Abstract
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.
Findings
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.
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References
deRenzo EJ, Conley RR, Love R (1998) Assessment of capacity to give consent to research participation: state of the art and beyond. Int J Law Health Care Policy 1:66–87
Carpenter WT Jr, Gold JM, Lahti AC et al (2000) Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry. 57:533–538
Moser DJ, Schultz SK, Arndt S et al (2002) Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry 159:1201–1207
Palmer BW (2006) Informed consent for schizophrenia research: what is an investigator (or IRB) to do? Behav Sci Law 24:447–452
Jeste DV, Depp CA, Palmer BW (2006) Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schizophr Bull 32(1):121–128
Candia PC, Barba AC (2011) Mental capacity and consent to treatment in psychiatric patients: the state of the research. Curr Opin Psychiatry 24:442–446
Dunn LB, Candilis PJ, Roberts LW (2006) Emerging empirical evidence on the ethics of schizophrenia research. Schizophr Bull 32(1):47–68
Jeste DV, Palmer BW, Golshan S et al (2009) Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Schizophr Bull 35(4):719–729
Bhansali S, Shafiq N, Malhotra S et al (2009) Evaluation of the ability of clinical research participants to comprehend informed consent form. Contemp Clin Trials 30:427–430
Padmavati R, Rajkumar S, Srinivasan TN (1998) Schizophrenic patients who were never treated-a study in an Indian urban community. Psychol Med 28:1113–1117
Srinivasan TN, Thara R (2002) Management of medication non-compliance in schizophrenia by the families in India. Schizophr Bull 28(3):531–535
Padmavati R, Thara R, Corin E (2005) A qualitative study of religious practices by chronic mentally ill and their caregivers in South India. Int J Soc Pychiatry 51(2):139–149
ICH Harmonized Tripartite Guideline for Good Clinical Practice E6(R1).(1996) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for human use
Agarwal AK (2010) A review of Indian psychiatry research and ethics. Indian J Psychiatry 52:S297–S305
Chaturvedi S, Somasekhar BS (2009) Reporting ethical aspects in published research articles in the Indian Journal of Psychiatry. Indian J Psychiatry 51:34–37
Lee A (2012) Regulation failing to keep up with India’s trials boom. Lancet 379:397–398
Chatterjee S, Naik S, Dabholkar H, Padmavati R, John S, Koschorke M, Thara R (2014) Trials of interventions for people with psychosis. In: Thornicroft G, Patel V (eds) Global mental health trials. Oxford University Press, London, pp 141–159
Chatterjee S, Leese M, Koschorke M et al (2011) Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial. Trials 12:12
Chatterjee S, Naik S, John S, Dabholkar H, Balaji M, Koschorke M, Varghese M, Thara R, Weiss HA, Williams P, McCrone P, Patel V, Thornicroft G (2014) Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial. Lancet 383(9926):1385–1394
Appelbaum PS, Grisso T (1995) The Mac Arthur Treatment Competence Study. I: mental illness and competence to consent to treatment. Law Hum Behav 19(2):105–126
Schulz KF, Altman DG, Moher D, The CONSORT Group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Trials 11:32
Farooq S, Nazar Z, Irfan M et al (2011) Schizophrenia medication adherence in a resource poor setting: randomised controlled trial of supervised treatments for out- patients for schizophrenia (STOPS). Br J Psychiatry 199:467–472
Li Z, Arthur D (2005) Family education for people with schizophrenia in Beijing, China Randomised controlled trial. Br J Psychiatry 187:339–345
Thara R, Srinivasan ST (2000) How stigmatising is schizophrenia in India? Int J Soc Psychiatry. doi:10.1177/002076400004600206
Jahan F, Roshan R, Nanji K, Sajwani U, Warsani S, Jaffer S (2014) Factors affecting the process of obtaining informed consent to surgery among patients and relatives in a developing country: results from Pakistan. East Mediterr Health J. 20(9):569–577
Acknowledgments
The authors gratefully acknowledge the Wellcome Trust for having provided the academic grant for conducting the COPSI trial. The generous participation of people with schizophrenia and their family is greatly appreciated, as without their support, the study would not have been possible. The authors are also grateful to all the COPSI staff members—Dr.Vikram Arunachalam and Dr.Yamani Kanappan at Chennai, Minakshi Pisal, Uday Chavhan and Prashant Potdar at Satara and Anthony Lobo, Basvaraj Katti, Swamini Kakodkar, Arthi Rajan and Fatima Gomes at Goa, who conducted the interviews across the sites and to Nupur Lala who helped with the initial data management framework. We would also like to specifically thank all the collaborating Psychiatrists in the COPSI study—Dr. T. C. Ramesh Kumar, Dr. R. Padmavati, Dr. H. Dabholkar, Dr. P. Dabholkar, Dr. A. Chavan, Dr. R. Deshpande, Dr. R. Hegde, Dr. P. Pai Kakode, Dr. M. Chagas Silva and Dr. P. Castelino, for their role in coordinating various aspects of the study at the three sites. We are also grateful to the IRB’s of Sangath and SCARF for their valuable comments in designing the consent procedure. The ethics committees at the KCL and the LSHTM also provided a critical and independent overview of the ethical aspects of the trial which we benefitted from. Finally, we wish to thank the members of the Trial Monitoring Committee—Professor Mohan Isaac (Chairperson), Baljeet Ahluwalia, Professor P. Chandra, Professor R. Raguram and Additional Professor K. Thennarasu for their active and valuable contributions in developing and monitoring the procedure.
Conflict of interest
The authors have no conflict of interest to declare.
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Trial registration ISRCTN 56877013.
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Chatterjee, S., Kieselbach, B., Naik, S. et al. Customising informed consent procedures for people with schizophrenia in India. Soc Psychiatry Psychiatr Epidemiol 50, 1527–1536 (2015). https://doi.org/10.1007/s00127-015-1037-y
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DOI: https://doi.org/10.1007/s00127-015-1037-y