Ethics in research

MOOT POINT

In 1932, some 400 poor American men, all black, were diagnosed with syphilis. They were not told of the diagnosis or given treatment. They were merely kept under "observation"""well into the 1960s""so that the medical establishment could "understand" the course of the disease. The Tuskagee Study began as a clinical trial for testing a particular course of treatment. With the Depression, funding ran out and a stepped-down version of the trial began in a small area in Alabama. The "subjects" were not only strenuously denied new drugs when they became available but were also kept away from any chance contact with providers of new drugs. Only in the mid-1960s, when a former employee of the health department turned whistle blower did the survivors know all this. In a court case they were awarded compensation and the government was directed to provide lifelong care to survivors and some of their families. But the government agency maintained that these men had given their full consent to the experiment. In May 1997, President Clinton gave a public apology to the survivors. This experiment has raised many issues in ethical conduct. It is easy enough to dismiss this as an aberration in history. Unfortunately, there are many such cases despite the many codes of conduct in place today.

In the last couple of years, the Indian Council of Medical Research, India's nodal institution for medical research, has been taking steps to ensure that all its research projects are bound by its ethical code. Unfortunately, not all clinical research is necessarily scrutinised by the ICMR, because it is not mandatory for, say, drug companies to seek its approval. The ICMR has no authority to ensure the application of its elaborate code of ethics. In recent years, under pressure from foreign funding and collaborating institutions, the ICMR has begun to make its presence felt in some directions. It is now mandatory for all institutions undertaking research to set up institutional ethics committees. But since the idea and practice of ethics are so new in India, this has often led to piquant situations. For instance, institutional ethics committees are often put together at short notice although they are meant to be bodies in place permanently, with well-established norms of constitution and practice. In 2000, somewhat predating the publication of the research guidelines of the ICMR on the subject, a National Committee for Ethics in Social Science Research in Health (NCESSRH) was constituted, and it evolved, for the first time, comprehensive ethical guidelines for social science research in health. It has today had a major impact in furthering the study of ethics and its application.

Significantly, the guideline points out: "Sincere commitment to research in general and to the relevant subject in particular and readiness to acquire adequate knowledge, ability and skill for undertaking particular research are essential prerequisites for good and ethical research." How many research students pursuing MAs, M Phils and MDs are interested in research? And yet it is often mandatory for these students to undertake research dissertations. Or they take up jobs in research while waiting for something else to turn up. Disinterested research is likely to be poor science. A most important consideration in ensuring ethical research is that it must "pass" quality criteria. But how many institutions have such quality markers? It is hardly surprising that plagiarism, "restructuring", "recycling", or old dissertations are not uncommon.

Publication ethics has received scant attention in India. Medical journals published abroad are now, by and large, asking for statements on funding and an assurance that there have been no conflicts of interest. A survey by Madhukar Pai and Colford (quoted in a volume edited by Amar Jesani and Tejal Barai Jetly on ethics of social science research in health) found that eight of 15 journals required disclosure on funding support and only three about personal or financial conflict of interest. The last three years have, however, seen a better appreciation of these issues. Few Indian social science journals know how to detect or deal with plagiarism. In the course of teaching academic writing skills to research students and teachers, we have found that few know what plagiarism is, how to avoid it, or how to detect it in student assignments. Undoubtedly, a better appreciation of the need to inculcate research values may go some way in dealing with the problem. But perhaps journals that disseminate research findings ought to develop collectively comprehensive guidelines on plagiarism.

Surprisingly, none of the professional associations of social sciences seems to have evolved a comprehensive code of ethics. Nor has the Indian Council of Social Science Research (ICSSR) done much work on the issue. Ethical content and ethical perception are necessary components of good research. The maturing of social sciences in India must mean greater attention to the subject of ethics. There are many unresolved debates here. For instance, should research in economics using large databases and without a primary survey be subject to ethical review? The ICSSR needs to take up the challenge of developing ethics in social sciences seriously.

(The first National Bioethics Conference is being held in Mumbai on November 25-27, 2005.)