Challenges in conducting psychiatry studies in India

Abstract

A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) trained psychiatry investigators in India. Recruitment can be challenging due to issues such as strict eligibility criteria, (lack of) availability of caregiver, illness-related considerations, etc. Assessment of the consent capacity of patients is not simple, while structured assessments are not commonly employed. As the illness fluctuates, the consent capacity may change, thus requiring continued assessment of consent capacity. Study patients run the risk of worsening of illness and suicide due to exposure to inactive treatments; this risk is counterbalanced by use of appropriate study designs, as well as the indirect psychotherapeutic support received. Psychiatry studies are associated with a high placebo response. This necessitates conduct of placebo-controlled studies despite the attendant difficulties. Also, the high placebo response is often the cause of failed trials. Rating scales are essential for assessment of drug response. Some rating instruments as well as some rater training procedures may not be suitable for the Indian setting. Technological advancements may increase the procedural complexity but improve the quality of ratings. Psychiatry studies present monitors and auditors with unique scenarios too. Utilization of psychiatry specific training and expertise is recommended to ensure successful conduct of these studies in India.

Informed consent: Issues and challenges

“…The guidelines are prepared keeping in mind the western culture and may not replicate the same results due to cultural variability in non-western countries like India. [24] The dilemma in obtaining informed consent from subjects with cognitive impairment includes validity of informed consent by subject, implications and validity of third party consent, protection of human subjects. Regulations don’t provide information and guidance on ethical issues of psychiatry research.…”

Informed consent process: challenges in clinical practice

“…While preparing an iC form, a clinician should elaborate components in succession depending on their priority, with simple and understandable words of the patient's native language, enabling the laymen population to understand the message to be conveyed and generate interest and active and higher participation rate [12]. At times, clinicians present only superficial aspects, missing the temporary and permanent risk, complications, and discomforts which could be involved at the moment or in near future [8,13,14]. These concerns should be noted and explained without failure.…”

Awareness and Perception of Drug Trials among Patients with Mental Disorders

“…There is usually a study protocol that stipulates all the aims, objectives and other terms of reference of the study as the guide to each investigator. Consenting subjects will be administered the drug or placebo (as the case may be) and data about the subjects' health will be collected for statistical analysis [15] [16].…”