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Third parties in human subjects research

This presentation, developed by U-MIC at the University of Michigan, explores the critical role of third parties in human subjects research. It discusses definitions, ethical implications, and the necessity of informed consent when sensitive information is involved. The presentation emphasizes the importance of protecting third-party identities, the role of Institutional Review Boards (IRBs) in determining subject classification, and the legal considerations under HIPAA. Understand how to mitigate risks and ensure ethical compliance in research involving identifiable third-party data.

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Third parties in human subjects research

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  1. 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

  2. Third partiesin human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

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

  4. 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

  5. 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 Developed by: U-MIC

  6. mitigating risk to third parties Third parties in research • 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

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

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

  9. Adam Mrdjenovich IRB-HSBS University of Michigan thank you. Developed by: U-MIC

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