The ever-timely (ahem) Office for Human Research Protections (OHRP) has released a draft guidance about transitioning studies approved prior to the Jan. 21, 2019, Revised Common Rule implementation and compliance date. While this is only a draft and subject to revision, it supports what we’ve been hearing about how to handle studies initiated before Jan. […]

The Revised Common Rule (RCR), slated to take effect Monday, January 21, gives studies open prior to that date the choice of either staying with the current Common Rule regulations or transitioning to the RCR. The UAMS IRB will allow investigators to request consideration to change to the RCR with their next continuing review. The […]

While we prepare for the looming implementation of the Revised Common Rule (RCR), keep in mind that some research the UAMS IRB oversees is also subject to Food and Drug Administration (FDA) oversight. While the FDA promises to work on harmonizing its regulations to the extent possible with the RCR, we’re not holding our breath […]

The Revised Common Rule, slated to take effect after Jan. 19, 2019, will expand the types of studies eligible for exempt status review. That’s generally good news for researchers, as it reduces the regulatory burdens they face in carrying out research. One slight change will be somewhat in the other direction – the check-in the […]

We’ve revised IRB Policy 15.1 to reflect the requirements of the Revised Common Rule. While it will be added to the usual spot on our website after January 19, we wanted to make it available for reference before that date. A quick recap of the most notable changes to the informed consent information requirements: Consent […]

Sharing of participant-level data is becoming a hot topic of discussion, with valid arguments both for and against. For example, proponents argue that data-sharing can improve people’s trust in scientific publications, whereas those opposed cite privacy concerns. But what do clinical trial participants think about data-sharing? Stanford researchers recently asked more than 700 study participants […]

An new scientific review service will soon be available to researchers requesting TRI protocol assistance. For investigator-initiated clinical trial protocols that have not undergone peer review, an experienced clinical researcher and/or biostatistician can provide complimentary scientific reviews of protocols. This scientific review process will run concurrently with TRI protocol assistance activities and will not affect […]

The Revised Common Rule (RCR), slated to take effect Jan. 22, 2019, adds some new required elements to informed consent processes/forms, and also requires informed consent to begin with a “concise and focused presentation” of “key information” describing why some might, or might not, want to join a research study. A revised plain language informed […]

One of the more notable changes to take effect Jan. 22, 2019, with the Revised Common Rule is a significant expansion of the exemption categories. The changes will mean that many studies that require expedited status review under the current rule will qualify for exempt status. Chart review studies, including those that use data that […]

While CLARA was designed to be relatively simple to use (“If you can use TurboTax, you can use CLARA,” we like to tell people), the first few submissions can be a bit daunting. The “Help” section in CLARA has a user guide that can help you through those first few submissions. To access it, log […]