[E-research: problems with anonymity and consent]

Area of Science:

• Medical Law and Ethics
• Digital Health
• Clinical Research

Background:

• The Medical Research Involving Human Subjects Act (WMO) mandates written consent for all medical research participants.
• Current WMO interpretations strictly define "written" as "on paper," posing significant barriers to online research (e-research).
• E-research often addresses sensitive issues (e.g., sexual dysfunction, addiction, child abuse) where participant anonymity is paramount.

Purpose of the Study:

• To analyze the challenges posed by the WMO's written consent requirements for conducting e-research.
• To highlight how WMO regulations impede research involving sensitive topics and minors.
• To advocate for legal adaptations to accommodate modern e-research needs and ensure participant anonymity.

Main Methods:

• Analysis of the WMO Act's stipulations regarding written consent.
• Examination of the implications of "written" consent interpretation on e-research feasibility.
• Assessment of consent requirements for minors (ages 12-18) and their impact on anonymity.

Main Results:

• The strict "on paper" interpretation of written consent makes many forms of e-research, particularly those requiring anonymity, impractical or impossible.
• Consent requirements for minors, necessitating approval from both parents or guardians, severely compromise participant anonymity.
• The current regulatory framework struggles to balance the need for identifiable participants with the guarantee of anonymity in online studies.

Conclusions:

• The WMO Act's current consent procedures are outdated and present significant obstacles to the advancement of e-research.
• Adapting legal regulations to permit electronic consent methods is essential for facilitating online studies, especially those concerning sensitive health issues.
• Revising consent protocols, particularly for minors, is necessary to protect participant anonymity and encourage participation in vital medical research.