Evidence map›Paper›PMID 32937036›Full record

ArticleEthics & human research2020

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs.

Agata Ferretti, Marcello Ienca, Samia Hurst, Effy Vayena

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Ethics & human research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.3field-weighted citation impact, top 5% 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

16 citing papers in PubMed, 43 citations in OpenAlex.

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  16. The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study.Journal of empirical research on human research ethics : JERHRE
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Agata FerrettiPhD candidate in Bioethics at the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
Marcello IencaSenior researcher at the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
Samia HurstProfessor of medical ethics and director of the Institute for Ethics, History, and the Humanities & Department of Community Health and Medicine, University of Geneva, Switzerland.
Effy VayenaProfessor of bioethics and director of the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
ETH Zurich · CHUniversity of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft-law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.

Indexed as

Big DataEthical ReviewEthics Committees, ResearchBiomedical ResearchHumansbig databig data researchbiomedical researchinstitutional review board (IRB)research ethics

Identifiers

PMID32937036
PMCPMC7814666
OpenAlexW3087750143

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.