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Network
of Excellence
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CARiMan
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The
Internet Portal for Computer Aided Risk Management
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Responsible: IPA,
Kayser,
NIEB
Assistance:
all partners
The CARiMan work plan provides the means for investigating
the necessary standards regulations and directives at a European level. An
important novelty of this project is the integrated study of all issues involved
in risk management. Thus, technological standards will be considered in
association with national and European legal issues. Such standard are expected
to emerge from the project in the areas of wireless devices, man-machine
interfaces for risk management, security of data transmission, DBS and KMS
processing systems.
The main contribution to the standards
is a digital resources repository based in enterprise schema and vocabulary used
for provide the Info-Service identification of partners, members, companies and
participants. The variables and schemes used are standards vocabularies and
thesaurus, with info-services of classification and translation.
Ethical requirements will also be considered carefully during
the user requirements specifications and design phases of the CARiMan R&D,
particularly with regards to the treatment, management and security of personal
data. In general, the legal aspects with regards to the security of tele-monitoring
services will be extensively considered as complications could lead to expensive
legal actions. To that respect, extensive field tests will be performed to
validate the system’s efficiency and ease of use by risk managers,
governmental authorities, etc. This experience is expected to have a significant
impact on the standards for risk management in terms of technology, practice and
implementation. On the education level, one objective of CARiMan is to prepare
valid applications for regulatory licenses and/or accreditation.
Rapidly
advancing progress in clinical and experimental research in Europe requires
keeping science in harmony with ethical values. Studies planned within the
CARiMan framework will follow all guidelines present in the most important
pieces of European legislation and international conventions, as well as
international declarations and codes of conduct relevant to research activities
which include:
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Charter of Fundamental Rights of the European Union (signed in Nice, December 7,
2000, 2000/C364/01)
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Directives of the European Union (Directive 2001/20/EC of the European
Parliament and
of the Council of April 4, 2001 on the approximation of the laws, regulations
and administrative
provisions of the Member States relating to the implementation of good clinical
practice in the conduct of clinical trials on medicinal products for human use;
Council Directive 83/570/EEC of October 26, 1983 amending Directives 65/65/EEC, 75/318/EEC
and 75/319/EEC on the approximation laid down by law, regulation or
administrative action relating to proprietary medicinal products;
Directive of November 24, 1986 on the approximation of laws, regulations and
administrative provisions of the Member States regarding the protection of
animals used for experimental and other scientific purposes (86/609/EEC).
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Conventions of the Council of Europe (Convention for the Protection of Human
Rights and Dignity of the Human Being with regard to the Application of Biology
and Medicine: Convention on Human Rights and Biomedicine - Oviedo, April 4,
1997)
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Universal Declaration of UNESCO (Universal Declaration on the and Human Rights,
11 November 1997)
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World Medical Association (Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subjects, Edinburgh, Scotland, October 2000).
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UN Convention on the Rights of the Child Adopted
and opened for signature, ratification and accession by General Assembly
resolution 44/25 of 20 November 1989 entry into force 2 September 1990, in
accordance with article 49.
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Regulation of the European Parliament and of the Council of 18 December 2000, on
the protection of individuals with regard to the processing of personal data by
the institutions and bodies of the Community and on the free movement of such
data.
One
of the main requirements for research in CARiMan will be to protect privacy, and
dignity of the human subject. This seems particularly important as in several
Integrated Activities which are oriented on practical applications of new
technology in health care in humans. The leaders of individual research groups
will be responsible for assuring that all ethical aspects of the proposed
research and in educational activities are in compliance with national and
European guidelines and regulations. All work will be conducted in accordance
with the relevant local and national regulations, and will be subject to prior
authorisation by the competent national and institutional research ethics or
medico-ethical committees.
Research
will be carried out in accordance with relevant professional obligations and
standards. In particular, the design and performance of experimental procedures
involving human subjects and animals will be clearly formulated in an
experimental protocol. This protocol will be submitted for consideration,
comment, guidance, and where appropriate, approval to a specially appointed
national ethical review committee, which is independent of the investigator, the
sponsor or any other kind of undue influence.
The
research involving human subjects will be conducted only by scientifically
qualified persons and – in case of medical research - under the supervision of
a clinically competent medical person. All healthy subjects will be volunteers
and informed participants in the research project. The right of research
subjects to safeguard their integrity will always be respected. Every precaution
will be taken to respect the privacy of the subject, the confidentiality of the
patient's information and to minimise the impact of the study on the subject's
physical and mental integrity and on the personality of the subject. Each
potential subject will be adequately informed of the aims of experiments,
methods to be used, the anticipated benefits and potential risks of the study
and the discomfort it may entail. The subject will be informed of the right to
abstain from participation in the study or to withdraw consent to participate at
any time without reprisal. After ensuring that the subject understands the
information, the researcher will then obtain the subject's freely-given informed
consent in writing. In case of testing a child who is legally incompetent, the
investigator will obtain informed consent from his/her parents.
Summing
up, the research on human subjects will fulfil the following conditions:
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the research project will be approved by the competent body after independent
examination of its scientific merit, including assessment of the importance of
the aim of the research, and multidisciplinary review of its ethical
acceptability
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the persons undergoing research will be informed of their rights and the
safeguards prescribed by law for their protection
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the necessary consent will be given expressly, specifically and in a documented
form
Special
arrangements for protecting the confidentiality of personal data or information
about tested subjects/patients will be undertaken. In every study of this
proposal, personal data will be the subject of anonymisation. The process of
encoding and anonymisation of collected data will start just after the end of
experimentation in such a way that will in practice unable the patients/subjects
identification. There will be no theoretical or practical risk that a patient could be identified by the
recipient of the information. Special attention will be paid to participant’s
consent directions indicating the terms on which their personal information may
be disclosed and what and where data may not be disclosed.
As a result:
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patients identifying information will be replaced with other material when this
is appropriate
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the use of patient identifying information will be reduced to a minimum when it
does have to be used
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access to all information will be restricted to only those who really require it
The proposed research does
not involve:
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research activity aimed at human cloning for reproductive purposes
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research activity intended to modify the genetic heritage of human beings, which
could make such changes heritable
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research activity intended to create human embryos solely for the purpose of
research or for
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the purpose of stem cell procurement, including by means of somatic cell nuclear
transfer
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research involving the use of human embryos or embryonic stem cells
As
far as human material is concerned all samples will be properly coded and cannot
be related to individual persons. All data collected from the patients should be
appropriately secured with restricted access only for clearly stated personnel.
No data is allowed to be used by health care insurance companies, without
patient approval. All data relevant for the current or future health status of
the patients, even they have been considered healthy at the time of the
collection of biologic samples, especially for genetic studies, should be
immediately notified to the patients in order to enable them to make the
decisions for their health. All protocols in which human volunteers or patients
are involved will be submitted for approval by local medical ethics committees.
The procedures concerned are well known by the clinical partners who will
safeguard that the terms of the Helsinki Declaration and its subsequent
modifications will be applied.