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ACRP 2019 OnDemand


215 - Regulatory and legal changes, the Common Rule, and GDPR: How they can impact study data flow based on real and perceived changes to the privacy of information


Apr 14, 2019 3:15pm ‐ Apr 14, 2019 4:15pm


Credits: None available.

Non Member: $75.00
Members: $15.00

Description

The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common Rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.

Learning Objectives:

  • Understand the privacy implications of the revised Common Rule and GDPR on studies.
  • Identify the implications of the changes to the Common Rule and the implementation of GDPR on privacy considerations for studies.
  • Anticipate why study sites might not be willing to embrace the Common Rule changes as part of their oversight, even when the Common Rule permits less oversight of studies in some instances.

Speaker(s):

  • Marti Arvin, CHC, CHC-F, CCEP, CCEP-F, CHRC, Vice President of Audit Strategy, CynergisTek

Credits Available


Regulatory and legal changes, the Common Rule, and GDPR: How they can impact study data flow based on real and perceived changes to the privacy of information Exam

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