Competency to decide about treatment or research

Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders

“…It is possible that some patients held a "therapeutic misconception"-the belief, despite volunteering for a research study, that "decisions about their care are being made solely with their benefit in mind" (Appelbaum et al 1982;Roth et al 1982;Roberts and Roberts 1999). Patients may have been confused by the consent itself, which states that, if they enroll in the center, they will be eligible for other studies in which their medications may be changed.…”

Decisional capacity in mental illness and substance use disorders: empirical database and policy implications

“…The belief of some patients that they would be receiving treatment for their illness may be tantamount to the ''therapeutic misconception''-the assumption held by some research subjects (and not limited to those with psychiatric disorders) that ''decisions about their care are being made solely with their benefit in mind' ' Appelbaum, Roth, & Lidz, 1982;Roberts & Roberts, 1999;Roth et al, 1982). Helping ensure that potential participants do not confuse research with usual care thus deserves special attention from investigators (Roberts & Roberts, 1999).…”

“…There is a valid concern that some policies and regulations designed to protect patients may, in practice, actually impede the consent process (Cassileth, Zupkis, Sutton-Smith, & March, 1980;Roth et al, 1982). Legal considerations to protect the drug manufacturers, the clinicians, and the institution frequently lead to adding information to consent forms, increasing their length and complexity.…”

IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies

“…Such research has shown that approximately 90% of schizophrenic subjects exhibit adequate decisional capacity if they are exposed to additional educational materials beyond the standard consent form (Carpenter et al, 2000;Moser et al, 2002) and also that they remember relevant information about those materials (Wirshing, Wirshing, Marder, Liberman, & Mintz, 1998). Similarly, although there is some evidence of decisional impairment in depressed patients involving their clinical care (Roth et al, 1982), little impairment in decisional capacity has been documented among outpatient research participants with major depression (Appelbaum, Grisso, Frank, O'Donnell, & Kupfer, 1999). Hence, if the consent process is well managed, the data suggest that people with certain severe mental illnesses do not appear to require extensive restrictions on the consent process in order to ethically manage their participation in biomedical research.…”