HIPAA has been confusing for all of us as it applies to research. Even though we’ve been dealing with it for years, we still see scenarios that make us wonder whether HIPAA applies to a particular study and, if so, how to best meet HIPAA requirements. One thing to keep in mind is that HIPAA […]
A summation of what the Revised Final Rule delay means for us
Public Responsibility in Medicine and Research (PRIM&R), upon whom we rely for updates in the world of human subject protections, has come through again with a recap of how the delay in the implementation of the revised Common Rule affects us here on the ground. Some highlights worth mentioning: The current Common Rule requirements described […]
Revised Common Rule Effective and Compliance Date Delayed 6 Months…for now
That sound you hear is a giant sigh of relief from a whole lot of institutions subject to OHRP oversight. Late this afternoon, we received word of the planned Federal Register Publication of an interim Final Rule, delaying the effective and compliance date of the Revised Common Rule until July 19, 2018, which is 6 […]
Another tool to help with the informed consent process
Some great ideas regarding language to use during the informed consent process has come to us via firstclinical.com. Basic Concepts for Informed Consent covers some of the foundational elements behind the concept of truly informed consent, and translates them into language subjects are likely to understand. It addresses some of the issues that can be […]
Still in a holding pattern regarding the revised Common Rule
Will we, or won’t we, have to comply with the revised Common Rule in a few short weeks? That’s the big question to which there’s still no solid answer as of this writing. January 19, 2018, has a big, red circle around it on our calendar. That’s the date the revised Common Rule is slated […]
IRB Meeting Scheduling, Fifth Tuesdays, Bad Weather, Quorum, Etc.
As we turn the calendars to 2018, here’s a reminder to keep an eye on any deadlines that you must meet with IRB submissions. Remember the UAMS IRB Committee meets on the first four Tuesdays of every month, so there is an “off” week in any month during which there’s a fifth Tuesday. January, May, […]
A quick and simple word about creating assent materials
When a study proposes to include people who can communicate but cannot provide their own consent, the IRB will typically require some sort of assent process or document be used to explain the proposed research to the subject. This requirement is most often seen in studies involving minor children age 7 and up. Please keep […]
It sees you when you’re sleeping…aka musings about “data” and privacy
An IRB Blog Central staffer recently found herself purchasing one of those fancy-schmancy beds that can be adjusted all kinds of ways. While wandering around the showroom, she noticed a screen flashing statistics about Arkansans’ sleep patterns, and how they compared to those in the rest of the country. All of it based on *data* […]
Author: Research disputes head to court, create barrier
Research findings and publications can lead to more than just heated discussions and letters to the editor. It turns out they can also lead to lawsuits, according to a recent New York Times column. Its author goes on to discuss the chilling effects legal action can have on the research enterprise. Author Aaron E. Carroll […]
The final* Revised Final Rule
Remember that asterisk in our blog items that talked about the final* Revised Common Rule? Well, it’s still there. Most of the Revised Common Rule was, and still is as of this writing, slated to take effect in January 2018. However, even its authors agree that the revised rule introduces a lot of changes to […]