ESBIO Paris 7'9'2006

1
ESBIO Paris 7.9.2006

• - WP4
• Lisbeth E. Knudsen with
• Tina Mose, Marie Pedersen, Uffe Lind, Kirstine H.
  Ekholm, Thomas Ostermann
• Insitute of Public Health, Uiversity of
  Copenhaegn
• Aase Marie Hansen, National Institute of
  Occupational Health
• Marianne Thomsen, National Institute of
  Environmental Research

2
Workpackages of ESBIO

• WP 4 Ethical issues
• Objectives
• The objectives of work package 4 of ESBIO are to
  identify and analyse major ethical problems
  related to individualised biomonitoring. The
  processes of information of study persons and
  stakeholders should be described and analysed as
  well as the informed consent, data protection and
  dissemination. Specific attention should also be
  devoted to use of information obtained in common
  databases and adhering regulations in force and
  foreseen.
• workshop with stakeholders
• justified concept for dissemination and
  communication of results within participants of
  HBM

3
Workpackages of ESBIO

• Description of work
• Ethical rules and practise, social and legal
  aspects
• The PRIVIREAL website will be referred to
• Overview of legal constraints
• Overview of current practices in different
  countries
• Overview of new insights and trends based on
  current research related to ethics in population
  studies

4
WP4

• Questions to members deadline 1.9.2006 Ge, UK, Be
• Legal constraints Two law students working on
  the description of legal status in each country
  GE now approved by Niels, SWEDEN and Lithuania
  ready, UK almost
• Working steps may include
• How to get all relevant countries enrolled Spain
  Ireland, Lithuania,
• EEA collaboration
• WORKSHOP
• Informed consent
• Children
• Right to know not to know
• Timing of ethics approval protocol needs to be
  ready when applying
• Data protection data collection and exchange

5
Questionnaire to National stakeholders within
biomonitoring -DK- templateUKBEGELUX will
come
6
1Type of human biomonitoring activities in your
countryIndicate if the activities are
international, national, regional. Research
programs (eg EU financed projects) and NGO
monitoring (WWF and Greenpeace) are international
but national studies have been granted, some of
which only cover small populations or parts of
the country (DK)Across the UK there are
International, National and regional studies
(same BE, GE)Indicate whether they are research
studies or surveys. All programs have been
research except for the breastmilk POP
monitoring, which is part of WHO monitoring
(DK)Both types of study exist (UK)The national
HBM activities are population surveys, the
regional HBM activities are mostly research
studies (GE, BE)
7
2 Study population Indicate inclusion/exclusion
criteria and legal constraints that may limit the
selection of optimal composition and size of the
study population Study persons are normally
recruited by oral and or written invitation and
as long as the withdrawal is possible at any time
in the study no limitations in recruitment of
healthy adult study persons are set. For children
a specific justification is needed (DK, UK)These
are study dependentIn the surveillance program
of the Flemish community the exclusion criteria
are age, living for at least 5 years in the study
area, giving written informed consent and being
able to fill in Dutch questionnaires (BE)
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3. Involved organisations Give name(s) of all
organisations involved in the biomonitoring
activities (research institutions, governmental
institutions, regulators, industries,
NGOs)Universities of Copenhagen, Århus and
Odense, Sectorial institutions of Food safety,
occupational health, environment, ministries of
health, work and environment, industries
providing study persons or collaborating by
analysing samples, NGOs of wwf and Greenpeace,
doctors for the environment (DK, UK)VITO (
Flemish Institute for Technological Research),
WIV ( Wetenschappelijk instituut
Volksgezondheid)Provincial institute of Hygiene,
Antwerp, Universities of Antwerp, Hasselt, Ghent,
Louvain UCL (Brussels), Un. Liege, Ministries of
health and Environment(BE) All surveys have
been conducted by Fed. Environment Agency
(Umweltbundesamt), Berlin, by order of Min. of
Environment and Min. of Education and Research
since GerES IV), in close connection with the
National Health Interview and Examination Surveys
(NHIES) performed by the Robert Koch Institute,
Berlin, by order of Min. of Health. Additionally
involved Dr. G. Merkel, Faculty of Medicine,
Rostock UniversityProf. Dr. J. Angerer,
Institute and Out-patient Clinic for
occupational-, social- and environmental
Medicine, University of Erlangen-Nürnberg among
other academic researchers on federal state
level Dr. Rolf Eckard (University of Muenster,
Environmental Specimen Bank for Human Tissues),
Prof. Dr. Ulrich Ewers (Institute of Hygiene of
the Ruhr Area, Department of Environmental
Medicine and Toxicology, Gelsenkirchen), PD Dr.
H. Fromme (Bayerisches Landesamt für Gesundheit
und Lebensmittelsicherheit, Oberschleißheim), Dr.
Jochen Hardt (Augsburg Hospital, Institute for
Laboratory Medicine, Microbiology and
Environmental Hygiene), PD Dr. Ursel Heudorf
(Public Health Departement, Medical Services and
Hygiene, Frankfurt/M.), Dr. med. Birger Heinzow
(State Agency for Nature and Environment,
Schleswig-Holstein, Kiel), PD Dr. Michael Müller
(Occupational and Social Medicine, Faculty of
Medicine, Georg-August-University Göttingen), Dr.
Hermann Kruse (Institute of Toxicology and
Pharmacology for Natural Scientists, University
Medical School Schleswig-Holstein, Campus Kiel),
Dr. B. Link (Baden-Wuerttemberg State Health
Office, Stuttgart).(GE)
9
Initiators Indicate who (profession and
institute) initiate and plan biomonitoring
activities Researchers within biomedicine,
environment and health, occupational health with
medical, natural sciences or sociological
background. Industries may initiate as well as
NGOs(DK)The National Surveys initiated by
NHIES-coordinator at the Robert Koch Institute
and GerES-coordinator at the Fed. Environment
Agency, both located in Berlin. The regional
studies initiated by Universities, Public Health
Departments and State Agencies (DE)There are too
many institutes that investigate biomonitoring
studies University department- academic
researchers Charity funded research institutes,
Government funded research institutes, Government
Agencies etc(UK)Initiation by authorities of
the ministries of health and environment, the
planning and protocol is developed by biomedical
scientists, medical doctors and biostatisticians
(BE)
10
5Justification of interventions Indicate
justification of the activities, choice of
participants, biological tissues sampled Studies
are hypothesis testing and this determines the
selection and number of study persons as well as
tissues sampled. Power calculations are normally
requested (DK, UK)Choice of the participants and
biological matrices in function of the survey or
research purposes. Power calculations are done in
advance (BE). Since the main goal of the surveys
is to analyse and document the extent,
distribution and determinants of the exposure to
environmental pollutants of the German general
population, random sampling within the population
allows for addressing potential and suitable
participants. After having received extensive
information about the survey, candidates are
asked (in written form) for participation on a
strictly voluntary basis, comprising also the
sampling of body fluids or other specimen. The
written consent of participants can be withdrawn
any time without prior notification or
justification. Ad biological specimen sampled
and analysed The pollutant classes and
parameters included in the surveys were chosen
based on knowledge about human health risks,
their occurrence in the environment and the
availability of well-established sampling and
analytical methods suited to study a large number
of subjects. The selection of test design and
study instruments (sampling, ambient measurements
inside the homes, questionnaires) was based on
the following criteria availability of a
reliable analytical procedure, ethical
considerations (as far as possible non invasive
sampling), suitability for field work, acceptance
by the study participants, sampling, transport,
and storage without contamination, stability of
the samples, and reasonable costs. (DE)
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Ethical advice Indicate if ethical advice has to
be taken to determine the maximum of biological
samples taken Power calculations are normally
requested and if selected study groups are
included this has to be justified (DK)A detailed
scenario of the biomonitoring campaign is
forwarded for approval to the ethical committee
of one of the participating universities, power
calculations are requested (BE)There are
guidelines on the amount of blood that can be
taken from children of different ages. All human
studies (with one or two exceptions) have to get
explicit ethical approval as part of the grant
proposal process. The number of participants has
to justified from the point of view of the
outcome expected from the study. (UK)Power
calculations for number, analytical requirements
for volume of samples. On children maximally up
to 1 of their corporal blood volume allowed to
collect. No blood-sampling permitted on
Haemophiliacs and patients receiving drugs to
prevent blood coagulation. Preference to
non-invasive sampling (if possible), providing
flexibility to participants in regard to timing
of visits/sampling, anaesthetic plasters for
blood-sampling of children offered.(DE)
12
Recruitments Indicate how participants are
identified Oral and or written announcement,
approved by the ethics committee, or selection
from population databases/study
databases/cohorts/occupations/environments
(DK)Stratified randomisation (BE)Depend on the
focus of the study. We have found oral
communication to be more persuasive and
interactive with potential participants (UK)The
subjects are randomly selected from the subject
reservoir of the German National Health Interview
and Examination Survey, which is based on the
representative selection from the regional
registration offices with regard to age, gender,
community size and region.(DE)
13
Indicate how participants are invited to
participate Oral and or written invitation
stating the voluntariliness and right to withdraw
at any time. Indication of measures taken to
protect data confidentiality. Indications of
access to personal individual data. Indication of
risks. Specification of payment or other
incentives (DK)Oral and or written invitation
stating voluntarily and right to withdraw at any
time. Indication of measures taken to protect
data confidentiality. Indications of access to
personal individual data. Indication of risks.
Specification of payment or other
incentives.(BE)The selected persons receive a
letter of invitation 3 to 5 weeks in advance. In
GEerES IV only by personal contact or phone
call.(GE)
14
Indicate how lack of responses to invitation are
handled Follow up by renewed invitation eg by
telephone contact (DK)No further request to the
persons, but we try to get some information in
order to describe the representativity of the
responders versus non responders(BE)Depends on
the project from no further action to active
follow-up. Ultimately, NO has to be respected.
(UK) In case that a reply or the written
consent is not received the persons are asked
again, either by personal contact, by letter or
by phone call.(GE)
15
Indicate reasons for not participating The
ethics committees have decided to reject projects
with interviews of no participants claiming
these projects are not respecting the no to
participate of a study person. Reasons may
however be stated in interviews etc and they span
from lack of time and interest in participation
to active opposition to participate (DK)No
interest, lack of time Lack of interest to fear
of needles, Wider range of reasons lack of
time or interest, penetration of privacy,
suspicion of data misuse, opposition to research
or governmental initiatives, fear/shame of
disclosing moral hazards, language or
comprehension problems.
16
How participation was compensated/rewarded (type
and size of reward given) If yes, indicate why
participation was rewarded Small project related
gifts may be included, eg ipods to 24hours
participation in sampling studies, toys to
children. Compensation for travel expenses are
standard and in some instances also compensation
for lost working income (DK)Study participants
receive a report on their individual results,
including an interpretation of data and
recommendations if values are of concern. Since
ambient monitoring (drinking water, house dust)
and medical elements (hearing ability, allergies,
blood count, nutritional advise) became part of
the recent survey on children, information
benefit for interested participants increased. In
the pilot phase of GerES IV the use of incentives
has been successfully tested. Thus in GerES IV
incentives have been used and response rate did
increase. In GerES II also incentives were given
for participation in additional, laborious study
elements, such as duplicate study and
investigation of children.Incentives according
to target group items for children (up to age of
10) like toys, (painting) books, games or music
CDs. Kids between 11-14 years of age, were
rewarded with cash(12.50 ) AFTER their
individual examination exercise.
17
Motives of participation Indicate the motives of
participation of the participants donating
biological material Motives are spanning from
altruism (doing good to the society) to interest
in information about individual health status etc
(DK)Environment related health concerns,
curiosity on results, pride to be part of a large
survey, etc.(BE) Usually for the sake of health
researchsome have personal reasons such as a
death in the family or a member of the family
with an ailment (UK).
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Indicate which permissions from which authorities
to be obtained to be able to perform
biomonitoring activities The ethics committees
always have to approve when sampling and health
information is included. If information is stored
in a database which is the case always the data
protection Agency approves the registry. In case
clinical trials of medicines are involved also
the medicines agency has to approve (DK).The
approval of an Ethics Committee of Virchow-Clinic
(as part of Charité, Berlin) as well as of a data
protection officer see12 (for GerES it was
obtained under the guidance of the National
Health and Examination Survey). Regarding data
protection, the German Fed. Data Protection Act
builds the foundation the federal, regional
(federal state) and institutional (e.g. RKI, UBA,
etc) data protection officer have to
agree.(GE)There are local research ethics
committees (LREC) who ultimately report to the
Central Office for Research Ethics Committee
(COREC). These are National Health Service (NHS)
based committees who address both volunteer
studies with healthy volunteers, clinical trials
as well as other interventions where human
subjects are involved. This includes the
collection of biological tissues for biological
monitoring.(UK) Ethics committee ( approval)
and privacy commission ( notification) (BE)
19
Indicate if and when approvals from ethics
committees are to be achieved Always prior to
initiation and with information material used for
recruitment to be approved (DK, BE) Prior to
initiation of survey and all information
documents to be used for access and recruitment
of participants have to be approved. Furthermore,
in surveys on children the consent of BOTH
parents had to be obtained. (GE)Usually,
ethical approval must be either applied for or
granted before research funds will be made
available (UK).
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Ethical committees Indicate the institutions
approving the activity Regional ethics
committees, distinguished by geographical
location of the study manangement 12-20 members,
half of which are lay persons and the rest are
health personel. No demand of expertise in
statistiscs, law, paediatry or toxicology. Advice
from such specialists may be sought but not as a
rule. (DK) The German umbrella-organisation on
ethics is the "Nationaler Ethikrat".
Additionally, there are approx. 150
regional/institutional committees on ethics,
often part of a Research Institute/University.(se
e http//www.ethikrat.org/links/national.html).
Usually 12-20 members composition widely
multidisciplinary and depending on scope of
ethics (Embryonic/stem-cell research, genome
analysis, dignity of terminally ill persons,
organ donation, etc, etc) (GE)LREC and if the
study is National COREC. 10 -20, with lay
members as well as expert members. (UK)Ethical
committees associated with universities or
hospitals About 10 people, participants are
biomedical professionals , in some commissions
one or two philosophers or lay persons
participate (BE)
21
Nature of personal data Indicate how
confidentiality is ensured (anonymous,
identifiable, coded) Samples and information is
kept coeded and even in some instances double
codedSamples are anonymised by the use of codes.
Samples are usually analysed blind and only
senior staff are able to decode and interpret
personal data.(DK) New legislation requires
the use of sample management systems. Personal
data is not published with out consent from the
individual. Even regional data where group may
feel the information is too specific need to have
full consultation this is part of the
communications strategy that should be developed
during the project planning stage (UK)
Personal-data (name, address, phone number) and
survey-data get coded initially (made anonymous)
and keep stored separately. Personal-data
including the codes applied are taken into
custody of the data-protection-officer assigned
to. Codes are only traced back to the
participants for the purpose of delivering their
individual reports and (if initially intended
informed about) in case of study
follow-ups.(GE)The assigned data-protection-offi
cer is in charge of all data transactions
regarding the personal data. Personal-data get
deleted after end of survey, respectively anytime
if person withdraws consent to participation (BE)
22
Indicate how the privacy legislation is ensured
The data protection law requires a log kept on
all data transactions (DK) Federal- and
federal-state data-protection-officers must
approve the survey. EU regulations
covered!(GE)Only the medical doctor responsible
for contacting the participants has the key for
identification, all other researchers work with
anonymous data (BE)
23
Indicate if personal data were deleted at the end
of the study Normally the registries are approved
with an expiry date at which time all identifiers
have to be deleted. The anonymized database may
be transferred to centralised statistics unit to
serve as source for comparison etc and made
avaialbale upon application to other research
groups.
24
Biological banking Indicate if banking of
biological samples is used Most biomonitoring
studies include biobanking which are regulated as
the data with an expiry date of identification In
Denmark several biobanks have been developed with
the aim of follow-up studies combining biological
measurements with health data. A unique personal
identifier system enables effeicient coupling of
registries, which however is strictly regulated
and implies an approval from the Health Ministry
of each data coupling (DK)In the frame of
surveys smaller fractions of the specimen (blood,
urine, house dust) are stored for later
measurements. In the frame of the Environmental
Specimen Bank for Human Tissues banking of
biological samples is a goal.Specify if
short-term or long-term storage is promoted.For
the Environmental Specimen Bank for Human Tissues
long-term storage is applied. In regard to
surveys storage time depends on the amounts
remaining and foreseen plans of further
investigations. During the run of the survey,
remaining amounts serve as quality control
measures, in order to be able to re-analyze
samples if necessary (GE)Storage is project
specific. New legislation indicates that samples
can not be stored for future novel analyses. In
order to go back to samples and analyses for
something not indicated in the original ethical
approval requires new ethical approval. There
is one large BIOBANK (500, 000 samples to be
collected) and smaller cohorts studies where
samples are stored for future study depending on
hypothesis generation. In order to access these
samples a full project proposal has to be
submitted with specific ethical approval. The
same process is necessary for access to data
collected in association with the biological
samples (UK).
25
Follow-up Indicate if follow-up questions to
participants considering incidental findings were
foreseen In most studies this is the case,
however depending on the predictive value of a
given result (DK) The written consent covers
the assent to be contacted again if RKI intends
to conduct another study. Participants receive
their individual reports and are requested to
submit their new address in case of moving. (GE)
26
Intellectual property right Specify if and how
the intellectual property rights were followed
The ownership to databases, biobanks and
registries must be specified at initiation of the
study and is normally institutional (DK)The
UBA, on behalf of the federal government, is
owner of the GerES data generated. IPR in terms
of a patent is neither intended nor likely.UBA
has DPR and therefore the privilege to publish
first, a "public use file" (anonymous) is made
available for research and policy makers later.
(GE) Intellectual Property (IP) rights are
always included in the research proposal and this
would include databases and any foreground
information produced as a consequence of the
study. This is very project specific, and needs
to be considered at the planning stage. Large
studies would have steering groups who would lead
on the subsequent use of data etc. In order to
use stored health information in public
registries the project has to go through COREC.
(UK)This is negotiated prior to the study and
depends on the contract In most cases, the
sponsor owns the data ( eg ministries) , a
steering group decides on data availability to
other research groups. Requires specific approval
from the Health Ministry. (BE)
27
Invitation to participate Indicate how
participants are invited to take part in
biomonitoring Targetted information is normally
used with all mentioned media(DK)Posters,
flyers, internet information, telephone call,
information at schools (BE)Participants receive
detailed written information, flyers and answer
sheet for expressing their (written) consent
first. The Medical Association, children's health
organisations and local authorities are informed
and asked for support. Media (print, broadcast,
TV) receive information in and are requested to
announce the activities. Accompanying media
brochures, flyers and websites are disseminated.
Expert Team of the UBA RKI can revert to
accumulated expertise from previous
surveys.Expected duration of the subjects
participation. Different modules (interviews,
physical examinations, specimen collection) are
explained (GE)
28
Training of professionals in contact with
participants Indicate if special attention is
paid to communication with the participants and
if any training took place. Indicate training of
staff providing information to study persons
Normally nurses and others trained in
communication of health issues(DK) A
communication plan accompanies the biomonitoring
campaigns and is developed in collaboration with
social scientistsLanguage skills are and always
have been regarded as essential for all
participants. The competence in language is
assessed, inter alia by field personnel and
(telephone) interviewers. Since the embedding of
migrants, the information sheets on data
protection and the form of written consent have
been translated to several languages. Training
of field staff and (telephone) interviewers
physical appearance, proper conversation,
striking the right note, courtesy and commitment
alike, appropriate doggedness, extensive
knowledge about questionnaires and all elements
of the survey being relevant for the
participants, handling of urine samples, useful
coping strategies and techniques to avoid
"transmitter-receiver"-problems. (UK)
29
Reporting results Specify how results (including
frequency, content, media such as report,
website, mail, hotline) are reported to
participants, public authorities, the general
public Results are normally communicated to
participants o group level by information
meetings and/ or public media. Also scientific
communication is part of the study
protocol(DK)Individual results are reported by
letter to the participants, they also get a
report of the group results. For professionals, a
more detailed report is available. All reports
are publicly available on the internet. A three
monthly digital newsletter is available. A press
release and press conference is organised , when
group results become available. (BE)
30
Communication needs There are complicated
communication issues and most of these have to be
considered in the planning stage. Individuals
are rarely given personal data in biomonitoring
surveys and research projects. These issues
are further complicated by the data projection
act in the UK. In future individuals may insist
on their results. The interpretation of these
results where it is not possible to make a risk
estimate or to give advice on the possible health
outcomes or how to avoid exposure is a very
difficult area. (UK)
31
RecommendationsClear communication Transparent
and understandable aimsLay appreciation of the
project and the outcomesInvolvement of all
stakeholders including NGOsClear reports and
presentations at National and International
Level. (UK)Transparancy and intensive
communication with all stakeholders according to
rules which are developed prior to the study.
Participation of stakeholders and having them
involved from the start of the
study.Multidisciplinary approach for study
design, conducting and reporting of the study
Combining medical, toxicological, environmental,
social and biostastistical expertise. (GE)
32
Practical information and Contacts
Members of the ESBIO Consortium

• 11 Active Members with specific tasks
• Reinhard Joas, BiPRO GmbH, Germany (Coordinator)
• Fátima Reis, Instituto de Medicina Preventiva,
  Faculdade de Medicina de Lisboa, Portugal
• Greet Schoeters, Flemish Institute of
  Environmental Technology (VITO), Belgium
• Lisbeth Knudsen, University of Copenhagen,
  Denmark
• Louis Bloemen, ENVIRON, The Netherlands
• Ludwine Casteleyn, University of Leuven, Belgium
• Marek Jakubowski, Institute of Occupational
  Medicine, WHO collaborating Centre, Poland
• Marike Kolossa-Gehring, Federal Environmental
  Agency, Germany
• Maryse Lehners-Arendt, Initiativ Liewensufank
  asbl, Luxem- bourg - International Baby Food
  Action Network
• Nadine Fréry, National Institute of Public Health
  Surveillance (InVS), France
• Stella Canna Michaelidou, State General
  Laboratory, Ministry of Health, Cyprus
• 11 Ad Hoc Members
• Aleksandra Fucic, Institute for Medical Research
  and

Deadlines
Oral presentations - Call for speakers Participant
s are encouraged to submit abstracts (300 words)
01/12/06
Call for Speakers and Participants Ethical
practises and communication in human
biomonitoring - ESBIO workshop Copenhagen March
11-13, 2007
Poster presentations Call for
abstracts Participants are encouraged to submit
abstracts (300 words) being consistent with the
theme Registration by mail to L.Knudsen_at_pubhealth
.ku.dk
01/03/07
Meeting place University of Copenhagen
Contacts Chairpersons of the workshop Lisbeth
E. Knudsen, PhD E-mail L.Knudsen_at_pubhealth.ku.dk
Greet Schoeters, professor
E-mail Greet.schoeters_at_vito.be
Coordinator of ESBIO BiPRO Reinhard
Joas E-mail mail_at_bipro.de EC Project Officer DG
Research Tuomo Karjalainen E-mailTuomo.Karjalaine
n_at_cec.eu.int Policy DG involved DG
Environment Birgit Van Tongelen E-mail
Birgit.Van-Tongelen_at_cec.eu.int Further
information on ESBIO is available
at www.eu-humanbiomonitoring.org ESBIO has
initiated an European Inventory on Human
Biomonitoring Activities via www.HBM-inventory.or
g PRIVIREAL examined the implementation of the
Data Protection Directive 95/46/EC in relation to
medical research and the role of ethics
committees www.privireal.org Contract no.
SSPE-2005-022580
ESBIO is funded by the European Commission
(Directorate-General Research) under the 6th
Framework Programme for Research and
Technological Development in close cooperation
with Directorate-General Environment
33
Ethical Practises in Human Biomonitoring
Workshop on Ethical Practices in Europe
Human Biomonitoring and ESBIO

• Human biomonitoring is a scientific technique for
  assessing human exposure to and health effects
  from environmental pollutants. It is based on
  sampling and analysis of human tissues and fluids
  (e.g. blood, urine) and it is seen as a powerful
  tool to support environment policy as well as
  public health policy.
• The figure illustrates the exposure-disease
  sequence in which biomarkers can measured as
  indicators of environmental exposures, early
  predictors of adverse human health effects and
  susceptibility.
• The European Environment and Health Strategy
  adopted by the European Commission in 2003
  presented a new vision on how to address
  environment and health in an integrated way and
  puts health in the centre of environmental
  policy. Based upon the Strategy the Commission
  adopted in 2004 a Communication on the
  Environment and Health Action Plan 2004 2010.
  In Action 3 of this Action Plan the European
  Commission announces to develop a coherent
  approach to Human Biomonitoring in Europe in
  close cooperation with the Member States.
• The ESBIO project (Expert team to Support
  BIOmonitoring in Europe) was launched by the
  European Commission in October 2005 and consists
  of 22 European experts on human biomonitoring,
  coming from national governments, research
  institutes, industry and NGOs in 17 Member
  States and Croatia.

• An overview on how ethical issues are already
  practiced in different countries and projects,
  current legislation and optimal harmonized
  procedures related to individualized
  biomonitoring identified and analyzed as an
  important part of the ESBIO project will be
  presented at the workshop.
• The workshop will provide two days of debate on
  identifying major items for guidelines for
  ethical issues in human biomonitoring. The
  workshop will focus on the following themes
• Justification of interventions
• Autonomy
• Beneficence
• Non-maleficence
• Transparency
• Recruitments
• Motives of participation
• Altruism, benefit, knowledge, citizenship,
  voluntary
• Information practices
• Situated informed consent
• Critical circumstances
• Decision-making capabilities
• Assent
• Right to know and not to know
• Target group specific communication

Human biomonitoring studies are increasing in
Europe, however no uniform guidelines on ethical
issues such as how to inform the participants and
how to protected personal data exist.
Research with and on human individuals is
necessary and appropriated communication is
needed.
European practices in informing, consenting and
managing ethical issues related to human
biomonitoring studies gathered from the inventory
by SCALE, the PRIVIREAL website and from
interviews with stakeholders (e.g., study
persons, nurses, technicians, researchers,
regulators, etc.) will be identified and analyzed
in ESBIO. Specific attention will be devoted to
the use of biobanks and information obtained in
common databases and adhering regulations in
force and foreseen. In order to identifying
major items for guidelines for ethical issues in
European human biomonitoring, this workshop aims
to invite a broad range of stakeholders.
The figure illustrates the various groups of
stakeholders involved in the different steps of
human biomonitoring. Two days of presentations
by the various stakeholders allowing diverse
views and understanding of the advantages and
limits of human biomonitoring to be debated may
improve to the current understanding of factors
causing ethical conflicts by promoting exchange
of experiences.