| Domain |
Standards |
| Domain I: Organization |
I-1: Organization has systemic and comprehensive human protection program |
| I-2: Adequate resources exist for program implementation |
| I-3: Transnational research activities are consistent across sites and respectful of local laws and cultural context |
| I-4: There is adequate response to research participant concerns |
| I-5: There are performance metrics and continuous process improvement |
| I-6: Financial conflicts of interest are identified and managed to minimize impact |
| I-7: There are policies and procedures governing use of investigational products |
| I-8: There is collaboration with public, industry, and public stakeholders |
| Domain II: IRB or EC |
II-1: Structure and composition of IRB/EC is appropriate to the amount and nature of the research reviewed |
| II-2: IRB/EC evaluates each research protocol to ensure protection of participants |
| II-3: Approved protocols abide by applicable laws and regulations |
| II-4: Additional protection is provided to vulnerable research participants |
| II-5: IRB/EC maintains documentation of its activities |
| Domain III: Researcher and research staff |
III-1: Adherence to ethical principles and rights and welfare of research participants are primary concerns when designing study |
| III-2: Researchers and staff meet all regulatory requirements and applicable laws |
