Written informed consent in health research is outdated

R. Broekstra, E. L. M. Maeckelberghe*, R. P. Stolk

*Corresponding author for this work

Research output: Contribution to journalEditorialAcademicpeer-review

3 Citations (Scopus)


Reference to the Declaration of Helsinki as assurance for ethical principles for medical research involving human subjects has become a meaningless mantra. The participants’ relationship with researchers has been distrusted-based with Written Informed Consent (WIC) hereinafter referred to as WIC) placed as an important barrier to protect participants’ autonomy. Today the mantra is dictated by many details in consent forms and ever more strict regulations. Globally, especially in Europe as well the USA, establishment of privacy and protection of research subject regulations reveal similar obstacles and critiques, for example in the recently accepted European General Data Protection Regulation and the proposed changes to the Common Rule from September 2015. In a digital revolution ethical principles need to be reassured in a novel way, especially for the increasing use of data...
Original languageEnglish
Pages (from-to)194-195
Number of pages2
JournalEuropean Journal of Public Health
Issue number2
Publication statusPublished - 1-Apr-2017

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