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The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018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...
Jul 19, 2018 | Featured News Article, Hot Topics, Regulatory Updates
On June 18, 2018, the general compliance date for the Final Rule was delayed for an additional 6 months but allows for the use of three burden-reducing provisions during the period of time from July 19, 2018 through January 19, 2019. Download; Thinking Points –...
Jan 19, 2017 | Regulatory Updates
As you likely have heard the final revisions to the Common Rule were released yesterday, to be published in the Federal Register today, January 19. We are happy to provide you with a summary of the changes. Please note that the new administration still has the ability...
