We’ve been seeing device studies off and on for years, but we still don’t fell like we’ve mastered all the regulatory ins and outs of studies that involve investigational devices. In trolling around the FDA’s website not long ago, we found a guidance that has a lot of good information about device studies and what […]
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A change in how to access documents in CLARA
In the past, CLARA users could access study documents via live links at the bottom of a particular form (new submission form, modification form, etc.). We’ve made some changes in CLARA related to document access, so those links will no longer be live. To see documents in CLARA, you’ll now go to the “documents” tab. When […]
A hint from the technical side for drafting contingencies
When they’re reviewing a study, some reviewers (and some of the IRB office staff, too!) like to open a separate document in Word or some other program to draft contingencies as they work through a study. Then, they copy and paste those contingencies into CLARA when they wrap up their review. There’s nothing inherently wrong […]
First blog quiz for CRS credit hour expires soon
The first IRB Blog quiz you can take to earn 0.5 hours toward earning or retaining your Certified Research Specialist (CRS) certificate will be available for only about another month! So hurry and log on at learnondemand.org to earn your credit. We’re planning to post a second quiz around September 18, and the first quiz […]
Vulnerable populations in Chart Reviews
When completing a new submission form in CLARA, one question will ask you about the vulnerable populations that will be, or potentially could be, included in the study. This question is included because specific regulations come into play when vulnerable populations are included in research, and the IRB must make additional determinations when it approves […]
IRB Members Self-Evaluations
An email with an attached self-evaluation was sent to all IRB reviewers Wednesday, Aug. 12. We know that completing self-evaluations might rank somewhere between “cleaning the gutters” and “going to the dentist” on the fun scale. However, we do ask that you take the time to complete the evaluations and return them to us. We will […]
A reminder about stacking — stack clean and tracked-changes items separately
You’ve probably seen our previous blog items about “stacking” documents in CLARA. Briefly, all versions of a single document should be stacked atop one another in chronological order, with the most recent version on top. Please note that the clean and tracked-changes versions should be stacked separately, with all of the clean copies in one […]
Pinker to bioethicists: Get out of the way
The free marketplace of ideas can be an interesting place. In a recent Boston Globe opinion piece, psychologist and Harvard faculty member Steven Pinker has a recommendation for bioethicists who weigh in on the merits of biomedical research: Get out of the way. “A truly ethical bioethics should not bog down research in red tape, […]
Industry-sponsored studies and prereviews
In an attempt to reduce the number of times study teams have to get with sponsors regarding consent form changes, the IRB is changing its prereview of sponsored studies. When a new industry-sponsored study arrives at the IRB for review (remember that it may stop at several other offices before getting to the IRB), we […]
Prereview of industry-sponsored studies
In an attempt to streamline the overall approval process of industry-sponsored studies, IRB office prereviews of those studies will be handled a little differently In the future. When our only prereview contingencies involve changes to the consent or HIPAA authorization forms, we will send those studies to the full board for review with those contingencies […]