Guest guest Posted August 3, 2010 Report Share Posted August 3, 2010 Hi, Fresh or re-consent is taken in following conditions which even may require amendment of the ICD : 1. Availabilty of new information which would necessitate deviation of protocol. 2. When a research participant regains consciousness from unconscious state or is mentally competent to understand the study. If such an event is expected then procedures to address it should be spelt out in the informed consent form. 3. When long term follow-up or study extension is planned later. 4. When there is change in treatment modality, procedures, site visits. 5. Before publication if there is possibility of presentation of photographs (which should be camouflaged adequately). (Source: Ethical guidelines for Biomedical research on Human participants. Indian Council of Medical Research New Delhi 2006) Quote Link to comment Share on other sites More sharing options...
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