New Final Common Rule – Summary of Changes

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...

What Are Research Risks?

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...

Accreditation Tip: Get Rid of the Silos!

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...

Accreditation Tip: Element I.5.B

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...