AIR 42 · CSE 2018 · GS4 · 58 pages

Nandini Maharaj: GS4 answer copy

18 answers by Nandini Maharaj, as written in the test. Each question opens a page with how other toppers answered it.

The questions

  1. Q14Regulation and procedure of human clinical trials vary from nation to nation. Stem cell research, as an emerging biomedical field, requires approval for human trials and encounters multiple challenges. You are the head of a team of scientists who developed a new Tissue Engineering system, which appears to be a promising means of regenerating heart tissue. Trials of the system have already been conducted on animals and yielded good results. Millions of people suffering from critical heart diseases would benefit immensely if this medication is immediately made available to them. However, you need to conduct human clinical trials before it could be commercialised. It is also known that the stringent regulatory environment in the country will mean that human trials and final approval will take many years before it is made commercially available. On the other hand, regulation of clinical trials in many poor countries is weak and quick approval is possible. Many of your competitors also resort to human trials in these countries, often bribing the officials for getting quick approvals. Given this situation, answer the following questions: (a) Identify the ethical issues which arise during clinical trials. (b) Given the above situation, would you prefer to shift human trials to a third country where regulations are lax? Give reasons in support of your choice. (c) Suggest a framework of standard procedure to minimise ethical conflicts and speed-up the approval process of new medicines.25 marks

The answers

Question 1(a) · 10 marks · 109 words written

The more remotely power is exercised from the people, the greater is the distance between authority and accountability. Discuss.

Opening

Power is considered most accountable when exercised locally.

Body · points and prose

→ this is the premise of federalism and decentralisation.

When distant authorities exercise power, there is fear of → apathy → disconnection

Close

Thus the Indian constitutional amendments of 1993, 73rd & 74th, mandate local governance.

The frightful and debilitating impact of colonialism is a manifestation of problems of remote governance.

During the 2nd World War, the British powers took away grain from Bengal to feed the British Army. As a result, 3 million people in Bengal died (Great Bengal Famine of 1943). They were not connected with the plight of Bengalis, and yet exercised power over them. The results were catastrophic.