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IRB Accreditation and Local IRB Operations

IRB Accreditation and Local IRB Operations. Libbie Stephenson, UCLA Thomas Lindsay, UMN Jacob Carlson, Purdue IASSIST Conference, May 2009 Tampere, Finland. Privacy.

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IRB Accreditation and Local IRB Operations

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  1. IRB Accreditation and Local IRB Operations Libbie Stephenson, UCLA Thomas Lindsay, UMN Jacob Carlson, Purdue IASSIST Conference, May 2009 Tampere, Finland

  2. Privacy • "privacy has several meanings and guises, depending on the period and location with which one is dealing." Hanneke Ronnes IASSIST May 2009

  3. Hot issues in the continuing debate on privacy and confidentiality • Consumer guidelines • User-generated content • Third-party applications • Data sharing summit IASSIST May 2009

  4. Human Subjects Guidelines ~ International Perspectives • International Compilation of Human Subject Research Protections • Research Ethics Committees in Europe • CESSDA(with thanks to Hillary Beedham) IASSIST May 2009

  5. Evaluation and Accreditation • Association for the Accreditation of Human Research Protection Programs • Benefit to the institution • Benefit to review boards • Benefit to the researcher • Benefit to research subjects • Benefit to data access and data sharing? IASSIST May 2009

  6. Effect of accreditation on local practices Changes in the way public data are defined! Public data is not covered by human subjects research guidelines. IASSIST May 2009

  7. Human Subjects Decision Tree Data has PID PID is coded separately from data Data has no PID Does PI have access? Yes No Data is pre-existing AND subjects cannot be identified NOT human subjects research NO Yes Expedited orFull review Exempt Certification IASSIST May 2009

  8. Researchers, Archives and Review Boards • Change in perspective • Push-back from faculty • Constant communication • Next steps for IASSIST IASSIST May 2009

  9. Next Steps for IASSIST • Engage the ethics review groups in discussion • Train and educate our users and ourselves • Work to develop a global “conscience” that leads to common practices • Communicate with other constituencies IASSIST May 2009

  10. Interest group on human subjects protections • Role and function of human subjects review boards • Influence on data management, dissemination, curation and preservation • Issues related to protection of human subjects laws and policies established in IASSIST member countries IASSIST May 2009

  11. Thank You! • Thomas Lindsay • lindsayt@umn.edu IASSIST May 2009

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