27 Automated IRB compliance and secure data delivery in i2b2
Objectives/Goals: To address the manual, time-consuming processes of validating IRB compliance and ensuring the secure delivery of i2b2 data, this project automates compliance checks, streamlines Protected Health Information (PHI) access, and provides timely, secure data availability while reducing...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2025-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124007180/type/journal_article |
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| author | Hakob Abajian Venkat Vuppula Johnson Kwong Praveen Angyan Shakeel Usmani Saurav Limbu Brittney Arvizu Hira Sherazi Swaroop Samek Maryam Abdallah Amy Chuang Daniella Garofalo Neil Bahroos |
| author_facet | Hakob Abajian Venkat Vuppula Johnson Kwong Praveen Angyan Shakeel Usmani Saurav Limbu Brittney Arvizu Hira Sherazi Swaroop Samek Maryam Abdallah Amy Chuang Daniella Garofalo Neil Bahroos |
| author_sort | Hakob Abajian |
| collection | DOAJ |
| description | Objectives/Goals: To address the manual, time-consuming processes of validating IRB compliance and ensuring the secure delivery of i2b2 data, this project automates compliance checks, streamlines Protected Health Information (PHI) access, and provides timely, secure data availability while reducing administrative burdens and non-compliance risks. Methods/Study Population: This project enhances the i2b2 application to automate compliance processes and facilitate secure data delivery through integration with REDCap. By linking i2b2 with the IRB system, the application performs automatic compliance checks for project requests, verifying GCP and HIPAA certifications, only allowing the release of IRB-approved PHI variables, safeguarding against unauthorized data access. Manual signatures confirm non-automated compliance processes. Once verified, the application automatically creates a REDCap project, assigns user access, and securely delivers data, ensuring compliance with HIPAA regulations. Results/Anticipated Results: The automated system successfully streamlined IRB compliance checks and data delivery for i2b2 requests. Validation of certifications like GCP and HIPAA, now occurs automatically, significantly reducing the risk of non-compliance. Personnel access to data is limited to IRB-approved PHI, ensuring data security and adherence to institutional standards. The integration with REDCap has reduced manual processes, cutting data request processing time to approximately 30 minutes. Researchers and administrative staff experienced a notable decrease in administrative burden, with faster, more efficient access to approved data while maintaining full compliance with IRB and HIPAA regulations. Discussion/Significance of Impact: The lessons learned can be adapted by institutions to improve compliance efficiency and reduce administrative overhead. Implementing similar automation of certification checks and data delivery, sites can enhance data security, minimize errors, and ensure faster, compliant access to research data. |
| format | Article |
| id | doaj-art-3e7929dbfdce4c8e93c65a0fe87f7907 |
| institution | DOAJ |
| issn | 2059-8661 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj-art-3e7929dbfdce4c8e93c65a0fe87f79072025-08-20T02:40:52ZengCambridge University PressJournal of Clinical and Translational Science2059-86612025-04-019101010.1017/cts.2024.71827 Automated IRB compliance and secure data delivery in i2b2Hakob Abajian0Venkat Vuppula1Johnson Kwong2Praveen Angyan3Shakeel Usmani4Saurav Limbu5Brittney Arvizu6Hira Sherazi7Swaroop Samek8Maryam Abdallah9Amy Chuang10Daniella Garofalo11Neil Bahroos12University of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaUniversity of Southern CaliforniaObjectives/Goals: To address the manual, time-consuming processes of validating IRB compliance and ensuring the secure delivery of i2b2 data, this project automates compliance checks, streamlines Protected Health Information (PHI) access, and provides timely, secure data availability while reducing administrative burdens and non-compliance risks. Methods/Study Population: This project enhances the i2b2 application to automate compliance processes and facilitate secure data delivery through integration with REDCap. By linking i2b2 with the IRB system, the application performs automatic compliance checks for project requests, verifying GCP and HIPAA certifications, only allowing the release of IRB-approved PHI variables, safeguarding against unauthorized data access. Manual signatures confirm non-automated compliance processes. Once verified, the application automatically creates a REDCap project, assigns user access, and securely delivers data, ensuring compliance with HIPAA regulations. Results/Anticipated Results: The automated system successfully streamlined IRB compliance checks and data delivery for i2b2 requests. Validation of certifications like GCP and HIPAA, now occurs automatically, significantly reducing the risk of non-compliance. Personnel access to data is limited to IRB-approved PHI, ensuring data security and adherence to institutional standards. The integration with REDCap has reduced manual processes, cutting data request processing time to approximately 30 minutes. Researchers and administrative staff experienced a notable decrease in administrative burden, with faster, more efficient access to approved data while maintaining full compliance with IRB and HIPAA regulations. Discussion/Significance of Impact: The lessons learned can be adapted by institutions to improve compliance efficiency and reduce administrative overhead. Implementing similar automation of certification checks and data delivery, sites can enhance data security, minimize errors, and ensure faster, compliant access to research data.https://www.cambridge.org/core/product/identifier/S2059866124007180/type/journal_article |
| spellingShingle | Hakob Abajian Venkat Vuppula Johnson Kwong Praveen Angyan Shakeel Usmani Saurav Limbu Brittney Arvizu Hira Sherazi Swaroop Samek Maryam Abdallah Amy Chuang Daniella Garofalo Neil Bahroos 27 Automated IRB compliance and secure data delivery in i2b2 Journal of Clinical and Translational Science |
| title | 27 Automated IRB compliance and secure data delivery in i2b2 |
| title_full | 27 Automated IRB compliance and secure data delivery in i2b2 |
| title_fullStr | 27 Automated IRB compliance and secure data delivery in i2b2 |
| title_full_unstemmed | 27 Automated IRB compliance and secure data delivery in i2b2 |
| title_short | 27 Automated IRB compliance and secure data delivery in i2b2 |
| title_sort | 27 automated irb compliance and secure data delivery in i2b2 |
| url | https://www.cambridge.org/core/product/identifier/S2059866124007180/type/journal_article |
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