[The scientific committee system]

Area of Science:

• Biomedical research ethics
• Clinical trial regulation
• Public health policy

Context:

• Established national system of Scientific Ethical Committees since 1992.
• Danish model features lay majority on all committees.
• Law based on informed consent principle.

Purpose:

• Summarize the evolution of Denmark's Scientific Ethical Committee system.
• Highlight the impact of new legislation implementing EU directives.
• Detail changes in biomedical research project approval timelines.

Summary:

• Denmark's Scientific Ethical Committees, established in 1992, operate nationally with regional and central bodies.
• A lay majority characterizes committee composition, upholding informed consent.
• New 2003 legislation aligns with EU Good Clinical Practice, introducing 60-day approval limits for research projects and single-committee review for multi-center trials.

Impact:

• Streamlined approval processes for biomedical research.
• Enhanced compliance with European clinical trial standards.
• Strengthened ethical oversight in Danish medical research.