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Brochure:

Hartstichting

Version: December 2017

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Content

1 Background ......................................................................................................... 2 2 Purpose of this Impulse Grant ................................................................................ 3 3 Main criteria ........................................................................................................ 3

3.1 Theme and ambitions (the consortium contributes to) ......................................... 3 3.2 Scientific excellence ....................................................................................... 4 3.3 Realistic strategy for technology transfer or valorisation ...................................... 4 3.4 Proof of effective collaboration and management ................................................ 4 3.5 Important general aspects .............................................................................. 5 3.6 Budget/ duration ........................................................................................... 5

4 Review process .................................................................................................... 6 4.1 First check by Dutch Heart Foundation .............................................................. 6 4.2 Combined role of ISAC-CVON and Committee Societal Quality (CSQ) .................... 6

4.2.1 Code of Conduct on Confidentiality and Conflicts of Interest .......................... 6

5 Recommendations from the committee ................................................................... 7 6 Preliminary time schedule ..................................................................................... 7 7 After decision/ after granting ................................................................................. 8

7.1 Complaints procedure .................................................................................... 8 7.2 After granting ............................................................................................... 8

Annex one ................................................................................................................. 9 Clear definition of and ambitions for the theme of the consortium ................................... 9 Scientific quality ...................................................................................................... 9 Realistic trajectory for strategy of knowledge application .............................................. 10 Consortium and development ................................................................................... 10

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1 Background

The Dutch Heart Foundation (DHF) is a charity that funds research, education and awareness

campaigns aimed at reducing the burden of cardiovascular disease in the Netherlands.

In the next twenty years the number of people with cardiovascular disease (CVD) in the

Netherlands will increase with 30%. In 2025 seven million people will suffer from a chronic

disease of which two million will be chronically ill due to cardiovascular disease.

Starting in 2018 the DHF will further strengthen her focus on finding and implementing new

possibilities to detect and solve cardiovascular diseases at an earlier stage. Preventing

damage due to cardiovascular disease as early as possible is essential to reduce the increase

in chronic CVD and the accompanying loss in quality of life. Therefore, it is necessary to

determine with more precision if someone is developing a cardiovascular disease. Additionally,

it is important to develop earlier and better treatments to prevent, lessen and/or repair

(early) damage. The main goal of this strategy is create solutions for large groups of people

suffering of CVD and to lower the disease burden of CVD in the year 2030.

In 2011 we started (together with NFU, KNAW and ZonMw) the CVON (CardioVasculair

Onderzoek Nederland) initiative aimed at creating collaboration of the best researchers at a

national level in the most promising research areas in the Netherlands. Consortia, funded

according to this initiative, are committed to solve important healthcare problems and are

multidisciplinary and translational in nature.

In 2014 the first national cardiovascular research agenda was developed together with the

Dutch public and major stakeholders, including patients, healthcare professionals, scientists,

volunteers and donors. This unique and comprehensive approach resulted in a research

agenda with ambitious aims and objectives for the mid- and long term of the following five

research themes (the links are to our website (in Dutch):

1. Earlier recognition of cardiovascular diseases

2. Cardiovascular disease in women

3. Better treatment of heart failure and arrhythmias

4. Acute treatment of strokes

5. New ways to keep up a healthy lifestyle

In June 2014, the founders of the CVON programme (KNAW, ZonMw, NFU and Dutch Heart

Foundation) approved the continuation of the CVON strategy, with an emphasis on creating a

long-term support for successful consortia, as also advised by the International Scientific

Advisory Committee of CVON (ISAC-CVON).

In the CVON programme the role of the ISAC-CVON is pivotal. This committee was – and is-

key in the selection of the CVON proposals and is involved in the monitoring of the progress of

the granted consortia.

Since 2017 the founders of the CVON program have expanded their collaboration with the

participation of the Netherlands Heart Institute, TTW, Health Holland, “Harteraad” (formerly De

Hart&Vaatgroep) and the ministry of Economic Affairs. Together they have aligned their

activities in the field of cardiovascular research to form the Dutch CardioVascular Alliance

(DCVA). This Alliance is committed to reduce the cardiovascular disease burden by 25% by

catalysing the translation of excellent Dutch science into patient solutions. The DCVA will

execute both the Dutch Heart Foundation Research Agenda and the Dutch National Research

Agenda by focussing on early detection of disease. This will reduce the number of chronic

patients and recurrence and counter the growth of healthcare costs by detecting cardiovascular

disease before irreversible damage has occurred.

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2 Purpose of this Impulse Grant

Based on the developments within the DHF, the CVON strategy, the DCVA strategy and the

recommendations of the ISAC-CVON, we have decided to further invest in well performing

consortia and to provide them the chance to build a long-lasting strategy based on national

collaboration around a major cardiovascular challenge and to accelerate bringing their

solutions to clinical practice.

This resulted in the current CVON Impulse Grant as outlined in this document.

The purpose of the Impulse grant is to create the opportunity for successful consortia to

continue their research for another 3-5 years and to further develop alliances of researchers

from academia and companies and other potential stakeholders around well-defined themes

with high impact.

Essential for this grant is that (part of) the results of the CVON 2012 consortia will be taken

into the next step on the translational research pathway.

3 Main criteria

The following principles are important in the review process:

Clear definition of the theme the consortium contributes to, including well-defined

ambitions for the short and longer term.

Scientific Excellence (the original CVON Criteria): the scientific programme for the

grant continuation based on the achievements in the past period and the objectives

for the continuation period.

Realistic strategy for technology transfer or valorisation and (future) implementation.

Also collaboration with users, private partners and patient involvement will be

reviewed.

Proof of effective collaboration with added value within the consortium and other

relevant consortia and partners.

Addressing important general aspects within the research policy of the DHF: male-

female differences, open access/ open science and development of talent.

In the next paragraphs the main points will be addressed. In annex one, the specific

questions that will act as a checklist for the evaluation of the application are indicated.

3.1 Theme and ambitions (the consortium contributes to)

In order to have a clear view of how the results of the research done by the consortium will

contribute to a reduction of the burden of CVD, the consortium has to address the scope, size

and impact of the health care problem the consortium will focus on.

We challenge the research leaders to formulate ambitions, preferably in a similar way as with

the themes of the research agenda, considering scope, size and impact of the healthcare

problem, the offered solution and how this contributes to the ambitions of the DHF that are

outlined in paragraph 1. This means that a short-term ambition (5 years) and a long-term

ambition (2030-2035) should be formulated with milestones (short-term), including necessary

non-scientific needs/actions. This in collaboration with other (CVON) consortia that work on

the same healthcare problem and preferable with stakeholders/(end-)users for example the

Dutch patient organisation De Hart&Vaatgroep (from January 2018 Harteraad). The

consortium has to define which part of the formulated ambitions/ milestones is the subject of

the research proposal for the next five years and for what additional funding will be sought by

the consortium or is beyond the scope of the current time window.

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As mentioned in paragraph 1, the Dutch Heart Foundation and the Dutch Cardiovascular

Alliance have a primary focus on early recognition of CVD and the related solution of this early

diagnosis. Early recognition should be part of the overall research plan of the consortium.

3.2 Scientific programme

The achieved main results of the consortium during the first phase should be internationally

competitive, have a scientific impact and should be (potentially) relevant for health care/

patients. As mentioned in the purpose of the Impulse grant, it is essential that (part of) the

results of the CVON 2012 consortium will be taken into the next step on the translational

research pathway. The consortium has to pay attention to the translation of the results and

possible new findings. The entire translational research pathway must be clear, but the entire

pathway does not have to be executed: either fundamental - clinical or fundamental -

epidemiological. This still means that as during the first phase the basic and clinical research

parts still have to be strong and synergistic. The newly proposed scientific programme and

the constitution of the consortium should be innovative to international standards and the

aims and plan of work have to be feasible.

3.3 Realistic strategy for technology transfer or valorisation

Based on successful findings, obtained in the first phase, the consortium should indicate in

this application how the next step(s) on the translational research pathway will be taken. This

should result in the next Market Readiness Level to clinical applications. The envisioned end

product(s) and the intended target group(s) for the product(s) should be indicated as well as

the impact of the product(s) on care. The several lines of development should be illustrated in

a flowchart for which a format is attached. An assessment whether this strategy for

technology transfer or valorisation is realistic and time- and cost-effective, will be part of the

evaluation of the application. The consortium is obliged to involve an HTA-expert to indicate if

their strategy is realistic. The outcome of the consultation/ analyses with this HTA-expert are

part of the proposal as well as how this will be continued during the project.

The DHF promotes the application of knowledge and stimulates the involvement of

appropriate stakeholders in the consortium by making funds available to match investments

from these third parties up to € 500.000. With this instrument, we aim to maximize the

chance for appropriate and fast implementation of the research results in (clinical) care for

cardiovascular patients.

Additionally, a user committee has to be installed, which has the task to monitor the use of

the acquired knowledge (see our website). The DHF strongly encourages to include

industry/third parties, patients and other (end) users in the consortium, especially patient

involvement has to be addressed.

3.4 Proof of effective collaboration and management

As was evaluated during the midterm review, the sustainability of the cardiovascular research

theme is important and should be extended beyond the duration of the present program. The

further development of the research theme within the Netherlands should continue during this

second phase. This is greatly dependent of the collaboration within the consortium. Therefore,

the consortium has to show the added value of this collaboration by indicating which

collaborative results were/will be achieved: (new) research angles/lines, mutual publications,

mutual grant applications/ funding/matching (adding to the theme), mutual meetings,

conferences, etc.. Also, the consortium has to address which steps have already been taken

to implement their knowledge into e.g. products, guidelines, commercial spin-offs etc.. This is

the output from the consortium in the first phase.

For the next phase, the DHF encourages the consortium to re-think/ redefine the composition

and the specific features of the consortium and the involved research - and WP-leaders in

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order to further optimize the quality of the consortium and to make it more suitable in view of

the developments within the theme. For example are the research leaders still the most

suitable leaders for the next phase? Can we foster talent from within or outside the

consortium to become a WP leader or research leader? Do we need additional expertise or a

partnership with private partners to be (more) successful in our next phase?

3.5 Important general aspects

The proposal will also be reviewed on the following general aspects. These items have to be

reflected in the whole proposal.

Differences between men and women

‘Cardiovascular diseases in women’ is the second topic on the research agenda of DHF. All

proposals must contribute to a better understanding of and address differences between men

and women in the prevention, diagnosis and treatment of cardiovascular diseases.

Research proposals on new technologies should identify how these technologies can

potentially be applied for cardiovascular diseases both in men and women. See the site of

Standford university for tools that can be used to integrate sex and gender aspects in

research applications.

Open access/ open science

The DHF has the ambition that all publications that are the result of research that is funded by

the DHF is published in an open access journal. Find out more on our Open Access in

publications policy (see also our website (in Dutch)).

The consortium has to outline in the proposal how the acquired data will be handled (data

stewardship). Therefore the consortium is strongly advised to involve a data-expert in their

consortium and is obliged to allocate resources for data-management into the budget. After

having been awarded the Impulse grant, the consortium will be asked to hand in a Data

Management Plan (DMP; format will be provided by the Durrer Center). This DMP is

considered to be a dynamic document and will also be used to monitor progress on data

management.

Development of talent

As during the first phase, stimulation/ development of talent within the consortium is an

aspect that has to be addressed. For this second phase, the consortium should redefine the

talent program in line with experiences from the first phase. The consortium has to take into

account that next to a consortium specific part, the consortium is also required to participate

in a collaborative program with the other CVON consortia in collaboration with other CVON

consortia (e.g. (for this moment) call for innovative ideas (‘Crazy ideas’) as organized by

Young@Heart and NL-HI congress).

The aims of the talent programme and which criteria are used to asses talents should be

made clear.

We expect that talented PhD students will get a postdoc position within next phase of the

consortium. Also, talented postdocs from outside the consortium may be included. To

stimulate the appointment of postdocs within the consortia, the ratio of requested postdoc vs

requested PhD students is at least 1:2. The success of the first phase talent programme

should be demonstrated by providing an overview of PhD students and postdocs that obtained

prestigious (postdoc) positions internationally or were offered prominent research positions in

academia or industry.

3.6 Budget/ duration

The available funding will be 3 million euro of which 10% should be dedicated to the talent

programme. The consortium should contribute to the activities organized in collaboration with

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the other CVON consortia and have to allocate 17,5% of the talent programme budget for

this. If applicable any other specific conditions for consortia about this available funding of 3

million euro will be communicated separately.

The duration of this granting period is a minimum of 3 to a maximum of 5 years.

Matching funding

Additional funding up to 0,5 million euro is available for 1:1 matching by (a) private

party(ies). The contribution of the private party has to be in cash and a solid letter of

commitment between the consortium and the private partner(s) is obliged for this additional

funding. The work done by this additional funding has to have an added value for this

consortium.

The request should be done preferable for the total amount of 0,5 million euro. If this is not

possible, please contact us, so we can discuss if a part of the amount can be requested.

The request can be part of the current proposal and requested budget, but it can also be

submitted during the term of the proposed project. If a proposal for this additional funding is

submitted in a later stage, the proposal will also be evaluated by the ISAC-CVON/Committee

Societal Quality.

Please contact at all times DHF if and when this additional application will be submitted. The

DHF will give you the specific requirements of this matching funding. Secondly, timely

informing will allow the DHF to additionally budget the requested amount in the requested

year or in light of budget constraints in the consecutive year.

4 Review process

4.1 First check by Dutch Heart Foundation

The Dutch Heart Foundation will do the first check if the application:

is in line with the purpose of the call

if the consortium has correctly addressed all the important elements in the application

if the conditions of the DHF are included in the application

is eligible in terms of the format used

4.2 Combined role of ISAC-CVON and Committee Societal Quality (CSQ)

After the first check is done by the Dutch Heart Foundation internally and if an application is

eligible, a committee, consisting of members of the ISAC-CVON and members of the CSQ, will

evaluate the application on the main criteria (paragraph 3). The criteria are specified in annex

one.

The ISAC-CVON members will review the applications from a more scientific viewpoint

The CSQ members will review the applications from a more societal quality viewpoint.

The applicants will receive a compilation of the reviews of the members of this committee in

order to prepare for an interview with the ISAC-CVON/CSQ. During this meeting the

applicants are requested to present their application, information will be send when the

application is eligible.

4.2.1 Code of Conduct on Confidentiality and Conflicts of Interest

DHF asks active researchers from knowledge institutes and specialists from other knowledge

intensive organisations to participate in assessment procedures. These people are themselves

involved in ongoing or new research and often belong to large organisational associations and

research networks. Therefore, any conflict of interests, or anything that remotely resembles

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this, must be avoided in the assessment of research proposals. Additionally the confidential

treatment of all information must be guaranteed.

To ensure a fair assessment and transparency for researchers, DHF uses a Code of Conduct

on Confidentiality and Conflicts of Interest. This code stresses the necessity of confidentiality,

identifies possible forms of conflicts of interest and indicates the steps to be taken to avoid

conflicts of interest. Parties subject to the code of conduct are: referees, jury members,

committee members, members of decision-making bodies and DHF officers. The full text of

the code of conduct on conflicts of interest used by DHF is available at:

https://www.hartstichting.nl/wetenschappers/subsidiewijzer (in Dutch).

5 Recommendations from the committee

Only if the Consortium scores very good/ excellent for the past programme and for this

current proposal on all the criteria mentioned above, the consortium will be considered for a

grant continuation and the ISAC/CSQ is requested to formulate a recommendation of: must

be funded.

If the scores are lower and/or there are serious doubts about (parts of) the proposal the

ISAC/CSQ is requested to formulate the recommendation of: not to be funded.

If an application can be re-written for ‘minor’ issues within two months the recommendation

‘not to be funded, unless’ can be given. It has to be very clear what should be improved

within the programme and/or consortium.

6 Preliminary time schedule

December 2017

Brochure and application form sent to consortia

February-March 2018

Discussion meetings between consortium and DHF (if needed)

Deadline 17 April 2018 14:00 hours

Submission of proposals

End of April 2018

DHF informs whether eligibility requirements have been met.

Adjustments possible within 10 working days.

May-June 2018

Assessment by ISAC and CSQ members

18 June 2018

Compilation of the reviews sent to consortium

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27 June 2018

Meeting, including interview with ISAC and CSQ members

Mid-July 2018

Decision by board of DHF

7 After decision/ after granting

7.1 Complaints procedure

A research leader can submit a complaint about the procedure by completing a form that is

sent to the Complaints Committee of DHF. It is not possible to appeal against the outcome of

the procedure. The form can be found on the DHF website. Complaints should be submitted

within four weeks after receiving the notice from the CEO of DHF.

7.2 After granting

After granting, the consortium partners have to sign two legal documents:

1. A consortium agreement between the DHF and the consortium partners (will be sent

Q1 2018) in which the legal and financial conditions are stated. This agreement is

non-negotiable.

2. An intra consortium agreement (ICA) (see appendix and available on the website)

containing a.o. paragraphs on IP, organisational and publication arrangements. The

ICA becomes part of the consortium agreement. The IP paragraphs are non-

negotiable.

The agreement and ICA have to be signed and returned to our DHF office within 6 months

after receipt of the grant approval letter. The project can start when the agreements are

signed.

We explicitly advise you to carefully read the agreements and discuss them with the

consortium partners before submitting your proposal. Upon submitting a proposal all

consortium partners agree with the agreements.

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Annex one Checklist for the evaluation

Below the specific questions that will act as a checklist for the ISAC/CSQ to evaluate the

application are mentioned. As stated above the following criteria will be used for the Impulse

grant for the CVON2012 consortia:

Clear definition of the theme the consortium contributes to, including well-defined

ambitions for the short and longer term. Including male-female differences

Scientific Excellence (the original CVON Criteria): the scientific programme for the

grant continuation based on the achievements in the past period and the objectives

for the continuation period. Including male-female differences.

Realistic strategy for technology transfer or valorisation and (future) implementation.

Also collaboration with users, private partners and patient involvement will be

reviewed.

Proof of effective collaboration with added value within the consortium and other

relevant consortia and partners. Including open access/ open science and

development of talent

All criteria are regarded equally important and will have equal impact on the final verdict.

Clear definition of and ambitions for the theme of the consortium

Description of theme

Are the long-term ambitions and milestones, visionary and realistic?

Match of science-healthcare problem

Do the (main) results of the former scientific programme contribute to the described

healthcare problem? Are the results differentiated by sex?

To what extent is the described healthcare problem relevant for men and women? Is the

currently proposed scientific programme still contributing to solving the healthcare problem as

described in the proposal? How and to what extent contributes the research to solving the

specified healthcare problem in the short- and/or long-term for men as well for women?

Sustainability of theme

Is the long-term impact and sustainability of the cardiovascular research theme sufficiently

described as well as the future contribution of the research leaders and PIs in the

development of the theme? Consortium prospects and contribution to the specific research

field have to extend beyond the duration of the scientific programme with (at least) 5 years.

Scientific quality

The achieved main results

Are the achieved main results a) internationally competitive/ have a scientific significant

impact and b) (potentially) relevant for healthcare/ patients?

Are the main results linked to the milestones/ deliverables as set in the midterm report? Is

convincingly described why these results are the main results?

Synergy preclinical- clinical

Are both basic and clinical research parts strong and synergistic?

Internationally competitive

Is the proposed scientific programme and the constitution of the consortium internationally

competitive?

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Feasibility of aims

Are the set aims, as laid out in the proposal, feasible in the manner suggested? Are

(potential) differences between men and women addressed and linked to (the described

literature on) the healthcare problem?

Plan of work

Opinion about plan/ involved and required disciplines/ realistic budget/ timeframe. Are

(potential) differences between men and women addressed and linked to the described

literature and aims? Will the generated results and data be managed according to the FAIR

principles?

Infrastructure

Will the investments in this research proposal strengthen the infrastructure to such an extent

that it will support more than just the research proposal?

Realistic trajectory for strategy of knowledge application

Translational: next step realistic?

Has attention been paid to translation of the findings, and are the described plans to do so in

the future clear and sufficient? Is the next step clearly described? Is the envisaged end

product, process etc. realistic? How and to what extent are the differences between men and

women considered?

The entire translation axis must be clearly described, but the present proposal should not

cover the entire axis, but should enable translation to at least one step higher technology

readiness.

Impact of the envisaged end product

Does the consortium make clear that the envisaged end product, process will have an impact

on healthcare? Is the impact the consortium hopes to generate realistic? Is the strategy for

valorisation/knowledge transfer time- and cost-effective? Is HTA expertise during the term of

the proposed project guaranteed?

Knowledge transfer

Does the consortium make clear how they plan to make translatable findings available for

clinical research and ultimately application?

Does the proposal clearly describe how and to what extent the researchers will actively

engage in disseminate knowledge, and not only to immediate colleagues, but also to

scientists/(end) users who could take the next step in the research or its implementation, or

to professionals (in the broad sense) who could start working with the research results (Next

Step)? Are all the appropriate stakeholders involved?

To what extent is the specific knowledge, experience and expertise of professionals and

patients incorporated?

Consortium and development

Sustainability of consortium

• Did the consortium establish relevant international networks to strengthen their

position in internationally competitive research field?

• Did the consortium coordinate the applications for grants in the EU/ NIH or other

sources, to sustain this theme sufficiently? If yes, was it successful?

• Did the investments done strengthen the infrastructure to such an extent that it

will support more than just this CVON-project?

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Quality of research leaders and PIs in international perspective

Research leaders

The current research leaders showed strong and inspiring leadership.

Is the choice for the proposed research leaders (same or different as in former application)

logical? Do the proposed research leaders still/also show strong and inspiring leadership? The

committee judges the leadership of the research leaders during the presentation. The

proposed research leaders are willing and able to interact and start collaborations with other

consortia (leaders).

Principal investigators

If changed, are the changes logical and are these new PI’s strong candidates?

Consortium

Was there a good balance and integration in the collaboration between the research leaders

and the PIs? both ways. If not, did the consortium make the appropriate changes?

In the new setting:

• Is the composition of the consortium logical and are all needed expertises on board

to complete the research project in a satisfactory way?

• Inclusion of third party/ industry (if applicable): is the contribution of third party/

industry of added value?

• Collaboration with other consortia/ themes.

Development of talent

Had the previous talent programme had impact on/ was beneficial for the consortium and the

overall research theme?

Does the provided overview of the current/ future positions of the appointed PhD students

and Postdocs indicate that the actions within this work package have worked in developing

talent?

Is the new talent programme inspiring and effective?