[Skip to Navigation]
Special Communication
January 31, 2019

Biospecimens, Research Consent, and Distinguishing Cell Line Research

Author Affiliations
  • 1Department of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor
  • 2Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor
  • 3Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • 4Department of Otolaryngology–Head and Neck Surgery, University of Michigan Medical School, Ann Arbor
JAMA Oncol. 2019;5(3):406-410. doi:10.1001/jamaoncol.2018.6988

Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently “identifiable,” thereby necessitating informed consent for use in research. The famous cases seminal to this discussion involve cancer cell lines, but the unique features of this kind of biospecimen research were largely missing from the regulatory deliberation. However, special aspects of cell line research—at the stages of procurement, generation, evolution, and sharing—alter how society should balance participant interests against the goals of research. Recommendations are offered to cancer researchers and policymakers going forward to enable ethically appropriate regulation of biospecimen research across its diverse spectrum.