Context: Catch a cold and help scientists make new vaccines
Relevance: GS 4 Ethics (Medical Ethics)
About the Project:
- These projects are unique because it involves a Controlled Human Infection Model (CHIM) volunteers who take part in trials will be infected, under expert supervision, with infectious viruses or bacteria. Such studies, which are being employed in vaccine development in the United States, the United Kingdom and Kenya, are being considered in India.
- The Department of Biotechnology (DBT) is finalizing three projects worth ₹135 crores, involving Indian and European scientists, to develop new influenza vaccines. Under this model, volunteers will be infected with viruses or bacteria.
- A CHIM approach will speed up the process whereby scientists can quantify whether potential vaccine candidates can be effective in people and identify the factors that determine why some vaccinated people fall sick and others do not.
Ethical Guidelines in Clinical Reseach:
- The ethical guidelines in place today were primarily a response to past abuses, the most notorious of which in America was an experiment in Tuskegee, Alabama, in which treatment was withheld from 400 African American men with syphilis so that scientists could study the course of the disease.
- The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology, people who participate in clinical research make possible to secure knowledge.
- The risk in such trials is that intentionally infecting healthy people with an active virus and causing them to be sick is against medical ethics. It also involves putting human lives in danger. Clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of science.
- Some of the influential codes of ethics and regulations that guide ethical clinical research include:
- Nuremberg Code (1947)
- Belmont Report (1979)
- Declaration of Helsinki (2000)
- CIOMS (2002)
- U.S. Common Rule (1991)
- Using these resources of the guidance and other, seven main principles have been described as guiding the conduct of ethical research:
- Social and clinical value
- Scientific validity
- Fair subject selection
- Favorable risk-benefit ratio
- Independent review
- Informed consent
- Respect for potential and enrolled subjects
- Individuals should be treated with respect from the time they are approached for possible participation even if they refuse enrollment in a study throughout their participation and after their participation ends.
- Respecting their privacy and keeping their private information confidential.
- Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without penalty.
- Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating.
- Monitoring their welfare and, if they experience adverse reactions, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study.
- Informing them about what was learned from the research.
Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict.
The government should take proper regulation and consideration to make it effective for mankind.