Ethics review for international data-intensive research

Dove, Edward S.; Townend, David; Meslin, Eric M.; Bobrow, Martin; Littler, Katherine; Nicol, Dianne; Vries, Jantina de; Junker, Anne; Garattini, Chiara; Bovenberg, Jasper A.; Shabani, Mahsa; Lévesque, Emmanuelle; Knoppers, Bartha Maria

doi:10.1126/science.aad5269

Cited by 47 publications

(55 citation statements)

References 4 publications

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“…Current efforts by the Global Alliance and others to develop common review standards, procedures, and conditions for exchanging data should improve efficiency without compromising the role ethics review boards can play in ensuring that privacy, security, and concerns about potentially controversial or exploitative research are addressed and are perceived as being addressed by the public and relevant subpopulations [4,35]. Among other things, review boards can require specification of the terms of use in an agreement that includes sanctions for violations and is enforceable across jurisdictions [9].…”

Section: Strategies To Promote Global Genomic Data Sharingmentioning

confidence: 99%

Beyond Our Borders? Public Resistance to Global Genomic Data Sharing

2016

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Prospects have never seemed better for a truly global approach to science to improve human health, with leaders of national initiatives laying out their vision of a worldwide network of related projects. An extensive literature addresses obstacles to global genomic data sharing, yet a series of public polls suggests that the scientific community may be overlooking a significant barrier: potential public resistance to data sharing across national borders. In several large United States surveys, university researchers in other countries were deemed the least acceptable group of data users, and a just-completed US survey found a marked increase in privacy and security concerns related to data access by non-US researchers. Furthermore, diminished support for sharing beyond national borders is not unique to the US, although the limited data from outside the US suggest variation across countries as well as demographic groups. Possible sources of resistance include apprehension about privacy and security protections. Strategies for building public support include making the affirmative case for global data sharing, addressing privacy, security, and other legitimate concerns, and investigating public concerns in greater depth.

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Section: Strategies To Promote Global Genomic Data Sharingmentioning

confidence: 99%

Beyond Our Borders? Public Resistance to Global Genomic Data Sharing

2016

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“…In practice, the ICO and other regulatory bodies in the UK tend to default to the “consent or anonymise” model (partly due to the provision of rights to private life under Article 8 [1] of the ECHR).…”

Section: Main Textmentioning

confidence: 99%

“…The improvement of healthcare can be accelerated by an information governance framework that facilitates audit and research across an entire region [1]. The European Union (EU) offers an opportunity to maximise the benefits of harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), enabling improvement of healthcare by comparisons across the entire supranational trading bloc.…”

Section: Introductionmentioning

confidence: 99%

A critique of the regulation of data science in healthcare research in the European Union

Rumbold

Pierscionek

2017

BMC Med Ethics

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The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

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“…7 In consequence, the pursuit of local IRB review at multiple research sites resulted in redundancy and inconsistent outcomes and, it seems safe to say, offered no additional protection to participants. 8 The sIRB rule aligns in many ways with the NIH Single IRB Policy, which was announced in June 2016 and went into effect on January 25, 2018. This policy "expects" that, subject to a few exceptions, sIRB review will be undertaken for all NIH-funded multi-site non-exempt human subjects research protocols carried out at more than one site in the US.…”

Section: Introductionmentioning

confidence: 99%