India has become one of the world's preferred locations for clinical trials due to its low operating costs and well-educated workforce. The country's clinical trials business has exploded into a $1.8 billion dollar a year industry involving more than 100 domestic and multinational organizations, according to an Indian trade association. This phenomenal growth has raised concerns about exploitation and patient safety and made it more urgent that India shore up its bioethics infrastructure.
Since 2000, Fogarty's International Research Ethics Education and Curriculum Development Award (or Bioethics) program has been supporting efforts to increase local capacity in India and other low- and middle-income countries in this critical area by encouraging bioethics curriculum development and training activities. Indian scientist Dr. Nandini Kumar leapt at the chance to join the first class of trainees funded by the Fogarty program at the University of Toronto.
Photo courtesy of Dr. Nandini Kumar/ICMR
With Fogarty support, Dr. Nandini Kumar (left) has built
a bioethics program that has trained thousands of
researchers in India and throughout the region.
During the one-year master's course, Kumar and her developing country colleagues learned about philosophical and historical approaches to bioethics, regulatory codes and the multidisciplinary case study approach to research issues - taking into account the setting, population diversity and culture. As Assistant Director General of the Indian Council of Medical Research, Kumar was ideally placed to return home and help guide the development of her country's bioethics framework and policies, then in their infancy.
Because Fogarty 'trainees' are prepared to become the 'trainers', the program has a multiplier effect, expanding the field of bioethics and better integrating it into the research enterprise globally. "Dr. Kumar is a great example of leveraging funding from Fogarty," noted her Toronto mentor, Dr. Peter Singer. "It's obviously more cost-effective and sustainable if the leadership for global health education is in low- and middle-income countries."
Photo courtesy of USAID
India is a popular location for clinical trials
due to its low costs and educated
workforce. Fogarty’s training program is
helping to ensure biomedical research is
performed in an ethical manner and
vulnerable populations are protected.
After completing the course in 2002, Kumar was encouraged by Singer to apply for Fogarty support to plan her own bioethics training program, specially tailored to India's unique culture and research environment. She was successful in her bid for a planning grant, and then received a full Fogarty award to implement her program in 2005.
Kumar's priorities were to create a national task force and advisory committees for bioethics, develop a centrally coordinated network of faculty prepared to train in the topic, implement the curriculum and evaluate the results. Her overall goal was to build capacity in bioethics education that is culturally sensitive - with special emphasis on research ethics related to genetics, drug development - including traditional medicine - and social sciences and international research ethics.
India's bioethics guidelines are rooted in ancient philosophies of its traditional systems of medicine, which established that a physician’s primary concern should be for the safety and best interests of the patient and conflicts of interest should be avoided. The traditional systems were formalized in India's Drugs and Cosmetics Act in 1982 and have been updated and revised numerous times since then.
With more than one billion people, India is the second most populous country in the world. Despite its burgeoning economy, the country faces significant health challenges including high rates of malnutrition, a continuing battle against infectious diseases, in addition to early onset of chronic diseases such as diabetes and hypertension. Research controversies include targeting illiterate populations and preying on drug-naïve populations without according them the benefits of a study.
When Kumar began her training program, bioethics was not uniformly required study in Indian medical schools and the country had only a handful of self-taught experts and health professionals with formal training in bioethics.
She began with three components: a sensitization program to create awareness beginning at the undergraduate level, a short-term course for trainers as well as longer more intensive curriculum. She later added distance learning diploma and master's degree courses through the Indira Gandhi National Open University. An online program is being planned that will be mandatory for all researchers and research ethics committee members in India.
Photo by Ray Witlin/World Bank
Informed consent is a key component of
ethical clinical research and included in
the Indian Council of Medical Research
Kumar organized the development of teaching materials covering historical background, ethical principles, informed consent, research on vulnerable populations, inducement for study participation, institutional ethics committee frameworks and operations, standards of care, post-trial benefits, stored tissue, intellectual property rights and conflicts of interest. In addition to adding to the bioethics expertise in India, her courses also attracted trainees from elsewhere in the region such as Bangladesh, Nepal, Pakistan and Sri Lanka.
Over the past seven years, Kumar’s program has trained more than 2,000 scientists and health care workers. More than 50 of them completed the intensive course and two earned master’s degrees. The program has hosted nearly 34 intensive workshops in 16 Indian cities. Its distance learning programs train as many as 50 each year.
Many of the graduates have published papers, prepared curriculum for bioethics instruction at their own institutions, presented papers at national and international conferences, served as evaluators and set up or become members of ethics committees. As the field has developed, Kumar has become not only a national leader in bioethics but also a member of international panels, including the U.S. Presidential Commission for the Study of Bioethical Issues.
In 2007, India launched a clinical trials registry to bring transparency and accountability to the research community, re-establish public trust and encourage the publication of information on failed trials. Registration of trials is required by the Indian government and the country's major scientific journals require registration in order for results to be published.
Despite paving the way for these and other successes, Kumar admitted India remains a challenging environment for research ethics. "There's much more work to be done," she said. She views bioethics at the nexus of research and human rights. Although violations persist, she noted, they "can at least be curtailed by insisting and mandating that ethical principles be observed whenever there is human involvement." Bioethics is more important in developing countries like her own "where the population is more vulnerable."