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Proposed

Bill: Changes to the research ethics committee system

Official title (in Danish): Forslag til lov om ændring af lov om videnskabsetisk behandling af sund­heds­videnska­belige og sund­hedsdatavidenska­belige for­skning­s­pro­jek­ter, lov om videnskabsetisk behandling af kliniske afprøvninger af medicinsk udstyr og undersøgelser af ydeevne af medicinsk udstyr til in vitro-diagnostik m.v. og lov om kliniske forsøg med lægemidler. (Risikobaseret bedømmelse, tværfaglig ekspertise og øget information til forsøgspersoner i det videnskabsetiske komitésystem)

Bill · L 50 (2026-27)

In short

Reading time: 1 min
  • What is proposed:
    • The bill proposes three changes to the research ethics committee system, which assesses health research projects and clinical trials.
    • Projects with low or no risk must be able to be assessed by a sub-committee, a chair or a secretariat.
    • The committees must be able to set conditions that trial participants are informed in all cases where an exemption from the consent requirement has been granted, and the medical committees get one extra member.
  • Who would be affected: The bill will affect trial participants and the research ethics committees.
  • When: The bill has not been passed yet.

Written by AI from verbatim quotes from the source and checked by code and AI. Dates, tables and the fact box are calculated by fixed rules. Unofficial translation. Always read the original.

If the bill is passed:

  • Projects that must be notified to the committee system and that involve low or no risk can be assessed by a sub-committee, a chair or a secretariat.
  • The risk is assessed according to rules laid down in an executive order.
  • Each medical research ethics committee gets one extra member with knowledge of e.g. data ethics, philosophy or technological development.
  • The regional committees and the National Scientific Ethics Committee can set conditions on information to trial participants in all cases where an exemption from the requirement to obtain renewed consent has been granted. Today the option only applies to projects involving extensive mapping of the genome, so this is an extension. Trial participants will then have to decide whether they want to opt out of taking part in the project.

Sources and original

Read the official text (in Danish) →

Source: the Danish Parliament (ft.dk)

Translated from Danish · The Danish version and the original source apply.

Summary by the Danish Parliament (in Danish)

Den daværende regering (Socialdemokratiet, Venstre og Moderaterne) indgik den 21. november 2024 en aftale med Dan­marks­de­mokraterne, Socialistisk Folkeparti, Det Konservative Folkeparti, Dansk Folkeparti og Radikale Venstre om en strategi for life science ("Strategi for life science frem mod 2030"). Lovforslaget udspringer af analysen af Fremtidens komitésystem, som er udarbejdet med afsæt i life science-strategien fra 2024. Det foreslås, at projekter, der er an­meldelsespligtige til det videnskabsetiske komitésystem, kan bedømmes af et underudvalg, en formand eller et sekretariat, hvis de indebærer lav eller ingen risiko. Vurderingen skal ske efter regler for risikobaseret bedømmelse, som bliver fastsat i en bekendtgørelse. Det foreslås, at de regionale komitéer og National Videnskabsetisk Komité får mulighed for at fastsætte vilkår om information til forsøgspersonerne i alle sager, hvor der gives dispensation fra kravet om at indhente fornyet samtykke. Dette er en udvidelse af den gældende mulighed. Det foreslås, at hver af de videnskabsetiske medicinske komiteer suppleres med et tværdisciplinært medlem med kompetencer indenfor f.eks. dataetik, filosofi eller teknologiudvikling m.v. Lovforslaget er en genfremsættelse af L 132, folketingsåret 2025-26, 1. samling.

Source: Folketinget (ft.dk). Reproduced unchanged.

Timeline

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  1. Introduced · 8 October 2026
    Status in the Danish Parliament: Fremsat
    Folketingets Åbne Data – sagstrin: fremsættelse
  2. 1. beh./Henvist til udvalg · 22 October 2026
    Status in the Danish Parliament: 1. beh./Henvist til udvalg
    Folketingets Åbne Data – sagstrin: 1. behandling
  3. Passed
    Awaiting the Danish Parliament
  4. Enters into force
    The date is not known yet