Have you seen the new eIRB+ application for research projects involving greater than minimal risk activities?

Choosing the “Research Protocol Study (Greater than minimal risk) - Full Board” application routes the study through the full board review process in eIRB+. This means that your application will be reviewed and discussed at a convened, full board meeting of the IRB. 

What does greater than minimal risk mean?   

Greater than minimal risk means that the probability and magnitude of harms or discomforts anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

When should this application be used? 

This application should be used when your research creates/analyzes new information (including data and biospecimens) gathered through interaction or intervention with living individuals, and the research is considered greater than minimal risk. 

Can you give me some examples of greater than minimal risk research?  

• Medical research such as clinical trials testing new drugs or devices with unknown side effects; studies involving procedures like biopsies or spinal taps; studies involving radiation therapy or high-dose chemotherapy; etc.
• Psychological research inducing significant stress or anxiety through experimental manipulations; research on traumatic experiences or sensitive topics; etc. 
• Social science research on illegal activities or sensitive behaviors; vulnerable populations; etc.

Learn more about the Research Protocol Study (Greater than minimal risk) - Full Board eIRB+ application. 

eIRB+ PDF Quick Guides for each of the eIRB+ initial submission types are available.

These step-by-step Quick Guides provide overviews, screenshots, and tips for the eIRB+ application.

Virtual Institutional Review Board (IRB) Office Hours

DRAFT (Document Revision And Feedback Team) Services hosts IRB Office Hours weekly.

When:

• Tuesdays, 1 – 1:30 pm (with IRB Reliance Team)

• Thursdays, 10 – 10:30 am

Where:

Office Hours Zoom Link

Passcode: 133269

More information on what to expect during Virtual IRB Office Hours.

Attend a virtual eIRB+ Workshop to learn more about the updates to our submission platform and business processes.



eIRB+ Workshop sessions offer a comprehensive walkthrough of updated features, step-by-step application tutorials, and an opportunity to address any questions you may have.

Register now on the Course Registration System to secure your spot in upcoming training sessions. Multiple sessions will be available weekly throughout each month/semester.

After receiving a number of questions to clarify reconsenting requirements and after seeing a number of reconsiderations for changes to the reconsenting language, WCG IRB would like to make you aware of a wording change to one of the typical, commonly used phrases in WCG IRB approved consent forms.

The intended updated language is as follows:

WCG IRB reviewed new information in the above consent form(s). Please inform all participants for which there is an in-person or remote interaction and new subjects (if enrolling) of the changes. Document the communication in the research records (e.g., Note to File or participants signing the consent form). This is the Board’s minimum expectation – Sites can choose to inform or reconsent additional participants.

or

Please have all future participants sign the Consent Form(s) specified in this approval. This is the Board’s minimum expectation – Sites can choose to inform or reconsent additional participants.

WCG notes that the regulations do not require that participants sign a revised consent form when changes are made, just that they are informed. Given that, the new phrasing allows for more flexibility in informing participants and documenting that conversation in other ways outside of requiring signing of a consent form. It is important to note that if you prefer certain participants be reconsented with an updated consent form, please provide that information via the submission form when the consent form changes are submitted. The Board will accommodate the request if possible as well.

Once the updated phrases can be utilized by WCG IRB reviewers, a blog will be posted on the WCG website.

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