Clinics trials (CT) help to bring the safe medicines in the market. It is very important that the clinical trials are conducted in the ethical way. Some ethical issues involved in CT are as follows:-
1)Personal interest vs Social interest
Under this case it seems to be true that the principle of Utilitarian approach is blindly followed.That gives more emphasis on maximum good to maxiam number of people, irrespective at cost of individual rights.
2) Dilution of human values
Clinical issue is violating values like dignity and self respect, compassion,love,brotherhood attitude.Instead it promoting selfishness,cost benefit principles at large and unbounded scientific development at cost of social ethos.
It is well said that Technology without ethics is self-distructing threat to any nation.Because war cause monetary,political, economic damage ,loss of human lives but dilution of social ethos have long lasting negative impacts on nation than former one.
Therefore application of clinical trials should have strong,sound foundation of ethics.
Unequal burden: The maximum no. of recruits in such trials belong to lower income groups
2)Financial incentives greed: Inclines many to take part in more than one trials and also fudging their medical history. Such deception not only harms the individuals health but can lead to false trial and its data with ineffective medicine release. The WHO and European regulator found many Indian companies fudging bioequivalence data leading to bans and warnings
3)Absence of consent and transparency :often noticed when majority of trial subjects are illiterate indicating their vulnerability to human rights violations
Thus keeping all these issues in mind certain steps can be taken:
1)Create a national registry of clinical trials with subjects data being made anonymous to protect privacy
2)Balance the financial incentives given to reduce taking course of deception to earn more
3)Sustainable solutions such as having cross section of society being involved in trials rather than just the vulnerable group will improve trials.
4)Increase awareness among people about potential fallouts from such trials
5)Have a continued tracking system to give relief to any possible side effects so that tweaks can also be made in the drug delivered
CONCLUSION:With the government set to launch a new clinical trials policy that will promise greater transparency and better checks for patient safety we must also have active participation of civil society having a vigilant approach as even though the norms may get stricter an ethical science is always better than bad science.
