Stringent laws for clinical trials: pros and cons

Stringent laws for clinical trials: pros and cons

Introduction:

According to government data, in 2 years 370 people died in medical research out of which only 21 of the victims were compensated. The norms for compensation are not very clarified and since most of the volunteers are paid by the research organizations, there is confusion when claims for compensations are brought to court. Stringent laws for clinical trials to check the number of rising deaths each year in these trials also meant that cheaper medicinal researches were lessened. New norms started impeding clinical researches and attracted debates on the pros and cons of clinical trials in the country.

Pros:

1. Due to growth in technology, trained human power and infrastructure, medical research becomes easier than ever before as it is practiced with more physical interaction and better precautions. It has to be adopted for multiple reasons because there are large numbers of people who are subject to range of disease.

2. Such trials are affordable as low cost is incurred in it. In India work force is equivalent to technology which results in optimum utilization of resources and ultimately cheaper cost. Stringent laws made this difficult for cheaper medicines.

3. There are many international laws on medical research which ensures safeguarding of the rights of volunteers in medial trials. It is also helpful in creating international trade relations and for a developed nation it is important to stay ahead in the run when newer and better medicines have to be researched everyday for newer kinds of diseases and emergencies.

4. Clinical research without trials can prove to be dangerous. Every invention has its cons and nothing can really be achieved without taking risks. On ethical grounds and with complete precautions, medical trials should be given permits.

5. India’s clinical trials industry is at the verge of dying and this is a bad news for a developing nation. With more therapeutic counseling of the volunteers, clinical trials have to spread its wings out for a healthier India.

6. Penalty and prosecution laws on clinical trials have made the industry slow down to a great extent. With the risk of spending the next two year imprisoned, doctors have slowed down the research processes.

Cons:

1. Uncertainty and risks associated with new treatments cost the volunteers their lives. This makes it a serious issue and without strict scrutiny and laws it cannot be determined what steps need to be taken before permitting for a clinical trial.

2. Unethical practices like practicing a trial on a patient without their consent increases with strict laws as reported during treatment of the victims of the 1984 Bhopal gas leak. 14 patients lost their lives during the clinical trial and many more such incidents were seen rising before stringent laws were passed.

3. Clinical trials in India were being carried out without trained manpower or a clear-cut regulatory framework which in turn led to high fatality rate till the year 2005. Poor Indians were traded for money and were treated like mere objects of experiments.

4. Compensations were not given to the families of the victims of clinical trials. In the lack of norms to determine the rate of compensations, many families were simply denied the same.

5. Clinical trials are carried out to save lives and not to take lives of innocents, sometimes unethically and without proper consent.

Conclusion:

Stringent laws for clinical trials was absolutely necessary to ensure that the practice of research is being carried out under proper scrutiny and ethical terms are being taken care of. However, in the process of failure of these trials, norms for determining compensation should be framed. Only with proper documentation of the terms a clinical research should be carried out.