History of research involving mentally disabled persons - from exploitation through exclusion to appropriate inclusion

Introduction. The inability to protect their own interests makes mentally disabled subjects particularly vulnerable; they face an increased likelihood of being wronged or harmed in the context of research. Therefore, they are due to having extra protection and safeguarding. History of research misconduct and abuse of mentally ill patients. The 20th century abounds with examples of ethically inadmissible experiments conducted on decisionally impaired patients. The most infamous among them are surely the atrocities of the Nazi doctors, whose fraudulent ex­periments resulted in death of hundreds of thousands of imprisoned innocent and mentally ill individuals. Current and previous regulations and recommendations on research involving the mentally ill. Extreme use of potentially vulnerable mentally ill persons in research has led to a set of policies and practices for protection from exploitation and abuse of human research participants. While the regulations initially protected these vulnerable patients by prohibiting research including the mentally disabled, current guidelines propose appropriate safe­guarding so that they may be involved in appropriate research. Conclusion. Protection measures for the mentally disabled persons who are unable to consent to their involvement in research, by banning all biomedical research including the mentally ill are restrictive and unnecessary. Even if well-intended, such overprotection is discriminatory and implies that new treatments for conditions that directly affect the incapacitated subjects will not be developed. Providing that they are properly protected from unnecessary harms, appropriate inclusion of vulnerable mentally ill patients in research is necessary in order to meet their health needs in a safe manner.