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 […]
Great education opportunity at UAMS next week
Some of the biggest sessions at next week’s Advancing Ethical Research conference in San Antonio will be available remotely on the UAMS campus, thanks to the UAMS Office of Research Compliance. The conference, organized each year by Public Responsibility in Medicine and Research (PRIM&R), is the big human subject research conference each year, where thousands of […]
Even a minor protocol change can mean a lot of things need updates
Remember – when you need to change something in an approved study, please review the entire submission to make sure you catch and amend everything that needs changing. For example, even a minor protocol amendment, such as changing a study’s end date, or a staffer’s phone number, might require changing the new submission form, the […]
Holidays, inclement weather, can complicate IRB meeting scheduling
It’s that time of year again – winter (which is kinda of feeling like potentially a real thing so far this year) and the holidays both loom. Keep that in mind in your end-of-year planning if you have approval deadlines you really, truly need to meet. Here’s a reminder that, for reasons that are a […]
Joint OHRP and FDA guidance on meeting minutes
The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while […]
Scary goings-on in the CLARA document files
Well, we must admit we’ve been a little spooked lately by some of the document stacking issues we’ve seen in CLARA. Nothing chills our bones quite as much as seeing tracked-changes and clean copies of revised documents in a single stack. We shiver in horror whenever we have to send something back to have you […]