Competency to consent to research: a psychiatric overview

Area of Science:

• Bioethics
• Legal Medicine
• Human Experimentation Ethics

Background:

• Informed consent is a cornerstone of ethical human research.
• Competency is a prerequisite for valid informed consent.
• Current standards for assessing competency lack consensus.

Purpose of the Study:

• To review existing standards for assessing research participant competency.
• To analyze the hierarchical nature of these standards.
• To discuss the role of policy goals in selecting a competency standard.

Main Methods:

• Literature review of legal and ethical scholarship on human experimentation.
• Analysis of four commonly cited competency standards.
• Discussion of the relationship between competency standards and policy objectives.

Main Results:

• Four hierarchical standards for competency are identified: evidencing choice, factual understanding, rational manipulation, and appreciation of the situation.
• Each standard represents a progressively more stringent test of cognitive capacity.
• The choice of a specific competency standard is a policy decision, not solely a clinical one.

Conclusions:

• No single standard for competency is universally applicable.
• The selection of a competency standard should align with the ethical and policy goals of the research.
• Empirical data can inform, but not dictate, the consensus on appropriate competency standards for research participation.