NEWSLETTER

SPRING 2019

eIRB Is So 2018 – IRBNet Is So Hot Right Now

It’s all IRBNet, all the time, here at CHR. While the technical aspects of the transfer went according to plan, using the new system has some of us scratching our heads asking, “How did I do it in eIRB?”

We appreciate all of you who have come to us with various questions and IRBNet oddities so that we can in turn share them (and some helpful tips) with the rest of CHR. Here are some of the lovable quirks of our new system:

Cloning smart formsCloning staff forms and core data forms should work just fine, but don’t even try to clone that modification form. That functionality has been turned off to prevent errors, the thought being that each modification should be unique enough to warrant creating a new form.

Link your existing CITI training in IRBNet – The new system requires every study staff member engaged in research to link their CITI training. This includes all research staff, not just those accessing IRBNet. Log in to IRBNet, go to ‘User Profile,’ and click ‘Add an External Account.’ Enter your CITI account number (if you don’t know it, contact the RSPO and we can look it up) and click ‘Continue.’ You will receive an email from IRBNet. Open the email and click the appropriate link to verify your CITI training profile in IRBNet.

General guidanceIf your burning questions do not involve cloning modification smart forms or linking CITI training, good; there’s more to life than that. That said, if you have questions about specific processes, the KFRI website has a plethora of short videos on how to perform specific tasks in IRBNet. Check them out here.


New Common Rule Makes Some Types of Research Uncommonly Easy to Get IRB Approval

Because of the federal government shutdown in January, it’s likely you didn’t hear much about a major rule change that affects how federally funded research is reviewed by IRBs. The new common rule regulations increase flexibility in research on existing data, surveys, and interviews, and brief, non-invasive behavioral interventions to reduce burden on researchers.

In response, the RSPO has launched the Express Exemptions pilot program. If you think an upcoming project may meet the criteria for exemption, you can fill out a brief online form, schedule an appointment with our office, and if your project qualifies, walk away from the meeting with your approval letter. Learn more about the process and how to request a meeting on the Research Compliance page.

Social/Behavioral Research and Good Clinical Practice

In  September 2016, the NIH expanded its definition of clinical trials to include social/behavioral research: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The new definition may mean that studies not previously considered clinical trials will now meet the definition.

International Conference on Harmonisation Good Clinical Practice (ICH-GCP or just GCP) is the international gold standard for clinical trials. These are not federal regulations but best practice guidance. Due to the expanded definition of a clinical trial, we expect more social/behavioral research will be required to follow GCP. Many researchers at CHR are not familiar with GCP, so in 2017, Research Compliance established a work group to create materials for social/behavioral research that will help study teams navigate the standards.

The materials are posted on the Research Compliance website under Quality Improvement and Monitoring. They include an Investigator Guidance document, protocol deviation log, and training and delegation log. We updated our consent form template to comply with the new federal regulations and GCP. The consent form can be found on our website on the Forms and Templates page, as well as in the IRBNet, under the Forms and Templates tab.

The Investigator Guidance document covers GCP requirements, so if you are on a grant or have a protocol that requires the research to follow GCP, please use these tools. The Research Compliance Team (Melinda Allie and Andrea Seykora) is always available for consultation or to answer any questions.

Many thanks to the Social/Behavioral GCP Workgroup for helping create the materials: Andrea Seykora, Kaija Maggard, Mica Werner, Cheryl McGinley, Greg Clarke, Bobbi Jo Yarborough, Stefan Massimino, Michelle Henninger, Jen Rivelli, and Sara Gille.

Policy Updates

Consent key summary now requiredBoth the consent document and the consent process for new studies are now required to start with a concise summary of the studies’ key aspects.

The summary should include, at a minimum, the following information: 1) a statement that the project is research; 2) the purpose, duration, and procedures involved; 3) foreseeable risks; 4) expected benefits; and 5) alternatives to participation.

If you use the RSPO Consent Template to prepare your consent document, you will find the list of all five elements. The summary can be as brief as four paragraphs for some minimal risk research or as long as two pages for a clinical trial.

This is an updated requirement under the new common rule regulations that went into effect in January. Studies approved prior to January 19, 2019, are NOT required to include the summary.

 

IRB Tips and New Information

Continuing review for ceded studies – Did you know you don’t have to create a Continuing Review Smart Form for your continuing review for a ceded study? That’s right! Just upload the approval letter from the IRB of record and a memo briefly describing the status of the study at KPNW.

Note: Ceded studies do still require the Core Data and Study Staff Smart Forms to be completed for new and migrated studies.