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 –...
Jul 27, 2017 | Featured News Article, Regulatory Updates
On July 24, 2017 the FDA announced a new guidance, effective immediately, which will have significant impacts on industry, IRBs, and investigators. In short, the guidance is being issued to permit IRBs to waive or alter informed consent for minimal risk clinical...
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 | Regulations
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...
Jun 21, 2016 | Uncategorized
The NIH has released its final policy on the use of central IRBs for multi-site research. Starting May 2017, in multi-site studies in the United States involving non-exempt human subjects research funded by the National Institutes of Health (NIH), research...
Aug 17, 2013 | Hot Topics
Given the recent controversy of the SUPPORT study and the upcoming HHS Public Meeting on risks of standard of care research, we thought it would be an appropriate time to review the regulatory requirements regarding research risk. The federal human subjects...
Jan 4, 2013 | Accreditation Tips
One of the first points we make with clients beginning the accreditation process is to remind them about the name of the accrediting body. It is AAHRPP – the Association for the Accreditation of Human Research Protection Programs. It is not the Association for...
Oct 1, 2012 | Accreditation Tips
In AAHRPP’s payment model, incentives are provided to organizations that pay their application fee prior to submitting their Step One Application. AAHRPP guarantees an application fee through the end of the following year for organizations that prepay. If their...
Aug 14, 2012 | Hot Topics
A result of the new rational about human research protections that has taken place over the past decade is an increased attention on post-approval monitoring. Previously, after an IRB had approved a protocol, it conducted continuing review at least once a year and...
Aug 14, 2012 | Accreditation Tips
One of the more obscure requirements for AAHRPP accreditation is related to Element I.5.B. “The Organization conducts audits or surveys or uses other methods to assess the quality, efficiency, and effectiveness of the Human Research Protection Program. The...
