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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC 1
THIRD PARTIES in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative
Third parties in research human subjects interaction intervention identifiable information third parties • not involved in study • no interaction with researchers Developed by: U-MIC other individuals’ • lives • circumstances • perceptions • histories 3
Third parties in research 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? Developed by: U-MIC 4
Third parties in research 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 Developed by: U-MIC 5
Third parties in research 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. Developed by: U-MIC 6
Third parties in research IRBs should keep in mind: • Classifying third parties as subjects may impact primary subjects’ rights or welfare. • HIPAA may apply. Developed by: U-MIC 7
Third parties in research Third parties in human subjects research Developed by: U-MIC 8
THANK YOU. Adam Mrdjenovich IRB-HSBS University of Michigan Developed by: U-MIC 9
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