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, […]
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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 […]
Thinking about research ethics, with help from PRIM&R and First Clinical Research
We encourage our reviewers to use the “Question of the Month” feature on the Public Responsibility in Medicine & Research (PRIM&R) web page as a prompt about ethical questions in research. Per the website, “each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and […]
Holiday bonus for the learnondemand.org blog quiz
The 4th quarter IRB Research News and Tips blog quiz is now available at learnondemand.org! Get the most convenient 0.5 hours of Certified Research Specialist elective credit around. To access the quiz, go to the learnondemand.org link and type “IRB” in the search box at upper right. Please note you have to complete the entire […]
Research participation basics for potential subjects, and others
We know the federal Office for Human Research Protections (OHRP) mainly through its interactions with researchers and research sites. Now, however, OHRP has made available a wealth of resources for potential research subjects and others interested in research. The About Research Participation web page has videos and other resources describing research concepts. One aspect we […]
Record review studies also involve “human subjects” unless…
In research, the regulatory definition of a “human subject” encompasses more than just living, breathing, actual humans. In fact, a research study that involves accessing identifiable medical records involves human subjects, even if the investigators will have no direct contact with the study participants. Federal regulations governing research define human subjects as living individuals about whom an […]
Investigational drug studies need investigators’ brochures to be reviewed
When putting together a submission for study involving an investigational drug, please make sure the submission includes the related investigator’s brochure (the IB). The IB contains important safety information about the drug the IRB will need to see before it can review the study. All investigational drugs will have an IB provided by the study […]