Review of Scientific Self-Experimentation: Ethics History, Regulation, Scenarios, and Views Among Ethics Committees and Prominent Scientists

Abstract

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.

Neurobehavioural signatures in race car driving: a case study

“…The participant, LDG, is an author on this paper and gave informed consent to participate in the experiment and to publish the information and images in an online open-access publication. While all methods used in the study were approved by the Imperial College Research Ethics Committee and performed in accordance with the declaration of Helsinki, this study was a self-experimentation by an author 17 . The test drive was prescheduled for video production purposes by the racing team, who race in these conditions frequently.…”

Ethical Inclusion of Health Care Workers in Covid‐19 Research

“…Although our main focus is on enrollment of health care workers in Covid‐19 research conducted at their place of employment, one further question is whether any of the ethical considerations differ regarding the potential enrollment of employees who are also study personnel, including investigators and research coordinators 41 . There is a long history of self‐experimentation in medical research, 42 and the willingness of research personnel to expose themselves to the interventions under investigation can signal confidence—or overconfidence—that the risks and potential benefits are reasonable for others to undertake as well. However, there are also pitfalls in being too close to one's research, such as a lack of objectivity in data reporting, recording, and analysis; distorted perspectives regarding adverse events; or viewing promising signals as more substantial than is truly warranted.…”

Curiouser and curiouser: Meta-analysis of venom toxicity of 160 lethal ophidian species shows extraordinary variance, and falsifies common assumptions, providing a basis for estimating human lethal doses.

“…Nor is it common practice in testing to use test species that are not mice, pigeons, or rats, and this dataset is no exception. Thus, human lethal dose-response to ophidian venom is a thorny problem, as it is impossible to perform ethical lethal dose studies on humans [24]. This forces the use of animal studies, despite the problem that human dose-response may be different than other animals, including monkeys.…”