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Informed consent

Is broad biobank consent good enough?

Mikkelsen RB, Gjerris M, Waldemar G, et al. · BMC medical ethics · 2019

Open access · cc by · source: Europe PMC

Study-specific consent looks strict but fits biobanks poorly; a modified broad consent that is also ‘deep’ best protects participants on the authors’ criteria-based model.

Study at a glance

Design
Other — Criteria-based ethical argument for modified broad (‘deep’) biobank consent
N
Normative bioethics analysis; not an empirical sample
Population
Biobank consent models (study-specific vs broad vs modified deep broad consent)
Outcome
Deepened broad consent as best protecting participants for biobank reuse

Structured fields used in claim comparison tables when every cited study has a complete layer.

Key findings

Broad consent as usually practised is not enough unless deepened. Specific consent is the intuitive starting point but fails biobank reuse. Protection of participants is the test, not administrative convenience alone.

Methodology

They map why managers adopted broad consent, contrast study-specific consent, then argue for a modified version assessed against explicit criteria rather than slogans.

Limitations

This is a normative model paper, not a biobank RCT. It does not measure how ‘deep’ any existing form is.

How this study connects

Role on claims

Each row is a claim on a concept or method page where this paper supports, challenges, or qualifies the statement. Roles are hand-checked — not a model guess.

  • SupportsInformed consentconcept

    Study-specific consent fits biobanks poorly; a modified broad consent that is also ‘deep’ is argued to protect participants better.

    Evidence for the claim as stated.

  • SupportsInformed consentconcept

    Broad/deep biobank consent and dynamic consent both reject one-off study-specific forms, but one leans on criteria-based protection and the other on a living digital interface.

    Evidence for the claim as stated.

Open questions

Tensions this paper is part of

From concept pages' “where studies disagree.” Disagreement means the same question; scope means different assays, populations, or outcomes.

  • Scope difference — different assays, populations, or outcomes

    Broad/deep biobank consent and dynamic consent both reject one-off study-specific forms, but one leans on criteria-based protection and the other on a living digital interface.

    Also on this tension

Discoveries this paper informs or conflicts with

Related papers in this topic

Same topic cluster — not a recommendation engine.