Informed Consent, Inclusion Prioritized in Revised Ethics for Human Trials

By Shannon Firth,

The World Medical Association (WMA) voted unanimously today to approve revised ethical principles for human participants in medical research.

Updates to the WMA “Declaration of Helsinki” (DoH) include:

  • Respecting “individual autonomy” through “[f]ree and informed consent” that is given voluntarily by the person who will participate in the research
  • Replacing the term “physicians” with “physicians and researchers” to incorporate the broader healthcare community
  • Addressing structural inequities in medical research by “carefully consider[ing] how the benefits, risks, and burdens are distributed”
  • Weighing the harms and benefits of research inclusion and exclusion criteria to avoid perpetuating or worsening disparities in already vulnerable populations
  • Seeking informed consent from the legally authorized representative for participants who are “incapable of giving free and informed consent” Read more…