The principles of Good Clinical Practice (GCP) are derived from ethical standards stated in the Declaration of Helsinki — a key guidance document that was last revised in 2013.
The 2024 update to the Declaration of Helsinki enhances ethical standards in clinical research, emphasising protection for vulnerable populations, informed consent, community engagement and equitable benefit-risk distribution.
The substantive changes can be categorised into two areas:
- Participant-centred inclusion, respect and protection
- Research beneficence and value
These changes may impact pharmaceutical and biotech companies by requiring stricter ethical considerations in trial designs, participant safety and transparency.
As a global clinical research organisation, we can assist by ensuring compliance, managing informed consent processes and supporting patient outreach, helping sponsors meet these revised ethical requirements and uphold standards in medical research.
Read more about the updates and the full text here.