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Understanding Informed Consent for Genetic Sub-Studies: Important Guidelines

This presentation by U-MIC covers essential information on informed consent for genetic sub-studies. It discusses genetic research, including inherited traits and the implications of the Genetic Information Nondiscrimination Act (GINA) regarding health coverage and employment. Participants will learn about their rights concerning testing, counseling, and the storage of genetic information, as well as how to opt in or opt out of studies. The importance of clear consent documents is emphasized to ensure participant understanding and compliance.

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Understanding Informed Consent for Genetic Sub-Studies: Important Guidelines

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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. Informed consentfor Genetic sub-studies Developed by: U-MIC University of Michigan IRB Collaborative

  3. Informed consentfor genetic sub-studies genetic research • inherited human traits • Genetic Information Nondiscrimination Act (GINA) • health coverage • employment Developed by: U-MIC

  4. genetic information Informed consentfor genetic sub-studies • a person’s genetic tests • clinical • research-related • a family member’s genetic tests • dependents • up to fourth-degree relatives • genetic tests of • fetuses • embryos • a disease within a family • family history • genetic services • testing • counseling • education • doesnot include: • sex • age • genetic test • DNA • RNA • chromosomes • proteins • metabolites • genotypes • mutations • chromosomal changes Developed by: U-MIC

  5. genetic research Informed consentfor genetic sub-studies main study sub-study • opt in • subject takes part in both main study and sub-study • opt out • subject takes part in main study only Developed by: U-MIC

  6. genetic research Informed consentfor genetic sub-studies • sub-study consent • separate signature in main study consent document • separate sub-study consent document • storage duration and location • withdrawing specimen and information from study • results of genetic tests • controlling and sharing specimen • financial benefits • risks • GINA Developed by: U-MIC

  7. informed consentfor genetic sub-studies informed consent for genetic sub-studies Developed by: U-MIC

  8. Judy Birk Brian Seabolt IRBMED thank you. Developed by: U-MIC

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