Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders

HRP Consulting Group has prepared a set of sample IRB guidelines for investigators whose human-subjects research may be subject to a “stop work” or “pause work” directive from a federal funding agency. It recommends how to assess risk, plan for safe wind-down (or modification) of research, communicate with participants and stakeholders, protect participant safety (e.g. in therapeutic studies), and ensure proper data/ biospecimen and regulatory handling if funding or work is suspended.

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