Intended for healthcare professionals

Rapid response to:

Editorials Christmas 2010: Editorial

Self experimentation and the Nuremberg Code

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c7103 (Published 15 December 2010) Cite this as: BMJ 2010;341:c7103

Rapid Response:

There is unethical research; this is not it.

I think the relevant standard is not Nuremberg, but the Declaration
of Helsinki.

http://www.wma.net/en/30publications/10policies/b3/index.html

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.
http://www.sciencebasedmedicine.org/?p=6826 )

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
intervention.

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.

http://www.hopkinsmedicine.org/articles/change/checklist.html

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
Helsinki. The
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.

20 December 2010
David R. Whitlock
researcher
Nitroceutic LLC