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.

Daniel Alcides Carrión: una visión funcional / Daniel Alcides Carrión: a functional view

Se hace la consideración de Daniel Alcides Carrión, héroe de la Medicina peruana y de la Nación, desde el punto de vista fenomenológico, tanto filosófico como psicológico, considerando más la visión social que un fenómeno individual, bajo las influencias de las corrientes de pensamiento vigentes a fines del siglo XIX. Tanto el romanticismo como el positivismo fueron de origen europeo, pero influenciaron definitivamente en el Perú en la época de Carrión y, seguramente, tuvieron que ver en gran medida con su decisión a la autoexperimentación. Se hace especial mención a su rol pionero como investigador clínico y se remarca la necesidad de completar aquellos acontecimientos que formaron parte del funcionamiento del héroe en el tiempo histórico correspondiente...

A close vision is directed towards Daniel Alcides Carrión, hero of the Peruvian Medicine and the nation, from the point of view of phenomenology, both philosophical and psychological, considering more like a social vision that an individual phenomenon, under the influence of currents of thought prevailing at the late nineteenth century. Both romanticism and positivism were of European origin but definitely influenced in Peru at the time of Carrion and certainly had largely to do with his decision to self-experimentation. Special mention to its pioneering role is made as a clinical researcher and the need to complete those events that were part of the operation of the hero in the corresponding historical period...

"They Sweat for Science": The Harvard Fatigue Laboratory and Self-Experimentation in American Exercise Physiology.

In many scientific fields, the practice of self-experimentation waned over the course of the twentieth century. For exercise physiologists working today, however, the practice of self-experimentation is alive and well. This paper considers the role of the Harvard Fatigue Laboratory and its scientific director, D. Bruce Dill, in legitimizing the practice of self-experimentation in exercise physiology. Descriptions of self-experimentation are drawn from papers published by members of the Harvard Fatigue Lab. Attention is paid to the ethical and practical justifications for self-experimentation in both the lab and the field. Born out of the practical, immediate demands of fatigue protocols, self-experimentation performed the long-term, epistemological function of uniting physiological data across time and space, enabling researchers to contribute to a general human biology program.

Personal knowledge and study participation.

Scientists in earlier times considered personal research participation an essential component of their work.Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies.Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research.But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as a study subject, investigators and other research professionals can obtain valuable information about their work.

Pesquisa médica em seres humanos, não maleficência e autoexperimentação homeopática / Medical research in humans, non-maleficence and homeopathic self-experimentation

Este artigo, de natureza conceitual, objetiva estabelecer conexão entre a pesquisa médica em seres humanos, a não maleficência e a autoexperimentação homeopática. A pesquisa médica em seres humanos, geralmente realizada no outro, tem sido permeada de expressivos abusos em relação aos sujeitos participantes. É neste contexto que emerge a não maleficência, princípio ético básico limitante destas violaçães. A não maleficência é o pressuposto que deve nortear as decisães no campo da pesquisa médica, representando sua inocuidade ou moderação. No que tange ao sujeito que experimenta, a investigação no ser humano pode ser conduzida, também, como autoexperimentação, ou seja, como experimentação realizada em si mesmo. A autoexperimentação, de grande valor em diferentes áreas da medicina, é denominada, na homeopatia, de autoexperimentação homeopática. A autoexperimentação homeopática é dotada de importantes características não maleficentes, o que a torna prática ética segura, viável, reproduzível e consistente da pesquisa médica terapêutica em seres humanos.

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.

A living will clause for supporters of animal experimentation.

Many people assume that invasive research on animals is justified because of its supposed benefits and because of the supposed mental inferiority of animals. However probably most people would be unwilling to sign a living will which consigns themselves to live biomedical experimentation if they ever, through misfortune, end up with a mental capacity equivalent to a laboratory animal. The benefits would be greater by far for medical science if living will signatories were to be used, and also the mental superiority boast would no longer apply. Ultimately, it is argued that invasive biomedical experiments would be unacceptable in a democratic society whose members are philosophically self-consistent.

Self-experimentation, ethics and efficacy.

Much fundamental progress in medicine and, more broadly, in medical sciences has required or benefited from self-experiments. This review provides a definition of self-experiments in which experimenters themselves are subjects for their research, and it considers the logical steps which such experiments require. Lay, medical and scientific communities are often unaware of the contributions and the full range of outcomes from self-experiments. Hence, some implications for ethics committees are explored.

[The first to go--physicians who experimented on themselves]. / De gikk først--leger som eksperimenterte på seg selv.

Since ancient times, there have been rules for experiments on humans. Some have claimed that if one thinks an experiment might involve danger, it should first be tried out on oneself. There are, in fact, numerous examples of doctors who have undergone daring experiments on themselves. Among them are Max von Pettenkofer, who drank cholera bacteria, Werner Forssmann who catheterized his own heart, John Paul Stapp, who sat in a rocket sled at almost the speed of sound, and then made an abrupt stop. Doctors from Walter Reed's research team infected themselves with yellow fever, Erik Jacobsen demonstrated the effect of antabuse and alcohol on himself, Barry J. Marshall drank helicobacter pylori bacteria, Klaus Hansen drank heavy water, and Ole Jakob Malm transplanted foreign tissue onto his own skin in order to discern among different tissue types. This article describes these various experiments, why they were done, and their consequences. The perspective of ethics in such experimental research is briefly discussed.

[Self experimentation and in vitro research will not suffice: a plea for treatment]. / Wiel wir keine Ratten sind...Tierversuche in der Alkoholforschung: Ergebnisse sind für die Therapie alkoholkranker Menschen nicht zu nutzen.

Alcoholism in humans is a field in which lots of animal experiments, meaning the deaths of thousands of rats and mice, have been carried out and are still being carried out. The question is whether the results of these experiments can be of any help as far as this very complex human disorder is concerned. To find an answer to this question, 86 scientific papers of the years 1990 to 2000 have been analysed and their findings evaluated using up-to-date literature on the therapy of alcoholism. What was found was that animal testing has not led to an improved therapy.

Self-experimentation.

Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior investigators participate as research subjects.