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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :"ICMR guidelines suggest the need of EC approval for epidemiology.. 2009-08-18 00:57:45 
Sushma Naidu
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Joined: 2009-07-27 17:07:19
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Subject :"ICMR guidelines suggest the need of EC approval for epidemiology studies"

Hi,

For epidemiology studies, there are ICMR guidelines.  Please see the current guideline of 2006.  It is desirable to follow the usual ethical requirements for such studies e.g. EC approval.  The consent depends on the nature of survey and its impact on the participants. You need to consult the EC re: need for consent.  This applies to all surveys whether done in hospital or in community.

ICMR guidelines suggest the need of EC approval for epidemiology studies ( Thursday, March 06, 2008 08:00 IST by Dr Arun Bhatt )

Regards

 
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