The risks to subjects are equally proportional to anticipated benefits is not a Human Subjects Protection adopted by the US Health and Human Services.
The regulations, practices, and ethical considerations that safeguard the rights and welfare of people who take part in research as its subjects are collectively referred to as "human subjects protections" at the federal, state, and university levels.
An unpleasant incident can be either predicted or unexpected, whereas an unanticipated problem is by definition unexpected. Adverse events could or could not constitute unanticipated issues. Adverse events involve harm to participants; unexpected issues may increase the chance of harm even when no harm has actually happened.
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