Immortal Life of the Common Rule: Ethics, Consent, and the Future of Cancer Research.

The advent of the first immortal human cancer cell line in 1951 (HeLa) had profound implications for cancer research.1 Historically, the list of translational cancer research discoveries generated from human-derived cancer cell lines such as HeLa cannot be overstated.2-4 In addition, the future of the research enterprise undoubtedly depends on continued access to the biospecimens that generate such lines. However, it was the 2010 book, The Immortal Life of Henrietta Lacks, and its compelling story of the woman behind HeLa, that initiated an impassioned debate on the ethics and limits of research with such tissue.5 Applied laboratory scientists have a moral and ethical obligation to respect and honor the person from whom biospecimens were derived, but how that respect should be demonstrated is a matter of debate. The Common Rule, initially adopted in 1991, created an overarching guideline for federally funded human subjects research to provide oversight both in response to prior ethical transgressions and to present a unified ethical and regulatory framework for the future. But, in the ensuing years, the research landscape has dramatically changed in ways that could not be anticipated two decades past. Thus, a contemporary update to the Common Rule has been long overdue. After almost 6 years of careful analysis and vetting, along with public commentaries and spirited debate, 16 federal departments and agencies, including the US Department of Health and Human Services, published the eagerly anticipated final rule for the Federal Policy for the Protection of Human Research Subjects (Common Rule) on January 18, 2017, with a plan for implementation in 2018.6-8 The field of cancer research is currently in a watershed, further stimulated by the Cancer Moonshot and Precision Medicine Initiative. The pace of discoveries with immediate translational potential, particularly with regard to tumor biology/immunology and genomics, is frenetic. The translation of new laboratory data to applications at the bedside has never been more dynamic or fluid. Much of this research falls under the purview of the Common Rule and is accordingly dependent on and accountable to its stipulations and revisions. The goals of the Common Rule revisions include to “enhance respect and safeguards for research participants and to increase research efficiency by reducing unnecessary burdens and calibrating oversight to the level of risk. ”9(p2293) However, many stakeholders were concerned that several proposed changes would hinder the research enterprise unnecessarily, particularly in the field of oncology. For example, the proposed Common Rule changes in the notice of proposed rulemaking (NPRM), which preceded the final rulemaking, included efforts to require broad consent for all research with biospecimens. Under the previous version, biospecimen informed consent was only required if identifying information accompanied the sample.6 The intent of the proposal—which considers any human tissue to be a human subject triggering informed consent protections—was to respect participant autonomy, but it raised the possibility of serious unintended consequences. A lively discussion ensued regarding how best to balance the need to protect and respect current participants who provide their tissue to advance scientific knowledge while ensuring scientists have the ability to advance science for future patients using invaluable biologic specimens.9-11 Ultimately, the final Common Rule was receptive to such criticisms (Table 1). 13 Table 1. Summary of Major Changes to the Final Common Rule