Table 1.
Develop sample handling programs |
Develop the synthetic derivative |
Implement and validate de-identification methodology |
Convene ethics review and act on recommendations: |
Ongoing IRB oversight |
All patients should receive information about the project |
Patients should have the right to refuse to participate |
Develop a comprehensive education plan |
Ongoing external evaluation |
Assess the content and functionality of the database before enrolling participants |
Establish Ethics Advisory Board and Scientific Advisory Board |
Involve clinical operations and legal staff |
IRB, Institutional Review Board.