CEIOC Ethics Committee Sample Clauses

CEIOC Ethics Committee. On 15th September2009 the D2.3 Protocol for Ensuring Data Protection/Safety in neuGRID, along with a summary in Italian of the protocol (as required by CEIOC), was submitted to the Independent Ethics Committee CEIOC. The protocol has been discussed in the CEIOC meeting on October 21st and CEIOC gave favourable opinion to the deliverables, with a request of some clarifications. With regard to the “Protocol for ensuring data protection/safety in neuGRID”, paragraph 3.5 “Data Protection protocol. Open issue: subjects’ capacity to give informed consent”, the Ethics Committee asked for clarification of the “protective measures” that should be set up in the case of collection of data and images from subjects not fully competent to give a valid informed consent. In order to accomplish the request of CEIOC the original statement: “In case of subjects not fully competent to give informed consent, rigorous protective measures should be set up conformant with local regulatory frameworks where applicable “ has been modified as follows: “In case of subjects not fully competent to give informed consent, rigorous protective measures should be set up conformant with local regulatory frameworks where applicable. We regard as protective measures the participation of the caregiver family member (or the legally authorized representative in accordance with applicable law) in the informed consent process as well as the involvement of the local Ethics Committee in decisions about the enrolment of subjects not fully competent”. The WP2 answer to the request has been considered satisfactory by the CEIOC Ethics Committee. Moreover, CEIOC has been updated quarterly about the neuGRID project progress.
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Related to CEIOC Ethics Committee

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