Jan 14, 2019 | Common Rule Updates, Regulatory Updates
On January 2nd, the National Institute of Justice (NIJ) updated their guidance regarding Human Subjects Protections to remind organizations that: “Because the Department of Justice (DOJ) is not a signatory of the Revised Common Rule, the DOJ regulations regarding...
Jan 11, 2019 | Common Rule Updates, Regulatory Updates
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).” While the guidance is draft, it provides insight into OHRP’s...
Jan 11, 2019 | Common Rule Updates, Regulatory Updates
The Office for Human Research Protections (OHRP) sent out a notice (below) on January 9th informing the regulated community that there would be no further delays in the implementation of the revised Common Rule which will become effective on January 21, 2019 (with the...
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The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018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 –...
