Open AccessCausality assessment: A casualty of compensation?
Author(s) -
Anuradha Kulkarni,
Arun Bhatt
Publication year - 2013
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.120166
Subject(s) - causality (physics) , compensation (psychology) , clarity , process (computing) , subject (documents) , risk analysis (engineering) , risk assessment , medicine , psychology , computer science , computer security , social psychology , biochemistry , physics , quantum mechanics , library science , operating system , chemistry
Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment.