To gain access to CTN data stored at the NCGS, must the Recipient have IRB approval?
A15. Yes. As stated above, applicants should provide documentation of IRB review and either approval of the proposed project or exemption of the proposed project from the need for further IRB review. The IRB approval will not be required at the time the Access Request is submitted. However, no data can be released from the NCGS until evidence of IRB approval has been received. Q16. Must the Recipient follow the conditions for use of Biomaterials, Clinical Data, and Genetic Analysis Data as approved by the Institutional Review Board (IRB) of their own institution and the IRB of the NIDA contractor and subcontractor that operate the NCGS? A16. The Recipient must follow the conditions for use of Biomaterials, Clinical Data, and Genetic Analysis as approved by the Institutional Review Board of their own institution and of the IRB of the NIDA contractor and subcontractor that operate the NCGS in accordance with the United States Department of Health and Human Services regulation at 45 CFR P
