The Food and Drug Administration is expected to soon decide whether to approved a new drug, aducanumab, intended to slow the progression of Alzheimer’s-related symptoms. The need for better treatments for Alzheimer’s is not in question. However, debate is ongoing regarding whether this particular drug merits FDA approval. A recent New York Times opinion piece […]
Article: Reporting study results still lags
Despite a requirement to report clinical trial results, the number of studies actually reporting results on time remains painfully low, according to this recent New York Times article. Trial sponsor are to report findings within a year of collecting the most critical data, the author writes, a deadline that many miss. Read the entire article […]
Adding a Site to Clara When the UAMS Institutional Review Board Is the Institutional Review Board of Record
So, you’ve got a great multisite study started, for which the UAMS Institutional Review Board will be the institutional review board of record. You’re ready to take the step of submitting site addition modification forms in Clinical Research Administration (CLARA) to add additional sites. We’ve recently updated our method for entering sites into CLARA. Rather […]
Preparing for the AAHRPP site visit (March 2021 reviewer education)
This is our year to undergo the process to get reaccredited by the Association for the Accreditation of Human Research Protection Programs, or AAHRPP. We’ve already compiled and submitted the sizeable Step 1 application, and are now gearing up for our site visit, scheduled for May 16-18. The March 2021 IRB reviewer education gives a […]
Ethical payment to subjects in human infection challenge studies
We were thrilled to stumble across this newly available, open-access, paper titled Promoting Ethical Payment in Human Infection Challenge Studies in The American Journal of Bioethics. The paper discusses the process to determine ethically defensible compensation levels for research subjects, with special emphasis on trials that involve intentionally exposing participants to infectious agents, such as the virus that […]
AAHRPP Resources for IRB Reviewers
The Association for the Accreditation of Human Research Protection Programs, or AAHRPP, sets standards for human research protection programs (HRPPs). AAHRPP is our accrediting body, and its website has several resources that may help IRB reviewers in their review. Of particular note are AAHRPP’s tip sheets, which delve into detail about specific topics. We use […]
Personal data everywhere. And it’s for sale.
Today’s blog post theme isn’t so much about the specific items mentioned in these articles as it is about the general availability of data. When we think about data protections, it’s helpful for us to remember the context in which to think about confidentiality. First, here’s an article about how the intelligence community uses smartphone […]
New question added to modification and site addition forms
Sticklers for neatness that we are (as anyone who has ever stopped by IRB Blog Headquarters can attest – heh), we have added a query to CLARA’s “modification” and “site addition” forms. These forms now have a free-text box labeled “Notes for the IRB reviewer(s).” Please use this area to add any information the IRB […]
Tracking document changes
Since the IRB has started allowing the submission of only tracked-changes copies of revised documents, we’ve found that our reviews are a little easier, and CLARA document files are a little cleaner, for studies that only submit the tracked-changes copy. Therefore, the IRB now asks that you submit only a single copy of any revised documents, […]
What’s new in 2021 for the IRB
Happy New Year to all! Here’s our best guess as to what our IRB reviewers can look forward to in 2021. We’ll cover this information in our in-person education in January. Some of you will be selected to meet with our AAHRPP accreditation site visitors. We’re not quite sure when the site visit will take […]