environments, and user communities.
There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health ...discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Contradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues.
Ethics review for international data-intensive research Dove, Edward S.; Townend, David; Meslin, Eric M. ...
Science (American Association for the Advancement of Science),
03/2016, Letnik:
351, Številka:
6280
Journal Article
Recenzirano
Odprti dostop
Ad hoc approaches mix and match existing components
Historically, research ethics committees (RECs) have been guided by ethical principles regarding human experimentation intended to protect ...participants from physical harms and to provide assurance as to their interests and welfare. But research that analyzes large aggregate data sets, possibly including detailed clinical and genomic information of individuals, may require different assessment. At the same time, growth in international data-sharing collaborations adds stress to a system already under fire for subjecting multisite research to replicate ethics reviews, which can inhibit research without improving the quality of human subjects' protections (
1
,
2
). “Top-down” national regulatory approaches exist for ethics review across multiple sites in domestic research projects e.g., United States (
3
,
4
), Canada (
5
), United Kingdom, (
6
), Australia (
7
), but their applicability for data-intensive international research has not been considered. Stakeholders around the world have thus been developing “bottom-up” solutions. We scrutinize five such ef orts involving multiple countries around the world, including resource-poor settings (table S1), to identify models that could inform a framework for mutual recognition of international ethics review (i.e., the acceptance by RECs of the outcome of each other's review).
To update previous correspondence to this journal,1 we are pleased to report that, in large part through the efforts of the biomedical research community, a European General Data Protection ...Regulation that is favourable for research was agreed by Member States and Parliament in December, 2015.2 Although the Regulation will probably not apply until mid-2018, now is an appropriate time to highlight the implications for biomedical research.
Abstract
The delivery of good outcomes from human health research is entirely dependent on the proper functioning of the attendant regulatory systems. This article focuses on the
processes
of ...regulation themselves, and how these might be better understood, so that regulators and other stakeholders have a strong normative basis upon which to pursue the regulatory objective of achieving outcomes with maximum social value. The argument is made that the concept of ‘processual regulation’—which promotes a whole systems approach to regulation—can assist greatly in the design, implementation, and review of human health research. This moves beyond the current often-fragmented approach to regulation towards a joined-up, reflective, and responsive system that has fitness-for-purpose at its core.
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