20
Jun2017

As part of PRIM&R’s webinar series on the revised Common Rule, two members of our community were selected to write a series of blog posts about the webinars, what they learned from them, and how the information is applicable to their work. Now that the webinar series has concluded, we’re pleased to introduce them to you and share their thoughts over the next few weeks.

For those of us in human research protections, the Common Rule changes were the most hotly anticipated item of 2016. The unveiling of the final changes on January 19, 2017 has been, for so many of us, a source of confusion, consternation, stress, and in some cases, relief.

As technology and science have advanced at a dizzying pace, the rules had stood still, unable to adequately address ever-growing biorepositories, genomic analysis implications, and the advent of social media and electronic health tools. Now that the changes are here and we have a mandate to implement them, we are clamoring to understand the revisions and how to update our processes without disrupting and confusing the investigators and administrators we spent so many years teaching the former rules.

As the human research protection program (HRPP) team lead at Ochsner Clinic Foundation in New Orleans, I have been working closely with my team to further our comprehension of the final Common Rule and figure out how we are going to implement the changes in our various systems.  Since my role includes daily IRB operations, involvement in education and training, and assistance with quality assurance reviews, I’ve had an opportunity to consider how the changes will affect each of those areas in particular.  Yet, there is still so much information to digest! 

By attending the Focus on the Revised Common Rule webinar series my goal is to have a better grasp of how the changes to the rule will affect my work and to share what I've learned with my office and with the human subjects protections community. In particular, I'd like to focus on the new concepts of using broad consent and incorporating “key elements” into consent documents. I'd also like to focus on single IRB review—though we're still several years away from implementation of this piece of the rule change, we need to be ready for the effect it will have on our HRPP program. Additionally I, and I am sure many of you, find it perplexing that Subpart B involving pregnant women has not been changed, and instead this population is no longer mentioned within the text of the new Rule—I am looking forward to understanding the impact this will have on research involving these groups.

Amelia Walch-Patterson, MPH, CCRC, was selected to cover the biomedical bundle of PRIM&R's webinar series, Focus on the Revised Common Rule. She is the team lead for the Human Research Protection Program at Ochsner Clinic Foundation in New Orleans.  She has served as an IRB member since 2012 and joined the Ochsner HRPP team in 2015 after working as a research coordinator and QA specialist for pharmaceutical trials since 2010. In her current role she oversees the daily IRB operations, instructs new study coordinators during onboarding, and assists the QA team during extensive reviews.  She has been a PRIM&R member since 2015.

 

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