Options of Funding and Ethical Clearance for Medical Researchers in India

Introduction

Research is the creation of new knowledge and/or the use of existing knowledge to develop new concepts, methodologies and to broaden our understandings.¹ It is a stepwise process which uses collected information to increase our understanding of a topic or issue.² Medical research (research related to health) is the stepping stone towards making people healthier and providing quality care. It can be related to the disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, health care costs and use, and drug or vaccine efficacy and adverse effects.³ It helps the decision-makers in keeping up with the struggle of rapidly evolving scientific knowledge and applying it to healthcare practice, organisation, and policy. It involves the uptake of clinical procedures, technologies, and organisational models to achieve the best possible healthcare outcomes and to stop practices that are no longer supported by evidence to be beneficial.⁴

The research output from low- and middle-income countries (LMICs) such as India compares poorly with that of high-income countries.⁵ There has been an increase in the medical research in India but it is not adequate when compared to other countries or areas.^6,7 This phenomenon, dubbed the ‘10/90 gap’ by the Global Forum for Health Research, refers to the fact that of the over $ 70 billion spent worldwide on health research each year, only about 10% is invested in research into 90% of the Global Burden of Disease (GBD).⁸ The inequality rises from macroeconomic, power imbalances and resource drainage to perceived better prospects.⁹ Majority of research work in India takes place in the major teaching hospitals wherein the caseload is too high to dedicate a respectable amount of time to genuine research or for discussions. In such a scenario, there is a drill culture, where instead of coming up with better or more efficient ideas, healthcare workers are forced to stick to the norms. Risk-taking is not a viable option for the majority of healthcare professionals in India as such initiatives are often seen with suspicion and mistrust, and often lead to communication breakdown. The output of good-quality medical research from India is grossly inadequate, and there is a need for strategic planning. There is a gross low relative research output in several health conditions in India that have a high burden.¹⁰

A researcher can be affiliated with an academic (or other) institute/organisation or unaffiliated (independent). Affiliated researchers conduct research by using the facilities of their university, libraries, or by collaboration. Unaffiliated researcher (Independent researcher) is not affiliated with any institute/organisation.^11,12 He/she is motivated toward the research by personal interest or passion over the topic. An affiliated researcher can be limited by time constraints, lack of motivation and most importantly independence or freedom. It becomes important in many scenarios wherein an institution or its policies may keep many ideas in check, for the fear of disturbing the homeostasis of the societal fabric. In such a situation, independent research can be the ideal combination for an effective change agent. The independent researcher has the education, expertise, and motivation. He/she can be a change agent, or effective advocate, for an idea or cause.¹³ Both types of researchers can face several hindrances in conducting research. One of the major issues is the availability of funds and ethical clearance.¹⁰ There is also a lack of willingness for strategic collaboration, undermining the value of both research and its projected outcome.¹⁴ In such a situation it becomes difficult for the researcher to carry out research effectively and this, in turn, leads to a vicious cycle of losing out in the race for good quality research and study. In this article, we discuss the opportunities and options available for medical researchers in India in terms of funding and ethical clearance. This will ease the process of conducting research and will encourage researchers pro-actively by focusing on the issues related to finance and ethics faced by them.

Funding Options

Not all the studies require funding. Many studies have been done in the past without any financial support. It can be done by utilising the available infrastructure and resources or with the help of volunteers. However, most of the studies require financial support. The majority of the research, if undertaken under the purview of an institution, can be funded by the institute itself (intramural) or from outside the institute (extramural). Researchers who are not affiliated with any institute may face several challenges. The common funding options for an unaffiliated researcher can be through fellowships, grants or awards.

The ways to avail of funding for medical research are enumerated below:

1. Fellowships – Fellowships usually pertain to aids for research in a particular area. Fellowship may refer to just a position and may not include a financial component.

2. Grants – They usually cover expenses related to specific research. There is a funding opportunity followed by applications and decisions regarding the award of the grant. Details are provided in ►Table 1.

3. Awards – An acknowledgement or appreciation of the achievements in the respective field. It can be monetary and it can be used for the research.

4. Funding from the Ministries/organisation in India can be obtained under the projects/schemes. Most of this funding is availed through affiliating with the NGOs/associations/societies/bodies/institutes. A list of funding organisations is provided in ►Table 2.

5. Availing through registered organisations/societies/trust– Under this, organisations working on the related topic can be approached and research can be initiated in collaboration. Most of the registered organisations get funding for the research or they can apply for grants at various portals. For an independent researcher, working with an organisation makes it easier to get funds for research. From the funder's perspective, the accountability and transparency of the fund are relatively higher in the organisation. Various private companies in India try to invest more in Non-governmental organisations (NGOs) under the Corporate Social Responsibility (CSR).

6. Partnership with the other group of researchers who are working on the same area of interest.

7. Professional societies/associations/trust of medical professions can also be approached; e.g. Indian Medical Association (IMA), Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), Indian Academy of Pediatrics (IAP), Indian Radiology and Imaging Association (IRIA), Indian Association of Preventive and Social Medicine (IAPSM), Indian Public Health Association (IPHA), Association of Physicians of India.

Ethical Clearance

Details about when to approach an Ethics committee have been shown in ►Figure 1. For a researcher affiliated with an institution, any research taken up is addressed by the Institutional Ethics Committee (IEC) of the particular institution. In case of collaboration with any other institute, the Ethics Committee of the collaborating institute can be approached for a get-go from their side. For an independent researcher, one of the major challenges faced is getting ethical clearance for their research. Due to the lack of affiliation to an institute/organisation or lack of ethics committee, it becomes difficult to go start any research work. Even during the publication, ethical approval is one of the mandatory requirement.

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Fig. 1

Process for funding and ethical clearance in conducting a research study.

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Thus, the following are the ways for an ethical approval:

1. Approaching the IEC of the affiliated institute

2. An unaffiliated researcher may approach the ethics board of any institution/organisation with the request of overseeing the ethical aspect of their research process. However, in most institutional ethical committees, an independent researcher may not be entertained.

3. An unaffiliated researcher may collaborate with another researcher who is affiliated with an institute (having an ethics committee) to get the ethical clearance.

4. Central Ethics Committee on Human Research (CECHR) of Indian Council of Medical Research (ICMR)

5. Independent ethics committees – There are several independent ethics committees in India that a researcher can approach for ethical clearance. Details in ►Table 3.

6. Non-governmental Organisations (NGOs) – An NGO/society/trust can have its ethics committee which can be registered with National Ethics Committee Registry for Biomedical and Health Research (NECRBHR).

The Way Forward

Research today is one of the forerunners of health and development around the world. Research in India has a long and arduous way ahead in terms of galvanizing an entire cohort of Indian minds to the unexplored aspects of healthcare. The most efficient and easy option for an independent researcher is to get funding for research through collaboration with other researchers or organisations, and then apply for funding. To a certain extent, a collaboration provides certain advantages like the pooling of resources and a higher number of inputs to improve the quality of work. However, there are various challenges related to collaboration during sharing the responsibilities, credit, resolving disagreements and decision making.¹⁵ Funding for researchers needs to be made more accessible and flexible. There are very limited organisations that fund unaffiliated researchers. Promoting unaffiliated research should be a part of the policymaking directive. For ethics, we suggest a Central Independent Ethics Review Committee which would guide the nearest ethics committee to approach for approval. Fast-tracking of the research proposal can be done by segregating the research based on types and through undertakings. Promoting free and online training programmes for researchers can be also done to enhance the quality of their research. Leveraging the technology for the digitalisation of the process will ease and motivate the researchers. A central online portal with various funding available for the research will increase the opportunities for researchers. It would provide a boost to the researchers who struggle with their ideas in the absence of monetary inputs or a chance for their original work to be recognised.