Hanley Brian P, Bains William, Church George
1 Butterfly Sciences, Davis, California.
2 Rufus Scientific Ltd., Hertsfordshire, United Kingdom.
Rejuvenation Res. 2019 Feb;22(1):31-42. doi: 10.1089/rej.2018.2059. Epub 2018 Aug 8.
We examine self-experimentation ethics history and practice, related law, use scenarios in universities and industry, and attitudes. We show through analysis of the historical development of medical ethics and regulation, from Hippocrates through Good Clinical Practice that there are no ethical barriers to self-experimentation. When the self-experimenter is a true investigator, there is no other party to be protected from unethical behavior. We discuss the n-of-1 issue in self-experiments, and make suggestions for improving experiment design. We discuss real-world scenarios of self-experimentation: at universities, for independent single-subject investigators, investigator/employees at pharmaceutical firms, and nonscientist self-experimenters. Our survey of ethics committees regarding policy and review for self-experimenting investigators show that approximately one-third of ethics committee respondents had a policy regarding self-experimentation, and one-third did not require ethical committee review of proposed experiments. There was no relationship between having a policy and asking for review. We also surveyed member attitudes to, and experiences of, self-experimentation among members of the National Academy of Sciences, Royal Society, and European Academy of Sciences. To our knowledge, this survey is the first breakdown of self-experiments into impact-relevant type classifications, and represents an advance in the field. Half of our scientist respondents performed self-experiments, and roughly one-fifth had conducted serious self-experiments. Most responders thought self-experiments were valuable, however, biologics injections, radiation exposure, and surgical implants had negative ratings greater than positive. We conclude that self-experimenters should not have attempts made to terminate them, bar them from use of facilities, nor be barred from using themselves or their tissues except in exceptional circumstances. Organizational uncertainty over the ethical and regulatory status of self-experimentation, and resulting fear of consequences is unjustified and may be blocking a route to human experiments that practicing scientists widely consider appropriate, and which historical precedent has shown is valuable.
我们审视了自我实验的伦理历史与实践、相关法律、在大学和行业中的应用场景以及态度。通过分析从希波克拉底时代到《药物临床试验质量管理规范》的医学伦理与监管的历史发展，我们表明自我实验不存在伦理障碍。当自我实验者是真正的研究者时，不存在需要保护其免受不道德行为影响的其他方。我们讨论了自我实验中的单病例问题，并对改进实验设计提出了建议。我们探讨了自我实验在现实世界中的场景：在大学中，针对独立的单受试者研究者、制药公司的研究者/员工以及非科学家自我实验者。我们对伦理委员会关于自我实验研究者的政策和审查的调查表明，约三分之一的伦理委员会受访者有关于自我实验的政策，三分之一不要求对拟议实验进行伦理委员会审查。有政策和要求审查之间没有关联。我们还调查了美国国家科学院、英国皇家学会和欧洲科学院成员对自我实验的态度和经历。据我们所知，这项调查首次将自我实验细分为与影响相关的类型分类，代表了该领域的一项进展。我们一半的科学家受访者进行过自我实验，约五分之一进行过严肃的自我实验。大多数受访者认为自我实验是有价值的，然而，生物制剂注射、辐射暴露和外科植入的负面评价多于正面评价。我们得出结论，除非在特殊情况下，不应试图终止自我实验者，不应禁止他们使用设施，也不应禁止他们使用自己或自己的组织。组织对自我实验的伦理和监管地位的不确定性以及由此产生的对后果的恐惧是不合理的，可能正在阻碍一条实践科学家广泛认为合适且历史先例已表明有价值的人体实验途径。
