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# Guide on Human Research Protections During Covid-19
- URL: https://www.fdaweb.com/guide-on-human-research-protections-during-covid-19/
- Published: 2020-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:10:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146541

FDA is directing industry to a new [guidance](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html?ref=fdaweb.com) from HHS’ Office for Human Research Protections (OHRP) entitled “OHRP Guidance on Covid-19.” The guidance responds to questions the office has received from the research community about how human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the Covid-19 outbreak. The document discusses topics such as: (**1**) public health and clinical activities; (**2**) excluded public health surveillance activities; (**3**) legally required reporting; (**4**) research changes to eliminate apparent immediate hazards; (**5**) proposing and reviewing study changes; and, (**6**) whether suspensions of research must be reported.