17th August 2004
Research Ethics
Secretariat
South Eastern Sydney Area Health Service –
Eastern Section
Prince of Wales
Hospital
Randwick
NSW
2031
Australia
Via email: brehenyk@sesahs.nsw.gov.au
Dear sir or madam:
Please accept this letter as a formal
complaint against the
Retractable Syringe trial (the Wooldridge Trial) that you have recently
granted
ethics clearance.
There are many reasons why the outrageous Wooldridge Trial should never
have
been allowed to proceed. It is a human rights covenant, however, the Nuremberg Code,
which alone is sufficient to force the Trial's immediate abandonment.
The Code
was drawn up in 1946 during the Nuremberg Trials, in which 23 Nazi
physicians
went on trial for crimes committed against prisoners of war. It
consists of 10
conditions that must be met to justify research involving human
subjects. (1)
Half-a-century later, the Wooldridge Trial was granted its ethics
clearance by
the Australian government. Though a political initiative, the Trial is
being
conducted by a private Sydney
firm,
the Research Forum, which is faced with the impossible task of
conducting the
trial in an ethical manner.
The Forum's past customers include, AusIndustry, the Australian Customs
Service,
the Australian Taxation Office, Centrelink (Australia's welfare payment
agency), the Commonwealth Department of Finance, the Department of
Immigration
and of course, the Pharmaceutical Society of Australia.
After a presentation by the Forum's Dr Fadil Pedic, at this year's ANEX Harm Reduction conference, it
becomes
startlingly clear that the Trial violates almost all of the Code's
principles.
The Code states:"The protagonists of the practice of human
experimentation
(must) justify their views on the basis that such experiments yield
results for
the good of society that are unprocurable by other methods or means of
study .
. . however . . . certain basic principles must be observed in order to
satisfy
moral, ethical and legal concepts.” (1)
The failure of the Trial to comply with the Code's principles should be
grounds
for the cessation the Trial.
Principle 1: ". . . consent . . . is absolutely
essential (and
the subject) must have legal capacity to give consent”. There is
also
reference to fraud and deceit, and the stipulation that volunteers have
"sufficient
knowledge and comprehension of . . . the subject matter” so they
can make
an informed decision. They should be privy to all possible "inconveniences
and hazards” that might arise from the experiment.
The consent form issued to participants states:
"Potential physical risks include skin irritation or bruising
due to
using a different syringe type. Potential psychological risks include
distress,
fear, anxiety and frustration associated with trying the new syringe
type,
completing the survey or taking part in the focus group or being asked
to do
any of these.” (2)
The Forum has conveniently left out reference to other possible harms
associated with injecting drug use such as vein collapse, complications
associated with injecting into arteries, "dirty hits'', impact on the
immune system, endocarditis, abscesses, overdose, septicaemia, tetanus,
embolism, not to mention the risk of arrest and incarceration by
police. (3)
They also ignore risks associated with the presence of blood and fail
to warn
participants about other things that could potentially increase the
risk of BBV
transmission, such as helping each other use the devices, and the risk
of
blood-splatter when the syringe retracts. Yet in the Forum's
methodology
document, they merely state: "While vein care problems and
infection
are risks associated with injecting and injecting drug users, there is
no
evidence to suggest participation in the current study will increase
these
risks.” This is a cynical way for the Forum to say that " 'junkies'
are taking these risks anyway, and therefore we don't have to
worry about
that stuff". (4)
This clause in principle one is also a worry: "The duty and
responsibility for ascertaining the quality of the consent rests upon
each
individual who initiates, directs or engages in the experiment. It is a
personal duty and responsibility which may not be delegated to another
with
impunity.”
Responsibility for recruitment of Trial participants has been delegated
to
assistants who, while qualified to meet the requirements of most NSPs,
have
neither the knowledge nor expertise to conduct the Wooldridge Trials.
The Forum
has contravened the above clause by delegating responsibility with
impunity. (4)
Principle 2: “The experiment should . . . yield
fruitful
results for the good of society, unprocurable by other methods or means
of
study, and not random and unnecessary in nature.”
The Wooldridge trial is the most cynical exercise in making a cabal of
powerful
corporations richer. No good will come from it.
Principle 3: which states that "anticipated results
(should)
justify . . . the experiment”' - invalidates the Trial because of
the
fallacious arguments that brought it into being,
Principle 4:
“The experiment should be so
conducted as to avoid all unnecessary physical and mental suffering and
injury.”
This experiment
is conducted by the subjects of the Trial
themselves, people who inject drugs. On attending their local NSP,
service
users are asked to participate in the Trial. Volunteers are given a
package of
retractable syringes to take home (if they have one) to inject illicit
substances without any supervision whatsoever from the Trial
organisers. (4)
The researchers
would require a change in commonwealth and
state/territory legislation if they were to properly comply with the
Code's
fourth principle. It would be illegal for researchers to assist or
observe the
volunteers with the drug administration process, they could be charged
with
"administering a dangerous drug to another person". This important
legal point ensures that the fourth principle of the Nuremberg Code
cannot be
complied with in the current climate.
Principle 6:
"The degree of risk to be taken
should never exceed that determined by the humanitarian importance of
the
problem to be solved by the experiment.”
"Humanitarian
importance'' has nothing to do with the Wooldridge Trial. As clearly
indicated
by the evidence, the retractable syringe will have a limited impact on
the
HIV/hep C pandemics. There is however, a degree of risk that as nations
mandate
the use of these devices - at the behest of their corporate leaders
- rates of transmission of BBVs will increase.
Principle 7: "Proper preparations should be made and
adequate
facilities provided to protect the experimental subject against even
remote
possibilities of injury, disability, or death.”
As previously
stated, volunteers are provided with a
package of retractable syringes to take-away from the premises and use
at their
home or usual place of injection. Volunteers are not supervised at any
stage of
the injection process, due to the legal minefield facing the Forum and
the
Government. The only facilities provided for volunteers in the
Wooldridge Trial
are a website and a 1800 phone number, and a small monetary reward as
compensation - hardly adequate enough to "protect . . . against
even
remote possibility of injury". (4)
Principle 8:
"The experiment should be
conducted only by scientifically qualified persons. The highest degree
of skill
and care should be required through all stages of the experiment of
those who
conduct or engage in the experiment.”
The volunteers
in this Trial are forced to test this
experimental medical device on themselves, without adequate supervision
or
facilities. The volunteers in the trial receive no training whatsoever
prior to
their involvement, they are laypeople and should not be expected to
conduct
this experiment on themselves. (4)
The Nuremberg
Code determines "criminal culpability
and punishment" and should have been the reference point when
determining
whether or not the Wooldridge Trial received its ethics clearance.
Our organisation has developed an extensive
article
detailing our concerns about the introduction of retractable syringes.
You can
download this article at:
http://www.napnt.org/arse/syringegate.html
Please stop the
trial immediately.
If you require
further information please contact me on
0415 16 2525 or via email – gary (a)
napnt.org
.
Yours truly,
Gary Meyerhoff
Spokesperson
1.
National Institutes of Health. (2004) The Nuremberg Code reprinted from
Trials
of War Criminals before the Nuremberg Military Tribunals under Control
Council
Law No. 10, Vol. 2, pp. 181-182 [online]. Washington, D.C.: U.S. Government Printing Office, 1949. Available
from: <http://ohsr.od.nih.gov/guidelines/nuremberg.html>.
[Accessed on: 7th August 2004].
2.
The Research Forum. (2004).
Subject Information and Consent Form. Unpublished: Research Forum.
3.
Australian Injecting and
Illicit Drug Users League. (1992). Handy Hints. Canberra: AIVL
4. The Research
Forum. (2004) Workshop Agenda and Proposed Research Methodology.
Unpublished
report: Research Forum.
