Human Volunteer Studies: General and Special Populations
Chair: Professor M Rugg
Following a joint session with the Dosimetry Workshop to discuss
progress on the Standard Human Exposure System, the Workshop moved
on to consider progress with the human volunteer studies funded
under the Programme. Andrew Parkes described progress with the
project Conversations in cars: the relative hazards of mobile
phones. This study is currently at the most advanced stage
of any in the Programme. Although Dr Parkes was only able to discuss
preliminary results at the meeting, he expected that the full analysis
would be completed by the end of November and would be seeking
to prepare a full report for publication as soon as possible thereafter.
Progress with the three remaining human volunteer studies funded
in response to the First Call for Proposals has been slowed by
the need to develop a Standard Human Exposure System. The three
project leaders each described the background and rationale for
their proposed work. It was clear from the presentations that although
it had not been possible to commence experimental exposures, the
research teams had been carrying out preliminary work such as ensuring
that instrumentation would not be affected by radiofrequency fields,
or putting in place procedures to recruit subjects. Consequently
it is expected that experimental work will get underway promptly
once the exposure systems are ready for use. During the ensuing
discussion, it became clear that one of the major strengths of
the proposed studies would be a comparison between the effects
of modulated signals (simulating GSM mobile phones or TETRA emergency
services radio, as appropriate) and the unmodulated carrier signal.
There was discussion of the problems associated with variation
in SAR distribution in the head, which will depend on the model
of phone used, the exact position of the phone in relation to the
head and the frequency of the emissions. As it was clearly not
practical to test all possible combinations of these variables,
it was agreed that it would be important to ensure that exposures
were consistent across all subjects and studies; this was the reason
for developing the Standard Human Exposure System. It was also
agreed that a standard approach should be developed for assessing
the laterality of phone use in subjects.
The final session of the workshop moved on to a consideration
of how to investigate the issue of sensitivity to mobile phones
and base stations reported by some people. It was important to
assess this sensitivity under tightly controlled conditions. A
secondary goal may be to try and determine whether there are any
specific characteristics that may be used to define such populations.
The Programme already included one study designed to investigate
the sensitivity of people characterised by vestibular disturbance
and the Programme Management Committee had now decided to fund
a second study to investigate the issue of sensitivity to mobile
phone signals subject to completion satisfactory contract. Moreover,
the draft research specification for the Third Call (announced
by Sir William Stewart on the 11th of November) requested a two
stage project to examine sensitivity to base stations. The first
stage of this project would seek to define the study population,
whilst the second would be a provocation study; if necessary technical
assistance in terms of exposure and dosimetry could be made available
to potential applicants who were otherwise well qualified to conduct
this type of study.
Continuing with the theme of sensitive populations, the issue
of subject recruitment was discussed. Referral from GPs could not
generally be relied upon as most people suffering symptoms do not
consult their GP, but instead take personal action. In selecting
recruits it would be important to distinguish between those with
general sensitivity, and those who were apparently asymptomatic
apart from their sensitivity to phones or base stations. It could
be relevant to include both populations in any study; those with
a general sensitivity would probably be the most likely to develop
a disability and thus be a very important group, whilst those with
a specific sensitivity would probably be easier to study. It would
be important to consult Special Interest Groups about the design
of the base station provocation study from an early stage and it
is possible that they could have a role to play in the recruitment
of subjects. The draft research specification for the base station
provocation study does not call for the inclusion of children in
the study group as advice from ethical experts had suggested that
this would probably he unacceptable.
Summaries of the closed sessions
of the MTHR Research Seminar - 11th of November 2002
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