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Revisions recommended to human research regulations

A National Academies panel is recommending that the Common Rule, which governs research on human subjects conducted or supported by federal agencies, should be expanded to include a new category of studies that are “excused” and wouldn’t have to be vetted by an institutional review board or undergo any other form of human-subject research review.

In a report issued on 9 January, the committee specified that research on humans should qualify as “excused” if the only risks of harm to study subjects involve the possible disclosure of personally identifiable information.

In particular, the panel called on the Department of Health and Human Services (HHS) to specify in revised federal regulations that this exempted category includes studies using pre-existing research and other data that contains personal information; or benign interactions and interventions that occur in everyday life such as educational tests, surveys, focus groups and interviews.

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