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 […]

Projects that qualify for exempt status review under UAMS IRB policy 7.3 are not subject to many of the usual requirements in the Common Rule (current or, after Jan. 21, revised). However, the IRB still reviews all exempt status studies for compliance with the ethical principles underlying human subject research (beneficence, justice, autonomy) and, starting […]

We’re always pleased to find a concise and focused recap of the Revised Common Rule’s (RCR) key elements, given the massiveness of the change that’s to take effect Jan. 22, and the reams of information floating around online about it. The federal Office for Human Research Protections (the agency who finally gave us the RCR […]

Is any of your human subject research NIH-supported? If so, please review the newly released NIH notice about implementation of the final rule on the federal policy for protection of human subjects for a recap of how the Revised Common Rule (RCR) will affect your projects. Two changes in particular are specific to NIH-funded or […]

When studies involve collecting data on pairs or groups of individuals, remember that each person about whom you plan to collect data counts as a separate study subject. For example, if you are collecting datafrom both chronically ill people and their caregivers, each dyad counts as two subjects, not one. The same is true if […]

When you’re reviewing something for an IRB agenda, whether it’s a new submission, a modification, a continuing review, or anything else, please document a very brief summary of your review as a note in CLARA. You can describe the intent of the study, planned (or actual enrollment), whether any reports of note are included, etc. […]

So, someone in your department (maybe even you!) has set up a repository of human data and/or specimens, and now you’re ready to use that repository for research. Since the repository had IRB approval, and the subjects signed a consent for future use of the data/specimens, you’re good to go, right? Actually, no, you’re not. […]