Informed consent

Informed consent is the ongoing authorisation of research or treatment by someone able to decide, not a one-time signature. The evidence here is mainly conceptual argument (biobank consent models, screening nudges, the right not to know, capacity and unconscious motives) plus one empirical-ethics interview study of paediatricians and a critical review of research on children's competence.

Undergraduates learn a hospital consent form. These papers show where that model strains: future unknown uses of samples, test results nobody can interpret, children who may or may not be competent, and 'shared' decisions that doctors in fact steer.

Claim ledger

What the evidence shows

Drawn from 7 studies in this library. Mix labels say which citation roles are present; they are not a strength score. Supports means evidence for a finding; Challenges means evidence against a stated position; Qualifies marks scope.

• ● Supporting studies only

  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.

  2 studies
  1. 1Is broad biobank consent good enough?
  2. 2Can consent stay alive after enrolment?

  Study comparison

  Study	Role	Design	N	Population	Outcome
  Is broad biobank consent good enough?2019	Supports	OtherCriteria-based ethical argument for modified broad (‘deep’) biobank consent	Normative bioethics analysis; not an empirical sample	Biobank consent models (study-specific vs broad vs modified deep broad consent)	Deepened broad consent as best protecting participants for biobank reuse
  Can consent stay alive after enrolment?2017	Supports	OtherConceptual proposal of Dynamic Consent platforms for ongoing biomedical research participation	Design/ethics proposal; not an empirical trial N	Biomedical and biobank research participants facing changing secondary uses	Personalised online consent/communication as an alternative to one-off static consent

• ○ Limited citations

  Before asking 'to know or not to know', ask whether the finding means anything.

  For incidental genomic findings that are neither reliable nor actionable, arguments against a right not to know fail (they assume the information could save a life), while arguments for it support at most a narrower right not to be informed; the real questions are whether a result can be trusted and whether anything can be done.

  1 study
  1. 1Is there a right not to know uncertain genetic findings?

• ○ Limited citations

  Nudging toward a test is not harmless help when the test can be wrong.

  The 'help bad choosers' defence of nudging people into screening is undercut by epistemic risk, including false positives, which even challenges the automaticity of opt-out designs.

  1 study
  1. 1Should we nudge people into screening?

• ○ Limited citations

  We know surprisingly little, empirically, about when children can consent.

  A critical review finds legal consent ages vary widely between countries and look partly arbitrary, and that only two studies had assessed children on all four standard competence criteria; the authors call for a structured multidimensional tool, children aged 7 to 18, and real rather than hypothetical decisions.

  1 study
  1. 1Why is it so hard to judge whether a child can consent?

• ○ Limited citations

  'Shared' decision-making can be a label for decisions doctors actually direct.

  In interviews using clinical vignettes, 25 Australian paediatricians caring for children with life-limiting conditions described four approaches from family-led to doctor-directed; most called what they did 'shared decision-making' even when it was physician-led, and some deliberately steered parents while presenting the choice as shared.

  1 supporting · 1 qualifying

  Supports

  1. 1Who really decides for very sick children: doctors or parents?

  Qualifies

  1. 1Who really decides for very sick children: doctors or parents?— Self-reports about vignettes, not observed conversations; parents were not interviewed.

• ○ Limited citations

  Capacity debates also turn on whether stated wishes reflect settled motives.

  One normative argument claims autonomy can be undermined by unconscious forces at any age, so a best-interests case for gender transition depends on the self-diagnosis being correct, and definitions must be clarified before policy.

  1 supporting · 1 qualifying

  Supports

  1. 1Can unconscious motives undermine transition consent?

  Qualifies

  1. 1Can unconscious motives undermine transition consent?— A contested argument paper; it presents no data on how often self-diagnosis is mistaken.

Debates

Tensions and limits

Some items are genuine disagreements on the same question. Others mark different assays, populations, or outcomes.

Timeline

How understanding moved

Study years are when the paper was published. Evidence edits are dated changes to this page's claims. Explanations are when PaperFren added a Discovery — not a claim that the science happened that day.

Papers

7 studies in this library bear on Informed consent, ordered by citations.

• Can consent stay alive after enrolment?

  Dynamic Consent is a personalised online platform for consent and communication so participants can be invited, updated, and followed as research uses change.

  BMC medical ethics · 2017 · 193 citations

• Is broad biobank consent good enough?

  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.

  BMC medical ethics · 2019 · 79 citations

• Why is it so hard to judge whether a child can consent?

  We still have no reliable way to tell when a child can give valid medical consent, and the authors argue that systematic measurement, not more theoretical debate, is the way forward.

  BMC medical ethics · 2015 · 53 citations

• Is there a right not to know uncertain genetic findings?

  The author argues that genetic findings of uncertain significance are not really knowledge, so the familiar debate over a right not to know misses the point, though people may decline to be told them.

  BMC medical ethics · 2016 · 31 citations

• Who really decides for very sick children: doctors or parents?

  Many paediatricians call their approach shared decision-making but actually steer grave decisions themselves, which the authors argue is justified to protect the child but not merely to shield parents.

  BMC medical ethics · 2022 · 15 citations

• Can unconscious motives undermine transition consent?

  After the Tavistock litigation, the authors argue that accepting medical transition to promote well-being is in someone’s best interests only if their transgender self-diagnosis is correct — and unconscious forces can undermine autonomy in children and adults.

  Journal of medical ethics · 2021 · 8 citations

• Should we nudge people into screening?

  The help-bad-choosers argument says nudges fix deficient choosers; epistemic risk in screening (being wrong in knowledge-making, including false positives) undercuts that defence and even opt-out’s autonomy.

  Medicine, health care, and philosophy · 2024 · 1 citations

Questions

What is still open

1. 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.

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2. The paediatricians' study argues that preventing harm to the child can justify physician-led decisions, whereas the nudging paper warns against steering choices toward what experts think best. They concern different decision-makers (parents of a child vs. adults choosing screening), so this is a difference in scope, but both ask when guidance becomes manipulation.

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