The 3rd quarter blog quiz, that will earn you 0.5 hours of Certified Research Specialist Elective credit, is now live. Go to learnondemand.org and type “IRB” into the search box at upper right to access the quiz. Yes, you’ll have around 3 full months to complete this quiz to earn your credit. However, remember how […]
Simplifying informed consent language
A couple of things happened recently that got us thinking about the IRB approval criterion that requires informed consent information to be provided “in language understandable to the subject.” First, we prereviewed some industry study consent forms that were between 20 and 40 single-spaced pages, full of big words about serious disease. If I had […]
Searching the blogs
Q. How can I search for a specific blog item that I know I’ve seen, but I don’t know when? A. Short answer: If you know of a way, do let us know, because we haven’t been able to figure one out. Long answer: Someone had a great idea that we thought we’d share. If […]
New Requirements for Registration and Journal Publication Loom
The International Committee of Medical Journal Editors has started to implement requirements related to sharing individual patient data in manuscripts that report clinical trial results. Beginning July 1, 2018, all manuscripts submitted to ICMJE journals that report clinical trial results must contain a data sharing statement. Clinical trials that begin enrolling participants January 1, 2019, or later must […]
What do IRB members need to know about study design?
The Journal of Medical Ethics blog has a recent entry addressing findings of a study that examined the extent to which IRB members were familiar with some basic study design concepts. (In summary: not very familiar.) The blog entry author writes that she would expect IRB members to know enough about research design to be […]
Remember — neonates also count as subjects!
Many studies involving pregnant women also collect information about the pregnancy outcome. These studies can include both interventional and chart review studies. If you work in this kind of research, please remember that if you collect anything about the newborn, such as gestational age at birth, length, weight, Apgar score, etc., the newborn then meets the […]
PRIM&R director comments about new Common Rule’s informed consent requirements
It seems as though everyone involved in human subject protections struggles with the informed consent process. The desire to provide complete information to subjects can collide with a need to keep informed consent forms and processes simple and understandable. Eliza Hurley, director of the research professional organization Public Responsibility in Medicine and Research (PRIM&R), recently […]
NIH changes may boost young scientists’ funding chances
Perhaps in an attempt to reverse previously identified declines in research funding awarded to younger scientists (see here and here), the National Institutes of Health recently announced a plan to focus more on early and midcareer researchers in making funding decisions. More information about the change can be found in recent postings in Science and […]
Arkansas Children’s Hospital logo change — ACH researchers, this may be of interest!
We’ve learned, here at IRB Blog headquarters, that Arkansas Children’s Hospital is revising its logo. A researcher asked if she needed to submit modifications for study documents she needs to change to replace only the logo. In a word, no. If the only change you need to make is to update the logo, there is […]
UAMS Box is another data storage option
We’ve heard from some research staff, and confirmed with UAMS Information Security, that UAMS Box is now being offered as a storage option for research data. Box makes it easier to share data with collaborators, all while maintaining appropriate levels of access and security. “Box is a secure site and we have a Business Associate […]