Compensation guidelines for research-related injury in India could destroy investigator-initiated research.
نویسندگان
چکیده
© The National Medical Journal of India 2012 INTRODUCTION The Indian Council of Medical Research (ICMR) and the Central Drugs Standards Control Organization (CDSCO) of the Directorate General of Health Services (DGHS) in the Ministry of Health and Family Welfare (MoHFW) have uploaded the draft guidelines for compensation to participants for research-related injury in India and invited feedback and comments on these guidelines. These guidelines were meant to elaborate on and provide operating details for the ICMR Ethical Guidelines for Biomedical Research on Human Participants (2006) which specified that ‘research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability’. The ICMR draft guidelines were prepared by the Indian Society of Clinical Research (ISCR) and Forum for Ethics Committees in India (FERCI). The scope of these guidelines is all-encompassing, including sponsored, industry-driven research and academic, institutional and investigator-initiated research. The ICMR and CDSCO have invited comments on these draft guidelines with a view to getting more opinions on this very controversial and contentious issue.
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ورودعنوان ژورنال:
- The National medical journal of India
دوره 25 1 شماره
صفحات -
تاریخ انتشار 2012