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Delhi Technological University: HU-303: Professional Ethics and Human Values Assignment

The document discusses ethics in clinical research from the Indian perspective. It provides an overview of how ethical guidelines for clinical research were developed after discoveries of inhumane experiments on participants. The Indian Council of Medical Research laid out ethical guidelines in 2000 and revised them in 2006. A controversial cancer study from the 1970s-1980s showed the need for such guidelines. The guidelines provide 12 principles and ethics committees are responsible for reviewing research proposals to protect participants. Informed consent and vulnerable populations are important concepts. While India has guidelines, fully following and enforcing them through law remains a challenge, as does training researchers in ethics. Overcoming such challenges can help India conduct ethical clinical research.

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Raghav Punjani
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52 views3 pages

Delhi Technological University: HU-303: Professional Ethics and Human Values Assignment

The document discusses ethics in clinical research from the Indian perspective. It provides an overview of how ethical guidelines for clinical research were developed after discoveries of inhumane experiments on participants. The Indian Council of Medical Research laid out ethical guidelines in 2000 and revised them in 2006. A controversial cancer study from the 1970s-1980s showed the need for such guidelines. The guidelines provide 12 principles and ethics committees are responsible for reviewing research proposals to protect participants. Informed consent and vulnerable populations are important concepts. While India has guidelines, fully following and enforcing them through law remains a challenge, as does training researchers in ethics. Overcoming such challenges can help India conduct ethical clinical research.

Uploaded by

Raghav Punjani
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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DELHI TECHNOLOGICAL

UNIVERSITY
(Formerly known as Delhi College of Engineering)

HU-303: Professional Ethics and Human Values


Assignment

Submitted by:
Name - Raghav Punjani
Roll No. - 2K17/CO/249
Batch - A4
Ethics in Clinical Research:
The Indian Perspective

OVERVIEW
Ethics in clinical research focuses largely on identifying and implementing the acceptable
conditions for exposure of some individuals to risks and burdens for the benefit of society at
large. Ethical guidelines for clinical research were formulated only after discovery of inhumane
behaviour with participants during research experiments.

In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the
object of study. It focuses on improving human health and well-being, typically by identifying
better methods to treat, cure or prevent illnesses. Ethics in clinical research focuses largely on
identifying and implementing the acceptable conditions for exposure of some individuals to risks
and burdens for the benefit of the society at large.

THE INDIAN PERSPECTIVE


The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical
Research on Human Subjects’ in the year 2000 which were revised in 2006.In 1970s and 1980s
researchers at the Institute for Cytology and Preventive Oncology in New Delhi, carried out a
study on 1158 women patients of different stages of cervical dysplasia or precancerous lesions of
the cervix. These patients were left untreated to see how many lesions progressed to cancer and
how many regressed. By the end of the study seventy one women had developed malignancies
and lesions in nine of them had progressed to invasive cancer. Sixty-two women were treated
only after they developed localised cancer. After the controversy about the study became public
in 1997, the ICMR started developing ‘Ethical Guidelines for Biomedical Research on Human
Subjects’ and finalised them in the year 2000. It gives twelve general principles to be followed
by all biomedical researchers working in the country. The Ethics Committee stands as the bridge
between the researcher and the ethical guidelines of the country. The basic responsibility of the
Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects
of the project proposals received in order to safeguard the dignity, rights, safety and well-being
of all actual or potential research participants. A well-documented informed consent process is
the hallmark of any ethical research work. Informed consent respects individual's autonomy, to
participate or not to participate in research. Concepts of vulnerable populations, therapeutic
misconception and post trial access hold special importance in ethical conduct of research,
especially in developing countries like India, where most of the research participants are
uneducated and economically backward.

OPINION in regard to the ETHICAL THEORIES


A Deontological argument can be made against this practice. According to Kantian Theory, an
act is considered good if it is in accordance with some cardinal principles that govern our duties.
Any researcher must work in his/her best of abilities in accordance with another person’s basic
human rights and in the interest of science, not for personal gains. In today’s world just for some
profits many people are willing to risk another person’s life.

According to Aristotle, an action is right if it is what a virtuous agent would do in the


circumstances. A virtuous agent is the one who act virtuously, that is, one who has and exercises
virtues. This is called Virtue Theory. A virtuous researcher is one who sticks to his beliefs
irrespective of the circumstances. He/She will never look for ‘greener pastures’ while making a
compromise on his/her values and people’s opinion.

THE WAY AHEAD


Though we have formulated many ethical guidelines for clinical research, are we adequately
following them? The answer is ‘No’. This is because the ethical guidelines in India are just the
recommendations and not a law. For proper enforcement of these guidelines should be made a
part of the law as has been done in US and other countries of the world. Another issue lies with
the training of doctors and research scientists in our institutions. Doctors are specially trained to
be good clinicians but are never taught even the fundamentals of ethical clinical research. The
post graduate dissertation or the PhD thesis is a precious opportunity to train tomorrow's
investigators in the elements of ethical clinical research. Undergraduates should also be involved
in simple observational research.

Finally if we can overcome these challenges, we will make India a competent and credible place
of ethical clinical research.

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