What research guidelines is a person legally mandated to follow if they want to do medical experimentation on themselves?

There is a large amount of variation in the types of medical experiments so I wanted to ask people focusing on the change in practice as a function of the type of medical experimentation you do in the biological sciences (e.g., drugs, blood samples, tissue regeneration, testing medical equipment), including invasive and non-invasive studies. This question seemed almost equally suited to academia and biology SE, but given the focus on different types of biological experiments I felt this might be the more suitable site.

I am most interested on research practices in the United States, and anything touching FDA regulations would be great.

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    $\begingroup$ ncbi.nlm.nih.gov/pmc/articles/PMC3298919 seems to be a very relevant paper. $\endgroup$ – March Ho May 19 '15 at 20:21
  • $\begingroup$ I can't cite any sources, but self experimentation is far less likely to be regulated than trials on other people. We had a seminar speaker who was giving high doses of some molecule his lab was working on to himself and looking for side effects. Unfortunately I can't remember his name or his molecule. He did say that the university committee on human subjects didn't care if it was just himself. $\endgroup$ – user137 May 19 '15 at 21:00
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    $\begingroup$ And you are not going to be a able to statistically prove any thing with just one individual. There will be inherent bias in the experimental design, and ultimately worthless imo. $\endgroup$ – Rover Eye May 19 '15 at 23:11
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    $\begingroup$ Barry Marshall had drunk a solution of H.pylori to "prove" that it causes ulcer ! $\endgroup$ – biogirl May 20 '15 at 0:41
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    $\begingroup$ @RoverEye A self study could still be very useful in the case of a type of study that would be providing a massive stream of data even if conducted on one individual. $\endgroup$ – Skyler May 20 '15 at 3:33

One of the cornerstones of research ethics worldwide is the Nuremberg code, which was formulated shortly after the Second World War and set off by the cruelties performed by the Nazi Doctors. The Declaration of Helsinki, which is currently widely used as the guiding principle of research ethics, was directly inspired by the Nuremberg code.

Interestingly, article 5 in the Nuremberg code reads, and I quote:

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

Basically what this tells you is that when you are a physician, you are not only ethically allowed to experiment on yourself, even when you can reasonably expect death may follow, you are even allowed to put others at that risk(!) Admittedly, it does not specifically talk about non-physicians. Nonetheless, with regard to your question, this Nuremberg article implies that self-experimentation is allowed, regardless the risks.

Annas (2010), rightfully argues that, even where risks are minimal, prior ethics committee review of research should always be sought, if only to confirm the reasonableness of the risk assessment and regardless whether investigators are subjects.

The problem then becomes whether self-experimentation (an experiment done by the investigator on himself or herself only) must be reviewed and approved by an ethics committee before it is conducted. Here Annas (2010) concludes that:

[...] When an investigator proposes to experiment only on him or herself, that activity is not properly categorized as research at all, but as self indulgence (or, some may say, self abuse). Trivial interventions masquerading as research studies are primarily a source of amusement.

Although I do not necessarily share the concluding accusations against self-experimentation, I do share her view that self-experimentation should not be regarded as proper scientific research, and therefore should not be subject to ethical review.

Annas, BMJ (2010); 341: c7103


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