By Susan Night
It takes a special speaker to engage an audience and extract laughter when speaking on a federal notice of proposed rulemaking. That is exactly what Laura Odwazny was able to accomplish Monday afternoon at the Healthcare Research Compliance Conference with her update on the public comments and next steps for changes to the Common Rule.
The details of her presentation are beyond the scope of this blog post but we will focus on a few of the highlights beginning with Ms. Odwazny’s graphic of the rays of governmental sunshine spreading light across the 18 federal departments and agencies that have signed on to the Common Rule. The Common Rule, which first came into effect in 1981, is due for a makeover primarily because the landscape of research involving human subjects is vastly different today than it was when first implemented. Think about it, the Human Genome Project was not even completed until 2003, twenty-two years after the Common Rule was set in place.
Our speaker led us through the regulatory history of the NPRM on the Common Rule dotted with cartoons depicting contrasting perspectives on the Institutional Review Board. The NPRM was initially published on Sept. 8, 2015 and received 2,149 comments, the vast majority (80%) from individuals in their own capacity. Ms. Odwazny led the audience through a discussion of the goals of the NPRM, a summary of the major changes and an overview of the public comments. She provided an entertaining Siskel and Ebert thumbs-up/thumbs-down presentation of the public opinion of selected proposed changes. It was no surprise that changes to the informed consent form received a “thumbs-up” from the majority of those commenting!
What can the research community expect as next steps for the NPRM? The Office of Information and Regulatory Affairs notes on their website that the current administration expects to publish final rules in the Spring of 2016. Unfortunately, we are only a month away from the summer solstice so that deadline may not be met. Ms. Odwazny advised the audience to stay tuned…..after all, it is an election year.