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 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.

Stakeholders involved

(a) Patient

(b) Medical houses

(c) Common people who benefit

(d) Regulatory houses

(a) Ethical issues which arise during situation

(i) Human as means to achieve something Trials are conducted on human for which there is no surety of success.

(ii) Consent of person vs imposition In clinical trials the facts and risks are not clearly disclosed which leads to conflict of ethical values.

(iii) Poverty vs well being These trials are conducted on poor people who in return of money risk their lives.

(iv) Ethics of Medicine vs Company's profit As a company the purpose is to make the trial successful with the profits but medicine ethics talks about the noble values which it stands for.

(b) As a scientist I will have to ensure that medical discoveries happen which can save lives of many people. But along with that I will also have to

follow the ethical principles involved with my job.

I will not prefer to shift the trials to a country where conditions are lax as it will be a wrong means to achieve good ends.

• Using the loopholes in law between different countries will serve no purpose.
• Mahatma Gandhi has said that rights are not protected by law but moral and social conscience of the society.
• Shifting the trial to that country could set bad precedent as other countries may follow the same.

Laxity in rules may expedite the process but it will put the person on whom trials are conducted at risk.

Thus instead of shifting, looking at the severity I will ask my government to expedite the process. The disease and its cure can be a revolution and government will help in such process.

(c) Standard procedure to minimise ethical conflict.

Process of conducting trial

• It should be done under recording and CCTV cameras.
• Doctors from not only that institute but government appointed panel for such trials should be there.

Consent

• Proper consent of the individual should be taken on paper with all the risks associated with it told to the person
• It should not be under any pressure.

Compensation

• In case of any untoward incident compensatory mechanism to the patient and the family should be there.