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THIRD PARTIES in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

Third parties in research 3 Developed by: U-MIC human subjects interaction intervention identifiable information other individuals’ lives circumstances perceptions histories third parties not involved in study no interaction with researchers

Third parties in research 4 Developed by: U-MIC Not all third parties are considered study subjects. IRB makes the determination. Is third-party information private and/or sensitive? Can a third party be identified through research data?

Third parties in research 5 Developed by: U-MIC Third parties may have to provide informed consent if third-party information is sensitive confidentiality measures cannot mitigate risk IRB may grant a waiver of informed consent for third parties if research poses no more than minimal risk waiver will not adversely affect third parties’ rights and welfare research could not be conducted without waiver where applicable, subjects will receive information after participation

Third parties in research 6 Developed by: U-MIC mitigating risk to third parties Researchers may avoid collecting sensitive information. name relationship to subject other sensitive information Records may protect third parties’ identities. Third parties are considered study subjects only if data contain identifiable private information.

Third parties in research 7 Developed by: U-MIC IRBs should keep in mind: Classifying third parties as subjects may impact primary subjects’ rights or welfare. HIPAA may apply.

Third parties in research 8 Developed by: U-MIC Third parties in human subjects research

THANK YOU. Adam Mrdjenovich IRB-HSBS University of Michigan 9 Developed by: U-MIC