Q.4 Regulation 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 commercialized. 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 minimize ethical conflicts and speedup the approval process of new medicines. (20 Marks)

Mentor’s Comments- Give a brief introduction about human clinical trials and identify the ethical issues in clinical trials. Discuss the merits and demerits of shifting lab location and state your final stand on shifting the lab from the home country. Give a framework of standard procedure to minimise ethical conflicts and speed-up the approval process … Continue reading Q.4 Regulation 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 commercialized. 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 minimize ethical conflicts and speedup the approval process of new medicines. (20 Marks)