Fourth Joint Transnational Call (JTC 2017) - Translational research on rare cancers

Deadline: Feb 6, 2018  
CALL EXPIRED

1. MOTIVATION

Rare cancers are traditionally defined on the basis of epidemiologic statistics. Incidence, i.e., the number of newly diagnosed cases of a given disease per 100.000 persons per year (100.000/year), has been consistently identified as the most efficient indicator for rare cancer definition. In this regard, at the European level, an operational definition of rare cancers based on cancer registry data has been provided and adopted within the RARECARE project, an initiative focused on the surveillance of rare cancers in Europe (http://www.rarecare.eu/).

Accordingly, rare cancers are identified as diseases whose incidence, when individually considered, is lower than 6 newly diagnosed cases per 100.000/year in Europe. It is noteworthy that, if collectively considered, the 198 cancers identified by the RARECARE project represent the 22% of all newly diagnosed cancers in European countries each year, including rare adult solid tumors, rare hematologic cancers, and pediatric cancers (For the list of rare cancers, please visit the the following link: http://www.ecpc.org/Documents/Projects/RARECAREnet/RARECAREnet_list_of_rare_cancers.xlsx). When considering prevalence, the overall estimates raise to about 25%, which translates in about 4 millions of European people currently living with a diagnosis of rare cancer. In addition, survival rates for rare cancers are worse than for common cancers (47% versus 65%, respectively).

The diagnostic and therapeutic management of patients with rare cancers may pose particularly difficult challenges mainly related to the small numbers of patients diagnosed with the diseases of interest and difficulties in referring to large centers with multidisciplinary expertise.
Independently on the study design of choice, the low incidence of these diseases tends to significantly constrain the ability of performing studies with adequate statistical power. In addition, in rare cancers, the pressing issue of the inherently low numbers inevitably and largely translates into a limited availability of high quality, clinically annotated, bio-specimen samples and, consequently, a dramatic impairment in the ability to explore the underlying molecular mechanisms of rare cancers. The aforementioned limitations have an enormous negative impact on the number of treatments which have the potential to significantly affect patients’ outcomes. Such limitations may be efficaciously contained and significantly minimized by the development of transnational networks, which may serve as an effective strategy for generating high quality and rigorous scientific evidence concerning rare cancers. The creation and implementation of functional networks among the collaborating partners involved at an international level would undoubtedly enhance the translational research potentials of each of the institutions involved. Translational networks may allow the conduct of projects fostering the use of multimodal treatments involving conventional and targeted approaches, drugs successfully used in other neoplasms that may find application in rare tumors, orphan drugs and, most interestingly, novel drugs that may be applied to multiple rare diseases, making them appealing and economically sustainable.

International consortia with a focus on translational research in rare cancers hold great potential in promoting multidisciplinary collaborations that in turn can speed the rate at which pre-clinical research discoveries become clinically viable health technologies and interventions. Among the most timely and largely unexplored topics potentially relevant to a translational research agenda, the role played by environmental determinants, ethnic variation and racial disparities in rare cancers may exemplify potential issues to be efficiently addressed throughout a network-based approach.

The national/regional funding organisations listed below have agreed to participate in the TRANSCAN-2 Joint Transnational Call for proposals 2017 (JTC 2017):

• Austrian Science Fund (FWF), Austria

• Research Foundation - Flanders (FWO), Belgium, Flanders

• Fund for Scientific Research - FNRS (F.R.S.-FNRS), Belgium, French speaking

  community

• Estonian Research Council (ETAg), Estonia

• National Cancer Institute (INCa), France

• ARC French Foundation for Cancer Research (ARC Foundation), France

• Federal Ministry of Education and Research (BMBF), Germany

• General Secretariat for Research & Technology (GSRT), Greece

• The Chief Scientist Office in the Ministry of Health (CSO-MOH), Israel

• Ministry of Health (MoH), Italy

• Alliance Against Cancer (ACC), Italy

• Lombardy Foundation for Biomedical Research (FRRB), Italy

• State Education Development Agency (VIAA), Latvia

• Luxembourg National Research Fund (FNR), Luxembourg

• Dutch Cancer Society (DCS), Netherlands

• National Centre for Research and Development (NCBR), Poland

• Foundation for Science and Technology (FCT), Portugal

• Slovak Academy of Sciences (SAS), Slovakia

• Spanish Association Against Cancer Scientific Foundation (FCAECC), Spain

• National Institute of Health Carlos III (ISCIII), Spain

• The Foundation for the support of the Applied Scientific Research and Technology in

  Asturias (FICYT), Spain

• Ministry of Science and Technology (MoST), Taiwan

• Scientific and Technological Research Council (TUBITAK), Turkey

2. AIMS OF THE CALL

2.1 Scientific project

The projects proposed within the TRANSCAN-2 JTC 2017 call must address the following topic:

“Translational research on rare cancers”

The decisions concerning the focus of the present call are strongly motivated by the challenges related to research and treatment in rare cancers, which are intimately tightened to the low incidence of any single clinical-pathological entity currently listed among these cancers. On this basis, a network-based approach within the operating framework provided by TRANSCAN-2 could contribute to address compelling research questions in the area of interest. Indeed, the development and consolidation of consortia founded on international collaborations will allow to efficiently integrate resources spanning the entire continuum from diagnostics to therapeutics and maximize the efforts for collecting clinically annotated biological samples. Such consortia will serve as a guide to pool scientific expertise, share novel insights and eventually train young investigators. In this view, the proposals of the present call will have to cover a minimum of one of the specific aims reported below, and within the aim/s of choice, the applicants will have to address at least one of the topics listed as bullet points. Proposals addressing one single aim and one single bullet point within the chosen aim will be allowed.

Aim 1: Design and conduct of translational research studies exploiting/combining resources from current clinical trials, bio-repositories and epidemiology-type resources.

Translational cancer research on aetiology, pathogenesis and prognosis of rare cancers is tightly linked to the integrated use and facilitated access to biospecimens from patients. Translational research goals in rare cancers may thus be achieved throughout studies of cohorts of patients with available biospecimens adequately stored in biorepositories linked to cancer registry data.

•   Translational studies based on the analysis of data and/or of clinically annotated specimens from previously conducted/ongoing trials with adequate follow up.

•   Conduct of studies for cancer risk assessment in rare cancers leveraging upon access to institutional and/or national cancer registries.

•   Identification and characterization of the etiopathogenetic determinants involved in rare cancers aiming at increasing our knowledge of the underlying pathways to be targeted by means of existing or experimental therapies.

Aim 2: Development and exploitation of translational research platforms (e.g., patient derived xenograft models/organoids/tissue collections) to study drug responses/resistance and toxicity, and perform drug screens or repurpose approved anticancer drugs.

•   Tissue collection, and genetic and epigenetic characterization of patient-derived rare tumors xenografts (PDXs). PDX could be used to identify determinants of heterogeneity in patient response to therapy, and thus inform patient-oriented therapeutic decisions. PDX could be used to screen for candidate pathways and/or therapeutics.

•   Three-dimensional cultures (or 'organoids') obtained from patients’ rare tumors which closely replicate key properties of the original cancers. Organoid cultures could be amenable to the detection of genetic and/or epigenetic changes associated with drug sensitivity and may thus lead the way to targeted approaches that could improve clinical outcomes in cancer patients.

•   Other translational research platforms that give insights into the drug responses/resistance and toxicity of drugs, and help perform drug screening for the treatment of rare diseases (e.g., induced pluripotent cell clones established from patient tumors and normal cells and induced to differentiate in vitro).

  AIM 3: Implementation of precision biomarkers for better stratification of the clinical cohorts.

•   Validation and implementation of rare cancers associated biomarkers as molecular predictors of therapeutic response, treatment resistance and disease outcome.

•   Use of innovative, high throughput technologies designed to facilitate the comprehensive ‘omic assessment of genomes, transcriptomes, proteomes, metabolomes, etc. of patients affected by rare cancers.

•   Design and conduct of phase I and/or phase II clinical studies aiming at the validation and implementation of precision biomarkers (including approaches based on liquid biopsies to enable non-invasive assessment of tumour heterogeneity and to monitor tumour dynamics) in patients diagnosed with rare cancers.

Inclusive criteria:

1. Rare cancers. This criterion will be applied to each of the proposals submitted for evaluation. Rare cancers will be defined as diseases whose incidence, when individually considered, is lower than 6 newly diagnosed cases per 100.000/year in Europe.

The RARECAREnet cancer list is available at the following link:

http://www.ecpc.org/Documents/Projects/RARECAREnet/RARECAREnet_list_of_rare_cancers.

xlsx

2. Pediatric cancers. Pediatric cancers will be eligible if listed among rare cancers

http://www.ecpc.org/Documents/Projects/RARECAREnet/RARECAREnet_list_of_rare_cancers. xlsx

The following types of research projects are excluded from the call:

1. Studies on common cancers, i.e., cancers whose incidence is equal to/greater than 6

   newly diagnosed cases per 100.000/year.

2. Studies on biomarker discovery only.

3. Studies based on preclinical models only (e.g., transformed cell lines and animal models).

4. Phase III and IV clinical trials.

5. Studies not compliant with the COMMISSION REGULATION (EC) No 800/2008

   (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:214:0003:0047:en:PDF), with specific reference to the articles 30, 31, 32, and 33. For full reference, please see also the COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS of 20.12.2011 (link). Studies not compliant with the Commission Regulation (EU) No 651/2014 of 17 June 2014 (link).

2.2 Capacity building activities

Translational research has the ambition to remove barriers to multidisciplinary collaboration. It is envisioned that clinicians, researchers and the operational staff from various sectors (academia, industry, regulatory bodies) will effectively work together to expedite the translation of scientific discoveries to clinical application and to more rapidly fuel research directions with observational or clinical findings. In fact, the complexity of the process requires, at the individual and collective levels, the creation of translational medicine research interfaces/infrastructures.

To reach that goal, TRANSCAN-2 supports capacity building activities for promoting the formation and upgrading of multidisciplinary teams in an integrated process: i) exchange/mobility of individual researchers/professionals within the consortium in order to bring new expertise to an existing multidisciplinary translational team, and/or ii) recruitment of individual researchers/professionals by a translational research team in order to cover expertise and “knowhow” unavailable in the existing team. This type of activities, when present, will be supported within the projects which will be selected for funding under TRANSCAN-2 JTC 2017. Thus, applicants may add an additional part to cover these activities (with an associated separate budget, in compliance with the rules of the respective national/regional funding organisations).

These capacity building activities have to be fully coherent with the objectives of the research project, and aimed to strengthening the ability of participating team(s) to perform the work detailed in the project plan as well as to improve, in the long term, the quality and potential of the translational research performed by the team(s). Depending on the project these activities could be (the following examples are indicative only, and neither exhaustive nor prescriptive): 1) exchanges/mobility of investigators (especially young investigators) between teams and countries participating in the project, 2) short term training of scientists, operational staff, etc., 3) training technical workshop dedicated to relevant aspects of the scientific work planned in the project, 4) short training (1 or few weeks) of several partner teams by one expert, etc. Activities related to the dissemination of results such as hosting a symposium, conferences etc. are out of the scope of this capacity building activities component.

3. CALL IMPLEMENTATION BOARDS

The Call Steering Committee (CSC) and the Scientific Evaluation Committee (SEC) will manage the evaluation procedure of pre-proposals and full proposals and the final selection of research projects, with the support of the Joint Call Secretariat (JCS).
The CSC is composed of one single representative from each national/regional funding organisation participating in TRANSCAN-2 JTC 2017. The CSC will supervise the preparation and the implementation of the call and will take all decisions concerning the call. Based on the ranking list established by the SEC, the CSC will take the final decision on the proposals to be funded. Members of the CSC are not allowed to submit proposals to this call.

The SEC is a panel of internationally recognised scientific experts in charge of the evaluation of submitted pre- and full proposals. SEC members are not allowed to submit or participate in proposals within this call. SEC members must sign declarations on conflicts of interest and confidentiality. In the second step of evaluation (full proposals stage), in addition to the SEC members, external peer reviewers chosen for their knowledge in specific fields covered by the proposals will also contribute to the evaluation.

4. APPLICATION

4.1 Eligibility criteria

Joint transnational research proposals may be submitted by applicants belonging to one of the following categories depending on national/regional eligibility rules as specified in Annex 3:

•   Academic research groups (from universities or other higher education or research institutions).

•   Clinical/public health sector research groups (from hospitals/public health and/or
  other health care settings and health organisations).

•  Enterprise's research groups (depending on national/regional eligibility rules), with
  particular emphasis on small and medium-sized enterprises.

Only transnational projects will be funded. Each research consortium asking for funding must involve a minimum of three (3) research groups and a maximum of seven (7) research groups. The maximum number of 7 research groups could be increased only with partners from the following countries: Estonia, Latvia, Slovakia and Turkey, up to a maximum of 4 additional partners from the 4 countries, to reach a maximum total of 11 research groups in a proposal.

In each consortium, groups applying for funding must be from at least three (3) different countries participating in the call. In addition, a consortium must not involve more than two (2) research groups from one country (in such cases the minimum number of groups must be 4, coming from 3 different countries).

In order to strengthen the European translational cancer research area, a wide inclusion of research teams from all the countries/regions participating in the call is encouraged, with a particular attention to research teams from Estonia, Latvia, Slovakia and Turkey. A consortium may include one (1) research group (included in the maximum number of seven) with own funding from a country/region not partner in this call. This group must provide a written confirmation that its funding is already secured at the stage of the pre-proposal submission.

Each consortium must nominate a coordinator. The coordinator will be responsible for the scientific management (such as controlling, reporting, intellectual property rights issues, etc.) and will act as the interface with the JCS and the CSC. Each research team will be represented by one principal investigator only, who will be the contact person for the respective national/regional funding organisation.

Each consortium must involve at least one basic or pre-clinical research team and one clinical team. It is also recommended to include an expert team in methodology, biostatistics or bioinformatics, depending on the type of work planned. Consortia may also involve other teams with specialised skills and know-how (biobanks, model systems, technological platforms, etc.) or expertise (epidemiology and molecular epidemiology, early phase clinical trials, public health, ELSI, etc.). Consortia should have sufficient critical mass to achieve ambitious scientific, technological and medical goals and, along with the particular contribution of each research team, should clearly demonstrate its translational added value. The translational nature of the research results is the key goal of TRANSCAN-2 and, therefore, each consortium should also clearly demonstrate a knowledge transfer towards clinical, public health and/or industrial applications.

While the application will be submitted by the coordinator, the individual research groups will be funded by the funding organisation from their country/region that is participating in the TRANSCAN-2 JTC 2017. The applications are therefore subject to eligibility criteria of national/regional funding organisations.
The inclusion of a non-eligible partner in a proposal may lead to the rejection of the entire proposal without further review. Prior to submitting a proposal, applicants should take note of individual national/regional rules described in the Annex 4 of this document in order to verify their eligibility, the eligible costs and potential budget available. Therefore, applicants are strongly advised to contact their national/regional funding organisations (see Annex 1. Contact information of the national/regional funding organisations) for any clarification.

Please note that an eligibility check before the pre-proposal submission is mandatory for the Ministry of Health (MoH), Italy, Alliance Againsts Cancer (ACC), Italy, Lombardy Foundation for Biomedical Research (FRRB), Italy. Participants from Turkey should also submit their proposals in Turkish to TUBITAK electronically via ardeb-pbs.tubitak.gov.tr by 12th of February for pre- proposals and no later than 5th of June for the full proposal stage.

The duration of the projects shall not exceed three (3) years. According to the eligibility criteria of the funding organisations contributing to the TRANSCAN-2 JTC 2017, a research group may however receive funding for less than three years.

4.2 Submission of joint proposals

TRANSCAN-2 JTC 2017 will be implemented through a two-stage submission procedure: pre- proposals and full proposals. Both pre- and full proposals must be written in English and must be submitted to the JCS by the coordinator through the electronic submission system exclusively.
In preparing the proposals, applicants should strictly follow the rules described in this call text and in the document entitled “Guidelines for applicants”, and use the application forms available from the electronic submission system (http://transcan.cbim.it/). Applicants should take note of individual national/regional rules, and contact their national/regional contact points for specific questions.

The pre-proposals must be submitted to the electronic submission system no later than the 6th of February 2018, at 16:00 (Central European Time, CET). The information relating to the selected pre-proposal will be communicated by the JCS to the coordinators by April 2018.
The information provided in the pre-proposal application is binding for the entire application process. Thus, any substantial changes between the pre-proposal and the full proposal (e.g. composition of the consortia, objectives of the project, etc.) must be communicated in advance to the JCS with detailed justification and will only be allowed by the CSC under exceptional circumstances.

The full proposals will have to be submitted to the electronic submission system not later than the 30th of May 2018 at 16:00 (Central European Summer Time, CEST). Please note that full proposals will only be accepted from applicants explicitly invited by the JCS to submit them.
The decision on the results of the full proposals evaluation meeting will be communicated to all the (successful and unsuccessful) coordinators in October 2018. The coordinators of the full proposals will receive a summary of the evaluation conclusions in due time.

5. EVALUATION

5.1 Evaluation criteria

Pre-proposals and full proposals will be assessed according to the following criteria.

1. Excellence

1. Scientific quality of the proposal: soundness of the rationale including transdisciplinary considerations, clarity of the objectives, expected progress beyond the state-of-the-art, international competitiveness.

2. Relevance of the project regarding the topic (translational research on rare cancers) and the overall objective (translational cancer research) of the call; availability and quality of preliminary data.

2. Impact

1. Potential impact with reference to the development, dissemination and use of project results: potential impact of the expected results on cancer control, in terms of translation into public health or clinical practices (enhancing innovation capacity and integration of new knowledge) and/or into pharmaceutical/industrial applications; appropriateness of measures for the dissemination and/or exploitation of project results including socio-economic aspects and anticipation of intellectual property issues (patenting, industrial exploitation, marketing, etc.).

2. Impact with reference to strengthening the translational capacity building activities:
   This sub-criterion will be assessed at the level of the full proposal only and solely for the scientific proposals recommended for funding.

   The assessment of the capacity building component and associated budget will be performed under this sub-criterion after the scientific assessment of the proposal: hence, a proposal could be recommended for funding without the part related to capacity building activities if this part is evaluated as “poor”.

   The assessment under this sub-criterion will be performed independently using the following:

   • Content: relevance and coherence of the capacity building activities with the proposal objectives.

   • Candidate: background (scientific, medical, etc.), coherence with the CV, scientific production.
   • Host team: expertise of the host team in the field, research qualification of the responsible person.

3. Quality and efficiency of the implementation

1. Coherence and effectiveness of the work plan: appropriateness and feasibility of the methodology (including the clinical trial if applicable) and associated technologies used, with particular regard to the study design, the study population(s), study endpoints.

2. Statistical/bio-statistical aspects and power calculation (including the clinical trial if applicable): study design; sampling calculations; appropriateness and robustness of statistical analyses: adequateness of endpoints.

3. Quality of the transnational research consortium: experience of the research partners in the field(s) of the proposal (for young teams: appropriateness of their current work and training of their members); quality of the collaboration between the research teams and added value of the research consortium as a whole.

4. Appropriateness of the management structures and procedures, including risk and innovation management.

5. Appropriateness of the allocation of tasks and resources to be committed (personnel, equipment, etc.) and of the estimated budget.

6. Compliance with ethical rules and regulatory aspects.

5.2 Scoring
5.2.1 Range and interpretation of the scores
A scoring system from 0 to 5 will be used to evaluate the proposals performance with respect to each evaluation criterion, as follows:

0: fails to address the criterion or missing information;
1: criterion poorly addressed/serious weaknesses;
2: fair/ some weaknesses;
3: good/ shortcomings are present;
4: very good/ criterion well addressed;
5: excellent.

Please note that half marks may be given.

5.2.2 Thresholds and weighting

The threshold for individual criteria is 3. The overall threshold, applying to the sum of the individual scores, is 10.
To determine the ranking:

- the score of the criterion “impact” will be given a weight of 1.5.

In case of equal score, the “impact” score will be considered first, then the score of “excellence” and then of “quality and efficiency of the implementation".

5.3 Eligibility check of pre-proposals and first step of evaluation
5.3.1 Eligibility check
The JCS will examine all pre-proposals to ensure that they meet the call’s formal criteria (date of submission, number of participating partners, and countries/regions of provenience, inclusion of all necessary information in English, adherence to the application forms, document length). The JCS will forward the pre-proposals to the national/regional funding organizations, which will perform a formal check of compliance with their respective regulations.
After completion of the eligibility check, the CSC will take the final decision; the pre-proposals not considered eligible will be rejected without further review. The coordinators of the non-eligible pre-proposals will be informed accordingly by the JCS.

5.3.2 Evaluation of pre-proposals

Pre-proposals passing the formal eligibility checks will be reviewed by the SEC panel.
All necessary steps will be taken by the JCS and the CSC to ensure that the SEC members have no conflict of interest for those proposals that they are asked to review. The SEC members will be required to formally declare that no conflict of interest exists at any time of their evaluation duty and will sign a confidentiality agreement concerning all documents and the entire process. Each pre-proposal will be allocated to at least two (2) SEC members (one of whom will act as rapporteur). The SEC will meet, discuss the pre-proposals and establish a ranking list in accordance with the pre-proposals respective merit. Then, the CSC will decide, based on the SEC recommendations and budget consideration, how many pre-proposals will be invited to submit a full proposal. The JCS will communicate to each project coordinator the final decision with respect to their own application. Successful applicants will be invited by the JCS to submit a full proposal, with possible recommendations on the project from the SEC and the CSC.

5.4 Eligibility check of full proposals and second step of evaluation

An eligibility check of the full proposals will be performed by the JCS to ensure that they meet the formal criteria of the call and have not changed substantially from the respective pre-proposals. A full proposal may be excluded from further review, if criteria are not met or if the proposal objectives or the composition of the consortium deviate substantially from the previously submitted pre-proposal. In any case, major changes must be communicated in advance to the JCS, which will contact the concerned national/regional funding organizations to discuss the issue; a formal decision on whether such an exceptional change may be justified will be taken by the CSC. Each full proposal will be allocated to two (2) SEC members, possibly those who had reviewed the corresponding pre-proposal, an additional methodology review by two (2) SEC methodologist members, and to at least one (1) external reviewer. One of the SEC members will be appointed as rapporteur. The SEC members and the external reviewers will independently assess the full proposals according to the evaluation criteria mentioned above, and will deliver their evaluation reports to the JCS (via an electronic evaluation system).

5.4.1 Rebuttal stage

Once the evaluation by both the SEC members and the external reviewers is completed, each proposal coordinator will have access, through the electronic submission system, to the anonymous evaluation reports (not to the assigned scores) by the SEC members and the external reviewers. At this stage, each coordinator will have the opportunity to comment the evaluations, to reply to reviewer's questions and to clarify factual errors or misunderstandings. However, issues which are not related with reviewers’ comments or questions cannot be addressed and the work plan cannot be modified. The resubmission of the full proposal is not permitted in any case.

This response to reviewers’ comments is optional and must be submitted exclusively by the coordinator of the proposal through the electronic submission system, which will be available from the 7th of August 2018 to the 17th of August 2018 at 16:00 (Central European Summer Time, CEST).

In preparation of the second SEC meeting, all SEC members will get access to the evaluation reports and to the optional responses submitted by the coordinators following the rebuttal stage. During the second SEC meeting, each full proposal will be presented by the rapporteur and discussed by the SEC members on the basis of the individual evaluation reports to reach consensus scoring. As a result of these discussions and as an outcome of the SEC meeting, a ranking list of the full proposals will be established. In addition, each rapporteur will draw up an evaluation summary report resulting from the debate at the SEC meeting, which will be anonymized and sent by the JSC to the proposal Coordinator.

5.5 Funding decision

After the end of the evaluation process, on the basis on the ranking list established by the SEC and on the resources available for committed funds, the CSC will establish a final list of the projects to be funded. The CSC recommendations will be sent to the national/regional funding organisations for their final decisions.

The JCS will communicate to all project coordinators the final decision along with the summary of the evaluation conclusions (evaluation summary report), prepared by each rapporteur.

6. FINANCIAL AND LEGAL ISSUES

6.1 Funding model and funding details

The TRANSCAN-2 JTC 2017 funding organisations have agreed to launch a joint call using the “virtual common pot” funding model. This means that funding will be made available by each national/regional funding organisation according to their specific regulations, for research groups in their country/region.

The funding rate within the call will be variable up to a maximum of 100% of the funds requested, according to national/regional rules. Funding is granted for a maximum of three years according to national regulations. Each research project partner (including the project coordinator) will get a separate funding contract/letter of grant according to national/regional regulations from his/her national/regional funding institutions.

As a general rule, no changes to the composition of research consortia or in budget may occur during the contract/letter of grant. Any minor changes will have to be well justified and the relevant funding organizations will decide upon the proper action to be taken. However, in case of major changes, an independent expert may be consulted to help with the final decision of the funding organizations. The research partners shall inform the coordinator, the JCS and her/his national contact person of any event that might affect the implementation of the project.

Depending on the time needed for the administration of granting funds to the respective national/regional research groups, individual tasks of a research consortium are expected to start by April 2019. The official start date shall be communicated in the annual reports and shall appear in the consortium agreement established in accordance to section 6.2 below.

6.2 Research Consortium Agreement, ownership of intellectual property rights, ethical issues

It is mandatory for a funded research project consortium to sign a Consortium Agreement (CA), addressing the issues indicated in the document "Guidelines for Applicants". See link for an EU example of a CA. For the composition of the CA, the research consortium is strongly recommended to see legal assistance of a TTO (Technology Transfer Office) at their own institute. Also, the research consortium is strongly recommended to sign this CA before the official project start date. In any case the CA has to be signed no later than six months after the official project start date. The signed consortium agreement must be made available to the concerned TRANSCAN-2 JTC 2017 funding organizations.

Results and foreground IPR resulting from projects funded through the TRANSCAN-2 JTC 2017 will be owned by the organization that employs the participant who creates the results, respecting to international/national/regional rules on IPR. If several participants have jointly carried out work generating new IPR, they shall agree amongst themselves in the CA as to the allocation of ownership of IPR, taking into account their contributions to the creation of those IPR. European Commission ́s guidelines on IPR issues should be respected in TRANSCAN-2 JTC 2017 research projects.
The owner may protect foreground IPR at its own cost and risk, and grants the other parties in the research consortium free user rights of both background and foreground IPR as far as necessary for executing the TRANSCAN-2 JTC 2017 research project. Licencing or transfer of foreground IPR between consortium partners or to third parties will be on the basis of a market-based compensation. The consortium partners grant each other a free user right of foreground IPR for non-commercial research and education purposes during and after the TRANSCAN-2 JTC 2017 research project.

The results of the research project and IPR created should be disseminated and made available for use, whether for commercial purposes or not, in order to maximize public benefit. Dissemination should not conflict protection of IPR. In the CA the parties agree on the procedures for delaying dissemination of results to enable protection of IPR. The delay may not exceed 120 days after the originally planned date of dissemination.

The TRANSCAN-2 JTC 2017 funding organizations shall have the right to use reports, documents, and information submitted by the research partners for their own purposes, provided that the owners ́ rights are respected.
Any ethical issues, arising for instance if a research project includes a study on patients, should be addressed at the proposal submission stage, and subsequent authorization presented at the latest to the national/regional funding organizations, before the process of grant negotiation.

6.3 Confidentiality of proposals

Proposals and any relating information shall be kept confidential by the SEC members (including SEC methodologist members), the external reviewers and the CSC members. Proposals shall not be used for any purpose other than the evaluation and subsequent monitoring of the funded projects.

Full proposals will be required to include a publishable summary, which will clearly identify the main goals of the project. If a proposal is funded, this information will be published on the TRANSCAN-2 website. All other project details shall remain strictly confidential.

7. REPORTING AND DISSEMINATION

The coordinator of a funded transnational research consortium must submit annual scientific project reports (within 4 months after the end of a calendar year), and a final scientific project report (within 3 months after the end of the project) to TRANSCAN-2. All reports must be written in English and comply with the reporting form templates (one for the annual reports and one for the final report) that will be provided to the coordinators of the funded projects in due time.

In addition to these centrally-administered TRANSCAN-2 reports, principal investigators may be asked to submit financial and/or scientific reports to their national/regional funding organizations. Each individual contract/letter of grant will be monitored by the respective national/regional funding organizations.
In case of serious difficulties in the conduct of the research project, the coordinator shall promptly inform the JCS and the relevant funding organizations. These funding organizations will decide upon the proper actions to be taken.

Funding recipients must ensure that all results (publications, etc.) arising from the project include a proper acknowledgement that the project is collectively supported by the national funding organisations under the framework of the ERA-NET TRANSCAN-2 initiative.
The coordinators and/or principal investigators may be invited to present the results of their projects at TRANSCAN-2 symposia.

8. CONTACT AND FURTHER INFORMATION

The JCS is set up at the Alliance Against Cancer, Italy. The JCS will assist the CSC during the implementation of JTC 2017 as well as during the monitoring phase (until 3 months after the funded research projects have ended). The JCS will be responsible for the central management of the call evaluation and monitoring. The JCS will be the primary contact referring to the TRANSCAN-2 JTC 2017 procedures between the research consortia, the funding organizations (CSC) and the peer reviewers (SEC members and external experts).

Further information on TRANSCAN-2, the TRANSCAN-2 JTC 2017 and its planned time schedule is available at the TRANSCAN website: http://www.transcanfp7.eu. Before submitting a proposal, it is strongly advised to contact the national/regional funding organizations for any questions regarding JTC 2017 (see Annex 1).