TOPIC : Clinical research on regenerative medicine
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 28 July 2016||Deadline:||11 April 2017 17:00:00|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 20 October 2015||Deadline:||13 April 2016 17:00:00|
|Time Zone : (Brussels time)|
13 January 2017 09:44
Please note that Switzerland is now officially associated to the Horizon SC1 as well. Swiss participants are therefore eligible to receive Horizon 2020 SC1 support. Please see details in the note here.
Topic DescriptionSpecific Challenge:
Translating basic knowledge on regenerative medicine into the clinic is often delayed by the difficulty of undertaking "first in man" studies and carrying out the specific research needed for proving safety and efficacy of new treatments as well as reproducibility of their therapeutic effect. Moreover, financing for these steps in the new therapeutic field of regenerative medicine is particularly scarce, due to lack of established business and regulatory models. The challenge is to overcome these hurdles to in-patient research and to determine the potential of new regenerative therapies.Scope:
Proposals should target regenerative medicine therapies which are ready for clinical (in-patient) research and should focus on one specific clinical phase of work. Any stage of clinical work (e.g., first in man, late stage trial, observational study) may be proposed though later stages are preferred; clinical work should represent the core of the proposal. To justify the clinical work proposed, phase I proposals must present appropriate preclinical and toxicology data, and later phase proposals must present appropriate preliminary results.
Proposals should include authorization to conduct clinical trials and ethical approvals or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which are closest to having approvals in place for clinical work to start. Since the objective is to test new regenerative therapies, proposals may address any disease or condition but a justification for the choice must be provided. Proposers should also justify why the therapy proposed is regenerative and how it represents a new approach compared to any existing treatment. Sex and gender differences should be investigated, where relevant. To allow an adequate coverage in the field of regenerative medicine, proposals should take into account the projects previously funded under this topic in Horizon 2020.
The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
- Obtain results by means of in-patient regenerative medicine research that allows new therapies to safely reach the next level of testing or medical practice.
- Stimulate growth and competitiveness of European regenerative medicine including European small and medium-sized enterprises and industry operating in the sector.
- Increase the attractiveness of Europe as a location of choice for development of new therapeutic options.
- Lever existing investments in fundamental research into regenerative medicine.
- Develop new approaches to currently untreatable diseases.
Project abstracts will be provided on the call page on the Participant Portal.
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 some Horizon 2020 topics (to check funding conditions, follow the links to Australia, Brazil, Canada, China, Hong Kong & Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan, USA*).
*Note that US participants in projects under the Horizon 2020 "Health, Demographic Change and Wellbeing" Societal Challenge are automatically eligible for EU-funding according to the provisions in the relevant work programme
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme.
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, with the following exceptions: The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
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:
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Specific evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
- Additional provisions:
Horizon 2020 budget flexibility
- Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
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.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
- Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs.
- Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
- Additional documents:
H2020 Work Programme 2016-17: Health, demographic change and wellbeing
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
No submission system is open for this topic.
H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
National Contact Points (NCP) - contact your NCP for further assistance.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk- contact the Participant Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
Contact the EIT for further assistance related to the call, topics and the content of proposals via the Contact Page on the EIT website.
Clean Sky 2 National Contact Points - Clean Sky 2 JU States Representative Group
Clean Sky 2 Helpdesk: Info-Call-CPW-2014-01@Cleansky.EU
ECSEL National Contact Points – consult Annex G of the ECSEL Work Plan
ECSEL Helpdesk: firstname.lastname@example.org
IMI States Representative Group (SRG) – contact you SRG member for assistance.
IMI JU IT Helpdesk – for IMI2 topics contact the SOFIA IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
Shift2Rail Call Helpdesk: email@example.com
Ethics – for compliance with ethical issues, see the Participant Portal and Science and Society Portal
European IPR Helpdesk assists you on intellectual property issues
CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at firstname.lastname@example.org.
The European Charter for Researchers and the Code of Conduct for their recruitment
Partner Search Services help you find a partner organisation for your proposal
IMI Partner Search Tool helps you find a partner organisation for your proposal