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  • 자료마당
  • 통합자료실
  • 국외정보
  • 안전보건 규정

국외정보

게시판 상세페이지
RUSSIAN Health effects related to the use of radiotelephones 2004.06.14
작성자 : 관리자
 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

  ────────────────────────────────────

                             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

  ────────────────────────────────────

   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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