Transparency is key to ethical vaccine research—Response

doi:10.1126/science.abf4883

GSTDTAP > 气候变化

DOI	10.1126/science.abf4883
	Transparency is key to ethical vaccine research—Response
	Christi J. Guerrini; Jacob S. Sherkow; Michelle N. Meyer; Patricia J. Zettler
	2020-12-18
发表期刊	Science
出版年	2020
英文摘要	We share Estep and Church's goal of finding appropriate pathways for harnessing the benefits of citizen science. However, we respectfully disagree with their view of what responsible citizen science entails. The responsibilities of citizen scientists should be elevated when they develop and disseminate unproven public health interventions or online instructions for unknown persons to self-manufacture and self-administer such interventions. Responsible citizen science should comply with applicable laws. Because some of those engaged in do-it-yourself (DIY) vaccine efforts might not appreciate the scope of regulators' authority over vaccine candidates, our Policy Forum clarifies the law and provides recommendations to both citizen scientists and regulators to help achieve compliance. We reiterate that these regulations are not mere red tape; they help ensure that rigorous evidence of vaccine safety and effectiveness is obtained—and obtained ethically. Failure to comply with and enforce these requirements, and the subsequent proliferation of unproven vaccines—whether developed through DIY efforts or traditional approaches—may undermine public trust in vaccine safety and effectiveness. Responsible citizen science should also prioritize the safety of both its members and bystanders ([ 1 ][1]–[ 4 ][2]). Some citizen scientists might be willing to risk personal harm from their activities. But they should refrain from encouraging broad uptake of unproven interventions among healthy individuals whose risk-taking behavior may be affected and, in turn, affect others. Thus, although we applaud the Rapid Deployment Vaccine Collaborative's (RaDVaC's) commitment to open science, openly sharing interventions without sufficient evidence of safety and effectiveness is beside the point. Estep and Church liken their efforts to firefighters promoting safety, but responsible firefighters do not promote unproven—and potentially inflammatory—fire safety protocols. Furthermore, responsible citizen science should engage in ethical reflection ([ 4 ][2]). Risks to bystanders generally warrant independent ethics review by an institutional review board (IRB) or a similar body. Estep and Church argue that both IRB review and “standard clinical trial testing” are “incompatible” with iterative studies and self-experimentation. But IRBs and adaptive trial designs have been used for just such activities, including during the pandemic ([ 5 ][3]–[ 7 ][4]). Finally, we acknowledge that there is a lack of consensus on terminology for biomedical citizen science and understand that terminology choices have consequences ([ 8 ][5]–[ 10 ][6]). Although we respect RaDVaC's characterization of its efforts as “free and open-source,” we believe those efforts are also fairly described as DIY. Indeed, openness is a defining feature of DIY biology and other strands of citizen science ([ 1 ][1]–[ 3 ][7], [ 11 ][8], [ 12 ][9]). We stand by our position that providing instructions for home production and self-administration of vaccine candidates—whether open source or not—constitutes a DIY effort. 1. [↵][10]1. C. J. Guerrini et al ., BioSocieties 10.1057/s41292-020-00208-2 (2020). 2. Global Community Bio Summit, “Community ethics document 1.0” (2019). 3. [↵][11][DIYbio.org][12], Codes (2011). 4. [↵][13]Global Community Bio Summit, “Bioethics track: biohacker IRB + responsible disclosure” (2020); [www.youtube.com/watch?v=s7NDS6o6yz4&feature=youtu.be][14]. 5. [↵][15]1. A. Plump, 2. D. Reese , “Using a global network of adaptive clinical trials to fight Covid-19,” STAT (2020). 6. 1. R. Chen et al ., Cell 148, 1293 (2012). [OpenUrl][16][CrossRef][17][PubMed][18] 7. [↵][19]1. L. A. David et al ., Genome Biol. 15, R89 (2014). [OpenUrl][20][CrossRef][17][PubMed][18] 8. [↵][21]1. M. Trejo et al ., AJOB Empir. Bioeth. 10.1080/23294515.2020.1825139 (2020). 9. 1. C. J. Guerrini et al ., Am. J. Bioeth. 19, 17 (2019). [OpenUrl][22] 10. [↵][23]1. M. V. Eitzel et al ., Cit. Sci. 2, 1 (2017). [OpenUrl][24] 11. [↵][25]1. G. A. Sanchez Barba , Thesis, Delft University of Technology, Netherlands (2014). 12. [↵][26]European Citizen Science Association, “Ten principles of citizen science” (2015); [https://ecsa.citizen-science.net/wp-content/uploads/2020/02/ecsa\_ten\_principles\_of\_citizen_science.pdf][27]. C.J.G. receives funding from National Human Genome Research Institute grant K01-HG009355. M.N.M. had conversations, for a brief period of time in early April 2020, with some members of what would become RaDVaC in which she provided comments consistent with this Letter. She also served from 2014 to 2019 on the Board of Directors of [PersonalGenomes.org][28], a 501(c)(3) founded by George Church, a member of RaDVaC. P.J.Z. has received honoraria from the Gray Center for the Study of the Administrative State at George Mason University Antonin Scalia Law School and The Ewha Institute for Biomedical Law & Ethics at Ewha Women's University for academic presentations and workshops about FDA and COVID-19 products. C.J.G. and P.J.Z. participated in conversations with citizen scientists interested in establishing oversight mechanisms for citizen science. [1]: #ref-1 [2]: #ref-4 [3]: #ref-5 [4]: #ref-7 [5]: #ref-8 [6]: #ref-10 [7]: #ref-3 [8]: #ref-11 [9]: #ref-12 [10]: #xref-ref-1-1 "View reference 1 in text" [11]: #xref-ref-3-1 "View reference 3 in text" [12]: http://DIYbio.org [13]: #xref-ref-4-1 "View reference 4 in text" [14]: http://www.youtube.com/watch?v=s7NDS6o6yz4&feature=youtu.be [15]: #xref-ref-5-1 "View reference 5 in text" [16]: {openurl}?query=rft.jtitle%253DCell%26rft.volume%253D15%26rft.spage%253DR89%26rft_id%253Dinfo%253Adoi%252F10.1186%252Fgb-2014-15-7-r89%26rft_id%253Dinfo%253Apmid%252F25146375%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [17]: /lookup/external-ref?access_num=10.1186/gb-2014-15-7-r89&link_type=DOI [18]: /lookup/external-ref?access_num=25146375&link_type=MED&atom=%2Fsci%2F370%2F6523%2F1423.1.atom [19]: #xref-ref-7-1 "View reference 7 in text" [20]: {openurl}?query=rft.jtitle%253DGenome%2BBiol.%26rft.volume%253D15%26rft.spage%253DR89%26rft_id%253Dinfo%253Adoi%252F10.1186%252Fgb-2014-15-7-r89%26rft_id%253Dinfo%253Apmid%252F25146375%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [21]: #xref-ref-8-1 "View reference 8 in text" [22]: {openurl}?query=rft.jtitle%253DAm.%2BJ.%2BBioeth.%26rft.volume%253D2%26rft.spage%253D1%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [23]: #xref-ref-10-1 "View reference 10 in text" [24]: {openurl}?query=rft.jtitle%253DCit.%2BSci.%26rft.volume%253D2%26rft.spage%253D1%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [25]: #xref-ref-11-1 "View reference 11 in text" [26]: #xref-ref-12-1 "View reference 12 in text" [27]: https://ecsa.citizen-science.net/wp-content/uploads/2020/02/ecsa_ten_principles_of_citizen_science.pdf [28]: http://PersonalGenomes.org
领域	气候变化 ; 资源环境
URL	查看原文
引用统计
文献类型	期刊论文
条目标识符	http://119.78.100.173/C666/handle/2XK7JSWQ/308341
专题	气候变化资源环境科学
推荐引用方式 GB/T 7714	Christi J. Guerrini,Jacob S. Sherkow,Michelle N. Meyer,等. Transparency is key to ethical vaccine research—Response[J]. Science,2020.
APA	Christi J. Guerrini,Jacob S. Sherkow,Michelle N. Meyer,&Patricia J. Zettler.(2020).Transparency is key to ethical vaccine research—Response.Science.
MLA	Christi J. Guerrini,et al."Transparency is key to ethical vaccine research—Response".Science (2020).