The document provides a detailed overview of institutional procedures and ethical considerations for the conduct of human subjects research during the COVID-19 pandemic, as addressed by the Research Ethics & Compliance Committee as of May 2020. It outlines the criteria institutions use to determine which clinical trials may continue amid restrictions, emphasizing the prioritization of studies involving COVID-19, those offering direct therapeutic benefit, or those essential to patient care. The feasibility of ongoing research is assessed based on investigator availability, personnel, supply chains, access to research sites, and the capacity for participant monitoring, with participant safety remaining paramount in all cases. Institutions must coordinate with healthcare facilities to ensure research activities do not impede patient care or contravene local pandemic response measures.
The FAQs also address the management of recruitment for ongoing studies, adaptive strategies for protocol-required visits disrupted by pandemic-related restrictions, and the process for notifying authorities of trial suspensions or modifications. Protocol adjustments designed to eliminate immediate risks may be implemented promptly and reported retrospectively to Institutional Review Boards (IRBs), whereas other changes require IRB pre-approval. Guidance is provided on the handling of COVID-related precautions and the inclusion of associated risks in informed consent materials, clarifying that infection risk from research staff is considered a public health matter rather than a research risk. Regarding data privacy, the document advises strict adherence to institutional and legal standards in telework settings and during telehealth-based research visits, referencing temporary regulatory flexibilities and recommending secure, non-public-facing communication platforms. Ultimately, the guidance underscores institutional responsibilities to uphold participant safety, data privacy, and compliance with both research protocols and public health mandates during a public health emergency.
