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Record W3023644100 · doi:10.1093/jlb/lsaa010

Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies†

2020· article· en· W3023644100 on OpenAlex
James Scheibner, Marcello Ienca, Sotiria Kechagia, Juan Ramón Troncoso-Pastoriza, Jean Louis Raisaro, Jean‐Pierre Hubaux, Jacques Fellay, Effy Vayena

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueJournal of Law and the Biosciences · 2020
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
Fundersnot available
KeywordsData Protection Act 1998ConfidentialityLegislatureData sharingInformation privacyGeneral Data Protection RegulationCorporate governanceResearch ethicsPolitical scienceBusinessData governanceEuropean unionInternet privacyComputer securityMedicineComputer scienceEngineering ethicsLawEngineeringData quality

Abstract

fetched live from OpenAlex

Personalised medicine can improve both public and individual health by providing targeted preventative and therapeutic healthcare. However, patient health data must be shared between institutions and across jurisdictions for the benefits of personalised medicine to be realised. Whilst data protection, privacy, and research ethics laws protect patient confidentiality and safety they also may impede multisite research, particularly across jurisdictions. Accordingly, we compare the concept of data accessibility in data protection and research ethics laws across seven jurisdictions. These jurisdictions include Switzerland, Italy, Spain, the United Kingdom (which have implemented the General Data Protection Regulation), the United States, Canada, and Australia. Our paper identifies the requirements for consent, the standards for anonymisation or pseudonymisation, and adequacy of protection between jurisdictions as barriers for sharing. We also identify differences between the European Union and other jurisdictions as a significant barrier for data accessibility in cross jurisdictional multisite research. Our paper concludes by considering solutions to overcome these legislative differences. These solutions include data transfer agreements and organisational collaborations designed to `front load' the process of ethics approval, so that subsequent research protocols are standardised. We also allude to technical solutions, such as distributed computing, secure multiparty computation and homomorphic encryption.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.031
metaresearch head score (Gemma)0.019
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Science and technology studies
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.740
Threshold uncertainty score0.998

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0310.019
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.006
Scholarly communication0.0000.001
Open science0.0010.001
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.854
GPT teacher head0.626
Teacher spread0.228 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it