Informed Consent for the Human Research Subject with a Neurologic Disorder

Informed consent to human subject research: improving the process of obtaining informed consent from mentally ill persons.

This Note demonstrates that the federal regulations regarding human subject research must provide more specific guidelines that emphasize the process of obtaining informed consent from persons with mental illnesses. Part I discusses schizophrenia as a case example of mental illness that requires more stringent informed consent standards in human subject research. Part II describes the legal fou...

Informed consent and research subject understanding of clinical trials.

CONTEXT Current evidence suggests many clinical trial participants have incomplete understanding of research objectives and methods. OBJECTIVE Determine consent standards compliance, satisfaction with facility and study staff, and research subject understanding of clinical trials. DESIGN Retrospective review of responses gathered when subjects were interviewed at the inception of clinical t...

Beyond the informed consent procedure: continuing consent in human research.

An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a pr...

Informed consent for research in Borderline Personality Disorder

BACKGROUND Previous research on informed consent for research in psychiatric patients has centered on disorders that affect comprehension and appreciation of risks. Little has been written about consent to research in those subjects with Borderline Personality Disorder, a prevalent and disabling condition. DISCUSSION Despite apparently intact cognition and comprehension of risks, a borderline...

Beyond Nuremberg: A Critique of Informed Consent in Third World Human Subject Research