ETHICAL GUIDELINE FOR SCIENTIST/RESEARCHER/BIOTECHNOLOGIST

INTRODUCTION

Ethics is concerned with the conduct of human beings. All scientific activities, including those by the social scientists, are conducted with the participation of human beings or have an impact on human beings or on the wider society and environment. Therefore, it is essential that scientists/researchers understand ethical issues and the implications of their scientific work and act accordingly. For making ethical judgement, the scientists/researchers rely upon various standards of ethics, which could be universal or specific to the culture(s) or localities. Indeed, it is essential that researchers share and discuss the ethical issues in their work and evolve collective standards of their own.  Self-regulation and ethics have been issues for debate within research more often in medicine than in social sciences. The Second World War and the Nuremberg trials of doctor-researchers exposed the horrors of the fascist politics as well as unethical biomedical research. In the post World War period, therefore, the scientists paid increased attention to ethics in biomedical research. In the process, the quality and validity of unethical research was questioned, the human rights of participants recognised and ethical codes formulated. The Nuremberg Code (1947) was followed by the Declaration of Helsinki in 1964, which was amended subsequently (WMA, 1989). The Council for International Organisations of Medical Sciences (CIOMS) and the World Health Organisation (WHO) (1993) also proposed guidelines in 1983 and adopted them in 1992. These international developments followed as well as inspired several such initiatives at the national level and in various specific fields of biomedical research. India, too, did not remain unaffected. In 1980, the Indian Council of Medical Research formulated "Policy statement on ethical considerations involved in research on human subjects" and in 1997, it brought out the draft of "Consultative Document on Ethical Guidelines on Biomedical Research Involving Human Subjects". The issue of ethics in social sciences, unlike in medical research, has been given less prominence in India. Although many social scientists have paid serious attention to the appropriate conduct of research and set personal examples, they are often not discussed as ethics and no efforts are made to formalise some guidelines based on such experience(s).  National councils for social science research and their institutions have many guidelines either as administrative orders or for improving the quality of research but enough efforts have not been made to bring them together as comprehensive ethical guidelines. 

BACKGROUND

March 1, 1999

These ethical guidelines for biotechnology originated at the Center for Ethics and Toxics in Gualala, California with the realization that no guideposts existed for the development of the new science of biotechnology other than the rather non-specific tenets of science and medical ethics. A code or set of ethical principles serving as a guideline was needed because biotechnology has such great potential to reshape life generally and individual species particularly.  While humans have already reshaped the course of evolution during our short tenure on Earth, until now we have been powerless to intervene selectively into the genetic material of particular species. With biotechnological advances, it has proven possible to move and insert disparate genes from disparate species so that new genetic elements become permanent fixtures of the germ line of certain species.  The genes chosen to be ensconced in the descendants of such newly created transgenic animals or plants have never been chosen through open public debate, universally accepted standards, or determination of their intrinsic “good”. The shocking details of the post Second World War (1939-45) trial of German medical practitioners accused of conducting experiments on human participants without their consent and exposing them to grave risk of death or permanent impairment of their faculties raised grave concern about subjecting human subjects to medical research.

Thus, the first International Statement on the ethics of medical research using human

subjects namely, the Nuremberg Code was formulated in 1947. Although informed consent for participation in research was recorded in 1900, the Nuremberg Code highlighted the essentiality of voluntariness of this consent. In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United

Nations) expressed concern about rights of human beings being subjected to involuntary maltreatment. In 1966, the International Covenant on Civil and Political Rights specifically stated, ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.’ Based on the preliminary efforts of the Council for International Organisations of Medical Sciences (CIOMS) in 1964 at Helsinki, the World Medical Association formulated general principles and specific guidelines on use of human subjects in

medical research, known as the Helsinki Declaration, which was revised from

time to time. In February 1980, the Indian Council of Medical Research released a ‘Policy Statement on Ethical Considerations involved in Research on Human Subjects’ for the benefit of all those involved in clinical research in India. In 1982, the World Health Organisation (WHO) and the CIOMS issued the ‘Proposed

International Guidelines for Biomedical Research involving Human Subjects.’ Subsequently the CIOMS brought out the ‘International Guidelines for Ethical Review in Epidemiological studies’ in 1991 and ‘International Ethical Guidelines for Biomedical Research involving Human Subjects’ in 1993. The most recent documents on ethics are those of UNESCO’s “The Universal Declaration on Human Genome and Human Rights” (1997), “The International Declaration on Human Gene Data” (2003) and “Universal Declaration on Bioethics and Human Rights” (2005).

IMPORTANCE OF RESEARCH ETHICS

Designing and implementing an experimental study often requires us both to ask factual questions (“How does this disease arise? Does this drug produce a clinically important effect?”) and to make value judgements (“This intervention is likely to alter the natural course of this type of stomach cancer”, or “The unwanted effects of treatment are so severe that we should stop the trial”). As in managing ill patients, therefore, research requires not only scientific and technical knowledge, but also value judgements. These judgments need to be systemically analyzed and validated, just as with the results of experiments. So, ethics or moral philosophy is that set of rules which guides rational and good behaviour. Bioethics is that branch of ethics which deals with biomedical research, specifically with questions related to artificial reproduction, tissue transplantation and genetic engineering. Ethics cannot define absolute right or absolute wrong; even if it could, it may not be valid in all possible types of research. Also, how ethics translates into real behavior varies according to the religious, socioeconomic and political context. For this reason, they ought to be greater attention to humanist moral principles that transcend religion, while recognizing that any given community’s ethical guidelines are influenced by the legal, socioeconomic and political climate of the time.

REFERENCES

1.      Beauchamp T L, Childress J F. Principles of biomedical ethics. 4th ed. New York: Oxford University Press, 1994

2.      Dupre J. Human nature and the limits of science. Oxford: Clarendon Press, 2001

3.      Gillon R. Philosophical medical ethics. Chichester: Wiley, 1987

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