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

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.

Limits on risks for healthy volunteers in biomedical research.

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.