Decedents as Human Subjects, Identifiability Standards and Compliance With RCW 70.02.210

Seattle Children’s IRB has revised our policies and practices regarding decedents, identifiability standards, and health care disclosures to better align with the standards and requirements found in the Common Rule (45 CFR 46), HIPAA, and RCW 70.02.210. For questions about these changes, contact the IRB.

Research Using Specimens/Data From Deceased Individuals

• Research activities that are strictly limited to obtaining identifiable information and/or specimens related to decedents (i.e., all potential enrollees are deceased) will no longer be considered “human subjects” research.
• Researchers should instead submit protocol template HRP-503C “Other Status Determination Protocol” to request a not human subjects determination and to satisfy any HIPAA and RCW requirements.

New Interpretations on What Is Identifiable

• Previously, Seattle Children’s IRB used a HIPAA standard for de-identification involving the removal of 18 discrete identifiers to determine whether information obtained for research is identifiable.
• Moving forward, Seattle Children’s will apply the Common Rule definition of “individually identifiable”: “…the identity of the subject is or may readily be ascertained by the investigator or associated with the information” (45 CFR 46.102(f)).
• The Common Rule standard for de-identification is less conservative than the HIPAA standard. Some research activities that previously required review as human subjects research may now be reviewed as not human subjects research. See Table of Identifiability Standards – HIPAA vs. Common Rule (PDF) for more information. 

Compliance With RCW 70.02.210

• The IRB has made additional changes to ensure compliance with Washington state law RCW 70.02.210, which applies to disclosures of healthcare information for research by healthcare providers and/or healthcare facilities without prior written permission.
• These changes will largely be invisible to researchers. For more information, refer to the section on Washington law and Disclosures of Health Care Information found in HRP-103 Investigator Manual in the Click IRB library.