Self experimentation and the Nuremberg CodeBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c7103 (Published 15 December 2010) Cite this as: BMJ 2010;341:c7103
All rapid responses
Professor Annas stakes out a position in favor of beneficence over
autonomy, in asserting that a group of investigators experimenting only
upon themselves should be subject to ethics committee authority. The
justification for requiring oversight is potential harm: the investigators
could injure or even kill themselves in the attempt to gain knowledge.
My friends and I are whitewater kayakers. We engage in this activity
for no more noble cause than the challenge and enjoyment it brings. We can
most certainly be injured or killed in the process; two of us died in
paddling accidents in 2010. We are autonomous adults and have the right to
decide for ourselves to run rapids in little plastic boats for enjoyment.
By Prof. Annas' reasoning, if we were to do so for the purpose of
collecting analyzable data and creating generalizable knowledge, we would
no longer have that autonomous right, but would be subject to the approval
of an ethics committee.
We may freely choose to risk our lives for fun, but we may not for
science? I must differ. One either respects autonomy, or does not. The
yellow fever experiment exemption goes too far, in allowing unsupervised
inclusion of non-investigators as long as the investigators are included,
but Prof. Annas goes too far in the other direction. The ethics committee
does not acquire the right to exercise paternalistic judgment over our
choices merely because we intend to learn something and share it.
Competing interests: No competing interests
Contrary to the impression given in your editorial, self
experimentation has remained popular during the past 100 years and has
been important in many medical advances. These advances include the
foundation of respiratory physiology by J.B.S.Haldane and colleagues in
the 1920s and of cardiac catheterisation by Werner Forssmann in the 1930s.
Throughout most of the latter half of the 20th century Alexander and Ann
Shulkin synthesised and self experimented with a wide variety of drugs
exploring their psychoactive effects in great detail. In the 1980s
Barry Marshall did a series of self experiments involving gastroscopy and
ingestion of Helicobacter pylori, which established the link between
H.pylori and gastric pathology, recognised by the award of the 2005 Nobel
Prize in medicine. Mike Stroud's careful investigations during his epic
unsupported crossing of Antarctica with Ranulph Fiennes in 1992 advanced
understanding of nutrition in extreme conditions. A glance at the
internet with the help of Google will reveal descriptions of these and
other remarkable advances associated with self experimentation.
On a more everyday scale, any medical intervention can be regarded as
an experiment. Self experimentation can highlight problems in pilot, or
pre-pilot studies, and in this way prove highly valuable, though rarely
Self experimentation has the advantage of convenience. The process
of getting approval from an ethical committee can be slow and daunting
1,2. The results of self experiments are likely to be more relevant to
other humans than the results of similar studies on other animals.
Ethics committees can be valuable in ensuring that participants in
research competent to give consent do so without coercion in full
knowledge of the risks and that sentient beings not competent to give
informed consent are protected from ill treatment.
(1) Rees,M., Wells,F. Falling research in the NHS. BMJ 2010;340:c2375.
(2) Sandhu,J.,Khan,N. Our first experience of an ethics committee.
British Journal of General Practice, January 2011:70
Competing interests: Have self experimented with a variety of wart treatments to the benefit, I hope, of former patients.
Professor Annas's editorial demonstrates the difficulties in defining
I disagree that Groves' study was not research. (1) The argument that
he "was not seeking generalisable knowledge by testing a hypothesis" seems
Groves' introduction states the hypothesis: "Those in the know
suggested a new bike could knock 10% off" [the commuting time] sic, while
the objective states the generalisable knowledge he was seeking: "To
determine whether the author's 20.9 lb (9.5 kg) carbon frame bicycle
reduced commuting time compared with his 29.75 lb (13.5 kg) steel frame
So on the face of it Groves has fallen faul of the ethics committee
guidelines. I trust he is not an NHS organisation so the guidelines,
strictly speaking, would not apply to him. This reasoning would not
exonerate the BMJ though.
However, the main reason why the ethics committee guidance would not
apply is that Groves was using data that had been generated in any case,
and as such it was probably definable as a service evaluation under the UK
ethical committee guidelines.
It goes to show the ethical committee guidelines are missing one
vital component, a 'you're having a laugh, right?' clause. This should
exempt any researcher from the onerous process of obtaining ethical
approval when common sense should prevail.
(1) Groves J. Bicycle weight and commuting time: randomised trial.
BMJ 2010; 341:c6801
Competing interests: HB abandoned a research project as the ethical committee indicated we should obtain consent from approx. 30 PCTs to be allowed to post a questionnaire to approx. 50 GPs asking if they understood the way their global sum was calculated. Even if we had obtained the consent, the insurance purchased for the project was deemed insufficient without any indication why it was deemed to be so.
Is Professor and chair Annas serious, or is he poking fun at the
ethics committees? He actually suggests that ethics committees are better
placed to judge the safety of experiments on their own body than able
minded researchers. I would doubt that. It does reduce ethics approval to
what it often is: a compulsory administrative nuisance.
Particularly in cancer research I observe trials where the primary rule of
patient research, that participants have probably a better deal than non-
participants, is violated. An example are the very large prostate cancer
screening trials, where harms in the participants are certain but benefits
are uncertain and certainly limited.
I wrote a paper some years ago if the ethics committee would open up the
arguments supporting the (exceptional) inclusion of men 70-75 year old in
the Rotterdam prostate cancer screening trial. Due to the chronic nature
of prostate cancer, these men can only expect prostate cancer mortality
reductions after the age of 85. I am still waiting for their answer.
The emperors of ethics often have little clinical and epidemiogical
clothes, to judge about the delicate balance of harms and benefits.
Competing interests: No competing interests
I think the relevant standard is not Nuremberg, but the Declaration
The Declaration of Helsinki reminds publishers and editors that they
have ethical responsibilities too; they are not to publish research that
was unethical (paragraph 30).
There is some research that is unethical, for example most CAM trials
(homeopathy, acupuncture, chiropractic) are unethical because in many
cases they have negligible prior plausibility (in my opinion). (see
Evidence-Based Medicine, Human Studies Ethics, and the 'Gonzalez Regimen':
a Disappointing Editorial in the Journal of Clinical Oncology Part 1.
In my opinion these 3 studies do not rise to the level of being
unethical medical experimentation because there was no medical
intervention. Consumption of alcohol (by any route) by non-alcohol-
dependent individuals to the point of intoxication is not a medical
Martin McKee makes an excellent point. There was a episode a few
years back where Hopkins researcher Peter Pronovost did research on
whether or not checklists by hospital personnel improved infection control
and saved lives. It turns out it did, many hundreds of lives. But then
the Office of Human Research Protections decided that investigating the
effectiveness of checklists was "research", and so every patient that
might be affected by the infection control checklists needed to give
informed consent. Getting informed consent from every patient in the
hospital, or their health care proxy was not doable. How could individual
patients give informed consent to a checklist being used for procedures
they might have unless it was explained how those procedures would be done
both with and without the checklist? The requirement by the OHRP made the
research impossible to do.
If the research was unethical because informed consent was not
obtained, then even the preliminary results should not have been
published. If it was never published, there would be no way to know if it
saved any lives.
There is something wrong with how ethics are applied if research that
tortures and kills people the way the Gonzalez Regimen does is fine, but
research that saves lives like the Pronovost checklist is unacceptable. I
don't think the Pronovost checklist research violated the Declaration of
Gonzalez Regimen certainly did (in my opinion).
Competing interests: I am trying to commercialize a treatment that is very safe and which will save many lives. Because it has a "yuck factor" (living bacteria, less pathogenic than probiotic Lactobacilli) the barriers to entry are so high that it is taking a very long time.
I fail to see how the papers cited in this editorial clarify the
issue of ethical approval of self-experimentation at all. What ethical
principles are involved? We are not told. Surely autonomy of the
investigators should be considered (but isn't). Why do we feel an ethics
committee is better qualified than these investigators to decide what is
harmful? At least the investigators have a personal interest in the safety
of the procedures being investigated while an ethics committee would not.
Given the now accumulating evidence of how ethics committees delay the
conduct of life enhancing research, maybe we need more research into the
ethics of ethical review?
Competing interests: No competing interests