Ethics and Governance

The conclusion calls for stronger attention to ethical governance, privacy, bias, trust, data sharing, communication, infrastructure, and collaboration. The article presents CONSORT-AI and SPIRIT-AI as important reporting frameworks for evaluating AI clinical trials. The Kigali summit produced commitments related to AI education, data governance, and ethical, equitable AI solutions. AI raises concerns about regulation, trust, privacy, data sharing, human rights, and algorithmic bias. If complications exceed 10% in any participant group, study procedures and safety protocols are re-evaluated. Responsible AI is especially important in LMICs because health systems may face infrastructure, governance, workforce, and resource constraints. Participants are monitored for surgical or procedural complications for up to six months after enrolment. Invasive ophthalmic procedures use personal protective equipment and infection prevention measures because EBOV may persist in ocular fluids or tissues. Unexpected related serious adverse events perceived to be trial-related are reported by ward Nurse Unit Managers to the study team. Protected health information is de-identified, encrypted, access…