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 Table of Contents    
EDITORIAL  
Year : 2013  |  Volume : 55  |  Issue : 1  |  Page : 1-2
Ethical issues in psychiatry research: Special concerns for India


1 Department of Psychiatry, JSS Medical College Hospital, Mysore, Karnataka, India
2 Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India

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Date of Web Publication5-Jan-2013
 

How to cite this article:
Sathyanarayana Rao T S, Andrade C. Ethical issues in psychiatry research: Special concerns for India. Indian J Psychiatry 2013;55:1-2

How to cite this URL:
Sathyanarayana Rao T S, Andrade C. Ethical issues in psychiatry research: Special concerns for India. Indian J Psychiatry [serial online] 2013 [cited 2019 Aug 24];55:1-2. Available from: http://www.indianjpsychiatry.org/text.asp?2013/55/1/1/105498


In this issue of the journal, Avasthi et al. provides an overview of ethical issues in research. [1] The ethics of medical research in India, including psychiatric research, have been much debated. [2],[3],[4],[5],[6],[7],[8],[9],[10],[11],[12],[13] With specific reference to psychiatric research in India, we wish to address two of the principles that Avasthi et al. lists in his overview because we believe that these are important yet neglected in this country (and surely in many other parts of the world, as well!). These two principles are non-exploitation of research subjects and release of the results of the research into the public domain.


   Exploitation of Research Subjects Top


Avasthi et al. [1] provides a broad description of what non-exploitation entails. With specific regard to medical or hospitalization costs and insurance claims when adverse events occur, we make the following observations:

  • Patients in India seldom have the financial resources to settle their medical or hospitalization expenses and wait for the insurance claims to be settled in order to obtain their reimbursements. Thus, if the study concludes without the patients requiring additional medical attention, no ethical issues arise. However, if special outpatient or inpatient expenses are incurred as a result of adverse events, and if patients have to settle these expenses through their personal resources, they have effectively been exploited. What is the solution? A novel approach is one that had been adopted by the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, for many years. The NIMHANS Ethics Committee required clinical trial sponsors to provide an undertaking in the informed consent form that interim relief would be provided to patients and their families in the event of misadventure. The interim relief would cover all expenses related to investigation and treatment of the adverse event, and would include compensation in case of death. These benefits would help the family cope until the insurance claims were settled.
  • Patients in India do not have the ability to file claims with an international insurance company and defend these claims, if the claims are contested. Again, NIMHANS innovated by insisting that local insurance be obtained, so that claims could be filed in the city in which the study was conducted.
  • The lives of patients in India are valued at far lower levels than those of patients in Western countries. This is an unfortunate consequence of local insurance, and more attention needs to be paid to ensure that Indian subjects are treated at par with subjects recruited from other sites.
There are other ways, as well, in which research subjects may be exploited in India. For example, in some private medical institutions, research subjects pay for investigations the results of which are included as major or minor variables in the dissertations of postgraduate students. Clearly, actual or potential exploitation of research subjects exist in many garbs.


   Non-Publication of Research Top


There are hundreds of psychiatry postgraduate students who submit dissertations each year in part fulfillment of their course obligations. Scores of research papers are presented in state, zonal, and national conferences attended by psychiatrists. Much of this research is not published, judging from the contents of psychiatry journals published in this country and elsewhere. There are two possible reasons for non-publication of completed research: The research may not be publication-worthy, or the investigators may not be making the effort to prepare and submit their manuscripts. Either way, the subjects who participated in the research stand betrayed because they have suffered inconvenience related to the study procedures, or even risks, without the scientific discipline or future patients benefiting.

Part of the problem lies in the fact that faculty and students in psychiatry departments across the country are inexperienced in statistics and research methodology. Just one significant shortcoming in a study may compromise the conclusions of the entire work; in consequence, the study becomes unpublishable; or if it is published in a journal of low rank, it has no effect whatsoever in the scientific field. As a result, the participation of the research subjects remains wasted, rendering the study unethical.


   The Way Forward Top


The Indian Council of Medical Research has published schedule Y, which is a locally relevant version of guidelines for good clinical practice and ethical research. The Medical Council of India and many universities have mandated research publications criteria for the selection and promotion of medical faculty. There is a gradual increase in the emphasis on training in statistics and research methods. We hope that by bringing to the forefront certain issues related to ethical research, awareness will result in self-correction.

 
   References Top

1.Avasthi A, Ghosh A, Sarkar S, Grover S. Ethics in medical research- general principles and special reference to psychiatry research. Indian J Psychiatry 2013;55:87-92.  Back to cited text no. 1
    
2.Andrade C. Unmodified ECT: Ethical issues. Issues Med Ethics 2003;11:9-10.  Back to cited text no. 2
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3.Raval NK, Andrade C. Unmodified ECT vs modified ECT. Issues Med Ethics 2003;11:100.  Back to cited text no. 3
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4.Mudur G. Indian study sparks debate on the use of placebo in psychiatry trials. BMJ 2006;332:566.  Back to cited text no. 4
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5.Basil B, Adetunji B, Mathews M, Budur K. Trial of risperidone in India - Concerns. Br J Psychiatry 2006;188:489-90.  Back to cited text no. 5
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6.Murtagh A, Murphy KC. Trial of risperidone in India - Concerns. Br J Psychiatry 2006;188:489.  Back to cited text no. 6
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7.Srinivasan S, Pai SA, Bhan A, Jesani A, Thomas G. Trial of risperidone in India - Concerns. Br J Psychiatry 2006;188:489.  Back to cited text no. 7
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8.Chaturvedi SK, Somashekar BS. Reporting ethical aspects in published research articles in the Indian Journal of Psychiatry. Indian J Psychiatry 2009;51:34-7.  Back to cited text no. 8
[PUBMED]  Medknow Journal  
9.Agarwal AK. A review of Indian psychiatry research and ethics. Indian J Psychiatry 2010;52:S297-305.  Back to cited text no. 9
[PUBMED]  Medknow Journal  
10.Yee A. Regulation failing to keep up with India's trials boom. Lancet 2012;379:397-8.  Back to cited text no. 10
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11.Pauranik A, Bharani A, Bhargava S, Bajpai A, Jain H, Verma P. Misleading report on clinical trials in India. Lancet 2012;379:1947-8.  Back to cited text no. 11
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12.Kadam R, Karandikar S. Ethics committees in India: Facing the challenges! Perspect Clin Res 2012;3:50-6.  Back to cited text no. 12
    
13.Kadam R. Proactive role for ethics committees. Indian J Med Ethics 2012;9:216.  Back to cited text no. 13
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Correspondence Address:
T S Sathyanarayana Rao
Department of Psychiatry, JSS Medical College Hospital, JSS University, M. G. Road, Mysore, Karnataka - 570 004
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-5545.105498

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