Research News and Tips
Updated Informed Consent Policies
The IRB has posted updated versions of IRB Policy 15.1, Elements of Informed Consent, and of Policy 15.3, Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements. Policy 15.1 has been revised to make the mandated reporter statements required only “when applicable.” The language about reporting of infectious disease results has always […]
Read moreContinuing Review timeframes
Getting a continuing review (CR) approved can take some time. The CLARA system sends reminders about expiration dates 90, 60, and 30 days before expiration. Please submit continuing review forms to the IRB at least 30 days before your expiration date. A lead time of at least 60 days is preferred. These lead times will […]
Read moreModification form tips
When completing modification forms in CLARA, please help speed IRB review and approval by using the “Notes for IRB reviewer(s)” open text response to: –Specifically address whether any currently enrolled subjects will be affected by the proposed change and if so, how you will inform them of the change. For example, will they be asked […]
Read more“Key information” guidance draft arrives
Hot off the presses – the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued the long-awaited draft guidance on “Key Information and Facilitating Understanding in Informed Consent.” OHRP has required a “key information” discussion at the beginning of consent processes since the 2019 Implementation of the Revised Common […]
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Institutional Review Board Members Blog
Updated Informed Consent Policies
The IRB has posted updated versions of IRB Policy 15.1, Elements of Informed Consent, and of Policy 15.3, Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements. Policy 15.1 has been revised to make the mandated reporter statements required only “when applicable.” The language about reporting of infectious disease results has always […]
Read moreContinuing Review timeframes
Getting a continuing review (CR) approved can take some time. The CLARA system sends reminders about expiration dates 90, 60, and 30 days before expiration. Please submit continuing review forms to the IRB at least 30 days before your expiration date. A lead time of at least 60 days is preferred. These lead times will […]
Read moreModification form tips
When completing modification forms in CLARA, please help speed IRB review and approval by using the “Notes for IRB reviewer(s)” open text response to: –Specifically address whether any currently enrolled subjects will be affected by the proposed change and if so, how you will inform them of the change. For example, will they be asked […]
Read more“Key information” guidance draft arrives
Hot off the presses – the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued the long-awaited draft guidance on “Key Information and Facilitating Understanding in Informed Consent.” OHRP has required a “key information” discussion at the beginning of consent processes since the 2019 Implementation of the Revised Common […]
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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