What safeguards are in place to prevent disclosure of subject identities whose biomaterials and clinical data are sent and stored at the NCGS?
A22. Several safeguards are in place to protect subject confidentiality. First, biomaterials and clinical data sent to the NCGS are stripped of all subject identifiers and given a code by the Principal Investigator sending the samples. The NCGS then provides a new identifier number for the sample and informs the Principal Investigator of the new identifier number that corresponds to the code given by the Principal Investigator. Any samples containing subject identifiers submitted to the NCGS are returned immediately to the investigator. Second, a Certificate of Confidentiality also covers the NCGS. This protects the NCGS from court orders and subpoena to release information from the NCGS in most cases. Third, the NCGS must operate in accordance with the United States Department of Health and Human Services regulation at 45 CFR Part 46 concerning human subjects and its local institutional review board. Fourth, anyone given access to clinical data and DNA is forbidden to attempt to disco
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- What safeguards are in place to prevent disclosure of subject identities whose biomaterials and clinical data are sent and stored at the NCGS?
