Since we all – research teams and IRB alike – like to see research proposals get approved quickly, we thought we’d point out a couple of issues we’ve been seeing a lot of lately that will get you a contingency. — Incorrectly stacked documents. If your clean and tracked-changes copies of documents are not stacked correctly, […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
At long last — Draft FDA guidance on Part 11 compliance
The Food and Drug Administration, continuing its long tradition of issuing timely guidance, has issued a draft guidance about 21 CFR Part 11 – the regulation pertaining to the use of electronic records and electronic signatures in clinical investigations. A summary of the draft guidance is available here. The comment about “timely guidance” should be […]
Two simple fixes that will get things through the IRB faster
We at the IRB really hate to have to send submissions back due to minor little slip-ups, but we’ve been seeing a few little problems crop up lately. Since we’re a little short-staffed, we don’t really have time to sort through submissions that need some minor fixes to get them ready to review, so we’ve […]
We’re still thinking about informed consent processes and forms here
As we gear up for the implementation of the revised Common Rule, slated for January 2018, we’re still thinking about ways to make the informed consent process more meaningful for and understandable to potential subjects. The revised rule includes a requirement that the informed consent “begin with a concise and focused presentation of the key […]
Closure form enrollment tips
We’ve noticed a few trends on reporting enrollment on study closure forms that we’re hoping to nip in the bud: – When listing the total number of people who enrolled in your study, please be sure to include everybody who signed a consent form, even if they failed screening or didn’t actually participate in the […]
New CRS blog quiz is available
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 […]
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 […]
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 […]
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 […]