What steps will be taken to limit access to the GAIN database and to protect it from potential misuse?
As noted in the answer to question E1 above, access to the GAIN database will be limited to specific projects requested by the potential data user and approved by the Data Access Committee. In addition, both the requesting investigator and a responsible Institutional Business Official from the investigator’s institution or business entity must sign a Data Use Certification. Among other provisions, the Data Use Certification requires that these signatories certify their acknowledgment of the GAIN Policies, and their responsibility to comply with federal, state, and local laws and any institutional policies; that the data will not be used to identify or contact individual participants from whom phenotype data and DNA samples were collected; and that GAIN Project Datasets will not be transferred to anyone outside the Requesting Investigator’s immediate research staff. Finally, the GAIN Data Use Review Board (DURB) will provide ongoing, independent oversight of the data use policies and pa