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.
Consent Challenges in Research with Non-English Speaking Subjects: A Collaboration of the IRB and Interpreting/Translation Services
Presented by Jennifer McGaughey, Maria Davila and Alison-Arevalo-Amador from the Children’s Healthcare of Atlanta, Emory University
Enrolling non-English speaking subjects in research holds many challenges. Emory University and Children’s Healthcare of Atlanta (CHOA) have a unique relationship which results in CHOA research studies having oversight by both Emory and CHOA Institutional Review Boards. Issues surrounding the enrollment of non-English speaking subjects were identified by CHOA Translation Services, specifically that CHOA and Emory IRB regulatory requirements surrounding research and non-English speaking subjects were not the same. After assessing both regulatory requirements and best practices of Interpreter/Translation services, Emory and CHOA IRB’s and CHOA Translation Services collaborated to develop a guidance document that addressed the numerous issues encountered when enrolling non-English speaking subjects into research studies. Presentation will address these challenges, and their solutions, including –
- IRB/Regulatory requirements of Short Form Consent, including Witness and Interpreter signature requirements
- Terms and definitions and how they are used by both IRB/Research staff and Interpreter services
- Issues surrounding the translation/interpretation process in research vs. clinical care
- Use of family members (including minors) or fluent research staff as interpreters
- Other challenges related to availability of interpreters, delays due to clinical priority, potential sample bias, and associated costs
The presentation will conclude with real case studies and open discussion.