Safeguarding research subjects who lack decision-making capacity.
In keeping with the Declaration of Helsinki, health-care research generally requires the informed consent of those who participate in the study. This approach upholds the autonomy of the participants but restricts research to subjects who have decision-making capacity. In order that people who lack decision making capacity can benefit from properly conducted research, the Mental Capacity Act 2005 introduced safeguards that enable researchers to investigate the care and treatment of people with incapacity while protecting this vulnerable patient group. This article outlines the requirements that must be met when conducting research with subjects who lack decision-making capacity.
Griffith
Richard
R
School of Health Science, Swansea University. ricahard.griffith@swan.ac.uk
Tengnah
Cassam
C
D000328:Adult; D003657:Decision Making; D028744:Ethics Committees, Research; D005062:European Union; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*; D018579:Patient Selection; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D006113:United Kingdom