When submitting study modifications, please clarify in your submission whether any subjects are currently on study and, if so, if they will be affected by the change. For example, will anybody need to be reconsented, or will any study activities that directly involve the subjects change? If this information is included up front, the IRB […]

The Food and Drug Administration (FDA) has oversight over some, but by no means all, of the research that comes through the UAMS IRB. When submitting studies, please confirm that your consent and HIPAA authorization forms correctly reflect whether the FDA will have access to study records. Projects that involve FDA-regulated products such as investigational […]

For studies that involve an informed consent process, the new submission form requires a response to the query, “Explain how the possibility of coercion or undue influence will be minimized in the consent process.” We see a lot of variety in the responses to this query. However, what we don’t see a lot of are […]

Hint No. 1 – When completing your study’s continuing review form, please remember NOT to include with the form any document amendments you’re hoping to get approved. The IRB no longer reviews amended documents with continuing reviews, and hasn’t done so since we switched from ARIA to CLARA. In some cases, the IRB may have […]

When drafting your protocol, please pay close attention to how the subjects’ age range is described in the text. Different regulatory requirements apply to different ages, which is why the IRB may send contingencies asking you to be very, very specific when describing how old your participants are. For example, when we see an age […]

When completing a new submission form in CLARA, please pay close attention to the questions related to HIPAA and respond individually to each one. We understand that some of the questions may seem like forehead-slappers, such as a request to explain why access to the protected health information is necessary in a chart review study. […]

The IRB staff has noticed an uptick in recent weeks of IRB submissions describing projects that have already been completed. Fortunately, none of the projects in question met the regulatory definition of research requiring IRB review. However, please note that the IRB cannot review or approve projects that have already been completed. In fact, researchers […]

The Food and Drug Administration (FDA) has oversight over some, but not all, of the research that comes through the UAMS IRB. When submitting studies, please confirm that your consent and HIPAA authorization forms correctly reflect whether the FDA will have access to study records. Projects that involve FDA-regulated products such as investigational drugs and […]

The UAMS IRB requires all UAMS study staff engaged in research to complete human subject protection training once every three years. If you are new to UAMS from another institution, you may have already have done such training through citiprogram.org at your previous workplace.  To meet the UAMS training requirements, you might only have to […]

When typing in document names in CLARA, please keep the following points in mind: The name should include the document type, the version number, and the version date. Example: XYZ Protocol Version 3 14Nov2014. If the item you’re naming has a version number and date printed on it, the version number and date you type […]