Methodology

Project Structure and Scope

LawSeqSM is designed to clarify what the law currently is (including conflicting law, gaps, and evolving law) and to formulate recommendations on what the law should be in four key domains:

  • Liability includes tort and contract exposure of clinicians, laboratory personnel, and their institutions and describes the standard of care while protecting innovation in sequencing. Liability also applies to return of results and incidental findings, including duty to hunt, duty to return, and duty to warn.
  • Quality encompasses the law on the quality and validity of genomic sequencing results and interpretation, including evolving Clinical Laboratory Improvement Amendments (CLIA) and Food and Drug Administration (FDA) regulation plus state statutes that, along with laboratory accreditation and professional society standards, address analytic validity, clinical validity and utility, and overall quality.
  • Privacy and Access refer to privacy protections and regulation of data access, including under HIPAA (Health Insurance Portability and Accountability Act) and state law, focusing on privacy safeguards and what results go into the medical record, and rules under CLIA, the HITECH Act (Health Information Technology for Economic and Clinical Health), and other authorities on patient access to laboratory reports.
  • Framework means determining when the law and rules of research should apply versus the law and rules of clinical care, and whether innovation beyond this conventional dichotomy is needed, to address the translational process as genomic sequencing moves from research to clinical use.

Database Methodology

The LawSeqSM team assembled the legal resources in this website through structured searches across resources such as Westlaw, Lexis Advance, and specialty databases like those listed here. The Secondary Sources database includes key scholarly publications from the legal, bioethics, scientific, medical, and policy literatures. 

Empirical Methodology

The project team is conducting empirical research using mixed methods to ascertain what key stakeholders see as legal barriers and solutions. The Working Group has used a modified Delphi method to identify perceived legal problems. The project then administered a REDCap™ online survey to key stakeholder groups to ascertain perceived legal issues and solutions. Finally, semi-structured interviews have been conducted to gain a more in-depth perspective on perceived problems and solutions. The Working Group will use survey and interview results together with original research to generate analyses and recommendations. 

To learn more about the LawSeqSM project, click here. 
To send feedback to the LawSeqSM team, click here.