Informed consent in psychiatry

Psychiatry drug trials

While obtaining informed and valid consent for clinical pharmacological research on human subjects is a legal and ethical mandate, the validity of that consent is a matter of much higher concern in psychiatry patients than any other. With the Hippocratic oath compelling to ‘do no harm’, the protection of the concerned patient with a psychological disorder; who may thus have limited cognitive ability and information processing capacity, becomes a grey area that requires much lucidity to assure appropriateness. The consent procedure in psychiatry trials thus requires additional sensitivity and study; and sponsors need to be aware of its practical limitations and make their best efforts in the protocol to limit these.

Implications of consent: Customization

Individuals with psychiatric disorders, by definition have deficiency in emotional relatedness. Psychoses facilitates impaired reality testing too. This not a drawback, it is a well known and accepted fact taken into the diagnostic consideration of disorders that the pharmaceutical companies are setting out to establish a cure for. Trials in acute schizophrenia as well as those on schizophrenic children have diagnostic criteria suggesting severe symptoms (thus compelling absence of reality testing for study inclusion). Consent in such trials can seem futile as the person in context has definite deficiency in his or her capacity to understand and reason and offer approval for the process. Trial sponsors must be cognizant of the need to customize the process: what, when, who and how need to be considered in depth.

Clinical trial considerations

Today consent, assent, proxy consent, LARs are all commonplace concepts of discussion for IRBs and trial sponsors. Investigators always bear that primal responsibility of ensuring that consent is sought only when the subject has demonstrated adequate functional capacity for understanding. However the trial staff ought to be aware of these functional limitations in order to assure that investigators perform their task optimally. To become better equipped, study sponsor staff must seek outside consultation from representatives of patient advocacy groups, experts in consent capacity assessment, willing representatives from the subject population, legal, ethical and above all, medical psychiatric experts in order to gather the best possible knowledge and assist in optimal conduction of the informed consent process.

Consent in Psychiatry

Informed consent process demands soundness of judgment along with adequate comprehension ability. This can be very challenging in psychiatry for several reasons.

  • Inclusion demands judgment lack
  • Limited functioning capacity
  • Impaired emotional relatedness
  • Low consent capacity indices
  • Memory and attention deficits
  • Comprehension or language lag
  • Complex nature of information
  • Often therapeutic misconception

Expert guidance

External representation from the mental health field enhances trial sponsor understanding of the patient and clinical perspective of informed consent.

  • Awareness of screening methods
  • Enhanced patient comprehension
  • Knowing the psychiatric patient
  • Understanding cognitive deficits
  • Building rational expectations
  • Understanding of proxy consent
  • Awareness of validity indices
  • Assessing complexities and risks
  • Anticipate consent refusal issues