FC FELLOWSHIPS CALL FOR PROPOSALS 2016

Transcription

1 - FC - Fondazione Celiachia Foundation for Celiac Disease FC FELLOWSHIPS CALL FOR PROPOSALS

2 Table of Contents 1. Foreword 3 2. Documentation and Regulation/Policies 3 3. Legend 4 4. Eligibility criteria for Applicants 5 5. Eligibility criteria for the Hosting Institute and of the Head of the Hosting Lab 6 6. The Research Plan 7 7. Application Submission and Deadline 9 8. Funding, Legal Fulfilments, Annual Renewals and Reports The Review Process Report Meeting at the National AIC Congress Intellectual property Publications and Printed Materials Suspension, Waiver and Interruption, Revocation Transfer of the Applicant/Head of the Hosting Lab to another Institute Code of Conduct and Scientific Integrity Privacy Law (Informativa ai sensi dell art. 13 Del D.LGS 196/03) Competent law-court (Foro Competente) 22 2

3 1. Foreword The Fondazione Celiachia (FC) is releasing the FC Fellowships - Call for Proposals 2016 aimed at awarding up to 5 triennial fellowships to highly qualified young graduates and/or post-doctoral fellows who wish to broaden or acquire experience in scientific research within the field of celiac disease and dermatitis herpetiformis in public or private non-profit Italian research institutes/organizations. The total funding available for the FC Fellowships - Call for Proposals 2016 is 375, Documentation and Regulation/Policies Document FC Fellowships - Call for Proposals 2016 Application Form and Head of the Hosting Lab Letter Form Regolamento FC per i Bandi Fellowship Aim Sets the aims and objectives of the Call, along with the rules governing the granting process Standard Forms to be mandatorily used for submitting the Proposal. The documents contain all relevant instructions for correct filling in, and confirm or complete the rules expressed by the present Call Rules, policies and guidelines reported in the present Call are also described in Italian language for the use of the Hosting Institute. The document also contains additional administration rules and policies dedicated to the Hosting Institute 3 The present FC Fellowships - Call for Proposals 2016 and the annexed documents (Regolamento, Application Form, and Letter of the Head of the Hosting Lab, which confirm or complete the rules expressed by the present Call) do represent the Regulation and Policies; Applicants and Hosting Institutes are required to fully adhere to it. FC reserves the right of integrating the Regulation with ad hoc decisions in case of dissimilarities or other eventualities.

4 3. Legend Legend Applicant/Candidate FC Fellow FC Fellowship Definition The Applicant or Candidate is the young graduate and/or postdoctoral fellow who aims at receiving the FC triennial fellowship and submit the research plan The Applicant awarded by with the FC Fellowship Grant The FC Fellowship is the triennial employment contract between the Hosting Institute and the awarded Applicant. The gross amount of the triennial Fellowship is granted by FC upon a contract agreement between FC and the Hosting Institute, and is 25,000 per year. The gross amount only cover the personnel cost of the Fellow, whereas NO OTHER COSTS (such as consumables and other direct costs, indirect costs, general costs of the Hosting Institute) can be ascribed to the grant Head of the Hosting Lab Hosting Institute The Legal Representative of the Hosting Institute The Head of the Hosting Lab is the senior investigator coordinating the laboratory in which the awarded Applicant will perform the research plan The Hosting Institute is the public or private non-profit Italian research institute in which the Head of the Hosting Lab is working and the awarded Applicant will perform the research plan The Legal Representative, the authorized representative of the Hosting Institute, will be responsible, along with the Head of the Hosting Lab, of all the legal and administrative duties related to the FC fellowship award. The Legal Representative of the Hosting Institute signs the Application Form and the annexed Head of the Hosting Lab Letter Form, thus guaranteeing that the Fellowship and the research plan will be performed in the Hosting Institute under the conditions established within the Call and the annexed Regolamento FC per i Bandi Fellowship. 4

5 4. Eligibility criteria for Applicants At the time of the deadline for submission, the following eligibility criteria must be met: 1. Applicants must have obtained a Master s Degree (equivalent to the Italian Laurea Magistrale) or a Long Single Cycle Degree (equivalent to an Italian Laurea a ciclo lungo, lasting 5 or 6 years)or an equivalent non Italian degree in Medicine, Biological Sciences, Pharmacy, Chemistry, Agriculture or other scientific disciplines. The obtained degree should formally entitle the Applicant to embark on a doctorate in the country where the degree was attained. Applicants who have obtained a PhD will also be eligible. Applicants having obtained a Bachelor s degree (equivalent to the Italian laurea breve ) are not eligible 2. For all Applicants, the Degree (Laurea) must have been attained after 31 st December Applicants must submit research plans exclusively and fully focusing on celiac disease and/or dermatitis herpetiformis 4. The FC Fellow must not receive any other continuous employment income during the FC fellowship period (3 years), and the fellowship cannot be cumulated with any other revenue (fellowships, any kind of employment contract, collaboration contracts, etc.) 5. The Applicant and his/her Head of the Hosting Lab must not have any kind of active FC Grants in which they act as principal investigator, internal collaborator, fellow, doctorate, technician etc, nor as multicentre study partners receiving part of the funds of the active FC Grant. Exceptions are allowed only in case of Applicants/Heads of the Hosting Lab participating to other active FC Grants as external collaborators who do not receive FC funds 6. Only 1 Applicant per research group (i.e. having the same head of laboratory) can apply, and only 1 proposal per applicant can be submitted 5 Applications which do not fully adhere to the above requirements will be rejected

6 5. Eligibility criteria for the Hosting Institute and of the Head of the Hosting Lab At the time of the deadline for submission, the following eligibility criteria must be met: 1. The Hosting Institution is an Italian non-profit research organization (such as university, hospital or other research center) which irrespective of its legal status (public or private law bodies) has the primary goal to independently conduct non-profit biomedical research and to disseminate its results. Possible revenues coming from non-profit research activity must be completely reinvested in the non-profit research activities. Where the Hosting Institution also pursues economic activities, the financing, the costs and the revenues of those economic activities must be accounted for separately. Shareholders, members or other individuals that can exert a decisive influence upon the Hosting Institution cannot enjoy a preferential access to the intellectual property of the results generated by the non-profit research activity. 2. Hosting Institutes and the Head of the Hosting Lab must ensure optimal working conditions to the FC fellows: in addition to providing facilities, equipment, reagents, consumables and infrastructure, they are expected to offer adequate training resources and cover expenses for travel, conferences and meetings when these are deemed important for the training and education of the FC fellow. 3. The Head of the Hosting Lab is an investigator with proved experience in the field of celiac disease and/or dermatitis herpetiformis in whatever scientific discipline accepted by the FC Call (see the Research Plan Section), and is required to supervise the work of the FC fellow, and provide training and mentoring. A letter of the Head of the Hosting Lab signed by the Head of the Hosting Lab, the Applicant and the Legal Representative of the Hosting Institute must be included in the Application Form (Head of the Hosting Lab Letter Form), describing all resources and training opportunities available. The letter MUST commit the Hosting Institution and the Head of the Hosting Lab to: provide the necessary lab space and infrastructures to the FC Fellow make available the necessary resources (e.g. research grants held by the Head of the Hosting Lab) to the FC fellow for carrying out the proposed research plan make sure that the Head of the Hosting Lab will offer complementary skills training (e.g. written skills for preparation of grants and papers, ethical issues and regulations in biotechnologies etc.) and mentoring activities, following a specific training plan for the fellow (e.g. frequency of one-on-one meetings, lab meetings, participation to seminars and international congresses etc.) 6 Applications which do not fully adhere to the above requirements will be rejected.

7 Moreover, these conditions shall be maintained during the entire Grant duration. Disregarding these rules at any moment during the Grant will lead to the suspension of the FC Fellowship Grant, and complete refund will be requested by FC including funds already allocated 6. The Research Plan 6.1. Duration The FC Fellowships - Call for Proposals 2016 is aimed at granting triennial fellowships. For this reason, the present Call will only consider 3-years research plans submitted by young graduates and by post-docs in scientific disciplines, with a clear focus on celiac disease or dermatitis herpetiformis. The research plan, agreed with the Head of the Hosting Lab, will be included into the Application Form. Please make sure to propose a research plan that is consistent with the work of one person and with the triennial duration of the fellowship. Proposals that look like requiring the work of several people will be judged as not feasible by the Reviewers and will be scored as WEAK proposals (see Section 9) Research Topics 7 All proposed research plans must have a clear focus on one of the following research topics: 1. Celiac Disease 2. Dermatitis Herpetiformis ONLY ONE research topic can be indicated into the Application Form Research Areas Moreover, proposed research plans must fall into one of the following research areas: 1. Biomedical Research: Allergology Anatomic pathology - Histopathology Biochemistry Biology (structural, computational, signalling) Clinical trials Clinics (paediatrics or adult) Dermatology Drug discovery screening - development

8 Endocrinology Epidemiology - Prevention Genetics - Control of gene expression and epigenetics Gynaecology Immunology - Immunobiology Infection and inflammation Nutrition Oncology Preclinical study Proteomics 2. Food Technology Research: Grains chemistry and biochemistry Microbiology and grain biotechnology Grain genomics and proteomics Grain processing ONLY ONE research area will be indicated into the Application Form FC s HIGH Funding Priorities Research plans (whatever topics and areas) falling into one of the following definitions will be considered by the Peer Reviewers as high research priorities: 8 Proximity to find new pathogenic mechanisms Proximity to cure Natural history of the pathology by linking different phases of the disease to specific biological/genetic profiles Interactions between environmental risk factors, genetic profiles and intermediate biomarkers Innovation of clinical methodologies Evaluation in clinical practice of the efficacy of diagnostic and therapeutic approaches, in terms of outcome and quality of life New therapeutic drugs, procedures or strategies (pilot clinical studies) Critical evaluation of last generation drugs (their activity by mechanistic insights).

9 6.5. FC s LOW Funding Priorities The following kinds of research plans will receive low priority during the peer review process and have marginal chances of being funded: Studies that are essentially confirmatory in nature or represent marginal variationson-the theme of well-established concepts Studies contemplating descriptive screenings of molecules and/or phenotypes without mechanistic insights and/or elements of innovative discovery. These include purely descriptive microarray and proteomic profiling studies that are not associated with a strong strategy for clinical application, or the generation of chemical compounds without validating their activities in pharmacological and biological studies Generation of reagents and/or optimization of technologies, or creation of services/technological facilities in the absence of a coherent and innovative research plan Chemical and/or viral studies not embodied in the framework of mechanistic studies Requests for on-going routine collection of current statistics, such as celiac disease registry Descriptive epidemiology studies Health economics proposals Studies that do not contribute to build or expand an original and independent line of research Application Submission and Deadline 1. Documents for applying to the FC Fellowships - Call for Proposals 2016 are downloadable at the following FC webpage: 2. Download and complete the following documents: Application Form Head of the Hosting Lab Letter Form Each of the above Forms contain detailed instructions for completing requested data. The Application Form and the Head of the Hosting Lab Letter Form must be written entirely in English. For any doubts concerning the rules of the FC Fellowships - Call for Proposals 2016, and the completion of the Application Form and the other associated Forms, please send

10 an with your query to the FC :. FC will provide you a written answer. Questions will be accepted until 20 April 2016 at 18:00 o clock Italian time. Questions and Answers will be published on the FAQ page: 3. Each completed Form must be SAVED AS A PDF FILE: DO NOT SCAN completed Forms, but just SAVE each of them as a PDF file: scanned PDF files and image files will NOT be accepted 4. Moreover, print and sign the Signature Pages of the Application Form and of the Head of the Hosting Lab Letter Form: All signatures must be in blue ink Signed Signature Pages of the Application Form and of the Head of the Hosting Lab Letter Form must be scanned as PDF file 5. Also include a copy in PDF format of the degree certificate (certificato di laurea) mandatory reporting all of the following data: the University, the type of the degree, the degree score, the official date the degree was awarded, the title of the Thesis, and the Discipline 6. If applicable, also include a copy, in PDF format, of the Doctorate certificate (certificato di dottorato) mandatory reporting all of the following data: the University, the doctorate score or evaluation of the examining committee, the official date it was awarded, the title of the Thesis, the Discipline Finally, also include as PDF file a copy of the clearance of the Ethical Committee or of the Institutional Review Board. If not already available, the clearance MUST be obtained and sent to FC within 4 months upon the signature of the Grant agreement between FC and the Hosting Institute. 8. All PDF Forms and files and the scanned Signature Pages must be sent as attachments within one single communication: Be careful not to produce large PDF files: all the PDF Forms and files and the scanned Signature Pages taken together should not be larger than 12 MB and must be sent as attachments within one single communication. In case all the PDF Forms and files and the scanned Signature Pages taken together were larger than 12 MB, the files can be sent as a unique zipped folder which should NOT exceed 12 MB. The zipped folder must contain all the requested files.

11 9. The communication containing all the requested files (PDF Forms and files and the scanned Signature Pages) must be sent to the following address: The receives s from any other kind of addresses, including not pec addresses The deadline for submitting Applications (sending the containing all the requested files) is 26 April 2016 at 18:00 o clock Italian time Once received, the Application is considered as definitive, thus it cannot be amended/edited/integrated with missing data or documents Applications missing requested data or documents, as well as Applications not entirely written in English will be rejected 11 Applications presenting documents differing from the above Forms will be rejected Applications sent to FC after the indicated deadline will be rejected

12 8. Funding, Legal Fulfilments, Annual Reports 1. The FC Fellowship is a triennial employment contract between the Hosting Institute and the awarded Applicant. The amount of the triennial Fellowship is granted by FC (FC Fellowship Grant) upon a contract agreement between FC and the Hosting Institute, and is 25,000 per year (gross amount). Thus each triennial FC Fellowship Grant has a gross value of overall. 2. The gross amount of 25,000 per year will only cover the personnel cost of the Fellow (salary), whereas NO OTHER COSTS (such as consumables and other direct costs, indirect costs, general costs of the Hosting Institute) can be ascribed to the grant. All the other costs annexed to the research plan will be completely covered by the Head of the Hosting Lab and the Hosting Institute. For this reason, for the annual financial report requested by FC at the end of each Fellowship year, the Hosting Institute will be requested to provide the pay slips (buste paga) paid out to the Fellow during the reported period, which must overall account for 25,000 per year, including taxes if any. Please note that depending on the legislation and the rules applied by the Hosting Institution, the FC Fellowship may not be tax-exempt, in which case revenue taxes or social security contributions will be deducted. For instance, universities may be able to offer a tax-exempt fellowship, while this option may not be available in non-academic institutions. This will depend on the Hosting Institute only, and cannot be ascribed to FC whose allocation will remain gross amount per year Upon the signature of the Grant agreement by both FC and the Hosting Institute, FC will transfer the fellowship funds to the Hosting Institution, which will then pay the Fellow directly. 4. Within 60 days after the signature of the FC Grant agreement between FC and the Hosting Institute, the latter MUST finalize the fellowship contract with the FC fellow and MUST provide a copy of the contract to FC. The Fellowship will not be awarded in the absence of the necessary fellowship contract between the FC fellow and the Hosting Institute If the fellowship contract is not finalized within the time indicated above, the FC Grant will be blocked and the agreement between FC and the Hosting Institute will cease 5. For studies involving human subjects, human biological samples or for animal experimentation, the corresponding approvals of the competent authorities (i.e. Ethical Committee) are mandatory and must be submitted as soon as they are

13 available (best with the Application), and however not later than 4 months after the signature of the Grant agreement between FC and the Hosting Institute. The authorizations must be valid for the entire duration of the fellowship and a copy of such authorization must be provided, together with a copy of the informed consent form (if applicable) The approval document issued by the Ethics Committee MUST indicate: the date when the Ethics Committee meeting was held; approvals obtained more than 3 years ago (i.e. prior to 2013) are NOT acceptable; the name of the Applicant or of the Head of the Hosting Lab; a clear reference to the studies described in the proposal (e.g. the title of the application). Experimentation on animals (vertebrates, cephalopods and foetal forms of mammals) must conform to all regulations protecting animals used for research purposes. Research supported by FC that involves animal experimentation must comply with the principle of the Three Rs (3Rs) to Replace, Reduce and Refine the use of animals in research, as required by national and international rules The fellowship will not be awarded in the absence of the necessary authorizations. If the document will be not provided within the time indicated above, the FC Grant will be blocked and the agreement between FC and the Hosting Institute will cease 13 FC is not responsible for any inaccuracy in the ethical documentation provided and does not accept any liability for harm to participants in FC funded trials 6. The funds will be allocated on annual instalments. Allocation of 2 nd and 3 rd annual instalments will follow upon the presentation, and FC approval, of an yearly report through appropriate Forms provided by FC including: A financial annual report signed by the FC Fellow, the Head of the Hosting Lab and the Legal Representative of the Hosting Institute. The financial annual report will be represented by the pay slips (buste paga) paid out to the Fellow during the reported period, which must overall account for 25,000 per year, including taxes if any A scientific annual progress report signed by the FC Fellow and the Head of the Hosting Lab 7. For the entire duration of the FC fellowship the Fellow must guarantee a full time effort (100% of his/her working time) for 12 months per year on the Fellowship Project, and must operate within the indicated Hosting Institute and in the laboratory of the identified Head of the Hosting Lab.

14 Any change occurring in the relationship between the fellow and the Hosting Institution, or between the Head of the Hosting Lab and the Hosting Institution (e.g. termination, leave of absence, etc.), or any change of the Hosting Institution legal entity or organization (e.g. changes in Institution name, merging, Legal representative turn-over, changes in addresses) must be promptly notified to FC This condition shall be maintained during the entire Grant duration. Disregarding this rule at any moment of the Grant might lead to the suspension of the FC Fellowship Grant, and complete refund might be requested by FC including funds already allocated 8. The FC Fellow must not receive any other continuous employment income during the FC fellowship period (3 years), and the FC fellowship cannot be cumulated with any other revenue (fellowships, any kind of employment contract, collaboration contracts, etc.) 9. The Review Process All Applications received by FC within the framework of the FC Fellowships - Call for Proposals 2016 undergo the following steps: First Step Administrative Check of Conformity 14 Second Step Final Step Peer Reviewers Evaluation Approval of the Ranking List by the FC Board, and funding 9.1. First Step: Administrative Check of Conformity 1. All Applications undergo an initial administrative review by FC checking the compliance with guidelines and the eligibility criteria those Applications that are found to be non-compliant to any of the requirements and rules reported in the present Call and annexed Forms will be triaged out FC holds the responsibility and authority in making the final decision on the Application s completeness and eligibility 2. Applications that meet the eligibility requirements undergo a peer review process that ensures a fair, independent and expert evaluation of their scientific merit and competitiveness

15 9.2. Second Step: Peer Reviewers Evaluation 1. For the scientific evaluation of FC Fellowships, FC relies on the expertise of internationally recognized scientists working outside Italy 2. Applications are independently evaluated by three reviewers 3. Reviewer assignments are made in compliance with conflict of interest rules to ensure a review free from inappropriate influence 4. When accepting to evaluate an application, reviewers agree that they will maintain the confidentiality of the application and associated materials they have received Reviewers will evaluate the Applicants, the Head of the Hosting Lab and the Research Plan. Reviewers evaluate each proposal by a two-step procedure: A. Triaging the Proposal as Strong or Weak B. Score Evaluation of the Proposal A. Triaging the Proposal as Strong or Weak In this step, the reviewers evaluate the proposal as strong or weak on the basis of the following criteria: 15 Criteria Adherence to FC s high research priorities Consistency of the Proposal with a triennial duration Consistency of the Proposal with the selected Research Topics Consistency of the Proposal with the work of one person Description The Reviewers assign HIGH/LOW priority to each Proposal, with respect to FC s high research priorities. LOW priority Proposals will be scored as WEAK Proposals The Reviewers evaluate the consistency of the Proposal design, structure and purposes with a triennial duration Proposals not consistent with a triennial duration will be scored as WEAK Proposals The Reviewers assesse the consistency of the Proposal with the selected topics and areas Proposals not consistent with selected topics and areas will be scored as WEAK Proposals The Reviewers evaluate if the Fellowship Project Proposal is consistent with the work of one person Proposals that look like requiring the work of several people will be judged as not feasible by the Reviewers and will be scored as WEAK Proposals

16 At the end of this first evaluation step, the Reviewer ranks the Proposal as STRONG or WEAK: Proposals scored as WEAK by at least 2 out of 3 Reviewers will be triaged OUT, and will NOT enter the Ranking List. B. Score Evaluation of the Proposal Strong Proposals are further evaluated by the Reviewers. This second part of the assessment is made of two Evaluation Areas. Each Evaluation Area has an overall weight and is in turn composed of different criteria. To each criterion the Reviewer assigns a score and a written comment: Weighted Evaluation Areas Proposal s intrinsic Scientific Value (50% weight) Feasibility of the Proposal (50% weight) Scored Criteria Clearness of the Proposal s purposes Design and tasks of the Proposal and of the research plan: background, rationale and aims, experimental design, methodologies (Preliminary data supporting the working hypothesis, if the case), benefits in using animals (if applicable) Improvement of basic/clinical comprehension of the disease Methodological or conceptual innovation of the Proposal Potential difficulties, pitfalls, caveats and limitations of the Proposal, and their impact on the success of the research Applicant s education/publications, track record and professional and research experience (Curriculum Vitae of the Applicant) The relevance of the competence of the Head of the Hosting Laboratory in terms of expertise in the field, track record, international standing and ability to provide mentoring (Curriculum Vitae of the Head of the Hosting Lab) with respect to the success of the Proposal s aims. Also methodologies, instruments, lab space, infrastructures, and resources made available by the Head of the Hosting Laboratory, as well as the complementary skills training/mentoring activity offered by the Head of the Hosting Laboratory and the training plan dedicated to the FC fellow are evaluated as directly relevant to the success of the Proposal s aims The consistency of the estimated Research Budget Plan with respect to the design and the aims of the Proposal 16

17 The score system adopted by the Reviewers during the assessment of the project is here represented: Score Value 0 Unacceptable 1 Very Weak 2 Weak 3 Acceptable 4 Good 5 Very Good For each Proposal, the scores received from the 3 reviewers will be averaged to generate the Proposal s global score, which will be used to rank the Proposals in the Ranking List. Two Ranking Lists will be obtained at the end of the evaluation process: 1. The Ranking List of Proposals submitted by graduated Applicants 2. The Ranking List of Proposals submitted by Post-Doc Applicants By comparing the Proposals submitted by the same category of Applicants, FC aims at guaranteeing the best equal treatment of all Candidates Final Step: Approval of the Ranking Lists by the FC Board, and funding Provided that funds are available, FC s Board of Directors meets to decide on the allocation of funds to the most deserving Proposals of both Ranking Lists. FC reserves the right of allocating funds only to most deserving Proposals of only one of the two Ranking Lists, depending on funds availability and results of the evaluation process. At the end of the review process, all Applicants will be notified of the result of their application with a communication from FC that will include the reviewers comments. The identity of the reviewers will not be disclosed. The decision cannot be appealed 10. Report Meeting at the National AIC Congress Applicants holding a FC Fellowship Grant are invited to the Scientific National AIC Congress yearly taken in November. A first Progress Report is held at half of the triennial fellowship and a Final Report is presented at the end of the fellowship.

18 11. Intellectual property The Applicant and the Head of the Hosting Lab undertake to notify FC as soon as possible and however with the progress and final reports, in accordance with the good faith and fairness criteria, either a) personally b) or through the reference Structure of any invention or result for which it is possible to obtain a patent, protection, industrial rights or similar, fine-tuned and/or developed by availing, even in part, of resources and/or tools procured, supplied or however made available to the Fondazione Celiachia Onlus. Being aware that the rights resulting from the invention are governed, except where agreed otherwise, by the applicable law on intellectual property (Legislative Decree nr. 30 of 10 th February 2005) and, insofar as compatible, by the civil code provisions on joint ownership (Arts It. Civil Code), the Applicant and the Head of the Hosting Lab undertake to consider FC as the only owner of the rights deriving from the invention, in particular regarding: The filing of the patent application The economic exploitation of the research results and of their technological transfer Without prejudice to the right of the Applicant/Head of the Hosting Lab to be recognised as the authors of the invention, the Applicant, the Head of the Hosting Lab and FC agree that profits resulting from the exploitation of the invention will be distributed as follows: 50% to FC 50% to the Hosting Institute/Head of the Hosting Lab/Applicant 18 The Applicant and the Head of the Hosting Lab also undertake: To mention FC in all documents or publications referred or however connected with or related to the Foundation s Grant, as specified in this Regulation To act so as not to jeopardise in any way the suitable protection of their own and of FC s rights regarding the aforementioned results, expressly undertaking a secrecy and confidentiality obligation, also with regard to what is indicated in paragraph below ( Publications and Printed Materials ). 12. Publications and Printed Materials The Applicant and the Head of the Hosting Lab shall previously send the Foundation a PDF copy of the publication, report or congress papers they intend to make with regard to the research/training activities carried out through the funding of the same Foundation, first of all to keep the Foundation informed and, moreover, to permit the organisation of activities of disclosure agreed with the same researcher/fellow to the media and through the communication instruments of the Foundation and of the AIC. All the above is to be

19 implemented both during and after the period of the research supported, even in part, by FC s funding. Such materials are to be sent through transmission means allowing prompt information, at least thirty days before the date scheduled for their disclosure. Upon sending the materials, the expected publication data and the name of the magazine are to be specified, or the date and place of the congress, where the disclosure should take place. At any rate, and leaving aside the above indications for the protection of intellectual property, which apply to all activities supported/funded under this regulation, in each publication and disclosure activity the Foundation s contribution will always be acknowledged through a note included in the publication or materials, formulated as follows and mentioning, where possible, the identification number code of the Grant: was also supported by the FC (Fondazione Celiachia Onlus) Grant nr.. The Applicant and the Head of the Hosting Lab shall ensure their availability for any press office activity organised by FC and shall therefore be ready to contact the mass media in the forms and manners deemed appropriate by the same FC. The Applicant and the Head of the Hosting Lab and the Organisation or Institution where they operate undertake, at the same time, not to develop any press office activity relating to the research funded/co-funded by FC without a prior consent of FC. 13. Suspension, Waiver and Interruption, Revocation 19 Submitting a funding Application implies a commitment for the Applicant and the Head of the Hosting Lab, which becomes a legally binding obligation in case of notice of acceptance, to implement the project/activity in accordance with good faith, fairness, specific diligence, responsibility and reliability criteria. Therefore, the following hypotheses of suspension, waiver, interruption shall be limited to exceptional situations. FC in fact draws the utmost attention on the nature of the funds it destines for the funding of projects, which come from private sources, such as fund-raising, donations, legacies, or from 5 per mille, and it consequently requires that the beneficiary is fully aware, from the moment of the submission of the Application, that if the same is accepted, the relationship originated will entail mutual obligations and commitments, as FC should and will give account of the best use of the allocations among the various stakeholders. The beneficiary shall therefore not be allowed to withdraw, or to unilaterally modify any of the constitutive elements of the project, or to resolve all or part of the obligations undertaken, unless this occurs within the limits and at the conditions set forth in this Regulation.

20 The funding granted by FC shall therefore be binding, to all effects and purposes, for the researcher and the institution or reference organisation, or the organisation to which they belong, where the research takes place Suspension Suspension shall mean a temporary, and not final, stop of the research activities. The suspension can refer to exceptional circumstances, due to personal or organisational factors, or to force majeure which may for a limited and defined period prevent or hinder the continuation of the activities, and therefore reduce or jeopardise the usefulness or validity of the research activity. The request for suspension made by the Applicant must be accompanied by an authorisation of the Head of the Hosting Lab. If the suspension is accepted by FC, it will imply an extension of the time schedule as originally defined. Requests for suspension must be made without delay, taking in view the time and manner in which the underlying circumstances have materialised, and observing the general good faith, fairness and diligence criteria. Notwithstanding the above, based on the reasons and justifications offered by the Applicant and also in view of the rationale and of the confirmation of the targets and results of the project study despite the longer time required, FC reserves the right to accept or refuse the request. Therefore, the request for suspension shall have no effect if it is not expressly accepted by FC: failure to accept it shall have the effect of an interruption of the project under the following provisions. 20 The suspension of the Fellowship shall imply the suspension of payments for the period in question. Requests for suspension for further periods, in addition to those already allowed, on the same project shall not be admitted Voluntary waiver and interruption Unless it depends on exceptional factors, of subjective or objective nature, or on force majeure, voluntary waiver of projects or fellowships has consequences on the assessment of good faith, fairness, diligence in the fulfilment of the obligations undertaken by the Applicant, and will also have a negative impact on the evaluation of any subsequent application. In such cases, the project ends and the funding is consequently interrupted, and the Researcher shall forfeit the funding and any residual amount not yet paid will be retained by FC. If the Foundation has already made an advance payment, any amount not yet spent at the date of the waiver must be returned, within and not later than 30 days after the cessation of the Fellowship. The scientific reporting and activity obligations referring to the period of actual performance shall remain unprejudiced.

21 Interruption of the Fellowship is treated in the same way as voluntary waiver if it does not depend on reasons or intent of the Applicant, but on serious external factors of particular importance Revocation In case of serious non-compliance, for a long time, with the obligations under this Regulation, particularly as regards the compliance of the project activities with the object of the funding, the reporting activity, the observance of provisions concerning scientific integrity, notice of the results, protection of property, and any derived charters and, more generally, with all requirements under Law, FC reserves the right to revoke the project with the same effects as those resulting from waiver and/or interruption. Revocation will also be possible if impediments or significant changes, either of objective or of subjective nature, are found to affect relevant and significant aspects of the project to be approved, regardless of any specific faults of the Applicant or of the reference organisation; in no event shall the Applicant and the respective reference organisations/hosting institutes modify elements liable to affect the contents subject to assessment. The following may, for example and without limitation, constitute cases of change/impediment which FC may consider as reasons for revocation: Changes in the position of the Applicant resulting in possible incompatibility and/or conflict or however in the reduction or loss of autonomy and independence Changes in the identification of the reference/hosting institute, also in view of the nature and characteristics of the same Change in the type and nature of the relation between the Applicant and the hosting institute Subjective and/or objective impediments preventing actions for a period exceeding the maximum admitted suspension. 21 Revocation may take place only after a written notice has been sent by FC, indicating the serious non-compliance or the change/impediment found and provided that no arguments or justifications deemed acceptable by FC have been given in writing within the stated period, of no less than 15 days. The situations resulting in the revocation, insofar as they may be ascribed to the Applicant or the reference/hosting institute, may imply liability to FC and are unfavourably considered; participation in the subsequent Call is however excluded.

22 14. Transfer of the Applicant to another Institute Transfer of the Applicant to another Institute is considered by FC as an exceptional event due to force majeure and rarely accepted by FC. In any case, the Applicant must demand FC s authorization first. FC reserves the right to deny the transfer or, where it is not possible to avoid the transfer, to block the Fellowship Grant, by applying the same rules of the Voluntary waiver and interruption 15. Code of Conduct and Scientific Integrity The Applicant will act with honesty, fairness, seriousness and responsibility and in good faith in each activity relating to research and study activities conducted by the same, as well as those connected therewith (such as, for example and without limitation, during trial design, date generation and analysis, funding applications, publication of results, recognition of direct or indirect contributions of colleagues, collaborators and others, reports on activities and costs, etc.), always keeping scientific integrity and the superior interest of research as their primary reference in their conduct in view of the institutional objectives of FC. 16. Privacy Law (art. 13 D.LGS 196/03) Relating to the Italian Law 30 giugno 2003 n. 196, art 13, FC will treat all data provided by the Applicant and the Head of the Hosting Lab only for the aims of the Call and for the allocation of funds. All data requested in the Forms annexed to the present Call are mandatory in order to allow FC to perform the conformity and scientific evaluation of each Application. FC undertakes the responsibility to maintain all data highly confidential and protected. Only for awarded research plans, diffusion of research activities will be regulated by the Grant Fellowship Contract between FC and the Hosting Institute. 22 Ai sensi dell art 13 del decreto legislative 30 giugno 2003 n. 196, i dati personali e sensibili forniti dai candidati sono trattati per le finalità di gestione del presente bando e per la successiva eventuale attribuzione del finanziamento. La comunicazione di tali dati è obbligatoria ai fini della valutazione sia formale che scientifica. FC s impegna a garantire che i progetti presentati e non approvati e i relativi giudizi e valutazioni non siano divulgati, e vengano conservati in modo sicuro e non accessibile. Per i progetti finanziati, le modalità si diffusione e divulgazione saranno trattate in fase di contrattualizzazione del Grant. Firmando l Application Form, il PI e il Rappresentante Legale s impegnano ad accettare queste regole. 17. Competent law-court (Foro Competente) For whatever controversy, the competent law-court is the one sited in Genova, Italy.