Ethical issues in vaccine clinical trials

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

B.D. Darade and A.S. Khairnar

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Participation of children in vaccine trials is a complex, legal, and ethical issue. Greater efforts should be made to develop vaccines in developing countries. Such trials involve not only significant scientific challenges but also complex economic & ethical considerations, Paediatric age groups are significantly vulnerable as a research subject, in a vaccine trials conducted in developing countries. Such trial should be justified with the participated populations. There should be equitable sharing of benefits and risks. Ethically and scientifically explanation about the use of population. End point priority after vaccine trial is to improve child survival and prevention of diseases & to overcome the morbidity and mortality. The inform consent form should explain the purpose, risk & benefits, comparator & care. It should be voluntarily and inform. This topic explains vulnerability of child, benefits and risk, adolescent participation, inform consent/confidentiality, compensation, and regulatory framework.

Biography :

I did my medical graduation in B.H.M.S. Myself is doing PG.in Pharmaceutical Medicine From "University Department of Interpathy Research and Technology (UDIRT)",Maharashtra University of Health Sciences (MUHS), Nashik.