Health Quote by Ezekiel J. Emanuel
““for exemptions for their outbreak investigations rather than quibble over whether such investigations are research or public health practice. There is nothing in an outbreak investigation that presents to the subjects risks as great as those presented by research on public benefit or service programs (particularly “possible changes in or alternatives to those programs”), a category that is already exempted at 45 CFR 46.101(b)(5) of the U.S. federal regulations.31””
About This Quote
Source Regulation Commentary: 45 CFR 46.101(b)(5) Interpretation, 2008
Outbreak investigations are exempt from research regulations because they pose less risk than public‑benefit research.
In simple terms: Outbreak probes are less risky than research.
Recognize regulatory exemptions for public health work.
Themes
Mood
Type
When to use this quote
- disease outbreak response
- program evaluation
- policy drafting
Key Concepts
Questions to Reflect On
- When should additional safeguards be added?
- How do we ensure ethical standards without formal review?
Exemptions may limit oversight of participant protections.