Informed consent tricky in incapacitated patients
Informed consent tricky in incapacitated patients
Increased interest by researchers in doing more studies on degenerative diseases such as dementia, Alzheimer’s, or mental illness is causing hospital ethics committees to re-examine their roles in granting access to their incapacitated patients.
Ethics committees are encouraging psychiatric professionals’ participation on a number of issues, including seeking advice on informed-consent procedures, with a special review of patients who lack capacity and those with marginal or progressively diminishing capacity.
At the same time, hospitals are beginning to examine the function of the decision maker (agent/surrogate) in enrolling an incapacitated patient in clinical research trials.
"In general, the whole issue of informed consent is tricky in psychiatric settings, particularly with geriatric patients," says Robert Roca, MD, director of geriatric services at Sheppard and Enoch Pratt Hospital, an inpatient psychiatric facility in Baltimore.
"Participation in clinical trials is qualitatively different than standard medical treatment," cautions Donald L. Rosenstein, MD, chief of psychiatry consultation-liaison service and chair of the ethics committee at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD.
As many as half of all dementia patients develop psychiatric disorders with psychotic and behavioral symptoms that are difficult to treat. Present drug therapies treat only the forgetfulness associated with Alzheimer’s.
Many of these patients develop hallucinations, delusions, and wandering and "sundown syndromes" that cause them to want to wander and seek to "go home," especially in the evening. No medication or behavioral intervention is known to help in most circumstances, and research is vital to help these patients and future patients. "As the number of Alzheimer’s patients grows, this type of research will become increasingly needed and increasingly complicated," predicts Roca.
Psychiatric patients of any age are also of concern to bioethics professionals because of the need to have informed consent and maintain patient autonomy.
"Because NIH is a dedicated research hospital, our sensitivity to this issue may be greater than other hospitals but it is certainly not unique to NIH," says Rosenstein.
Rosenstein encourages all hospital ethics committees to review their institution’s informed- consent procedures for patients with capacity concerns as his committee has done over the past year.
Like NIH, your facility may have policies and guidelines for treating patients with cognitive impairment. But have the policies "grown up" with the conditions now afflicting patients?
Be especially responsive to situations in which the patient becomes more unable to make decisions over time (e.g., Alzheimer’s) or has episodic cognitive impairment (early dementia or mental illness), he warns.
When does the potential benefit for these patients or others outweigh potential risk? Medical research involving patients with mental illness is crucial in order to battle these conditions but patients must be protected, say Rosenstein and others.
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