New NIH Regulations Say Most Basic Human Brain Research Is a Clinical Trial

Area of Science:

• Neuroscience
• Behavioral Science
• Biomedical Research

Background:

• The National Institutes of Health (NIH) has introduced new definitions for clinical trials.
• These definitions broadly encompass human brain and behavioral research.

Purpose of the Study:

• To analyze the impact of new NIH definitions on biobehavioral research.
• To highlight potential challenges for noninvasive studies like neuroimaging.

Main Methods:

• Review of new NIH clinical trial definitions.
• Analysis of regulatory, reporting, and funding implications.
• Assessment of potential impacts on basic science research.

Main Results:

• Virtually all human brain and behavioral research is now classified as clinical trials.
• Noninvasive studies, including neuroimaging, face altered regulatory and reporting requirements.
• Increased administrative burdens pose a threat to the continuation of basic biobehavioral science.

Conclusions:

• The new NIH definitions present significant challenges for the biobehavioral research community.
• Urgent consideration is needed to mitigate the negative impacts on scientific advancement.
• The future of fundamental brain and behavior research may be jeopardized.