Mental Health Research in India: New Challenges and the Way Forward

Mental health research in India is still in its infancy. The limited research capacity, lack of adequate mental health professionals (MHPs), insufficient funding, inadequate research training opportunities, and low priority accorded to mental health by the government are some of the barriers to mental health research in India.^1-4 Further, administrative barriers include a lack of prompt ethical, scientific, and regulatory review at an institute or government level. ⁵ Recent scientometric studies point out that a few premier Indian institutes disproportionately dominate the mental health research output in the country. ⁶ Also, the involvement of the private practitioner in mental health research is minimal due to current regulatory mechanisms which are not conducive to include them in the research ecosystem.

On the one hand, to improve mental health research and address some of the existing barriers, many institutes and professional organizations have taken several innovative steps such as capacity building and research methodology training ⁷ ; on the other hand, there is the addition of new potential barriers to mental health research. In this article, we aim to discuss the potential impact of the new regulations on various components of mental health research, such as conceptualization and dissemination of findings. We also attempt to provide some feasible solutions.

The Potential Impact of New Regulations and Laws

• Mental Health Care Act (MHCA), 2017: Section 99 (2, 3) of MHCA, 2017, mentions that for a person with mental illness who is unable to give free and informed consent for research, the informed consent from a nominated representative can be obtained after approval from State Mental Health Authority (SMHA). ⁸ In our clinical experiences, these patients are most likely to have a diagnosis of acute and transient psychotic disorder, relapse of schizophrenia, episode of mania, severe depressive episode, dementia, alcohol withdrawal syndrome, delirium, or an attempt to suicide. In current practice, as a part of national and international guidelines and ethical regulations (Indian Council of Medical Research [ICMR] ethical guidelines—2017: section 6), mental health researchers are already obtaining informed consent from the caregivers of the patients.^9–12

  Practically, the permission from SMHA does not add any additional benefits in terms of protection of rights of a person with mental illness. But these regulations can increase the burden and stress on researchers due to increased administrative paperwork and delay in the approval of research proposal from SMHA. For multi-centric research involving different states, the process can be especially cumbersome to the researcher due to inter-state variation in the research approval process of SMHA. Further, the SMHA has only 6 MHPs (2 psychiatrists) out of 17 members, and voting is based on the final decision rather than scientific merit (section 56 [3]). These, together with the irregular meeting schedule of SMHA (section 56 [1]), can negatively impact the mental health research ecosystem. Postgraduate students of psychiatry and clinical psychology trainees, who are already burdened with clinical work, have to go through this tedious procedure (which will not be applicable for the postgraduate students of other medical disciplines) for getting research approval for their mandatory thesis/dissertation work. It may discourage researchers from studying patients with severe mental illnesses (where the capacity to consent is compromised). Similarly, Indian researchers may face challenges in collaborating with researchers of other countries in multinational projects, due to multiple logistic issues in getting ethics approval. These issues are also relevant for clinical/drug trials conducted on patients with severe mental illness.

• Virtual Conference Guidelines, 2021: On January 15, 2021, the Ministry of Education, India, issued new guidelines for holding or participating in virtual conferences, seminars, workshops, etc., with international members. ¹³ According to these guidelines, publicly funded institutes and universities have to seek and receive approval from the government before participating or holding virtual meetings. Furthermore, all sensitive matters (e.g., political, scientific, technical, commercial, personal with provisions for sharing of data in any form; presentations) and issues related to some Indian states (e.g., Jammu & Kashmir, North Eastern states) should receive additional approval from the ministry of external affairs.^13,14 Overall, the ambiguous and broad terms “scientific” and “sensitive” restrict the participation of mental health researchers in any virtual international conference and dissemination of study findings. For example, social, financial, and psychological factors related to farmer suicides or people living in the border states (e.g., Jammu and Kashmir or Northeastern states) are more likely to be perceived as sensitive information.

  In our opinion and experience, the conduct of conferences and webinars on virtual platforms during the COVID-19 pandemic has led to rapid knowledge dissemination surmounting barriers related to costs (e.g., high participation fees, lack of travel support for early career psychiatrists and researchers from many low-to-middle income countries including India) and logistics (difficulties in getting the visa, time constraints for the busy clinician in attending an in-person conference). ¹⁵ It has given more opportunities for people to participate and present their research work. The new guidelines are, perhaps, important from a national security perspective. Nonetheless, they will also impede mental health research in many ways, including restricting international training opportunities and posing difficulties in disseminating Indian perspectives and research findings.

Overall, the virtual conference guidelines and section 99 (2, 3) of MHCA, on implementation, can reduce the mental health research in critical areas mentioned above, lead to under-representation of Indian psychiatry at the international level, and increase potential threats of political abuse of mental health researchers working on vulnerable populations (e.g., farmer suicide, marginalized populations). Interactions with the leaders in the field are critical to enhancing opportunities for collaborative work and need to be encouraged by the removal of systemic barriers.

To address these challenges, large institutions and universities may develop a system or employ an individual to help navigate bureaucratic hurdles, but small, rural institutions and independent researchers may need support or suitable modifications and strategies. Given this scenario, we propose a few recommendations aimed at limiting the potential negative impact of these new measures and legislations.

Some Recommendations

• Exempting MHPs from the MHCA sections on research:

  In our opinion, the MHPs registered with professional bodies and MHP course trainees must be exempted from having to seek approval from SMHA for research. Indian MHPs are already following various professional, regulatory, and ethical guidelines^10,12 and are more proactive and supportive for the rights of persons with mental illness, and there is no evidence that the registered MHPs have violated the rights of persons with mental illness. Further, SMHAs should continue to assess the proposal for research on persons with mental illness, initiated by non-MHPs, for approval.

• Single window system for multiple approvals: To harmonize the research without delay in approval, it is important to establish a single-window system at the local or government level (Figure 1). The single window system should provide prompt support and guidance on multiple approvals (e.g., permission from multiple SMHAs, ethical and regulatory approvals [Health Ministry Screening Committee, Drugs Controller General of India clearance]). In the recent financial budget, the Government of India has announced a national research foundation to harmonize the research. ¹⁶ Under the aegis of such organizations, a single-window system can be created to help the researchers.

• Support to mental health researchers: The research in any field, including mental health, ultimately aims to find out the truth or approximate truth. Therefore, efforts should be taken to support researchers through clear rules and guidelines regarding international collaboration, processing of different approvals, and ensuring compliance. This will enable researchers to focus more on research than the paperwork.

• Encourage the virtual international academic events: Across the world, many social media sites (e.g., ResearchGate) are encouraging collaboration, independent of the geopolitical barriers, by bringing people together. Unfortunately, one government agency supports international collaboration, while another restricts them. Certainly, there may be a need for certain rules and regulations for international data sharing. Therefore, a simplified approval process and encouragement to participate in virtual international academic activities are much needed.

• Role of professional organizations: Good scientific research is hard enough to conduct, and multi-centric and international team-based research could be more difficult in the future in terms of conduct and dissemination of the findings. Professional organizations should be prepared enough to overcome the bureaucratic obstacles and support the Indian mental health researchers. For example, professional organizations (e.g., the Indian Psychiatric Society) can develop guidelines for researchers and stakeholders of SMHA regarding the review and approval of multi-state research proposals. Similarly, single window system, scientific review boards, and independent ethics committees (Ind EC: ICMR Ethical guidelines—2017: section 4) can be established at branches of professional organizations to facilitate independent mental health researchers or private psychiatrists. ¹⁰

Figure 1.

Proposed Model of Single Window System