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[E-research: problems with anonymity and consent]
Marla Woolderink1, Antoinette D I van Asselt, Constant P van Schayck
1Maastrichts Universitair Medisch Centrum, Maastricht.
Abstract:
The Medical Research Involving Human Subjects Act (WMO) requires that participants in medical-scientific studies provide written consent. This requirement makes e-research (online research) unnecessarily difficult and sometimes impossible. Much of e-research involves online interventions that focus on sensitive issues such as sexual dysfunction, addiction and child abuse, for which anonymity is an important condition. WMO procedures, however, strictly interpret the word "written" as "on paper", and participants are not permitted to give consent by email, for example. A second requirement, which mainly makes studies among minors between the ages of 12 and 18 more difficult, is that both parents or the guardian must provide written consent. This undermines anonymity to such an extent that virtually no subjects remain. Participants in medical-scientific studies must always be identifiable to the investigator. But, apart from this, he/she should be possible to guarantee anonymity within the regulatory framework. There is good reason to adapt legal regulations to today's needs.
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