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 […]
Risk to confidentiality is another risk of research
All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality […]
Stack audit responses just like you stack any other document in CLARA
Sometimes, for whatever reason, a study you’re working on will be audited more than once by the Office of Research Compliance. That means that you’ll be submitting more than one audit response to the IRB during the study. When that happens, the IRB asks that you “stack” new audit responses atop any previous audit responses […]
Conflicts of Interest and IRB Reviewers
The potential for actual or perceived conflicts of interest is always a concern in carrying out, reporting, and reviewing research. As reviewers, we have to be careful not to get involved in study reviews when a conflict exists. UAMS IRB Policy 3.3 spells out the various kinds of conflicts that need to be managed in […]
Where’s the human subject research determination form?
If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more […]