TOPIC : Validation of biological toxins measurements after an incident: Development of tools and procedures for quality control
|Publication date:||14 October 2015|
|Types of action:||IA Innovation action|
|DeadlineModel: Opening date:||single-stage 15 March 2016||Deadline:||25 August 2016 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
Recent incidents in Europe and worldwide recalled that biological toxins can be produced by laypersons or acquired illegally and intentionally released in a criminal act to harm people. While different technologies are available for toxin detection and analysis, recent findings have shown that the comparability of analytical results from different laboratories is poor, which cast severe doubts about the validation of current methods and about the overall validity of analytical data. This means that in case of a bioterrorist act using compounds such as e.g. ricin (or others such as abrin), saxitoxin, botulinum, neurotoxins, enterotoxins, etc. there is no guarantee that decisions to react are made based on data meeting basic quality requirements. The lack of quality assurance/quality control tools (e.g. certified reference materials of ricin, botulinum, etc.) and standard operating procedures hampers the validation and the EU-wide comparability of biological toxin measurement data. There is therefore a need to develop an EU-wide approach for enhancing validating analytical capacities for biological toxin measurements in case of bioterrorism threats, similarly to what exists regarding chemical threats.Scope:
The large variability among families of biological toxins complicates their measurement and unambiguous identification in human specimens, and environmental or food samples. Toxins are rapidly metabolised and degraded after incorporation, limiting the time window for successful identification and forensic analysis. Proposals should develop quality control tools, as well as the Standard Operating Procedures necessary for establishing a mechanism to systematically validate laboratory-based measurement techniques, including sample preparation strategies and analyses made in-situ issued by mobile and quickly deployable laboratories, which should be proposed for adoption at EU level.
Indicative budget: The Commission considers that proposals requesting a contribution from the EU of € 8million would allow for this topic to be addressed appropriately. Nonetheless this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
- Development, production and certification of reference materials for biological toxin determinations as a basis for strengthened validation capacities;
- Establishment of a stepwise learning inter-laboratory programme enabling relevant laboratories to improve their analytical skills and development and testing of an European Proficiency Testing (EPT) scheme from sampling to detection;
- Improved capabilities for the validation and testing of existing and emerging techniques, including sample preparation strategies, mobile laboratories for in-situ analyses and technical approaches for forensic analysis, for the detection and identification of biological toxins; Replacement of old "gold standards" employing animal experiments with death as endpoint for detection of potent biological toxins, by modern, in vitro methods as requested by EU regulations;
- Based on the outcome of the EPT scheme, development of Standard Operational Procedures for the validation of analytical techniques, including in-situ techniques for biological toxin determinations in human specimens, environmental and food samples
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to China, Japan, Republic of Korea, Mexico, Russia, Taiwan).
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme, with the following exception: At least 3 control laboratories[[Control laboratories are laboratories which provide bio-toxins measurement results to regional and national authorities.]] from different Member States or Associated Countries must be beneficiaries of the grant agreement and should be directly involved in the carrying out of the tasks foreseen in the grant.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme.
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- Indicative timetable for evaluation and grant agreement:
Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- Additional provisions:
Horizon 2020 budget flexibility
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
- Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
- Additional documents
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Innovation in SMEs
H2020 Work Programme 2016-17: Secure societies – protecting freedom and security of Europe and its citizens
H2020 Work Programme 2016-17: Fast Track to Innovation Pilot
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
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