Well, while we freely admit to muttering under our breath about some FDA research requirements, we want to take this opportunity to shout from the rooftops about a new FDA guidance indicating the agency will not object to the IRB waiving or altering informed consent requirements in some minimal risk research. This guidance – which […]

We recently received word from NIH about policy changes that people who conducted NIH-funded human subject research, or who seek to apply for NIH support for such research, need to know about it. The correspondence is below. Please contact the Office of Research and Sponsored Programs for more information about these changes. If you are […]

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, […]

The Food and Drug Administration, continuing its long tradition of issuing timely guidance, has issued a draft guidance about 21 CFR Part 11 – the regulation pertaining to the use of electronic records and electronic signatures in clinical investigations. A summary of the draft guidance is available here.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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]