Published March 4, 2026 | Version v1
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The 2-step Informed Consent tool: A Manual

  • 1. University of Bergen
  • 2. ROR icon TU Wien
  • 3. ROR icon Open University of Cyprus
  • 4. ROR icon International Hellenic University
  • 5. National Commission for Bioethics and Technoethics (former Hellenic National Bioethics Commission),
  • 6. European Commission

Description

This is the abbreviated version of the concept note on 2-step Informed Consent Process. For all deeper explanatory context we refer to its concept note. In this practical manual we shall focus on the What-to-do, Why-to-do-it, How-to-do-it, and Who’s-going to-do-it, with only the bare essentials, capturing the idealized abstract standard cases. We are going to present a methodology – or a tool if you prefer – to assess the ethical challenges when traditional informed consent seems not adequate to cover the future uses of the data or samples. We call it the “2-step Informed Consent Process” or “2ICP” for short.

Files

The 2step informed consent tool_A manual.pdf

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Additional details

Funding

European Commission
CHANGER - CHALLENGES AND INNOVATIVE CHANGES IN RESEARCH ETHICS REVIEWS 101131683