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[A modified informed-consent procedure in which the complete information is given retrospectively: no objection from

H Boter1, J J M van Delden, R J de Haan

  • 1Rudolf Magnus Instituut voor Neurowetenschappen, afd. Neurologie, Universitair Medisch Centrum Utrecht, Postbus 85.500, 3508 GA Utrecht. h.boter@azu.nl

Nederlands Tijdschrift Voor Geneeskunde
|January 18, 2005
PubMed

Insights

Patients generally accepted a modified informed consent process for a cerebrovascular accident study. This approach, providing full study details post-completion, did not deter participation or negatively impact trust.

Area of Science:

  • Medical Ethics
  • Clinical Research Methodology

Context:

  • Informed consent is crucial in clinical research, particularly for vulnerable patient populations.
  • Traditional informed consent procedures can sometimes pose barriers to patient recruitment and participation.

Purpose:

  • To evaluate patient acceptance of a modified informed consent procedure for a study on post-cerebrovascular accident care.
  • To assess whether delaying comprehensive study information until after questionnaire completion affects patient willingness to participate or their trust in healthcare providers.

Summary:

  • A descriptive cohort study involved 123 patients approached for a randomized trial.
  • A modified informed consent procedure was tested, where initial permission was sought for a questionnaire, with full study details provided post-completion.
  • Of 112 survivors, 102 were interviewed; 91% reported no decrease in trust, 1% a decreased willingness for future studies, and 3% dissatisfaction with the procedure.

Impact:

  • The modified informed consent procedure was well-tolerated by patients, with no significant objections or refusal to participate attributed to the method.
  • This approach may offer a viable alternative for improving recruitment in studies involving patient questionnaires, especially in post-stroke care research.
  • Findings suggest that ethical considerations regarding informed consent can be balanced with practical research needs without compromising patient trust or willingness to engage in research.
Abstract

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