The European Journal of Public Health
Volume 27, Issue 2, 1 April 2017
Written informed consent in health research is outdated
Eur J Public Health (2017) 27 (2): 194-195.
R. Broekstra; E.L.M. Maeckelberghe; R.P. Stolk
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…