EUTRICOD User Policy - Bernhard-Nocht-Institut für Tropenmedizin

EUROPEAN CENTRE FOR TRAINING AND RESEARCH
ON IMPORTED AND HIGHLY CONTAGIOUS DISEASES
(EUTRICOD)
USER POLICY
1. PREAMBLE
In the EUTRICOD project, a research infrastructure for imported and highly contagious diseases
is constructed at the Bernhard Nocht Institute for Tropical Medicine, Hamburg. This
infrastructure is open to researchers seeking to conduct a specific project involving BSL3 and
BSL 4 handling of pathogens, insect experiments or field studies in West Africa.
The User Policy is designed to ensure fair and equal access to the infrastructure. Applications of
users are reviewed and approved by a Scientific Committee (Appendix 1).
2. CATEGORIES OF USERS
2.1. Scientific collaborators
Members of other universities or research institutions who are integrated in the work of a
research group for the duration of the visit and who may set up possibilities for future
collaborations.
Duration: 1 month to 3 years
Conditions: The scientists are associated with a collaborating research group.
2.2. Guest scientists
Scientists or research teams wishing to benefit from the facilities of BNI in order to conduct a
specific research project.
Duration: 1-3 years
Conditions: Research teams will be associated to a Scientific Programme of BNI, which can
offer a supportive environment for the project.
Criteria: - Scientific excellence of the proposed project
- Complementarity of the proposed research with scientific programmes of BNI
- If applicable: approval of project by ethics committee
- If applicable: conformity with national gene technology regulation
2.3. Facility users
Scientists who need training in the specialised facilities of the laboratory, who wish to use them
to evaluate possibilities for their own institution, or to perform a specific experiment.
Duration:
Conditions:
1-6 months
Scientists will be associated to a Scientific Programme of BNI, which can offer a
supportive environment for the project. A reasonable user fee composed of
overheads and expenditures can be charged.
2.4. Trainees
BNI offers a highly qualified training to selected microbiologists in high-risk pathogen
diagnostics. Moreover, several European countries plan to construct BSL 4 laboratories and can
send staff to be trained and to evaluate possibilities for the construction planning.
Duration:
3-9 months
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Conditions:
Criteria
A reasonable training fee can be charged. Trainees are associated to the Virology
groups.
- High proficiency in standard microbiological practices and techniques,
- Security clearance,
- European interest (e.g. plans to establish national BSL 4 unit in home country).
3. ELIGIBILITY
Applications are welcome from scientists at any stage of their career. Scientists can be members
of research institutes, universities, corporate organizations or private companies. The
EUTRICOD infrastructure does not fund research visits. Applicants must bear their own costs.
Users working in the infrastructure funded under the EUTRICOD project will be required to
Accept FP6 ethical rules;
Conduct no experiments for military purposes 1 or with potential for dual use;
Follow specific SOPs of the infrastructure and safety rules;
Publish their results within a reasonable time in the open literature.
4. APPLICATIONS
Applications are constantly reviewed. There is no deadline for submission of applications.
Applications are submitted electronically by E-mail to the Bernhard Nocht Institute, at least three
months before the intended visit.
4.1. Content of applications
1) Curriculum vitae of the applicant (leading scientist) with references
2) A letter of recommendation from the applicant´s organization
3) A brief project proposal of no more than five pages indicating
- When and for how long the visit is intended,
- A potential collaborator or group for association,
- Why experiments can not be conducted at home organization,
- Specific facilities and equipment to be used,
- Nature and aims of the general research project
(without disclosing intellectual property),
- Description of experiments to be carried out,
- Funding.
4.2. Requirements for users of the BSL 3 and BSL 4 facilities
Visitors admitted for research and training in the BSL 4 unit will typically be sent by the
Government of their home countries. A security clearance of applicants will be a prerequisite
prior to admission.
After approval by the Scientific Committee, a project involving work in the BSL 3 or BSL 4
facilities of BNI will have to be evaluated by the German Federal Commission for Biosafety
(ZKBS). Details on the procedure will be communicated to the project leader with the approval
of his application.
1 “military purpose” being defined in accordance with article 52(2) of the Additional Protocol I to the Geneva
convention as “research aimed at an effective contribution to military action and offering a definite military
advantage”.
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4.3. Requirements for users of the BSL 3 laboratory at KCCR in Ghana
Applicants for a research projects involving work at the collaborative research centre KCCR in
Ghana are required to use a separate research application format (download at www.kccrghana.org
or the EUTRICOD website). Special rules apply for research applications involving
BSL 3 pathogens. These applications will be reviewed by the EUTRICOD Scientific Panel before
being processed to the KCCR in Ghana.
Research applications and ideas should be discussed well in advance with the Director of KCCR
for the necessary advice (scientific partner, ethical clearance, costs, logistics). Confidentiality is
ensured.
Research at the collaborative research centre KCCR in Ghana is governed by a State Agreement
between the Republic of Ghana and the Free and Hanseatic City of Hamburg. In essence, the
Agreement states that
all research will be conducted as collaborative projects with a Ghanaian scientist being a
co-principal investigator (intellectual property thus equally shared),
the activities of the unit are being supervised by an Advisory Board, which contains as
members the Vice Chancellor of KNUST, the Dean of the Medical School, the Director
and one other member of BNI, and is chaired by an outstanding Ghanaian scientist,
projects involving human beings are subject to review by the local Committee on Human
Research, Publication and Ethics.
In addition a procedure to ensure compliance of BSL3-related studies with FP6 ethical rules was
established in a separate agreement between BNI and its Ghanaian partners.
5. SELECTION
A Scientific Committee with three independent international experts reviews and approves
applications. Applicants will be notified by E-mail as soon as possible on the outcome of the
evaluation.
Approval of a project is based on scientific excellence but will also take into account the interests
of the European Community. Special attention will be paid to ensure equal opportunities for
access by new users, capability building and gender issues. Priority will be given to European
research teams who are working in regions of the Community where few such infrastructures
exist and knowledge transfer is of high interest. Association of European researchers wishing to
return from non-European countries will be encouraged. Other specific selection criteria are
given in Section 1 (Categories of Users).
5.1. Selection Procedure
Applications are reviewed monthly by BNI committee members and distributed by E-mail to the
external members of the Scientific Committee together with a standardized evaluation form. In
cases of competing applications, each Committee member is asked to supply a rating of the
respective applications.
The Committee Chairman collects the evaluation comments and prepares a compilation. Based
on the Committee´s approval, the Director of BNI decides on the final admission of applicants
and grants association status to the visitor.
In cases of contradictory evaluations, a discussion among commission members is initiated via
telephone conferences or meetings.
6. SUPPORT FOR VISITORS
Users will be associated to one of the three scientific programmes of BNI (Appendix 2). Where
appropriate, they will be integrated in one of the existing groups providing a supportive scientific
environment. The scientific programme co-ordinator or the respective BNI group leader act as
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the users´ contact person throughout their stay. Technical and logistical support required is
provided by the experiences staff running the facility. Technical backup will include provision of
offices and laboratory space, supervision of work in BSL 3 and BSL 4 laboratories, cell culture
and animal husbandry. Scientific backup will be provided by specific seminars and colloquia. If
desired, BNI administration will assist the visitor to find appropriate accommodation.
Upon arrival, the User Manual with the relevant SOP´s and regulations is handed out to the
visitor and equipment is demonstrated. Before commencement of the project, a provisional
workplan will be devised in order to facilitate the smooth integration of the visitor into the dayto-day
operation. Visitors may work independently or together with a BNI scientist.
7. COSTS
Depending on the category of user, a reasonable user or training fee may be charged, composed
of costs and overheads. Research teams from EC member states and associated countries will be
offered reduction of overheads until 2011. Research teams from German research institutions are
not entitled to discounted conditions under the EUTRICOD project. Training fees will be
offered at reduced rates to trainees from new member states of the European Community.
Unless working in a collaborative research project with BNI, users are required to bear their own
costs for travel, accommodation and consumables and to provide evidence of adequate funding.
8. FURTHER APPLICABLE DOCUMENTS
(available on the EUTRICOD website: www.bni-hamburg.de/eutricod)
8.1. Form sheets
- Research application EUTRICOD
- Research proposal KCCR
- Ethical issues checklist for KCCR projects involving research on BSL 3 viruses
- Evaluation checklist for EUTRICOD applications
8.2. Further applicable documents
- Procedure of admission of associated visitors in the Bernhard Nocht Institute for
Tropical Medicine” (update version)
- User contract (update version)
- User manual (update version)
This document was adopted in the 1 st meeting of the Scientific Committee.
Hamburg, September 5 th , 2006
_________________
Chairman
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Appendix 1
List of members of the EUTRICOD Scientific Committee
Date: September 2006
BNI members
Professor Bernhard Fleischer
Director
PD Dr. Stephan Günther
Head Department of Virology
PD Dr. Joachim Clos
Head of Commission for Biosafety and Genetic Engineering
External members
Professor Ernest Gould
Institute of Virology and Environmental Microbiology, Oxford, UK
Professor Johan Neyts
Faculty of Medicine
Katholieke Universiteit Leuven, Belgium
Professor Peter Sebo
Institute of Molecular Genetics, Czech Academy of Sciences, Prague, Czech Republic
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Appendix 2
Scientific Programmes of BNI
Activities and aims of the programme areas are deduced from the mission and aims of the
institute. Research activities orientate on the two main issues “relevance for disease prevention
and control” and “use of tropical infections as models for general issues in medicine and
biology”.
1 Parasitology research
Activities in the programme area concentrate on cellular and molecular biology of infectious
agents that cause tropical diseases.
Parasitic diseases play a major role in tropical countries. Many of them – like sleeping sickness
and malaria- exclusively occur in tropical countries. Parasitology research focuses on human
pathogens most relevant for morbidity and mortality in affected countries.
Research activities aim to improve control of tropical parasitic infections. Basic research aims to
understand the molecular basis of interaction with the host. Targets are invasion, mechanisms of
persistence and evasion strategies of the parasite. Information from parasite genome projects
allows for identification of novel pathways containing targets for therapeutic intervention.
Applying modern tools in molecular biology, cell biology and biochemistry, the following
activities are performed:
Department of Molecular Parasitology: Research on variability and pathogenicity, and
vaccine development;
Research Groups Malaria: Invasion of human cellular compartments and parasitic evasion
strategies;
Research Group Leishmaniasis: drug resistance, stage conversion on transmission from
insect to mammal, signal transduction pathways relevant for establishment of infection;
Research Group Biochemical Parasitology: characterization of targets for drug
development.
Research covers pathogens causing malaria, leishmaniasis and amoebiasis.
2 Medical microbiology research
Activities in the programme area concentrate on the host reaction to infection. Host reaction is
analyzed on the organism, organ system and cellular levels. Pathogens investigated are parasites,
bacteria and viruses of medical importance.
Research activities aim to understand specific reactions of the host in regard to infection with
pathogen and to deduce measures to influence these reactions. Reactions are of importance for
persistence and establishment of the pathogens, for immunity against subsequent infections and
for the development of pathogenetic mechanisms.
In this context, the following activities are performed:
Department of Immunology: studies on the role of innate and adaptive immunity and
cellular components in infection with Filaria, Plasmodia, Trypanosoma and Leishmania.
Animal models are used to study effects in vivo. Furthermore, studies on the role of the
immune system in pathogenesis, local and systemic mechanisms of cellular control in the
immune response; role of effector cells.
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Department of Virology: studies on immune response to viral infection and on
interaction of virus with host cell. Identification of antigenic determinants to study their
role in viral evasion, individual reactivity to virus determinants and epidemiological
relevance. Development of reverse genetic systems to study the role of single viral
proteins in the host cell. Studies focus on Arena-, Corona- and Flaviviruses, development
and evaluation of diagnostic assays
Research Group Helminth Immunology: interaction of the pathogenic nematode
Strongyloides ratti with its rodent hosts, nematode mediated modulation of host immune
response to bystander antigen and the parasite itself.
3 Tropical Medicine
Activities in the programme area focus on patient-related analysis of resistance, susceptibility,
pathogenesis and pathology of disease.
Starting points of studies are clinical patterns of disease and epidemiologic evidence of
individuals with natural protection from infection. Studies aim to identify metabolic, regulative or
cellular factors, which can protect individuals from infection or specific complications of the
disease.
Central activities are investigations on human genetic variants linked to resistance or
susceptibility, through linkage analyses and association studies of candidate genes. Included is
clinical characterisation of infections (attributes of pathogens, course of infection, pathogenesis
and pathology). This work leads to accompanying intervention and prevention studies in endemic
areas.
In this context, the following activities are performed:
Department of Molecular Medicine: studies on clinical and immunological
characterization of patients, genome-wide linkage analyses and genetic association studies
Department of Pathology: studies on cellular immune protection
Clinical Research Group: clinical characterization of patients and intervention studies
Research Group Infection Epidemiology: epidemiological studies and intervention
studies in endemic areas
Research covers malaria, tuberculosis, filarial infections and HIV/AIDS.
02/2008
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