Evidence map›Paper›PMID 30308031›Full record

ArticlePloS one2018

Considerations for ethics review of big data health research: A scoping review.

Marcello Ienca, Agata Ferretti, Samia Hurst, Milo Puhan, Christian Lovis, Effy Vayena

Open access · goldAbstract readScoping Review
In one paragraph

Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 1 pooled it
30.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 1 synthesis or guideline pooled it, 250 citations in OpenAlex.

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  17. Reframing data ethics in research methods education: a pathway to critical data literacy.International journal of educational technology in higher education · 2023
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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Marcello IencaHealth Ethics and Policy Laboratory, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.
Agata FerrettiHealth Ethics and Policy Laboratory, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.
Samia HurstInstitute for Ethics, History and the Humanities, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Milo PuhanEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Christian LovisDivision of Medical Information Sciences, Department of Radiology and Medical Informatics, University Hospital of Geneva, Geneva, Switzerland.
Effy VayenaHealth Ethics and Policy Laboratory, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.ORCID 0000-0003-1303-5467
ETH Zurich · CHUniversity Hospital of Geneva · CHUniversity of Geneva · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Big data trends in biomedical and health research enable large-scale and multi-dimensional aggregation and analysis of heterogeneous data sources, which could ultimately result in preventive, diagnostic and therapeutic benefit. The methodological novelty and computational complexity of big data health research raises novel challenges for ethics review. In this study, we conducted a scoping review of the literature using five databases to identify and map the major challenges of health-related big data for Ethics Review Committees (ERCs) or analogous institutional review boards. A total of 1093 publications were initially identified, 263 of which were included in the final synthesis after abstract and full-text screening performed independently by two researchers. Both a descriptive numerical summary and a thematic analysis were performed on the full-texts of all articles included in the synthesis. Our findings suggest that while big data trends in biomedicine hold the potential for advancing clinical research, improving prevention and optimizing healthcare delivery, yet several epistemic, scientific and normative challenges need careful consideration. These challenges have relevance for both the composition of ERCs and the evaluation criteria that should be employed by ERC members when assessing the methodological and ethical viability of health-related big data studies. Based on this analysis, we provide some preliminary recommendations on how ERCs could adaptively respond to those challenges. This exploration is designed to synthesize useful information for researchers, ERCs and relevant institutional bodies involved in the conduction and/or assessment of health-related big data research.

Indexed as

Big DataEthics, ResearchAdvisory CommitteesBiomedical ResearchDatabases, FactualDelivery of Health Care

Identifiers

PMID30308031
PMCPMC6181558
OpenAlexW2897037622

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.