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 | Hot Topics, 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...
Apr 29, 2016 | Hot Topics
How do we ensure that the signature on the document represents a truly informed study participant? Verifying individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical...
Aug 17, 2013 | Did You Know?
HRP Consulting Group has evaluated numerous institutions’ research ethics programs and has determined that the majority of the best institutions have one thing in common: those institutions have all, if not most, of their research ethics program staff CIP or...
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...
May 15, 2013 | Hot Topics
The Flexibility Coalition consists of institutions from across the nation who have achieved a more flexible approach to increasingly burdensome federal requirements, by finding simpler ways of reviewing studies. The freedom to be compliant yet flexible, is permitted...
Feb 19, 2013 | The HRP Take
Planning for the unknown is impossible, however planning for the loss of essentials is plausible. All institutions that conduct research should have an established emergency process and procedures that incorporate a routine self-evaluation and an assessment of...
Feb 19, 2013 | Accreditation Tips
Many people, when faced with the task of cleaning out their garage, open the door, look at all of the mess, close the door and decide to do it another time. What does this have to do with accreditation? When some institutions consider accreditation, they believe that...
