Protecting People With Decisional Impairments and Legal Incapacity Against Biomedical Research Abuse

• Published in: Journal of disability policy studies Vol. 18; no. 4; pp. 230 - 244
• Main Authors: Noble, John H., Sharav, Vera Hassner
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA Sage Publications 01.03.2008; SAGE PUBLICATIONS, INC
• Subjects: Accountability; Bioethics; Biomedical research; Biomedicine; Codes of conduct; Cognition & reasoning; Conflict of Interest; Conflicts of interest; Consent; Ethics; Etiology; Experiments; Federal Legislation; Government (Administrative Body); Human rights; Human subjects; Informed consent; Institutionalized Persons; Intellectual disabilities; Intellectual Disability; Laws; Marketing; Medical equipment; Medical research; Mental Disorders; Neurological Impairments; Patients; People with disabilities; Principles; Radiation; Regulatory agencies; Research ethics; Researchers; Review boards; Risk Assessment; Schizophrenia; War; War crimes; human participants abuse; Nuremberg Code; research ethics; conflicts of interest; decisional impairments; institutional review boards
• ISSN: 1044-2073; 1538-4802
• DOI: 10.1177/1044207307311532

Ethical and legal principles are provided for reviewing the ethics of recent cases of biomedical research abuse involving persons with decisional impairments or legal incapacity who were unable to understand the risks and benefits of the research to which they were subjected. Research abuse continues to occur despite guidance from the Nuremburg Code, the Declaration of Helsinki, the U.S. Belmont Report, extensive federal regulations governing human participant research, and several professional and disciplinary codes of ethics with which, the authors believe, the majority of researchers comply. Contributing to research abuse are weaknesses in the institutional review board and research ethics board review process; conflicting opinions about applicable ethical principles; mounting evidence of pervasive conflicts of interest; and dubious conflated research and marketing practices involving researchers, pharmaceutical and medical device manufacturers, and government research sponsors and regulatory agencies. Several recommendations are made to correct identifiable weaknesses and failures in the governance of biomedical research.