제 목 : Health effects related to the use of radiotelephones
국 가 : Russian
Possible health effects related to the use of radiotelephones
Proposals for a research programme by a European Commission Expert Group
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Executive summary
* Introduction
* Composition of the Expert Group
* Administration of the Expert Group
* Structure and content of the report
* Radiotelephones ?the technology and exposure of people
* Health concerns
* Thermal effects and exposure guidelines
* Non-thermal effects
* Electromagnetic interference
* Dosimetry and exposure systems
* Biology
* Human (laboratory) studies
* Biophysical and biological studies
* Epidemiological studies
* Research Monitoring Panel
* Information channels
* Publication of results
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Introduction
The recent expansion of telecommunications, and in particular personal
telecommunications, has led to a rapid increase in the number of
radiotelephone (mobile, cellular phone) base station antennas erected.
These are often sited in public areas, sometimes close to homes, business
premises and schools. Radiotelephone handsets are small, low power radio
transmitters that are held in close proximity to the head when in use, and
some of the power radiated by the antenna is absorbed by the head. It is
not surprising, therefore, that public and media concern about the possible
health effects of electromagnetic fields has focused on proximity to base
stations and on the use of handsets. For the purpose of this report, the
term 'radiotelephone' is used to denote mobile/cellular phones only.
Whereas a large database exists for possible effects on human health from
exposure to extremely low frequency (particularly power frequency)
electromagnetic fields, there are far fewer data for radiofrequency
(including microwave) fields, and very few related to the emissions and
exposures specific to personal radiotelephones. A comprehensive assessment
of the risk of effects on human health requires such data.
The Expert Group responsible for this report was set up by the European
Commission, to make recommendations for a programme of scientific research,
the results of which could contribute to a health hazard assessment of the
use of personal telecommunications.
Definitive answers about health hazards related to the use of
radiotelephones are unlikely to come about in the short term. Health hazard
assessment is carried out by considering critically all relevant published
studies where the strength of the evidence for the existence of an effect
and its magnitude is evaluated on the scientific merits of the studies,
both individually and collectively. Replication studies are particularly
important in this regard. No study or series of studies producing negative
results can prove that an effect does not exist. However, an accumulation
of well-performed studies producing negative results provides increasing
confidence in the absence of a significant adverse health effect.
The research recommendations of the Expert Group are thus directed towards
collaborative research which is directly relevant to possible adverse
effects on human health, and lends itself to attempted replication by other
researchers in relation to the biological model ?the biological endpoint
examined ?and the exposure system and dosimetric techniques used. The
recommended studies should, when taken together with other research already
being undertaken, provide important data which will contribute towards the
health hazard assessment.
The Expert Group recognises that risk communication is clearly as important
in this area of uncertain risk and unestablished effects as it is with
other aspects of electromagnetic field exposures, eg, power lines. However,
it notes that this should be tackled in a broader context and, also, that
it will form an important part of the World Health Organization (WHO)
5-year electromagnetic field research programme. Therefore, while noting
its importance, no specific recommendations are made in this report.
The Expert Group was also asked to provide recommendations on the
management structure of a scientific programme; a mechanism for the
participation of industry in financing it and in providing facilities and
information; and an estimate of the magnitude of the financial resources
required for its conduct. These recommendations should be considered and,
where appropriate, may be modified in relation to existing
administrative/financial arrangements within the European Commission.
Composition of the Expert Group
The European Commission appointed ten members to the Expert Group. The
professional disciplines covered medicine, epidemiology, biology, physics
and telecommunication engineering.
Administration of the Expert Group
The scientific work programme of the Expert Group and most of the
administration related to it was co-ordinated by the UK National
Radiological Protection Board (NRPB).
Structure and content of the report
The report:
* provides information on the technology of radiotelephones specifically
relevant to possible effects on human health
* provides information about the exposure of people associated with the
use of radiotelephones
* identifies those areas of research most relevant to the assessment of
risk of adverse effects on human health
* summarises relevant published and on-going research studies
* recommends areas of physical, biological and epidemiological research
to be included in a research programme relevant to the assessment of
risk of adverse effects on human health
* sets out a proposed structure for the management of a European
research programme
Radiotelephones ?the technology and exposure of people
Personal (cellular) telecommunications is a rapidly evolving technology
that uses microwave radiation to communicate between a fixed base station
and a mobile user. Presently, most systems employ analogue technology,
where the low frequency speech signals are directly modulated on to a high
frequency carrier in a manner similar to a frequency-modulated (FM) radio.
The power level is effectively constant during the modulation, although
some power control may occur. However, the recently introduced second
generation systems in Europe, USA and Japan employ digital technology,
where the low frequency speech is digitally coded prior to modulation.
There is a strong trend towards hand-held radiotelephones, which means that
the radiating antenna is close to the head of the user. In the relatively
near future the use of digital systems will predominate.
The dominant digital access technique in Europe is Time Division Multiple
Access (TDMA), which is used in Global Systems for Mobile communications
(GSM), Digital European Cordless Telecommunications (DECT), Digital
personal Communication System (DCS 1800), and Trans European Trunked Radio
(TETRA).
The electric and magnetic fields surrounding a radiotelephone handset near
a person's head are complicated functions of the design and operating
characteristics of the handset and its antenna, and the electric and
magnetic fields vary considerably from point to point.
Radiotelephone base stations use relatively low effective radiated powers
and produce very weak power density levels at the ground. Nonetheless,
public concern about the installation of new base stations has become an
important issue. The fact that the radiofrequency fields produced by the
base stations at points of public access are less than any national or
international radiofrequency exposure standard has apparently not reduced
the concern of many members of the public.
Health concerns
Public concern about the health hazards of electromagnetic fields from
radiotelephones has increased. Specifically, there is concern that, as the
handsets deployed in the new generation of personal telecommunications
systems are brought close to the head, there may be either a thermal insult
produced by power deposition in tissue (acute effects) or other (long-term)
effects.
A large body of literature exists on the biological effects of
radiofrequency and microwave radiation. However, only a few studies have
considered exposure specifically from radiotelephones or other radio
systems.
Overall, the existing scientific literature encompassing toxicology,
epidemiology and other data relevant to health risk assessment, while
providing useful information, provides no convincing evidence that the use
of radiotelephones, whether analogue or digital, poses a long-term public
health hazard. However, in view of the concern about possible biological
effects of the microwave radiation used, it is important to assess the
existing body of knowledge on microwave radiation-induced biological
effects.
Microwave radiation absorption occurs at the molecular, cellular, tissue
and whole-body levels. The dominant factor for net energy absorption by an
entire organism is related to the dielectric properties of bulk water,
which ultimately causes transduction of electromagnetic energy into heat.
For laboratory experiments, exposure conditions can be classified in three
categories: thermal, athermal, and non-thermal. There are no strict
boundaries for these different exposure regimens because a number of
factors may influence the characteristics of exposure.
Thermal effects and exposure guidelines
Radiofrequency (including microwave) radiation may be regarded for
convenience as part of the thermal environment to which humans may be
exposed.
There is currently a general consensus in the scientific and standards
community that the most significant parameter, in terms of biologically
relevant effects of human exposure to radiofrequency electromagnetic
fields, is the specific energy absorption rate (SAR) in tissue, a quantity
properly averaged in time and space and expressed in watts per kilogramme
(W kg-1). SAR values are of key importance when validating possible health
hazards and in setting standards.
Exposure guidelines are intended to limit both whole-body temperature and
localised temperature, and are expressed as whole-body SAR and as localised
SAR averaged over a small mass of tissue.
Thermal effects are well-established and form the biological basis for
restricting exposure to radiofrequency fields. In contrast, non-thermal
effects are not well-established and, currently, do not form a
scientifically acceptable basis for restricting human exposure to microwave
radiation at those frequencies used by hand-held radiotelephones and base
stations.
Non-thermal effects
A large number of biological effects have been reported in cell cultures
and in animals, often in response to exposure to relatively low-level
fields, which are not well established but which may have health
implications and are, hence, the subject of on-going research.
A substantial body of data exists describing biological responses to
amplitude-modulated radiofrequency (including microwave) fields at SARs too
low to involve any response to heating. It has been suggested that
non-equilibrium processes are significant in the bioenergetics of living
systems, challenging the traditional approach of equilibrium
thermodynamics.
The concept of an all-or-nothing effect under specific exposure conditions
challenges conventional assumptions that the magnitude of a response
increases with increasing exposure. If this could be reliably
substantiated, it would add weight to the argument that there are
non-thermal mechanisms involved in biological effects of electromagnetic
fields.
Also, reports of 'electrohypersensitivity' to exposure to electromagnetic
fields exist to a varying extent and form in some countries.
It is not scientifically possible to guarantee that low levels of microwave
radiation which do not cause deleterious effects for relatively short
exposures will not cause long-term adverse health effects. However,
currently available research findings provide no evidence that such
long-term hazards exist. In the context of radiotelephone use, only
epidemiological studies could provide such evidence.
Electromagnetic interference
The Expert Group agreed that an in-depth treatment of electromagnetic
interference effects related to radiotelephones, and a specification of
exactly what should be done in relation to these, is not an aim of this
report, but rather is a component of the much broader issue of
electromagnetic interference which is the responsibility of the
electromagnetic interference research and standards community. It is,
however, recognised that action in this field is urgently required.
Dosimetry and exposure systems
The Expert Group concluded that the main purpose of the dosimetry and
exposure components of a research programme should be to control exposure
parameters in experimental systems with the aim of ensuring the quality and
comparability of biological experiments carried out at different
laboratories. In formulating their recommendations in this area, the Expert
Group recognised the different requirements for in vitro, in vivo and human
(volunteer) experiments, and dealt with them separately. The overriding
principle is that the biological experiments should use values of
parameters close to those existing in a real user situation, be it a
handset held close to the head or irradiation from a more distant base
station.
Recent results have been reported on experiments with people using actual
functioning radiotelephones. In such cases there is no need to design an
exposure system, but all parameters that are critical in dosimetric terms
should be controlled. The way in which the telephones are operated is of
major importance (test, or stand-by, or listening modes, normal or
worst-case position, side of the head and movements, duration,
intermittence, etc).
Recommendations for dosimetry and exposure systems research
In order to acquire experimental data reliably relevant to possible effects
on human health, it is essential to carefully carry out laboratory
investigations. Along with the choice of biological models, it is necessary
to design appropriate new exposure systems or to improve existing ones. For
this purpose, the Expert Group recommends that work on exposure systems
should constitute a significant part of the research programme, and that
physics laboratories work closely with biology laboratories in this
respect. This will greatly facilitate control and intercomparison of
biological data.
The Expert Group recommends that dosimetry and exposure systems studies
should be supported as collaborative projects with the biological research
and should be directed towards:
* the design and testing of exposure systems for in vitro and in vivo
experiments including the presence of the specimen or animals
* for in vitro systems, the characterisation and control of relevant
exposure parameters
* for in vivo systems, the characterisation of tissue values of SAR
* exposure conditions that correspond to those relevant to the use of a
radiotelephone ?for comparison, other exposures may also be
appropriate
* for human studies, the assurance of well-defined exposure conditions
* in all cases, environmental factors that are monitored and controlled.
Biology
It is not the purpose of this report to provide an in-depth review of the
biological effects of electromagnetic fields in relation to human health ?
several such reviews already exist ?but rather to identify and summarise
the relevant studies that have been carried out and published, to identify
and provide information about on-going studies, and to recommend further
areas of research relevant to an assessment of the risk to human health
that might arise from the use of radiotelephones.
In order not to exclude any worthwhile research proposal, the
recommendations for biological (and epidemiological) research made by the
Expert Group are not specifically prescriptive but rather indicative of the
areas of research that should be addressed and prioritised. These, together
with recommended criteria for selection of research proposals, should both
encourage the submission of proposals from suitably qualified research
groups and aid the prioritisation and selection of the proposals for
funding.
The Expert Group considered the existing peer-reviewed literature and
on-going research in each of the subdisciplines, genetic, cancer, immune
system, nervous system, and other effects, focusing mainly on non-thermal
effects and particularly on those of relevance to human health and the use
of radiotelephones. Only effects that occur within the normal physiological
temperature range of the body were addressed.
Because several hypotheses for the demodulation of amplitude-modulated
fields exist, the Expert Group noted that it is important to address basic
interaction mechanisms in this research programme, albeit with a lower
priority.
Biophysical interaction studies
The Expert Group recommends that the following be considered:
* mechanisms of signal detection and the role of electromagnetic 'noise'
in biological structures
* molecular dynamics of proteins under electromagnetic exposure
* microdosimetry.
In vitro research
The Expert Group noted that cellular models are becoming more and more
popular in toxicology studies, although in vitro experiments lack the most
fundamental interactions between body organs and systems. However, many new
models and techniques have made in vitro research very informative. They
provide insight into cellular and subcellular mechanisms underlying the
interactions of radiofrequency radiation and biological systems. Within the
scope of this research programme, these new models and techniques should be
used in two complementary directions: towards better designed animal models
(promotion, cellular or humoural components, stress, ageing, etc) and
towards mechanisms of possible effects (role of extremely low frequency
(ELF) modulation, of membrane function and signal transduction, of free
radicals, of gap junctions, etc).
Recommendations for in vitro biological research
The Expert Group views three categories of electromagnetic interactions as
deserving particular attention and recommends further research into the
following:
* effects on membrane function and signal transduction pathways
* effects on biochemical reactions including genomic responses
* effects on cell cycle and proliferation.
In vivo research
Some of the proposed research topics use sensitive methods which may be
able to detect even minor abnormalities; the Expert Group strongly advises
that the severity of such abnormalities should be compared with those
induced by other known pathologies so that any possible health risks may be
evaluated objectively. It is important to consider possible synergism
between microwave exposure and other factors.
Genetic and cancer-related effects
The Expert Group notes that, as there is no convincing evidence that
microwave radiation is directly genotoxic or carcinogenic (under
athermal or non-thermal conditions), investigations on genetic and
cancer-related effects should be directed particularly towards their
possible promotional and co-promotional synergistic properties.
Effects on the immune system
Most in vivo reported results in the literature are either not
relevant to personal telecommunications emissions or contradictory.
Thus, this important biological system has a poorly-defined database.
There seems to be no consistent finding of alteration to the immune
system of animals acutely exposed to microwave radiation at moderate
power levels (corresponding to SAR values below a few W kg-1). Hence,
some recommendations can be made for further research, while bearing
in mind that effects on the immune system cannot be studied
independently of other systems, such as the haematopoietic, nervous
and endocrine systems.
Since few long-term exposure studies at low levels have been
performed, there is a need for well-designed experiments, linked with
cancer promotion studies.
Nervous system-related effects
For the evaluation of the effects of microwave exposure,
investigations on integrated neuronal function and cochlear function,
sleep pattern analyses and neurobehavioural studies would be
appropriate. The effect on electrophysiological function should be
carried out not only by recording conventional EEG and evoked
potentials ?these studies were essentially negative in the past ?but
also by magnetoencephalography because this method allows much finer
spatial and temporal resolution than previous recording techniques.
Such studies can be complemented by testing memory acquisition and
storage before and after microwave exposure.
For neurohumoural and neurotransmitter interactions, the effect on
pineal melatonin secretion requires further investigation. If previous
ELF findings could be replicated by continuous or pulsed microwave
exposure, such effects would be of considerable importance not only
for tumour proliferation but also for alterations of sleep pattern.
Another important health issue is the possibility that incidental
pathologies are aggravated by microwave exposure. This issue is
already under investigation in regard to tumour proliferation but it
should also include other pathological states, such as epilepsy,
inflammation or ischaemia. Appropriate experimental models would be
reperfusion injury after global ischaemia (for possible interference
with free radical reactions), permanent or reversible focal ischaemia
(to study complicating inflammatory responses), and kainate-induced
kindling (for the investigation of hippocampal seizures).
The effect of microwave exposure on permeability changes of the
blood-brain barrier should be addressed and, in particular, whether
previously described permeability changes are a direct consequence of
microwave exposure or side-effects of the experimental procedure, such
as immobilisation stress or cryptic thermal effects.
Recommendations for in vivo biological research
The Expert Group recommends the following lines of in vivo biological
research:
Genetic studies
o studies of genotoxicity on microwave-irradiated animals,
including irradiation following or preceding administration of
established chemical mutagens/carcinogens
o studies of genetic effects and morphological changes in brain
cells from animals exposed to radiofrequency microwave radiation
(for example, DNA damage).
Cancer studies
o studies of long-term carcinogenicity in normal or
sensitised/transgenic animals
o studies of the influence of microwave radiation on growth of
existing tumours.
Immune system studies
o long-term studies
o studies of the possible role of ELF-modulation.
Nervous system-related studies
o electrophysiological and neurobehavioural studies
o investigations of signal transduction pathways by study of the
genomic response of the brain
o effects of microwave radiation exposure on permeability changes
of the blood?rain barrier
o aggravation of incidental brain pathologies other than cancer
(inflammation, ischaemia, seizures) .
Human (laboratory) studies
The design and construction of handsets leads to energy absorption in those
brain and neck tissues near the antenna. Structures such as the vestibulum,
cochlea and acoustic nerve, other cranial nerves including vagus, facialis,
trigeminus, etc, the meninges, the carotids and salivary glands may
possibly be exposed.
Most animal laboratory projects focus on carcinogenesis, tumour promotion
and mutagenic effects. However, potential health effects might also be seen
as non-cancer disorders of the above-mentioned structures, and
physiological investigations and clinical examinations are needed to
complement cancer-oriented research.
Recommendations for human (laboratory) research
The Expert Group recommends that laboratory studies on volunteers should be
undertaken as follows:
* acute exposure of healthy volunteers to fields from handsets, and
investigations of possible neurophysiological effects including
neurotransmitter levels
* provocation studies, involving the acute exposure of people claiming
neurological symptoms associated with radiotelephone use to the
emissions from handsets and/or base stations
* disturbance of sleep patterns in people exposed to fields associated
with personal telecommunications
* acute exposure of healthy volunteers to fields from handsets and
investigations of possible effects on the immune system (lymphocytes ?
sub populations, etc).
All experiments using volunteers should be 'double blind' where
appropriate.
Epidemiology
Epidemiological research can be used to investigate directly the question
of whether or not radiotelephone use is a determinant of risk to human
health.
Epidemiological studies, unlike most laboratory studies, tend to take
several years and to be based on data arising from populations of many
thousands or even millions of individuals. Hence, epidemiological studies
are not likely to give the 'first warning' of any ill-effects of
radiotelephones. They need to be initiated, however, so that, in a few
years' time, they can provide the most direct information on whether
hazards to people exist.
The question of adverse health effects is a suitable one for
epidemiological enquiry, particularly because radiotelephones are widely
used in the population. Indeed, certain features of their use make it
likely that an epidemiological investigation could come to a successful
conclusion. The large number of users gives the potential for studies of
considerable power, based on hundreds of thousands or even millions of
exposed individuals (although not in the near future for large numbers with
very long-term exposure). The existence of quantified, recorded and dated
data about exposures, from billing records (compared with the far more
imprecise data usually available for many other epidemiological exposures,
for instance, diet) gives a basis from which exposures can be estimated
with some precision (although further data, beyond those from the billing
records, would be needed to maximise the quality of exposure estimates).
The exposure has laterality (users will hold the handset to either the left
or right ear), which would be expected to result in laterality of any local
effects; again, few other epidemiological exposures have this
characteristic.
Having examined the published scientific literature, the Expert Group
concludes that there are no published epidemiological studies on
cause-specific morbidity or mortality specifically relating to
radiotelephone use. There have been studies of health outcomes of
radiofrequency radiation exposure in various other circumstances, which
provide background information of interest in the context of radiotelephone
use, but not direct information on its possible hazards. The Expert Group
was able to identify epidemiological studies currently being undertaken on
health effects and radiotelephone use.
The Expert Group considers that studies should be inaugurated of risks of
certain cancers originating in parts of the head that receive radiation
exposures from handsets: namely, tumours of the brain and cerebral
meninges; acoustic neuroma; and salivary gland tumours.
Brain cancer is the issue on which public concern has focused in relation
to handsets, and although the radiation exposure is low, the brain is one
of the sites receiving some irradiation.
Acoustic neuroma and salivary gland cancers, although less common tumours,
occur in areas with direct exposure from handsets, with some specific
epidemiological characteristics.
Leukaemia in adults is considered worth investigation because of the
suspected sensitivity of the haemopoietic and animal systems to
electromagnetic energy.
Recommendations for epidemiological research
The Expert Group considers that epidemiological studies are a crucial
component in determining whether radiotelephones cause adverse health
effects, and that they should form a significant component of a research
programme.
The Expert Group recommends that:
* several studies of risk of brain cancer should be conducted, in
different countries
* at least one study each of the risk of acoustic neuroma, salivary
gland tumours and leukaemia in adults should be conducted
* the above studies should use personal data from the study subjects on
exposures and confounding variables, and should not be based solely on
billing records
* at least one cohort study of cause-specific mortality and cancer
incidence should be conducted, if proposals of sufficient power and
quality are put forward. Such a study should preferably be followed by
a nested case-control study.
Research management
In respect of its recommendations on the management aspects of the research
programme, the Expert Group recognises the need for the management
structure to harmonise with existing administrative and financial
procedures and customs within the European Commission. The recommendations
made should therefore be regarded in part, or in whole, as one option, but
the final management structure should be consistent with the following
principles.
* The research should be of the highest quality and should be directly
relevant to the question of possible human health effects related to
the use of radiotelephones.
* The research should be carried out and managed in a manner such that
the work is, and is seen to be, clearly independent of industry.
* The research programme should be co-ordinated and managed by a
Research Management Team.
* The assessment and selection of specific research proposals should be
carried out by an independent scientific panel ?Proposals Assessment
Panel.
* The disbursement of research funds should be carried out on the advice
of the Proposals Assessment Panel.
* The call for research proposals should be widely advertised.
* The progress of the funded research studies should be monitored by
aResearch Monitoring Panel comprising ad hoc independent scientific
experts.
* The results of the scientific research should be submitted for
publication in the peer-reviewed scientific literature.
Recommendations for research management
Research Management Team
The Expert Group recommends that a Research Management Team should be
responsible for the overall day-to-day administration and technical
management of the entire research programme. This Research Management Team
could be, for example, formed from within existing administrative
arrangements within the European Commission. Specific duties of the
Research Management Team could include:
* the provision of Secretariat services to the Proposals Assessments
Panel and the Research Monitoring Panel
* the handling of all correspondence between research teams, the
Proposals Assessments Panel, the Research Monitoring Panel, the
European Commission, the industrial and other funders, and the media
and other interested parties
* the organisation of all meetings in relation to the research projects
including, as appropriate, visits by members of the Proposals
Assessment Panel and the Research Monitoring Panel to research
laboratories, etc.
Research funding
A fundamental requirement of the funding mechanism is that industry and
other funding bodies should be provided with the opportunity to contribute
funding and materials in kind to the research programme, but should neither
have, nor be seen to have, any influence over the choice of research
studies funded, the conduct or the outcome of such studies, or the
publication of the results.
The Expert Group recommends that funding for the research programme should
be sought from the personal telecommunications industry and other
interested parties. Contributions should be used for the sole purpose of
funding the scientific research programme and its management. Public
acknowledgement of individual contributions for funding and materials in
kind should be by the mutual agreement of the funding body and the European
Commission. All donations or loans of materials in kind should be arranged
through the programme management and not given directly to the research
teams. A contribution to the funding or of materials in kind should confer
no rights to the contributor other than acknowledgement(s) of the
contribution made (where agreed) and information about the progress of the
study.
The allocation of funds to specific research projects should be decided
according to the recommendations for research funding of the Proposals
Assessment Panel and without consultation with industry or other funding
bodies unless required by the Commission.
Legally binding contracts covering the research should be between the
European Commission and each of the research teams undertaking the
research. Sub- and/or cross-contractual arrangements may be made in respect
of collaborative research between two or more research teams.
The estimated total cost of the research programme is 24 MECU.
Call for research proposals
It is envisaged that the timescale of the biophysical and biological
research programme will be 4 years, with individual research studies of
duration between 1 and 4 years. By necessity, the epidemiological (cohort)
programme may extend beyond this period and further funding may be
necessary. It is important, therefore, that there is flexibility so that
studies can be phased in as the programme develops. For example, it may be
appropriate to identify further projects in the mid-to-latter part of the
programme to clarify the results of studies completed in the early part of
the programme.
The Expert Group recommends that calls for specific research proposals
based on the recommendations of the Expert Group should be published. A
first call for research proposals should invite applications for proformas.
Interested research teams should complete these proformas providing, as
appropriate, details of their proposed research, the facilities afforded by
their laboratory, the qualifications and experience of the researchers, and
details of the funding required for the research. Proposals should be
assessed by theProposals Assessment Panel, who should recommend which
research studies should be supported. The Proposals Assessment Panel should
also indicate where collaborative projects appear either necessary or
desirable.
Proposals Assessment Panel
The Expert Group recommends the appointment of a Proposals Assessment Panel
comprising ad hoc appointed experts in the fields of scientific/technical
expertise required for the assessment of specific studies in respect of
potential funding within the scientific programme. The Research Management
Team should act as the Secretariat for the Proposals Assessment Panel and
should make all administrative and other arrangements necessary for it to
carry out its functions. It is recommended that specific tasks of the
Proposals Assessment Panel should include:
* critical review of proposals for research submitted for funding
* making initial visit(s) to and holding discussion(s) with prospective
research teams, as appropriate
* advising on the acceptability of specific project proposals in respect
of funding
* recommending changes to proposals for research studies and
collaborations between research teams, where identified as being
necessary and beneficial to the overall research programme.
Research proposals selection criteria
The Expert Group notes the importance of providing guidance on assessing
proposals for research. It therefore recommends the following criteria.
Dosimetry and exposure systems studies
* Laboratories and researchers must have proven experience in carrying
out and publishing the results of scientific work in the specific area
of microwave radiation exposure and dosimetry of living systems
* Exposure and dosimetry studies should form a collaborative part of a
biological research study.
* Each laboratory should specify the nature of the quality assurance
programme that it intends to follow in respect of its proposed
research, and quality assurance documentation specifically related to
the investigation should be made available to the Proposals Assessment
Panel.
* ?Where relevant, proven experience of dosimetric modelling using
numerical codes is necessary.
Biophysical and biological studies
* Laboratories and researchers must have proven experience in carrying
out and publishing the results of scientific work in the specific area
of biophysical/biological research.
* The researchers must have proven experience of electromagnetic field
dosimetry and exposure systems appropriate to microwave exposure or
enter into a collaborative arrangement with a laboratory with a proven
record of experience in the field.
* Proposals for research should:
* address issues relevant to human health
* set out to investigate exposure?esponse relationships
* allow differentiation between continuous wave (cw) and
amplitude-modulated effects
* allow differentiation between thermal and non-thermal microwave
effects
* characterise the experimental conditions such that comparison can be
made with radiotelephones
* employ appropriate negative and positive controls.
* The researchers should have access to and obtain statistical advice in
respect of the planning, performing and analysing the results of the
experimental work.
* For biological effects studies, priority will be given to funding
those studies where the biological model is exposed to a range of
exposures representing different radiotelephones.
* The protocols for studies should be produced at the outset of each
study and should be regularly updated where appropriate in order to
assist future replication of the study.
* Each laboratory should specify the nature of the quality assurance
programme that it intends to follow in respect of its proposed
research, and quality assurance documentation specifically related to
the investigation should be available on request to the Research
Management Team.
* Experimental studies involving the use of laboratory animals should be
carried out in strict accordance with relevant regulations applicable
to such use.
Epidemiological studies
The Expert Group considers that the following criteria are desirable and
should be applied when selecting studies for funding. It is recognised that
not all may be practical in any particular circumstance and judgement will
be needed on whether sufficient are met to make a study worthwhile. It is
suggested, however, that applicants should state the extent to which their
proposals meet the criteria, viz:
+ a proven track record by the applicants in successful conduct and
publication of high quality case-control/cohort studies; availability
of expertise on statistics and exposure assessments either among the
applicants or from collaborators
+ if case-control design; appropriate non-biased control group;
non-biased methods for data collection, applied in same way to cases
and controls
o if cohort design, methods that will give:
o complete follow-up for cause-specific mortality and preferably
also for site-specific cancer incidence
o data on changes of exposure over time for the full period of
follow-up to be analysed
o comparison of cancer incidence in the cohort with that in a
non-exposed cohort or from the appropriate general population
(from population based cancer registration)
+ use of recorded quantified exposure data from billing records and also
personal exposure data from individuals
+ adequate data on confounding variables, and method(s) to control for
confounding
+ for brain tumour study, diagnostic confirmation of cases
+ for acoustic neuroma, salivary gland and leukaemia studies;
histological/haematological diagnosis of cases
+ for brain tumour, acoustic neuroma and salivary gland studies; data on
laterality of tumour
+ for a case-control study, geographic and demographic choice of study
population to obtain a high prevalence of use, especially long-term
and long-ago use, in controls; calculation of power for a 5-year and
for a 10-year induction period (since first use)
+ experience of applicants in collaborative multicentre studies and
willingness to make data collection compatible with parallel studies
funded in other European countries
+ willingness to enter data into meta-analysis and to agree mechanisms
to prevent inappropriate preliminary publication.
Research Monitoring Panel
The Expert Group recommends the appointment of a Research Monitoring Panel
consisting of ad hoc appointed experts in the fields of
scientific/technical expertise required for monitoring the progress of
specific studies. It is recommended that the Research Management Team
should act as the Secretariat for the Research Monitoring Panel and should
make all administrative and other arrangements necessary for it to carry
out its functions.
The Expert Group recommends that the functions of the Research Monitoring
Panel should include:
* making site visits to the research laboratories to monitor progress on
specific studies
* discussing progress and points of concern with the research teams
* advising the Research Management Team on the acceptability of progress
made on specific projects in respect of continuity of funding
* recommending changes to research studies (including curtailment,
extension, re-direction and collaboration) as appropriate
* critically reviewing progress reports from the research teams and
material intended for publication.
Information channels
The Expert Group recognises the importance of good communications among all
of the stakeholders in the research programme. It therefore recommends that
the Research Management Team should be responsible for communications and
dissemination of information between the funding agencies, the European
Commission, the research teams, the broader scientific community, the media
and the general public. The Research Management Team should prepare a
report of overall research progress with a recommended frequency of twice
per year. Annual open meetings could provide the opportunity for the
Commission and the funding bodies to learn of progress and to provide
feedback.
It is recommended that a scientific research newsletter and, if possible,
Internet homepage should be available to the public and to all interested
parties. The newsletter and Internet homepage should be prepared and
updated regularly by the Research Management Team. For completed research
studies, statements, written for non-scientists, should be published in the
newsletter (and on the Internet homepage), summarising their key findings.
Publication of results
It is the recommendation of the Expert Group that the results of all the
research should be placed in the public arena without undue impediment. It
is, however, recognised that, in the interest of sustaining a consistent
high standard and quality of presentations for the entire research
programme, some editorial control may be necessary. It is, therefore,
recommended that draft reports of all studies or intended presentations at
scientific and other meetings should be subject to comment by the Research
Monitoring Panel. However, it is emphasised that their final content and
presentation should rest with the authors of the studies' reports. Results
of biological research of an interim or preliminary nature should not be
presented at public or scientific meetings without the prior approval of
the Research Monitoring Panel. The results of the scientific research must
be submitted for publication in peer-reviewed scientific journals.
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