1. 45 C.F.R. Part 46(“Common Rule”).https://www.hhs.gov/ohrp/regulations‐and‐policy/regulations/45‐cfr‐46/index.html
2. Rethinking the Regulatory Triggers for Prospective Ethics Review
3. Data Monitoring Committees — Expect the Unexpected
4. Department of Health & Human Services(2020a)Federal Policy for the Protection of Human Subjects (“Common Rule”).https://www.hhs.gov/ohrp/regulations‐and‐policy/regulations/common‐rule/index.html