Issues of Informed Consent in Patients

with Psychiatric Disorders

Laura B. Dunn, M.D.

Assistant Professor of Psychiatry

UCSD

Outline

• Conceptual framework for informed consent

• Possible ways in which psychiatric disorders could affect informed consent

• Empirical evidence regarding effects of psychiatric illness on aspects of informed consent

• Discussion

Ethical clinical research

• Requirements (Emanuel et al., JAMA, 2000)

• Value

• Scientific Validity

• Fair Subject Selection

• Favorable Risk-Benefit Ratio

• Independent Review

• Informed Consent

• Respect for Enrolled Subjects

Informed consent: Conceptual model

Fully Informed VoluntaryDecision-Making Capacity

Understanding Appreciation ReasoningExpression of

a Choice

VALID CONSENT

Issues with conceptual model

• Differences in application by different practitioners/evaluators

• No gold standard for assessment

• In existing instruments, generally no cut-point for determining capacity vs. incapacity

• Emphasis on cognitive processes and rational decision-making

Psychiatric research

• Areas of ethical concern/controversy: • Challenge and withdrawal studies

• Placebo-controlled trials

• Determining capacity• Who determines capacity?• When should capacity assessment be done?• How should capacity assessment be done?

• Proxy consent

Psychiatric research ethics• National Bioethics Advisory Commission: (NBAC,

1998)

• Focused almost exclusively on psychiatric disorders• Recommendations became focus of controversy

• NIMH view: (Hyman, 1999)

• View that mental illness=incapacity is disrespectful and inaccurate

• Consent as a process, rather than discrete point in time or signing a document

• Sliding scale: addl safeguards when increased likelihood of decisional impairment and for higher risk studies

• Recognition that IRBs may be overworked

Barriers to consent: Literature review

• Review of 34 studies (research and treatment; psychiatric and other populations) (Dunn and Jeste, 2001)

• 5 studies in psychiatric populations

• Psychiatric illness per se not synonymous with impaired decision-making capacity

• Patients with psychiatric disorders and older patients show improvement with specific interventions

Understanding of consent• Problems with understanding:

• Awareness of being in study• Placebos, randomization, equipoise• Risks & benefits• Ability to withdraw• “Therapeutic misconception”• Dual roles of physician/researchers

• Complicating factors: • Protocols becoming more complex, technical• How much understanding is enough?

Barriers to informed consent

• Participant-related factors:

• Consent- and protocol-related factors:

• Investigator-related factors:

•Age•Education, vocabulary•Cognitive impairment•Psychiatric/medical sxs•Previous experiences•Emotional variables

•Readability•Presentation/format•Length•Complexity/level of detail•Risk:benefit ratio

•Attitudes/beliefs•Knowledge•Previous experience•Conflict of interest

• Serious mental illness: prevalence appx 1%

• Manifestations include hallucinations, delusions, disorganized speech or behavior, apathy, anhedonia, avolition, emotional blunting, and affective flattening

• Major areas of functioning (work, education, and relationships) are affected in most individuals with this disorder, although it is important to remember that remission is not uncommon, especially in later years.

Background: schizophrenia

• Usually (not always) associated with mild to moderately severe neuropsychological impairments

• Although psychotic symptoms fluctuate over time, cognitive deficits usually stable over time

• Most frequent impairments: attention, working memory, learning, and executive functions/ abstract reasoning.

• Comorbid psychiatric conditions, including mood disturbances and substance use, are common

Background: schizophrenia

Theoretical effects of psychiatric illness on decision-making

• Cognitive effects (SCZ, depression, dementia)• Affective states: hopelessness/fixity, undervaluing

positive outcomes, lack of concern re: own well-being

• Paranoia: fear of negative effects (e.g., of meds)• Lack of insight and denial common

• Presence or severity of illness itself• Need for treatment

• Instability of mental state

• Outpatients with moderate depression (Appelbaum et al., 1999)

• Performed well on MacCAT-CR (research-related decision-making); some concern re: appreciation that treatment assignment would not be individualized for their needs

• No correlation between depressive sxs and performance

• Hospitalized depressed patients (Grisso and Appelbaum, 1995)

• 25% showed some difficulties with decision-making re: treatment

• 14% tended not to acknowledge potential value of treatment

Empirical studies: depression

• Outpatients• Pts < Normal controls on understanding but improved

with practice (Dunn et al., 2002)

• Hospitalized patients (Grisso and Appelbaum, 1995)

• 25% met definition of impaired on each of 3 measures (understanding, appreciation, and reasoning), much higher proportion than pts w/depression or pts w/heart disease

• 1/3 tended not to acknowledge some aspect of their disorder; 13% tended not to acknowledge potential value of treatment

• 48% of SCZ group showed adequate performance on all 3 measures

• Impairment on 1 measure did not predict impairments on others (i.e., varying performance across measures was typical)

Empirical studies: schizophrenia

• Patient ratings of hypothetical protocols (Roberts et al., 2002)

• Four vignettes of varying degrees of risk (blood draw, blood draw with medication washout, med trial, med trial with placebo arm)

• Patients discerned different levels of potential harm across the vignettes, but perceived greater harmfulness in med trials than predicted by psychiatrists

Empirical studies: schizophrenia

• Most beneficial strategies:• More organized or structured procedures• Corrected feedback, multiple learning trials• “Advance organizers”• Summaries of information

• Education and vocabulary levels positively correlated with understanding of consent (regardless of age)

(Dunn and Jeste, 2001)

Strategies to enhance consent

Informed consent: Conceptual model

Fully Informed VoluntaryDecision-Making Capacity

Understanding Appreciation ReasoningExpression of

a Choice

VALID CONSENT

Information

• What does it mean to be “fully informed?” • Relevant information? Who decides?

• Risks and benefits? Every possible risk? (Forms become very long)

• HOW should information be provided?

• When do subjects need to be informed again?

Voluntary Participation• Absence of coercion, but…

• Coercion can be subtle• What factors may influence

voluntarism? (Roberts, Am J Psych, 2002)

• Developmental factors

• Illness-related factors

• Psychological issues; cultural and religious values

• External features and pressures

Decision-making Capacity• What is a reasonable level of capacity?

Who decides?

• Can decision-making capacity be improved?

• Can cognitive screening tests serve as assessments of decision-making capacity?

• Are there known risk factors for impaired decision-making capacity?

Sample responses• What is the purpose of this study? (compare meds)

“To cure schizophrenia.”• Do you think you have been asked to be in this

study for your personal benefit? (No, but could help)

“Yes…because they want to study a way to get me on a new medication.”

• Do you believe you could get a medicine that does not work well for you? (yes)

“No…because this is only research.”• What are the chances of getting each type of pill? (1

in 3)

“Good…More likely to get one than the other.”

Discussion questions• Are individuals with psychiatric disorders

different from those without psychiatric disorders in their ability to provide valid informed consent for treatment and/or research?

• How do empirical studies of decisional capacity inform this question?

• How do psychiatric illnesses affect the key components of informed consent?

Discussion questions

• Should special protections exist to protect psychiatric patients who are considering participating in research?

• Can/should informed consent procedures be modified for certain populations, given the nature of their illness or the nature of the study or treatment being considered?