Page 14 - Research Compliance Welcome Package (1.4.19)

• IRBs rely upon the information you submit to them (e.g., study application) to prompt consideration of how use/disclosure of PHI is adequately addressed, so be sure your submissions adequately address all uses.
• The term de-identified is often misused to refer to the removal of direct identifiers such as name, but all 18 identifiers have to be removed for it to meet the requirements for de-identification.
• Research sponsors should be educated on privacy in research and have appropriate protections built into their studies; however, not all sponsors are created equal. BSWH is the covered entity responsible for protecting our PHI.
• Securing research data is not a new concept; however, specific standards must be met for electronic PHI (ePHI) storage and transfer to external parties in an electronically secure manner.
Available Resources
• HIPAA Security and Privacy Rules: 45 CFR 160 and 45 CFR 164
• HHS Guidance
• Baylor Scott & White Privacy & Security Handbook
• BSWH Policy for the Use & Disclosure of PHI for Research Purposes
• BSWH Policy for De-Identification of Protected Health Information
• BSWH Policy for Creating & Using a Limited Data Set
Research Compliance Office Contact Information
Please contact the Research Compliance Office with questions regarding privacy in research.
Stephanie Worley
Jennifer Gibbons-Ramirez Lindsey Estep
Michelle Edens
Research Integrity Officer Consultant
Consultant
Consultant
(254) 215-9025 (254) 215-9027 (254) 215-9028 (214) 820-6524
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