On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct ...
Sham controls can be integral to CV device trials, providing a unique way to overcome the placebo effect, but they also present an ethical minefield of concerns that merit close consideration, a new ...
Federal regulations at 45 CFR 46.102 item (j), define minimal risk as "... the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than ...
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