Legal

While there exist a variety of concerns that may fall under the purview of a legal department, we have grouped concepts below under

• Liability
• Regulations
• Privacy

Liability

• Is re-interpretation required? No.
• Duty to warn
• Risk of patients interpreting their results for themselves incorrectly and making bad decisions because of that
  • Address: add disclaimer to not use this ad medical advice and consult doc with questions or concerns. Can also pass on PI contact info.
• “never say never” in ICF – even if pt doesn’t want other results, should leave door open for urgent results/duty to care
• Sharing with minors – what are some approaches?
• Do sponsors use data that they don’t “own” (eg RWE) and can they share results from that?

Regulations

Laws, regulations, and guidance (including Ethics Committee and regulatory guidance or position papers) vary considerably across countries on the issue of return of individual research results to study participants.

In general, two types of regulations need to be considered:

1. regulations for the return of results by researchers
2. rules governing the individual’s right of access to personal information.

In some countries, laws grant study participants broad access to their individual research results upon request; in other countries, laws may place restrictions on access.

If you are pursuing the return of IRR at your organization, make sure to identify local individuals who know and can represent the relevant laws and regulations, and their interpretation. Remember, laws and regulations are constantly evolving.

• Regs:
  • US:
    • HIPAA
    • CLIA
    • Common Rule
    • Genetic Information Nondiscrimination Act
    • Genetic Privacy Laws – 50 state survey (link)
  • International:
    • GDPR
    • Link to HHS International Compilation of Human Research Standards
  • Review HIPAA/CLIA clash

Privacy

• Address medical record stuff