Critics of autoexperimentation object to the practice on both methodological and ethical grounds.
METHODOLOGICAL ISSUES. The worth of an experiment depends upon its scientific merit, upon its permissibility from ethical and legal perspectives, and upon its advisability on other grounds. Before any experiment is carried out, each of these elements must be assessed. Autoexperimentation suffers from three major methodological problems. First, there is an inherent difficulty in observing oneself dispassionately. This difficulty often leads to the confusion of objective and subjective data. Second, it is virtually impossible to establish adequate controls, particularly because autoexperiments tend to involve serial observations of one individual. Third, it is very difficult to extract statistically valid information because of the typically very small numbers of subjects and experiments. As a general rule, the likelihood that useful data will result from experiments on very small groups is determined by the likelihood that the data would not be materially affected by iterations (repetitions of the experiment) on larger groups.
Because of these weaknesses, autoexperimentation rarely proves to be a wholly satisfactory experimental method. There may be two important exceptions, however: pilot studies to establish the feasibility of a procedure or the safety of a pharmacological agent in normal subjects; and studies in which the scientist consents to be treated as an ordinary research subject and to remain under the supervision of other investigators for the duration of the experiment. It is worth noting that the second exception complies with the provisions of the Declaration of Helsinki stipulating that "the responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research" (World Medical Association, p. 3).
ETHICAL ISSUES. Autoexperimentation is clearly often heroic, but the basis for the alleged obligation to engage in this practice is less clear, for it is not clear that there are good moral reasons to encourage—let alone require—autoexperimentation. As discussed above, autoexperimentation is not always good science, for it may lack adequate controls and sufficient subjects to generate meaningful results. Therefore, autoexperimentation makes sense more as a potential condition to involving noninvestigator subjects in further testing than as a substitute for using such subjects. However, autoexperimentation may not be sufficient to establish that lay persons may appropriately participate in an experiment, for the investigator may be more risk-accepting than other subjects, or may not be medically representative of all potential subjects, or may not meet the physiological qualifications for subjects in that experiment. It is also unclear that autoexperimentation is necessary to establish that noninvestigators should participate in an experiment, for the processes of institutional ethics review and informed consent are probably better ways to determine whether that is appropriate. Of course, these points may not apply when the risks are exceptionally high and the need for the research exceptionally urgent.
To the extent there is an obligation for researchers to engage in autoexperimentation, that obligation does not always outweigh the problems with autoexperimentation. The fundamental issue is whether any of the precautions required to protect the subject in other forms of human experimentation may be legitimately suspended in the case of voluntary autoexperimentation.
The three basic arguments that have been brought to bear on this question are not easily reconciled: (1) Individuals are entitled to assume voluntarily risks they may never impose on others; (2) under proper circumstances, both self-sacrifice (martyrdom) or assumption of high risk for good reason (heroism) are universally lauded; and (3) societies have a vested interest in protecting the welfare of their members, and some degree of regulation in recognition of this interest is required or, at the very least, ought to be permissible.
Libertarians argue that the principle of autonomy grants scientists the right to engage voluntarily in risky behavior. On this basis, they refute the applicability of regulations for the protection of human subjects in autoexperimentation. Champions of a more paternalistic approach, in contrast, oppose unlimited risk taking in any experimental context because of the following concerns:
1. Many risks have been undertaken for unimportant goals;
2. Habitual risk takers might turn to autoexperimenta-tion even when other, more desirable forms of investigation exist;
3. Investigator—subjects may be at greater risk than other potential subjects because curiosity, enthusiasm, and other intangible factors may induce them to ignore risks that would otherwise deter a prudent individual from participation (Bok);
4. Certain levels of risk are, or ought to be, beyond consent (Bok);
5. Investigators reckless with respect to their own safety are wont to become reckless in other aspects of their investigations;
6. The autonomy of investigator—subjects might be tainted by various levels of institutional or peer coercion, or even by self-imposed psychological pressures (Dagi and Dagi); and
7. Large-scale, unregulated autoexperimentation might subvert accepted guidelines for the protection of human subjects under other experimental conditions.
The apparent contradiction between concerns (3) and (4), on the one hand, and the respect and admiration traditionally accorded to martyrs and heroes in Western society on the other, is not easily reconciled.
Finally, because most scientific research is now done in teams, the simple model from earlier days of a lone researcher experimenting upon himself does not fit all current autoexperimentation. "Group autoexperimentation" can involve vulnerable subjects when junior investigators, students, or laboratory technicians participate as subjects. Some recent research ethics policies addressing autoexperimenta-tion reflect concern for such investigator—subjects.
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