Customising informed consent procedures for people with schizophrenia in India.
BACKGROUND
There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so.


METHODS
Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach.


RESULTS
434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent.


CONCLUSIONS
The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.
Sangath, Goa, India. sudipto_dr@yahoo.com.au.
Sudipto
S
Chatterjee
World Health Organization, Geneva, Switzerland. beritkieselbach@gmail.com.
Berit
B
Kieselbach
Sangath, Goa, India. smitan@sangath.com.
Smita
S
Naik
Samarth, Chennai, India. shubakumar@samarthngo.org.
Shuba
S
Kumar
Schizophrenia Research Foundation, Chennai, India. Sujitjohn@scarfindia.org.
Sujit
S
John
Sangath, Goa, India. madhs@hotmail.com.
Madhumitha
M
Balaji
Institute of Psychiatry, Kings' College, London, UK. mirja.koschorke@kcl.ac.uk.
Mirja
M
Koschorke
Parivartan, Satara, India. hamid.dabholkar@gmail.com.
Hamid
H
Dabholkar
National Institute of Mental Health and Neurosciences, Bengaluru, India. mat.varg@yahoo.com.
Mathew
M
Varghese
Sangath, Goa, India. vikram.patel@lshtm.ac.uk.|London School of Hygiene and Tropical Medicine, London, UK. vikram.patel@lshtm.ac.uk.|Centre for Global Mental Health, London, UK. vikram.patel@lshtm.ac.uk.|Centre for Mental Health, Public Health Foundation of India, New Delhi, India. vikram.patel@lshtm.ac.uk.
Vikram
V
Patel
Institute of Psychiatry, Kings' College, London, UK. graham.thornicroft@kcl.ac.uk.|Centre for Global Mental Health, London, UK. graham.thornicroft@kcl.ac.uk.
Graham
G
Thornicroft
Schizophrenia Research Foundation, Chennai, India. thara@scarfindia.org.
Rangaswamy
R
Thara
D000328:Adult; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007194:India; D007258:Informed Consent / Q000941:ethics; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D010358:Patient Participation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology; D016312:Treatment Refusal
COPSI trial; Capacity for consent; India; Informed consent procedure; Schizophrenia