Fondazione Celiachia Foundation for Celiac Disease Fondazione Celiachia ... research within the...

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FC Fellowships - Call for Proposals 2017 FC - Fondazione Celiachia – www.celiachia.it Scientific Office Via Caffaro 10, 16124 Genoa, Italy [email protected] 1 - FC - Fondazione Celiachia Foundation for Celiac Disease FC FELLOWSHIPS CALL FOR PROPOSALS 2017

Transcript of Fondazione Celiachia Foundation for Celiac Disease Fondazione Celiachia ... research within the...

Page 1: Fondazione Celiachia Foundation for Celiac Disease Fondazione Celiachia ... research within the field of celiac disease and dermatitis herpetiformis in public or private non-profit

FC Fellowships - Call for Proposals 2017

FC - Fondazione Celiachia – www.celiachia.it

Scientific Office

Via Caffaro 10, 16124 Genoa, Italy

[email protected]

1

- FC - Fondazione Celiachia

Foundation for Celiac Disease

FC FELLOWSHIPS

CALL FOR PROPOSALS 2017

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FC Fellowships - Call for Proposals 2017

FC - Fondazione Celiachia – www.celiachia.it

Scientific Office

Via Caffaro 10, 16124 Genoa, Italy

[email protected]

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. Expected Outcomes of the Triennial Fellowship Project 7

7. The Research Plan 8

8. Application Submission and Deadline 10

9. Funding, Legal Fulfilments, Annual Instalments and Reports 13

10. The Review Process 16

11. Report Meeting at the National AIC Congress 19

12. Suspension, Waiver and Interruption, Revocation 20

13. Transfer of the Applicant/Head of the Hosting Lab to another Institute 22

14. Code of Conduct and Scientific Integrity 22

15. Intellectual property 22

16. Publications and Printed Materials 23

17. Privacy Law (Informativa ai sensi dell’art. 13 Del D.LGS 196/03) 24

18. Competent law-court (Foro Competente) 24

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1. Foreword

The Fondazione Celiachia (FC) is releasing the ‘FC Fellowships - Call for Proposals 2017’

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/organisations.

Each Triennial FC Fellowship is granted for a total of € 85.000, of which € 75.000 for the

triennial gross salary of the FC Fellow (€ 25.000 per year gross salary) and € 10.000 to be

used during the Triennial FC Fellowship program exclusively for the purchase of

Consumables and Supplies.

The total funding available for the ‘FC Fellowships - Call for Proposals 2017’ is € 425.000.

2. Documentation and Regulation/Policies

Document Aim

FC Fellowships - Call for

Proposals 2017

Sets the aims and objectives of the Call, along with the rules

governing the granting process

Application Form

Application Signature Page

Form

Head of the Hosting Lab

Letter Form

Head of the Hosting Lab

Letter Signature Page Form

Standard Forms to be mandatorily used for submitting the

Proposal. The documents contain all relevant instructions for

correctly filling in, and confirm or complete the rules expressed by

the present Call

Regolamento FC per i Bandi

Fellowship

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

The present ‘FC Fellowships - Call for Proposals 2017’ 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.

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3. Legend

Legend Definition

Applicant/Candidate The Applicant or Candidate is the young graduate and/or post-

doctoral fellow who submits the Application Form for the

Fellowship research plan and aims at receiving the Triennial FC

Fellowship Grant

FC Fellow The Applicant awarded with the Triennial FC Fellowship Grant

Triennial FC Fellowship The FC Fellowship is the triennial employment contract between

the Hosting Institute and the awarded Applicant.

Each Triennial FC Fellowship is granted by FC for an overall amount

of € 85.000, of which € 75.000 for the triennial gross salary of the FC

Fellow (€ 25.000 per year gross salary) and € 10.000 to be used

during the Triennial FC Fellowship program exclusively for the

purchase of Consumables and Supplies.

Head of the Hosting Lab The Head of the Hosting Lab is the senior investigator coordinating

the laboratory in which the awarded Applicant will perform the

research plan

Hosting Institute 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 of

the Hosting Institute

The Legal Representative is the authorized representative of the

Hosting Institute, who 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 Signature Page Form and the Head of the Hosting Lab

Letter and Signature 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.

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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 obtained after 31st December

2010

3. Applicants must submit research plans exclusively and fully focusing on celiac disease

and/or dermatitis herpetiformis

4. 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, Head of the Hosting Lab, 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 any FC funds

5. Only 1 Applicant per research group (i.e. having the same Head of the Hosting Lab)

can apply, and only 1 proposal per applicant can be submitted.

Applicants can submit Proposals also when holding other positions, but this condition must

be declared in the dedicated Section of the Application Form including the starting and

ending dates of the position/positions held and the site/centre/institute where the

position/positions are held. However, it is mandatory that the awarded Applicant gives up

all open positions before starting the Triennial FC Fellowship contract as described in

Section 9 of this Call.

Applications which do not fully adhere to the above requirements will

be rejected.

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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 organisation (such as university,

hospital or other research centre) 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), is required to supervise the

work of the FC fellow, and provide training and mentoring. A letter of the Head of the

Hosting Lab 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.).

Applications which do not fully adhere to the above requirements will

be rejected.

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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. Expected Outcomes of the Triennial Fellowship Project

As pointed out in Sections 1 and 10.2 of the Call, the Triennial Fellowship not only aims at

carrying out a Research Plan and achieving the expected results, but should also point at

broadening the experience of the young Candidate in scientific research within the field

of celiac disease and dermatitis herpetiformis.

As key outcomes of the Triennial Fellowship, FC expects that the FC Fellow will:

Run the Research Plan as reported in the Application Form, and yield the expected

results

Improve his/her expertise and knowledge in the field of celiac disease/dermatitis

herpetiformis, and his/her track record. In particular, it will be expected that the FC

Fellow will publish at least one or more papers about the Fellowship Project as first

Author in the international Journals (Pubmed quoted)

Acquire/improve his/her technical skills in terms of methodologies, instruments,

organisation of lab space and resources

The above aspects are considered directly relevant to the success of the Fellowship

Proposal’s aims. Annual Progress Reports and the Final Scientific Report will be used by the

FC Fellow to describe his/her achievements.

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7. The Research Plan

7.1. Duration

The FC Fellowships - Call for Proposals 2017 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).

7.2. Research Topics

All proposed research plans must have a clear focus on ONLY ONE of the following

research topics:

1. Celiac Disease

2. Dermatitis Herpetiformis

ONLY ONE research topic can be indicated in the Application Form.

7.3. Research Areas

Moreover, proposed research plans must fall into ONLY ONE of the following research

areas:

Allergology - Biomedical Research

Anatomic pathology – Histopathology - Biomedical Research

Biochemistry - Biomedical Research

Biology (structural, computational, signalling) - Biomedical Research

Clinical trials - Biomedical Research

Clinics (paediatrics or adult) - Biomedical Research

Dermatology - Biomedical Research

Drug discovery – screening – development - Biomedical Research

Endocrinology - Biomedical Research

Epidemiology – Prevention - Biomedical Research

Genetics - Control of gene expression and epigenetics - Biomedical Research

Gynaecology - Biomedical Research

Immunology – Immunobiology - Biomedical Research

Infection and inflammation - Biomedical Research

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Nutrition - Biomedical Research

Oncology - Biomedical Research

Preclinical study - Biomedical Research

Proteomics - Biomedical Research

Grains chemistry and biochemistry - Food Technology Research

Microbiology and grain biotechnology - Food Technology Research

Grain genomics and proteomics - Food Technology Research

Grain processing - Food Technology Research

ONLY ONE research area can be indicated into the Application Form.

7.4. 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:

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. This also includes defining harmful components of gluten

Innovation of clinical methodologies

Evaluation in clinical practice of the efficacy of diagnostic and therapeutic

approaches, in terms of outcome and quality of life. This also includes improvement

of the quality and safety of the gluten-free diet, and innovation of food products

New therapeutic drugs, procedures or strategies (pilot clinical studies)

Critical evaluation of last generation drugs (their activity by mechanistic insights).

7.5. 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 “variations-

on-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

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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.

8. Application Submission and Deadline

1. Documents for applying to the FC Fellowships - Call for Proposals 2017 are

downloadable at the following FC webpage:

www.celiachia.it/Fondazione/BandoFellowship2017

2. Download and complete the following documents:

Application Form

Application Signature Page Form

Head of the Hosting Lab Letter Form

Head of the Hosting Lab Signature Page Form

Each of the above Forms contain detailed instructions for completion.

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 2017, and

the completion of the Application Form and the other associated Forms, please send

an email with your query to the FC Scientific Office: [email protected]. FC

will provide you a written answer. Questions will be accepted until 27 April 2017 at

18:00 o’clock Italian time. Questions and Answers will be published on the FAQ page:

www.celiachia.it/Fondazione/BandoFellowship2017

3. The Application Form and the Head of the Hosting Lab Letter Form must be each

completed and saved as two distinct PDF files:

DO NOT SCAN them, but just SAVE them as PDF files: scanned PDF file and image

file will NOT be accepted

4. The Application Signature Page Form and the Head of the Hosting Lab Letter Signature

Page Form must be completed, printed, signed and scanned. All signatures must be in

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blue ink. The two Forms must be sent as separate annexes along with the Application

Form and the Head of the Hosting Lab Letter Form.

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

7. If applicable, also include a copy of the clearance/clearances (for human and/or

animal experimentation) of the Ethical Committee/Institutional Review Board, as PDF

scan. If not already available, the Applicant is required to send a copy of the

clearance submission/submissions (on Institutional Paper, signed by the Applicant

and the Head of Laboratory) to the Ethical Committee/ Institutional Review Board, as

PDF scan. Please note that it is not possible to submit the Application Form in the

absence of the above described documents (clearance ore clearance submission)

8. All Forms and files must be sent as attachments within one single email

communication:

Be careful not to produce large PDF files: all the files taken together should not be

larger than 12 MB and must be sent as attachments within one single email

communication.

In case all the files taken together are 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.

9. The email communication containing all the requested files must be sent to the

following email address:

[email protected]

The [email protected] receives emails from any other kind of

addresses, including non-pec email addresses

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The deadline for submitting Applications (sending the email containing

all the requested files) is 29 April 2017 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. FC reserves the right to ask for clarifications concerning

the submitted project proposal to the Applicant and/or to the Head of

Laboratory and/or to the Institution at any time during the evaluation

process.

Applications missing requested data or documents, as well as

Applications not entirely written in English will be rejected.

Applications presenting documents differing from the above Forms will

be rejected.

Applications sent to FC after the indicated deadline will be rejected.

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9. Funding, Legal Fulfilments, Annual Reports

9.A Funding

1. The FC Fellowship is a triennial employment contract between the Hosting Institute

and the awarded Applicant. The overall amount of each FC Triennial Fellowship (FC

Fellowship Grant) is € 85,000 and is made of the following two typologies of funding:

€ 75,000 for the 3-years Personnel Cost of the FC Fellow (triennial gross salary)

€ 10,000 exclusively for Consumables and Supplies to be purchased during the FC

Triennial Fellowship Research Plan

2. The 3-years Personnel Cost of the FC Fellow (€ 75,000 triennial gross salary).

The 3-years Personnel Cost of the FC Fellow (triennial gross salary) is € 75,000 (€ 25,000

per year) and will only cover the gross personnel cost of the Fellow (salary), whereas

NO OTHER COSTS (including consumables and other direct costs, indirect costs,

general costs of the Hosting Institute, etc.) can be ascribed to this part of the FC

Fellowship Grant.

Please note that depending on the legislation and the rules applied by the Hosting

Institution, the FC Fellowship contract 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 contract, 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 to the FC Fellow salary will remain €

25,000 gross amount per year.

3. Consumables and Supplies (€ 10,000).

With the exception of the 3-years Personnel Cost of the FC Fellow (€75,000 triennial

gross salary), all the other costs annexed to the FC Triennial Fellowship Research Plan

will be completely covered by the Head of the Hosting Lab and the Hosting Institute.

However, the FC Fellowship Grant also includes € 10,000 that can be used exclusively

for Consumables and Supplies to be purchased during the FC Triennial Fellowship

Research Plan, according to the Estimated Budget Plan reported in Section 9 of the

Application Form.

9.B Legal Fulfilments

1. Hosting Institutes of the selected Candidates will receive a Grant agreement

(“CONTRATTO DI GRANT FELLOWSHIP TRA FC E L’ISTITUTO”). Within 90 days after the

signature of the FC Grant Agreement between FC and the Hosting Institute, the FC

Fellow and the Hosting Institute MUST finalise the following mandatory steps:

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Provide a copy of the fellowship contract between the Hosting Institute and the FC

Fellow (“CONTRATTO DI BORSA DI STUDIO TRIENNALE TRA L’ISTITUTO E IL BORSISTA

FC”). Among the other requested data, it is mandatory that the fellowship

contract starts between February and March of the year following the launch of

the FC Call (for the FC Call 2017, the fellowship contracts must start between

February and March 2018)

In case the FC Candidate is holding other positions, provide a copy of the

document in which the FC Candidate declares to give up the position he/she is

currently holding at the Hosting Institute or at any other site/centre/institute. The

FC Candidate must provide such a renunciation document for each of the active

positions he/she is holding or is going to hold. The FC Fellow must not receive any

other continuous employment income during the Triennial FC Fellowship period,

and the Triennial FC Fellowship cannot be cumulated with any other

revenue/contract (fellowships, any kind of employment contract, collaboration

contracts, etc.)

In case the FC Candidate is holding other positions, provide a copy of the written

approval by the site/centre/institute of the renunciation document of the FC

Candidate for each of the active positions he/she is holding or is going to hold

In case of human/animal involvement, provide a copy of the Ethical Committee

approval to the Triennial FC Fellowship Research Plan. In fact, for studies involving

human subjects, human biological samples and/or for animal experimentation,

the corresponding approval of the competent authorities (i.e. Ethical Committee)

is mandatory and must be provided together with a copy of the informed consent

form (if applicable). 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. 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. The approval document issued by the Ethical

Committee MUST indicate:

The date when the Ethical Committee meeting was held; approvals obtained

more than 8 months before the submission of the Application Form, as well as

approvals relating to other projects will NOT be accepted

The name of the Applicant and/or of the Head of the Hosting Lab

The title of the Fellowship Proposal and a clear reference to the study

described in the Fellowship proposal.

2. The FC Fellowship Grant will not be awarded in the absence of even one of the

requested documents and/or in case of delivery after the fixed deadline. This will lead

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to the cease of the Grant agreement (“CONTRATTO DI GRANT FELLOWSHIP TRA FC E

L’ISTITUTO”).

3. For the entire duration of the Triennial 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.

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 organisation (e.g. changes in Institution name, merging, Legal

Representative turn-over, changes in addresses, etc.) must be promptly notified to

FC

4. Conditions described in the present Section shall be maintained during the entire FC

Fellowship Grant duration. Disregarding these conditions at any moment of the Grant

might lead to the suspension of the FC Fellowship Grant, and complete refund might

be requested by FC

9.C Annual Instalments and Reports

1. Upon the receipt of all the requested documents within the fixed deadline, FC will

transfer the first annual instalment of the FC Fellowship Grant (€ 25,000 for the FC

Fellow gross salary, plus the amount requested for the first year – out of € 10,000 - for

the Consumables and Supplies) to the Hosting Institute.

2. The FC Fellowship Grant will be allocated on three annual instalments. Each annual

instalment is made of € 25,000 for the FC Fellow gross salary, plus the amount

requested for each year – out of € 10,000 - for the Consumables and Supplies.

Allocation of 2nd and 3rd annual instalments is made at the beginning of the

corresponding year of the Triennial FC Fellowship Program, and will follow upon the

presentation, and FC approval, of an yearly report through appropriate Forms

provided by FC, including:

A Scientific Annual Progress Report signed by the FC Fellow, the Head of the

Hosting Lab and the Legal Representative of the Hosting Institute

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 comprise the following documents:

The 12 pay slips (buste paga) paid out to the FC Fellow during the reported

period, which must overall account for 25,000 € per year, including taxes if

any. The pay slips MUST report the name of the FC Fellow, the Hosting

Institution and the title and the number of the FC Fellowship Project

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The reporting of the amount spent each year – out of € 10,000 - for the

Consumables and Supplies. The corresponding invoices MUST report the

Hosting Institution and the title and the number of the FC Fellowship Project

10. The Review Process

All Applications received by FC within the framework of the FC Fellowships - Call for

Proposals 2017 undergo the following steps:

First Step Administrative Check of Conformity

Second Step Peer Reviewers’ Evaluation

Final Step Approval of the Ranking List by the FC Board, and funding

10.1. – First Step: Administrative Check of Conformity

1. All Applications undergo an initial administrative review with 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 of 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.

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10.2. Second Step: Peer Reviewers’ Evaluation

1. For the scientific evaluation of FC Fellowships, FC relies on the expertise of

internationally recognised 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 on 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:

Criteria Description

Adherence to FC’s high

research priorities

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

Consistency of the

Proposal with a triennial

duration

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

Consistency of the

Proposal with the selected

Research Topics

The Reviewers assess 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

Consistency of the

Proposal with the work of

one person

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

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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.

The Reviewer assigns a score to each criterion and provides a written comment:

Weighted Evaluation Areas Scored Criteria

Proposal’s intrinsic Scientific

Value

(50% weight)

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; originality of the Proposal

Feasibility of the Proposal

(50% weight)

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

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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.

10.3. 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

11. Report Meeting at the National AIC Congress

Applicants holding a FC Fellowship Grant are invited to the Scientific National AIC

Congress held yearly in November. A first Progress Report is requested at half of the

triennial fellowship and a Final Report is presented at the end of the fellowship.

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12. Suspension, Waiver and Interruption, Revocation

Submitting an 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 to 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.

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.

12.1. 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 (including those circumstances foreseen by law in the Fellowship Contract

between the Hosting Institute and the FC Fellow - “CONTRATTO DI BORSA DI STUDIO

TRIENNALE TRA L’ISTITUTO E IL BORSISTA FC” – such as maternity leave, disease etc.), 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.

Requests for suspension must be urgently forwarded to FC, and shall contain detailed

reasons for the suspension request.

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.

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

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is not expressly accepted by FC: failure to accept it shall have the effect of an interruption

of the project.

The suspension of the Fellowship shall imply the suspension of payments for the period in

question. Requests for suspension for further periods on the same project, in addition to

those already allowed, shall not be admitted.

12.2. 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: the Fellow

and/or the Head of the Hosting Lab/the Hosting Institute shall forfeit the funding, and 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. Of course, any residual amount not yet

paid will be retained by FC.

The scientific and financial reporting, and other activity obligations referring to the period

of actual performance shall remain unprejudiced.

Any interruption of the Fellowship depending on reasons or intent of the Applicant/the

Head of the Hosting Lab/the Hosting Institute is treated in the same way as voluntary

waiver. Exceptions due to serious external factors of particular importance will be

evaluated by FC.

12.3. Resolutory Clause and Revocation of the Fellowship Grant

In case of non-compliance with any of the obligations under this Regulation, FC reserves

the right to revoke the project with the same effects as those resulting from waiver and/or

interruption. The revocation will apply for any of the following reasons (the list is not

comprehensive):

Scarce or none compliance of the project activities with the object of the funding

Insufficient, omitting or inadequate scientific/financial reporting activity

Scarce or none observance of provisions concerning scientific integrity

Omitted or insufficient notice of the results

Failure to comply with protection of property

Impediments or significant changes, either of objective or of subjective nature, of the

project

Any change in the content of the Grant Agreement

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

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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

Suspensions not approved by FC

The situations resulting in the revocation, insofar as they may be ascribed to the Applicant,

the Head of the Hosting Lab or the Hosting Institute, may imply liability to FC and are

unfavourably considered; participation in the subsequent Call is however excluded.

13. Transfer of the Applicant and/or Head of the Hosting Lab

to another Institute

Transfer of the Applicant/Head of the Hosting Lab 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 urgently demand FC’s authorization first together with a

letter signed by the Head of the Hosting Lab and the Legal Representative of the Hosting

Institute. 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 Resolutory Clause

and Revocation of the Fellowship Grant.

14. 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, 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

his/her primary reference in view of the institutional objectives of FC.

15. 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

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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 no.

30 of 10th February 2005) and, insofar as compatible, by the civil code provisions on joint

ownership (Arts. 1100 – 1139 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.

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 the paragraph

below (‘Publications and Printed Materials’).

16. 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 present with regard to

the research/training activities carried out through the FC funding, first of all to keep the

Foundation informed and, moreover, to permit the organisation of activities of disclosure –

agreed with the researcher/fellow – to the media and through the communication

instruments of the Foundation and of the AIC. All the above is to be 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 shall always be

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acknowledged through a note included in the publication or materials, formulated as

follows and mentioning 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 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.

17. Privacy Law (art. 13 D.LGS 196/03)

Relating to the Italian Law 30 June 2003 no. 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.

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.

18. Competent law-court (Foro Competente)

For whatever controversy, the competent law-court is the one sited in Genova, Italy.