Informed consent in psychiatry outpatients.

BACKGROUND & OBJECTIVES: Comprehension and process of consent are important for persons with mental illness as they may not be impaired in considering research participation. The American Psychiatric Association developed a detailed Cultural Formulation Interview (CFI). The present study was a part of field testing of CFI, aimed to standardize cultural information affecting the patients' management in India. This paper describes the process and conclusions from the consent-seeking process of this study.

METHODS

The purpose and procedures about field trial of the CFI were introduced and the patient and caregiver were requested for participation. Consent process was carried out step by step, by reading out the consent form to the first new patient of the day in the psychiatry outpatients department of a tertiary care hospital in north India, inviting questions followed by the 'comprehension' questions. The entire process was audiotaped without any personal identifiers. The process was repeated if not comprehended.

RESULTS

A total of 67 patients consented, 11 refused and majority were educated more than secondary school. Some concerns shown by the patients and caregivers included risk of participation, loss or benefits of participation, privacy, etc. All types of mentally ill patients participated in the study.

INTERPRETATION & CONCLUSIONS: Translations of consent forms used simple words, consonant with understanding of the potential participants. Patients' belief that participating in this long process would improve their care, and serve humanity, influenced their decision to participate. Except for intoxication and severe psychosis, patients could understand and comprehend issues around consent. Main issues were confidentiality and culture. Our experience in the psychiatry OPD refutes the commonly held belief that mentally ill persons lack comprehension and ability to consent.