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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.

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

    For open-ended research, consent must be broad-and-deep or revisable, not frozen at enrolment.

    Study-specific consent fits biobanks poorly; one argument favours a modified broad consent that is also 'deep', while another proposes dynamic consent — a personalised online platform through which participants are updated and re-asked as uses change.

    Evidence for the claim as stated.

  • SupportsInformed consentconcept

    Broad/deep biobank consent and dynamic consent both reject one-off study-specific forms, but one relies on criteria-based governance and the other on a living digital interface that keeps asking participants.

    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.

  • Disagreement on the same question

    Broad/deep biobank consent and dynamic consent both reject one-off study-specific forms, but one relies on criteria-based governance and the other on a living digital interface that keeps asking participants.

    Also on this tension

Discoveries this paper informs or conflicts with

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.

Inspect source passages

Is broad biobank consent good enough?

These passages occur verbatim in the stored paper text. They support the points listed below; they do not verify every statement in the explanation.

Debate?

biobanks as a vital research tool in the medical sciences has led to widespread debate in the literature about how to best handle the informed consent proc

Managers adopted?

broad consent model have generally been adopted by those managing biobanks (although there are significant variations in the implementation of informed con
Read passages in the original paper

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.

Related papers in this topic

Same topic cluster — not a recommendation engine.