Information Risks & IRB Strategies for Technologies Used in Research
Information Risks & IRB Strategies for Technologies Used in Research: A Guide for Researchers, IT, and IRBs 1 Last updated: September 25, 2016 Table of Contents 1. Overview Pg.3 2. Data Classification Pgs. 4-5 3. Technologies Pgs. 6-31 Live Two-Way Communication 3a. Pgs. 6-10 3b. Physical Storage Pgs. 11-15 3c. Mobile Devices and Applications (Apps) Pgs. 16-21 Pgs. 22-26 3d. Survey Tools 3e. Cloud Service and Storage Pgs. 27-31 4. Additional Resources Pgs. 32-39 4a. Investigator ChecKlist for Securing Research Data Pgs. 32-33 4b. Guidance on When to Encrypt Data Pg. 34 4c. Points to Consider When Choosing a Cloud Service Pgs. 35-36 4d. Glossary of Common Terms for Technologies Used in Pgs. 37-39 Research 5. Attribution, Sharing, and Adapting Pg.43 6. Acknowledgements and Contact Us Pg.44 7. Bibliography Pgs.45-50 2 Last updated: September 25, 2016 1. Overview The use of technologically interconnected products and services continues to revolutionize the design and conduct of research as researchers can now more easily find, recruit, and communicate with subjects, as well as select cohorts from larger candidate pools, and may do so with greater precision. New tools enable electronic data capture through surveys and devices that collect, analyze, and store a multitude of biological and environmental measures. These technological innovations raise important legal, regulatory, and ethical questions for researchers and institutional review boards (IRB) alike. Among them, do IRBs and researchers understand how information is collected, used, and stored in sufficient detail to protect human research subjects? Can IRBs and researchers assure patients that uses of technology conform to promises or assurances made during the informed consent process? At stake are research subjects’ privacy, confidentiality, and trust in the medical research enterprise.
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