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CHAPTER 7

Ethics in Biomedical Sciences

Sanjay A. Pai

Ethical issues abound in the field of scientific research, including medical research, and have been
addressed in various fora for many decades now. However, the topic has not been given much thought
or importance in India until fairly recently. The interest that has now been seen over the past few years
is probably linked to many reasons — the presence of journals such as Indian Journal of Medical Ethics
and The National Medical Journal of India (both of which I am associated with), which often contain
articles on the subject; the realization that research misconduct does take place even though it is rarely
recorded in India; and finally, contemporary emphasis on research publications being necessary for
promotions in Indian academia.

The ethical issues that come to mind when one thinks of the word ‘ethics’ or “research misconduct”
include authorship issues such as plagiarism, fraud, and fabrication, publishing in predatory journals.
These topics have been addressed elsewhere in the book. I address other, less well-known subjects, but
which are of importance.

General Overview

Why does the question of ethical issues arise in biomedical research, or indeed, in science? In looking
at the concept of ethics in biomedical research there has to be some reference to science in general
as well. In that case, there may be some overlap between this article and some of the others in this
book . We need to examine one wonderful definition of science provided by Linus Pauling, the two-
time Nobel prize awardee (one in chemistry, 1954 and the other in peace, 1962). “Science is the search
for truth, that is the effort to understand the world: it involves the rejection of bias, of dogma, of
revelation, but not the rejection of morality.” All of these components are important — that science is
the search for the truth is what all of us are taught; that it involves questioning dogma is also known
to us. Few, however, are told about the importance of morality and ethics in the concept of science.
Ethics deals not just with the black and white areas, but also with the grey zones. There is, obviously,
an overlap with legal issues, but all that is legal is not necessarily ethical (many, including me, would
consider the death sentence as a prime example of this) and all that is illegal is not always unethical
(examples of which I shall not elaborate on!). Thus, science and scientific research consists of doing
what is correct and of following the golden rule: Do unto others as you would have them do unto you.

Research is, of course, essential at all times, as it is the curiosity that human beings have shown that
has made them different from animals. However, this curiosity and the explorations that it involves
must be done within established boundaries. The science must be performed in such a manner that
the methods and the results must be reproducible by other groups of scientists. Further, the research
must be performed within the existing social and scientific norms and must be useful to society or
at least, expand the horizons of our knowledge. Protection of the research participants is paramount
and researchers must take great care — this is morally as well as legally binding on them. A major role
of the ethics committee or the institutional review board is to carefully study the research protocol
and establish that the risks to the participants are reduced and that there exists an acceptable risk- to-
benefit ratio.

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