Based on these selleck Vandetanib guidelines, Emanuel et al., proposed essential requirements, which are vital for ethical conduct of research globally and in developing countries.[3,4] These requirements are: Value: Research should have social or scientific or clinical value. Scientific validity: The methodologically for research must be rigorous, based on accepted scientific principles and methods Fair subject selection: The selection of subjects should be based on scientific goals, considering potential distribution of risks and benefits amongst the target population, and protection of vulnerable population. Favorable risk-benefit ratio: The potential risks to research participant should be minimized, and the potential benefits enhanced, and the potential benefits to individual subjects and society are proportionate to or outweigh the risks.
Independent review: The research study should undergo a review by individuals who are not affiliated to the research. Informed consent: Individuals should be informed about all aspects of the research study ?C purpose, procedures, potential risks, benefits, and alternatives, ?C and provide their voluntary consent Respect for enrolled subjects: The research participant’s privacy should be guarded. They should have the option to withdraw, and their well-being should be monitored. The basic premise of these principles is that they provide an ethical framework which should minimize the possibilities of exploitation of research subjects in developing countries. We need to reflect on how these principles have been practiced in Indian setting.
The evaluation of social value of any new intervention is under government/regulatory purview. The current controversy about the need for cervical vaccine in India raises questions about how the process is carried out and who is responsible for this evaluation. The assessment of scientific validity and favorable risk-benefit ratio is done by the regulatory authorities and ethics committees (EC). The Indian regulatory authorities Cilengitide require phase III data in at least 100 patients for a drug already approved in other countries, and on at least 500 patients for a new drug substance discovered in India. These numbers are not as per current international regulatory expectations and do not appear to be scientifically or statistically acceptable. Since last year, the new drug advisory committees (NDAC) advise the selleckbio regulatory authorities in approval of clinical trial.