Concurrent Session #4
Implementing Limited IRB Review with Limited Resources
Presented by Katie Speanburg and Sean Owen from Abt Associates
The focus of the session will be how IRBs with limited resources can apply the final revisions to the Common Rule exemption categories related to the new type of review: “limited IRB review” to “assess the adequacy of provisions to protect the privacy of subjects and the confidentiality of data.”
We have several learning objectives:
- Describe how IRBs can operationalize a limited IRB review process with institutional partners like IT Security to ensure the protection of sensitive data and regulatory compliance.
- Teach participants how to classify the sensitivity of data and studies according to the new exemption criteria as well as the need for limited IRB review.
- Briefly describe common security certifications that reduce the IRB burden of reviewing those product’s protections.
- Use example studies to learn how to use our data security plan template, including ensuring consistency with other study protocol documents such as consents and data use agreements.
Using the innovative tools, partnerships, and process we developed at our small volume social-behavioral IRB, we will give a presentation that demonstrates how anyone can leave the conference and implement this at their home institution. Our presentation will include how to choose compliant data security tools for a shoe-string budget, which institutional partners to engage, and strategies to train researchers on the processes. We will use a case study to walk through an exemption that requires “limited IRB review,” show-casing the integration of data security tools, the review process, and data security plan template. We will incorporate any additional guidance issued by HHS and OMB after January 31, 2018 about limited IRB review.