The CLARA new submission form will ask you to provide a “lay summary” of your study. Please take some time to draft a complete, short, non-scientific-reader friendly study description in response to this question. Do not cut and paste protocol text, as protocols are written for other scientists. Nor should the answer be limited to […]
Staff Only modification changes
The IRB has simplified the process of submitting staff-only modifications. While these forms are still required to be submitted to ensure the study staff lists in CLARA are accurate, they will no longer be “acknowledged” by the IRB. Instead, when you sign off on the form, it will appear in CLARA with a “completed” status. […]
Updated Federalwide Assurance, Compliance Statement
Some study forms and many study sponsors request information about their research sites’ Federalwide assurance, or FWA. UAMS recently renewed its FWA to indicate that we have a new Institutional Official, Vice Chancellor for Research and Innovation Dr. Daniel Voth. The new expiration date for our FWA is June 10, 2029. We have also updated […]
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 […]
Continuing 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 […]
Modification 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 […]
“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Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued the long-awaited draft guidance on “Key Information and Facilitating Understanding in Informed Consent.”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 […]
FDA guidance on charging for investigational drugs
The Food and Drug Administration (FDA) has just released a Q&A formatted guidance about charging for investigational drugs under an IND. While the guidance is geared toward industry, it contains helpful information for investigators who sponsor their own INDs, and for study teams and HRPP staff involved in drafting consent forms and creating budgets. We […]
FDA to allow consent waivers
The Food and Drug Administration (FDA) has made it official – it will allow waivers/alterations of informed consent processes for certain studies, according to a new rule to take effect this month. You may recall the FDA issued a guidance in 2017 saying it would not object to consent waivers/alterations on certain minimal risk studies. […]
CLARA form’s HIPAA section updates
The CLARA new submission form’s HIPAA section has been updated to make it easier to describe specific protected health information (PHI) elements to be accessed/recorded/used in research. Instead of asking you to describe “PHI data elements,” the first question now asks you to describe “specific health information that will be used/recorded for the research.” We […]