By Barbara J. Evans, MS, PhD, JD, LLM (Alumnae College Professor of Law; Director, Center on Biotechnology & Law, University of Houston)
This post is part of a series on how patients are creating the future of medicine. The introduction to the series is available here, and all posts in the series are available here.
The citizen science movement goes beyond merely letting people dabble in science projects. It involves giving regular people a voice in how science should be done. And citizen science calls for a new, citizen-led bioethics.
Twentieth-century bioethics was a top-down affair. Ethics experts and regulators set privacy and ethical standards to protect research subjects, who were portrayed as autonomous but too vulnerable and disorganized to protect themselves. The Common Rule’s informed consent right is basically an exit right: people can walk away from research if they dislike the study objectives or are uncomfortable with the privacy protections experts think are good for them. An exit right is not the same thing as having a voice with which to negotiate the purposes, terms, and conditions of research.
Economist Albert O. Hirschman—perhaps best known for his role in developing the market-concentration index the Department of Justice uses to evaluate mergers—wrote about how consumers behave when presented with unsatisfactory products. (See Exit, Voice, and Loyalty, Harvard University Press, 1970.) Some customers exit—they stop buying a firm’s products—but exit may be ineffective when there is a monopoly supplier and no alternative product is available. Other customers voice their discontent, complaining to management and negotiating for better products.
A central failing of the Common Rule—one that the final rule published on January 19 of this year did nothing to address—is that it gives people an exit right (informed consent) but gives them no real voice in setting the goals of research or the privacy and ethical protections. Lacking a voice, people CRexit—they withhold consent under the Common Rule (CR) and walk away from research. Surveys suggest that up to 80% of Americans would like to see their data used to advance science, but do not contribute their data. This CRexit can be seen as a vast popular rejection of the top-down protections afforded by current regulations.
Achieving the goals of twenty-first century informational science requires a BioEXIT—a citizen-led uprising to establish a marketplace of alternative data access and privacy standards to bring back the millions of Americans who have CRexited from research.
