ARIA, the IRB’s old electronic submission system, is no longer active, but you can still find items that you uploaded to current studies that originated in the ARIA system. How? By looking in the right place in CLARA. When you log into a study, go the “Forms” tab. If the study was open before the […]
Yikes! How closely should I review this gigantic case report form?
The short answer: You may not need to review it at all. Please check with the IRB office (Edith Paal prereviews almost all of the new submissions before you see them, so she’d be a good place to start) to see if you need to do anything with the CRF in the file. The less […]
Reminder — the IRB does not need to routinely review or approve case report forms
When submitting studies to CLARA, please keep in mind that the IRB does NOT routinely need to see case report forms (CRFs). If they are submitted with a study, the IRB will not review them closely and will, in fact, try to remember to ask you to delete them from the submission before we approve […]
Course instructors – help us help your students get set up in CLARA
If you are leading a class in which all of the students will be required to make a submission in CLARA, we can help get your students’ accounts activated before they begin their new submissions. Please send Kate Henning an email at khenning2@uams.edu and cc irb@uams.edu with a list of all students whose CLARA accounts should […]
Answering the “How will potential subjects be identified” question on the new submission form
The “Subjects” section in the new submission form includes the following question – How will potential subjects be identified? When completing the form, keep in mind that this question is asking how you plan to find potential subjects in the first place. Every now and again we see people describe their plans for identifying the […]
Questions about audits? Feel free to ask ORC staff or study teams
If you’ve been assigned an audit to review for an upcoming meeting, and have some questions about the audit report, please keep in mind that you are welcome to contact Office of Research Compliance (ORC) staff before the meeting for more information. The auditors involved in each audit are listed on the front page of […]
Reminders regarding human subject research determinations in CLARA
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 […]
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, […]