The two big headlines for India in the field of economics in 2019 were the sharp slowdown in growth and the award of the Nobel Prize to Indian-origin economist Abhijit Banerjee and his partners, Esther Duflo and Michael Kremer.
Banerjee, Duflo and Kremer were awarded for their work on Randomised Control Trials (RCTs), which have important implications for the field of development economics.
But the most important implication of their work should perhaps be for the framework of conducting trials in India.
The question of ethics and guidelines
While the largest number of RCTs takes place in the US, where most researchers conducting the trials are based, India tops the list of RCTs outside the US, as well as those conducted in poor countries. Data with the American Economic Association shows that 247 RCTs have been conducted in India since 2012.
Why do researchers prefer India to other poor countries? While part of the answer lies in the large pool of subjects (poor people), relative safety of researchers, and the use of English in most parts of India, the country also lacks a legal framework for conducting non-clinical trials.
Universities in the US have Institutional Review Boards (IRBs) or ethics boards that ensure that the experiment follows ethical standards. These standards often depend on whether the researcher is following the regulations laid down in the relevant laws and guidelines in the country in which the experiment will be conducted.
For example, guidelines in many countries require that those on whom an experiment is conducted should be among those who would benefit from its policy implications. Or, that the researcher has to obtain informed consent from the participants. Geotagging of subjects, feeding tablets to children, asking subjects to view violent videos, monetary incentives for bribing public servants may not be permitted by guidelines.
By now, countries such as Kenya, Malawi, and many other poor countries have laws or regulations in place, and a regulatory body that requires researchers to register with it, and follow the guidelines in place for conducting experiments on human subjects.
India has guidelines for clinical trials, not for non-clinical ones
India was also a popular destination for biomedical and health trials. Then, in 2017, the country put in place ethical guidelines for biomedical and health research involving human participants that addressed concerns in subject areas where there was scanty guidance available, such as public health research, social behavioural research, or dealing with vulnerable populations.
The intent was to improve the conduct of biomedical research in India.
However, India has not yet brought in regulations about how RCTs should be conducted and kept in check. Experiments that are not possible to conduct in other countries are still done in India.
In the absence of a regulator or an institution that gives permissions for the experiment, the procedure typically requires approval from the university IRB to which the researcher is affiliated, but no one in India sees anything going on. The university IRB rules may require that country guidelines be followed, but if there are no country guidelines, universities are likely to be more lax. Experiments not allowed in the US are approved by IRBs for a country like India, because there is no law stating what isn’t allowed.
When the researcher comes to India, she does not require permission for the experiment. There is no mechanism for oversight. Often, consent is not taken from the subject; this violation is often not even recorded. It is not in the interests of governments and academia and funding agencies to protect the subjects from invasive experiments by researchers.
What India needs to do
India’s Parliament needs to enact a law and create a regulator and a framework for social science RCTs as well. An institution like the UGC, ICSSR or a similar body should be made responsible for preparing ethical guidelines for non-biomedical trials on human subjects, registering experiments conducted in India, and ensuring that they follow ethical guidelines.
High-quality journals and university departments and IRBs would not accept research that violates ethical guidelines. This would provide a framework to protect vulnerable populations from such research.
India has a large population of poor people, and after the Nobel Prize, organisations such as Banerjee and his partners’ Poverty Action Lab that conduct experiments on poor people will, no doubt, get a boost in both resources and interest. This would inevitably result in more experiments.
It is the job of the Indian legislature and government that the interests of the poor and vulnerable, on whom these experiments are conducted, are protected.
The author is an economist and a professor at the National Institute of Public Finance and Policy. Views are personal.