NSW Ombudsman rejects complaint
Text of letter follows
Re: your complaint about the Department of Corrective Services
In response to your complaint I have assessed all the materials you have
provided and have interviewed Acting Assistant Commissioner McCornish and
Secretary of the Institutional ethics Committee, Mr. Simon Eyland. In addition
I have had access to the transcript of the meeting of the Committee on
12 March 1997.
At the outset I should explain that the Ombudsman is not in a position
to substitute her views for those of a public authority or a properly constituted
body. This office can only assess whether the conduct of the body (the
Institutional Ethics Committee in this case) might constitute misconduct
in terms of section 26 (1) of the Ombudsman Act.
The Institutional Ethics Committee includes a range of community and departmental
representatives with broad experience in prison related matters. The Committee
was essentially established to examine the large number of applications
to do research within the prison system. It has met only three times since
being constituted in April 1996. I understand that your application is
the first and only approach to conduct a trial of a medical treatment in
NSW prisons to be dealt with by the Committee.
The Committee has raised with you, in person and in writing, their concerns
that you are proposing a trial of the herbal formula. By definition, no
guarantee can be given of the impact of the formula on those using it and
its efficacy in conjunction with existing HIV/AIDS treatments. As the committee
made clear in the meeting of 12 March 1997 the Department of Corrective
Services has a duty of care to ensure that inmates are not exposed to an
increased risk as a result of their incarceration. In addition, the Department
and the Committee must counter any public perception that prisoners are
involve din a trial simply because they are a "captive" population. The
overriding consideration is that prisoners are not free to choose in the
same sense as those at liberty in the community. They are incarcerated
and the Department of Corrective Services has a responsibility for their
welfare notwithstanding any wish they may have at the time to participate
in an activity.
I also note that the Committee was not satisfied that you had adequately
explained why you needed to involve prisoners in particular in the trial.
The number of identified HIV positive inmates is insignificant, even in
terms of your trial, and would seem to add little weight to any conclusions
that might ultimately be drawn. Other than being incarcerated it is hard
to see what special attribute the prison population would bring to the
trial of which you are a proponent.
Clearly, neither the IEC nor this office, is in a position to make a technical
judgment about the safety or efficacy of the KM1 formula. That is what
the trial is for. My understanding is that the Committee has a broader
concern about the safety of a product which remains untested.
Whether or not specific, fully tested, medications are prescribed or allowed
for individual inmate patients is another matter. Inmates are free to request
particular treatments and it is a matter of clinical assessment by medical
staff whether complementary medication is provided.
I am aware that it has taken some 16 months for Corrective Services to
assess and finally reject your application. At least initially this delay
was due to the formation of the Ethics Committee which first met in April
1996, some 3 ½ months after you applied to conduct the trial. The
situation was not helped by the fact that the Committee only planned to
meet twice a year. I realize that this may mean substantial delays but
it seems to match arrangements for such groups in the medical sphere and
appears to fit with guidelines from the National Health and Medical Research
Council.
You have also raised the concern that no specialist advice on the therapeutic
aspects of the matter was available to the Committee. Based on my understanding
of the function of such committees i believe that it is an assessment not
of the technical or scientific merit of a product but whether it has met
certain ethical criteria.
Finally, I understand that certain practical difficulties exist which might
have a n impact on the operation of such a trial within the prison system.
At present HIV positive inmates are not grouped within NSW prisons but
scattered across the gaols. The monitoring and dosing of such prisoners
would be a matter to be negotiated with the medical staff of Corrections
Health Service. (You may wish to approach that authority about this matter).
It is almost certainly impractical to consider removing inmates from prison
to facilitate treatment. The current inmate population also means that
your preferred numbers (20 male and 20 female) are not available to participate
in your trial.
The Ombudsman fully understands and supports your efforts in trialing HIV
treatments of any sort. Nevertheless, the Department and the Institutional
Ethics Committee in particular, has a responsibility to consider the welfare
of all inmates. The Committee does not appear to me to have acted unreasonably
in assessing and rejecting your application.
No further action will be taken in connection with this matter. If you
have any questions concerning this decision please contact me on the above
number. Ms Clover Moore MP, made submissions of your behalf and on that
basis has been informed of my decision in this matter.
Yours sincerely,
Jim Milne
Senior Investigation Officer for the Ombudsman |
