Evidence map›Paper›PMID 29150824›Full record

ArticleJournal of community genetics2018

Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape.

L Kalokairinou, H C Howard, S Slokenberga, E Fisher, M Flatscher-Thöni, M Hartlev, R van Hellemondt, J Juškevičius, J Kapelenska-Pregowska, P Kováč and 15 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of community genetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

39 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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  8. Article
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  10. Article
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  12. New insights from the last decade of research in psychiatric genetics: discoveries, challenges and clinical implications.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2023
    Article
  13. Evaluation ofFrontiers in molecular biosciences · 2023
    Article
  14. Review
  15. Article
  16. Review
  17. Genomic health data generation in the UK: a 360 view.European journal of human genetics : EJHG · 2022
    Article
  18. Article
  19. Article
  20. Article
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

25 authors.

L KalokairinouDepartment of Public Health and Primary Care, Centre for Biomedical Law and Ethics, University of Leuven, Kapucijnenvoer 35, Box 7001, 3000, Leuven, Belgium. louiza.kalokairinou@med.kuleuven.be.
H C HowardCentre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
S SlokenbergaCentre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
E FisherRobert Koch-Institute, Berlin, Germany.
M Flatscher-ThöniInstitute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria.
M HartlevFaculty of Law, University of Copenhagen, Copenhagen, Denmark.
R van HellemondtLeiden University Medical Centre, Leiden, the Netherlands.
J JuškevičiusFaculty of Law, Mykolas Romeris University, Vilnius, Lithuania.
J Kapelenska-PregowskaFaculty of Law and Administration, Nicolaus Copernicus University, Toruń, Poland.
P KováčForensic.sk Inštitút forenzných medicínskych expertíz s.r.o, Bratislava, Slovakia.
L LovrečićClinical Institute of Medical Genetics, University Medical Centre Ljubljana, Ljubljana, Slovenia.
H NysDepartment of Public Health and Primary Care, Centre for Biomedical Law and Ethics, University of Leuven, Kapucijnenvoer 35, Box 7001, 3000, Leuven, Belgium.
A de PaorSchool of Law and Government, Dublin City University, Dublin, Ireland.
A PhillipsSchool of Law, Trinity College Dublin, University of Dublin, Dublin, Ireland.
L PrudilAK PRUDIL a spol, Brno, Czech Republic.
E Rial-SebbagInstitut national de la santé et de la recherche médicale, Paris, France.
C M Romeo CasabonaThe University of the Basque Country, Leioa, Spain.
J SándorFaculty of Political Science, Legal Studies and Gender Studies of the Central European University, Budapest, Hungary.
A SchusterDepartment of Legal Sciences, University of Trento, Trento, Italy.
S SoiniHelsinki University Central Hospital, Helsinki, Finland.
K H SøvigFaculty of law, University of Bergen, Bergen, Norway.
D StoffelUniversity Paris-Est Créteil, Créteil, France.
T TitmaSchool of Governance, Law and Society, Tallinn University, Tallinn, Estonia.
T TrokanasSchool of Law, European University of Cyprus, Egkomi, Cyprus.
P BorryDepartment of Public Health and Primary Care, Centre for Biomedical Law and Ethics, University of Leuven, Kapucijnenvoer 35, Box 7001, 3000, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.

Indexed as

Direct-to-consumer genetic testsGenetic counsellingInformed consentIn vitro diagnostic medical devicesMedical supervisionRegulation

Identifiers

PMID29150824
PMCPMC5849704

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.