Self-experimentation, ethics, and regulation of vaccines

Science
25 September 2020 Vol 369, Issue 6511
http://www.sciencemag.org/current.dtl

Self-experimentation, ethics, and regulation of vaccines
By Christi J. Guerrini, Jacob S. Sherkow, Michelle N. Meyer, Patricia J. Zettler

 

Science25 Sep 2020 : 1570-1572
DIY COVID-19 vaccines raise legal and ethical questions
Summary
As the coronavirus disease 2019 (COVID-19) pandemic continues to sweep the globe, several groups have been working to develop and self-administer unapproved, unproven interventions that they describe as vaccines for COVID-19 (1–4). Some of the interest in these do-it-yourself (DIY) approaches apparently stems from a belief that self-experimentation is never subject to time-consuming ethics board review or regulation, such as by the U.S. Food and Drug Administration (FDA). This belief is legally and factually incorrect, and the misunderstanding has potentially important public health implications. Any failure by the FDA to regulate DIY vaccines would permit vaccines of dubious safety and effectiveness to endanger public health and would signal a lowering of standards that—in an age blighted by vaccine skepticism and during a highly politicized pandemic—could undermine public trust in all vaccines, however developed (5). Further, some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Even when ethics review is not required, citizen scientists must take seriously their heightened ethical responsibilities when promoting DIY interventions, especially those with potentially serious public health and societal effects, such as COVID-19 vaccines. Given the proliferation of citizen science efforts to fight COVID-19 and the general confusion (even among sophisticated scientists) that surrounds the regulation of DIY research, regulatory leadership is badly needed.