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['Informed consent' and prerandomization].

A J de Craen1

  • 1Leids Universitair Medisch Centrum, afd. Klinische Epidemiologie, Leiden.

Nederlands Tijdschrift Voor Geneeskunde
|August 5, 2000
PubMed
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Randomised controlled trials often randomize first, then obtain informed consent. This pre-randomisation (Zelen design) enhances internal validity but faces ethical debate. A modified consent process may resolve this conflict.

Area of Science:

  • Medical research methodology
  • Clinical trial design
  • Bioethics

Context:

  • Randomised controlled trials (RCTs) typically involve informed consent before participant randomisation.
  • Pre-randomisation (Zelen design) reverses this order, randomising first, then obtaining consent.
  • The ethical permissibility of pre-randomisation in medical research is currently debated in the Netherlands.

Purpose:

  • To explore the ethical considerations and methodological implications of pre-randomisation in clinical trials.
  • To propose a modified informed consent procedure that balances internal validity with ethical standards.

Summary:

  • Full informed consent prior to randomisation can compromise internal validity by potentially biasing participant allocation.
  • Pre-randomisation enhances internal validity by preventing knowledge of group allocation from influencing participant decisions.

Related Experiment Videos

  • A proposed solution involves informing participants that some study details are withheld until after randomisation to maintain trial integrity, with subsequent full disclosure.

    • Impact:

    • This approach aims to preserve the methodological advantages of pre-randomisation while upholding ethical principles of informed consent.
    • It offers a potential resolution to the ongoing debate regarding the use of Zelen designs in medical research.
    • Facilitates robust clinical trial design with enhanced internal validity and ethical compliance.