Research News and Tips
Alzheimer’s Drug Study Raises Questions
A recent New York Times article has been the talk of the human research protection community of late. The article describes how some participants in an investigational Alzheimer’s disease drug study were not told they had a genetic test result that may have indicated increased risks of the test article for them. The story raises […]
Read moreCLARA question changes
Some CLARA form questions have been revised with the intent of making them clearer about the information requested. In the “Subjects” section of the new submission form, questions about enrollment have been revised to read as follows: How many subjects/charts/specimens do you need to include to be able to complete your study? See help text […]
Read moreRevised IRB Policies Now Posted
The IRB, with the assistance of the Human Research Protection Program Advisory Committee, recently completed its annual policy review, and revised IRB policies are now posted on the IRB’s website. A summary of the changes made is available here. Note that we did not edit the grammar on our summary of changes; please excuse any […]
Read moreNew FDA guidance on electronic documents and signatures
The FDA has released a new guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations. The guidance provides information in a Q and A format about the FDA’s expectations for the use of electronic systems and records in research. The guidance also includes a section specific to electronic signatures in research. Do […]
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Institutional Review Board Members Blog
Alzheimer’s Drug Study Raises Questions
A recent New York Times article has been the talk of the human research protection community of late. The article describes how some participants in an investigational Alzheimer’s disease drug study were not told they had a genetic test result that may have indicated increased risks of the test article for them. The story raises […]
Read moreCLARA question changes
Some CLARA form questions have been revised with the intent of making them clearer about the information requested. In the “Subjects” section of the new submission form, questions about enrollment have been revised to read as follows: How many subjects/charts/specimens do you need to include to be able to complete your study? See help text […]
Read moreRevised IRB Policies Now Posted
The IRB, with the assistance of the Human Research Protection Program Advisory Committee, recently completed its annual policy review, and revised IRB policies are now posted on the IRB’s website. A summary of the changes made is available here. Note that we did not edit the grammar on our summary of changes; please excuse any […]
Read moreNew FDA guidance on electronic documents and signatures
The FDA has released a new guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations. The guidance provides information in a Q and A format about the FDA’s expectations for the use of electronic systems and records in research. The guidance also includes a section specific to electronic signatures in research. Do […]
Read moreWant to read more stories like these?
New to Research or to the UAMS Institutional Review Board?
Hints to Get Your Studies Approved Faster
Yes, the UAMS Institutional Review Board looks at the big things when it reviews studies — are risks to subjects minimized? Are there appropriate provisions for obtaining the informed consent of subjects? etc. etc. But the little things can also slow down your study’s trek towards Institutional Review Board approval. Have you tracked your changes in […]
Read moreHow Do I Submit Something to the Institutional Review Board? FAQs
We get a lot of queries from people who are new to research asking about how to submit something to the UAMS Institutional Review Board. Here is a rundown of the most frequently asked questions related to Institutional Review Board submissions, and their responses. Does my project need Institutional Review Board review? Submit a human […]
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