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• If a minor agrees to enroll, should they have access to their genetic results and risk factors before the age of consent?  What are the relevant state laws?
  • What should the protocol be for sharing this information?
  • Should both parents and participating minors have access to the information?
  • What are the different considerations for privacy and protections based on whether the parent manifests versus carries certain disease markers?
  • Is there variation in state laws that govern adolescents’ access/electronic access to sensitive data/consent to sensitive research that might limit their participation?
• What are researchers’ obligations for the timing, level of detail, and education around the return of participant results?
  • Variations related to participating minors and/or parental preference for participating minors?
  • Variations related to participating family members?
• Are there policies or legal requirements related to the portability of sensitive information? Will the results be available electronically? Will participants be able to share this information electronically, if they so choose? Are researchers obligated to make this information portable/shareable?
• HD mutations predict disease with almost perfect certainty, do considerations change if weakly correlated genetic risk factors are identified? Do considerations change when a disease is medically actionable? If symptoms may only manifest much later in life? If a genetic test result would impact reproductive decisions but not health (i.e. carriers)?
• Which privacy protections are in place to prevent/limit disclosures of risk to external parties (both electronic systems protections and policies and procedures)? Disclosures of disease to external parties?
• Depending on identification of disease vs. carrier status vs. non-carrier status, to whom, if anyone, should this information be disclosed (e.g., primary care provider, specialist)? Should there be procedures that allow participants to express their preferences and how should those be tracked?
• In the event of accidental/unauthorized disclosure to a third party (e.g., primary care provider, family member, educational institution), what protections are in place to prevent discrimination based on risk? Based on disease? (Genetic Information Nondiscrimination Act of 2008 (GINA) applies to only two cases: health insurance and employment; not educational settings, for example).
  • Is it necessary to discuss these policies/gaps as part of the consent process to ensure the participant understands the risks of participating in the research?
    • Loss of autonomy as to when the participant finds out their disease status
    • Conflicts between when a parent wants their child to find out about disease status vs. legal requirements for disclosure
    • Others?
• Due to the genetic and (potential) disease-related information, where should Max house the research data? A separate database? Should it be linked in any way to the patient’s existing EHR within the School of Medicine system?
• How should a situation be handled in which a minor wants to know the results, but the parent does not want to give permission for the minor to see the results?
• Should the researchers follow the recommendations of the American Academy of Pediatrics and the American College of Medical Genetics?
  
  

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