Nov 29, 2018 | Common Rule Updates, Regulatory Updates
The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements” (i.e., the revised...
Nov 15, 2018 | Regulatory Updates
On November 13th, the FDA announced a proposed rule to amend its regulations to allow for waivers and alterations of consent for certain minimal risk research. Comments on the proposed rule will be accepted through January 14. 2019 via regulations.gov or in writing...
