Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI Experiment

Principal investigator(s)

  • Gloria Petersen, PhD (Mayo)
  • Barbara Koenig, PhD, RN (UCSF)
  • Susan M. Wolf, JD (University of Minnesota)

This empirical and normative bioethics research project was created to guide policy and practice about the disclosure of genomic incidental findings (GIFD), a much-debated topic. With ethical guidance from a multidisciplinary ELSI Working Group, we conducted an experiment designed to develop strategies for offering incidental findings to family members of probands in a biobank for pancreatic cancer. Given that the majority of the pancreatic cancer probands are deceased, many concerns needed to be addressed: Who should be offered the findings, given that notification of the proband’s legal next of kin may not assure that biologically at-risk family members are informed? Since relatives were not involved in the original biobank informed consent process, how should re-contact be managed? What disclosure procedures best meet family members’ concerns? Is there an ethical threshold for determining when the researcher is obligated to offer GIFD? Our approach was informed by studying the preferences of biobank research participants (including kin). A partnership among 3 PIs—a genetic epidemiologist who directs the SPORE biobank (Gloria Petersen), an empirical researcher (Barbara Koenig), and a bioethics and law scholar (Susan Wolf)—combined the strengths of Mayo Clinic and the University of Minnesota. This project generated much-needed data on proband and family preferences, produced detailed analyses of the legal and ethical issues raised, created consensus recommendations, devised methods for honoring preferences, and advanced sound biobank governance.

Project outcomes