Mar 17, 2019 | Common Rule Updates, Uncategorized
News Flash: IRBs must continue to determine that research within the expedited categories is minimal risk OHRP released 8 new FAQs regarding the revised Common Rule on March 15th. Importantly, among these is the following clarification that because the Federal...
Jan 18, 2019 | Common Rule Updates
On 1/18/19 OHRP issued a FAQ recommending that IRBs continue to conduct continuing review of research that is eligible for expedited review under the current categories 8(b) or 9 of the OHRP Federal Register list even though continuing review is not required for such...
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The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”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The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018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 –...
Jun 28, 2017 | Common Rule Updates, Featured News Article
We are happy to help you and your organization as you prepare for the “Common Rule” changes. Download the following electronic copies so that you may pass them along to your institution and/or colleagues: Implementing the Revised Common Rule – 10...
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...
