Once a human subject research determination form is submitted into CLARA, the IRB office will determine whether the project meets the definition of research involving human subjects. If you get back the letter saying that the project is research involving human subjects, the next step is to start a new submission in CLARA. Please remember […]
Blog
Should people have access to their own genomes?
Not all that long ago, researchers and IRBs didn’t have to wrestle with the larger implications of genetics research. Scientific advances in this area mean we now have to consider the implications of the use and study of genetic information. An upcoming lecture will address one aspect of this issue, and we encourage reviewers to […]
Human Subject Protections — The U. of Minnesota Experience
Ideally, human research protection programs (HRPPs) stay out of the “above the fold” position in newspapers, because “above the fold” is where stories about big failures tend to wind up (or did, back when printed newspapers were still really a thing*; “on the homepage” may be a better way to put it now). The University […]
AAHRPP reaccredition process ongoing
The UAMS Institutional Review Board has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2005. In fact, we were one of the first two dozen or so institutions to earn that accreditation when it became available. Our next reaccreditation application is due in the fall of 2015, […]
Upcoming live course on Research Misconduct offers CRS and SOCRA credit
Check one of your Certified Research Specialist requirements off your to-do list by attending an upcoming live class – and earn some SOCRA credit to boot. Dr. Thomas Cunningham of the Medical Humanities department is scheduled to present a class on Research Misconduct Friday, May 29, from 11 am to 1 pm. The class will take place in […]
PI change requires a full modification form, and not a staff-only modification
The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular […]
IRB Member Handbooks are in
Additional copies of the IRB Member Handbook have arrived. Please send an email to paalediths@uams.edu if you need a copy. We are also bringing them to each week’s meeting to distribute as needed. Please note you do NOT need to replace an older edition of this book that you may already have. The changes in […]
Please write long when responding to audits
When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. […]
Monday midday is the soft deadline for reviews
IRB Chair Allen Sherman reminds reviewers that it would be hugely helpful to have contingencies and notes for a Tuesday meeting entered into CLARA by noon on the Monday right before the meeting. Allen does at least a brief review of all agenda items, and sometimes needs time before the meeting to follow up on […]
A fresh start when drafting HIPAA authorization forms
When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template […]