Regulations Applied Biomedical Research with a Primary Societal Finality (TBM)

The General Regulations apply.

Art. 1.

Pursuant to article 17, § 1. of the Decree of 30 April 2009 on the organization and financing of the science and innovation policy and the decision of the Flemish Government of 15 September 2006 for the financing of applied biomedical research with a primary societal finality, the Flemish Government provides a subsidy to support applied biomedical research projects.

All provisions of the TBM decision apply, as well as any amendments, additions or substitutions made or to be made thereto and any implementation measures taken or to be taken by the FWO Board of Trustees under the aforementioned decisions.

Art. 2.                    

Projects only qualify for a grant under the TBM programme if each of the following conditions is met:

1. The project proposal is aimed at the development of a new therapy,diagnosis and/or specific prevention of a particular human disease or medical issue or a comparison of existing therapies, diagnostics or preventive methods in order to find out their relative efficacy and cost effectiveness.

2. The research is positioned late in the path from discovery to a specific application.

3. The research offers a clear applicability with an added value for the Flemish health situation, including at least a positive medical impact for a particular group of patients or a cost reduction for the Flemish healthcare system. At the time of submitting the application (or in the near future) there is no industrial interest in the project, nor is there any reason for the existence of a potential spin-off.

Art. 3.                    

These regulations apply to Applied Biomedical Research projects with a Primary Societal Finality (TBM)* of the Research Foundation - Flanders (FWO).

*Dutch nomenclature: Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit (TBM)* van het Fonds Wetenschappelijk Onderzoek - Vlaanderen (FWO).

Art. 4.                    

A project application can be submitted by all Flemish research centers[1], such as e.g., university hospitals, universities, university colleges and strategic research centers. Companies cannot submit an application. An applicant is defined at the level of the legal entity, not at the level of a department or research group. The applicant will hereinafter be referred to as host institution.

A TBM project proposal is submitted by at least one Flemish research center. This implies that all Flemish universities and their university hospitals and all Flemish university colleges qualify as applicants under the TBM programme. In addition, all other organizations that meet the definition of a research center and that are established in the Flemish Region can apply for a TBM project.

Art. 5.                    

A consortium of host institutions or a single host institution can submit an application. Given the clinical focus of the programme, the consortium of applicants must however include at least one Flemish hospital, qualified as research center, for at least 10% of the total budget[2]. If the application is submitted by a consortium, the main applicant will act as main host institution.

Art. 6.                    

The host institution, or the main host institution in the case of a consortium, will appoint a supervisor. The supervisor must be employed by the (main) host institution and is responsible for the proper execution of the project. The supervisor acts as representative and spokesperson of the consortium vis-à-vis the FWO and also ensures the coordination of the activities of the allocated project support and the reporting on the project. The (main) host institution ensures that the supervisor has sufficient time and experience to carry out this assignment properly.

All host institutions must subscribe to the principles of the TBM programme in the form of a declaration of intent. Moreover, if several host institutions are involved in the project, and if the project is approved, all these host institutions shall conclude a mutual agreement governing the practical cooperation, as well as mutual agreements concerning the ownership and utilization of the research results (see also articles 21 and 25).

Art. 7.                    

Non-Flemish research centers may be included as co-applicant in the consortium. A condition is, however, that the total budget for non-Flemish research centers does not exceed 20% of the total budget.

Art. 8. (as amended by decision of the board of trustees of 25/05/2022 and 30/11/2022)             

In a project, the implementation of specific operational subtasks may also be outsourced to subcontractors [3]. In this capacity, companies can also participate in a TBM project. These will always be routine tasks, without any creative input. However, the cumulative contribution of subcontractors should be limited to 30 per cent and, in exceptional cases, to 50 per cent of the total available funds.

Art. 9.                    

Applications for grants must be timely submitted electronically in English, using online completed forms. The submission deadline is specified on the FWO website. All correspondence with the FWO occurs via the supervisor as responsible spokesperson.

Art. 10. (as amended by decision of the board of trustees of 25/05/2022)

The project budget ranges between 215,000 euros and 850,000 euros, and the project duration from 2 to 4 years. In exceptional cases, up to 1,280,000 euros can be awarded for large-scale and/or multi-center trials. The support percentage amounts to 100% of the accepted projects costs.

Art. 11.               

The rules to be followed for preparing the project budget are set out in the cost model, which is available on the website (http://www.fwo.be/en/fellowships-funding/research-projects/tbm-projects/). All acceptable costs are real costs that must be capable of being justified. A project application is only admissible when it has been prepared in accordance with the modalities set out in the cost model.

Art. 12.               

The FWO awards a grant in the form of a maximum amount and under the condition that the regulations are scrupulously and consistently adhered to.

The beneficiary of the grant may terminate the grant agreement in a substantiated, registered letter. If there are several consortium partners, this shall be done in consultation with the other parties involved.

The FWO may autonomously suspend, revise and recover the grant under the conditions and modalities set forth in articles 34, 35 and 36.

Art. 13.               

The grant may only be used for the financing of the project. Any non-compliance in this respect is considered as inappropriate use of funds for the application of articles 34, 35 and 36.

Art. 14. (as amended by decision of the board of trustees of 18/09/2019)      

Positive balances of the awarded staff and consumables funding may be used for the charging of costs as set out in article 11, up to two years after the end date of the agreement.

Art. 15.               

After the submission, FWO assesses whether the project applications are formally eligible based on the following criteria:

1. The project application was submitted via the FWO e-portal and was received within the deadline;

2. The project application was prepared in accordance with the information requested in the FWO e-portal;

3. Each applicant from the consortium meets the definition of research center;

4. The consortium of applicants includes at least one Flemish hospital (or ITM), qualified as research center, and the aggregated share of the Flemish hospitals (and ITM) represents at least 10% of the total project budget;

5. The project application contains a declaration by the supervisor of the project proposal, in which he/she declares (i) that the aggregated share of the Flemish hospitals or the ITM amounts to at least 10% of the total project budget and (ii) that all contact persons of the participating research groups as mentioned in the project application are aware of and agree to their contribution to the project proposal, as outlined in the project application (part of the terms of agreement in the e-portal);

6. For each applicant, the project application includes a declaration of intent signed by the institution’s representative;

7. The project application includes a research proposal which positions itself within the objective of the call (see article 2);

8. The project application is written in English to allow for its assessment by international experts;

9. The project application includes a project budget prepared in accordance with the cost model.

Art. 16. (as amended by decision of the board of trustees of 30/11/2022)     

The FWO Board of Trustees will decide on the (in)eligibility of the project application. If a project application is considered ineligible, the (main) host institution will be notified thereof as soon as possible. Projects that are found to be ineligible will not be considered in the further assessment and selection procedure.

The FWO may contact the applicant during the eligibility analysis to complete the application. The FWO may also use information from other financing bodies.

The FWO regulations for internal and external peer review apply.

Art. 17.               

Irrespective of the assessment procedure, the Board of Trustees may make a negative decision or set additional conditions spurred by the failure to meet additional obligations or authorizations imposed by the authorities, or following incorrect behavior during previous applications concerning the provision of information, substantive and financial obligations or reporting.

Art. 18.               

In the case of a positive decision by the Board of Trustees, a grant agreement is drafted in which the contractual modalities of the project between the FWO and the project applicants are set forth. The agreement is drafted by the FWO. Both the main host institution and the other participating host institutions must sign this agreement.

Art. 19.               

The main obligation is a commitment of resources. The necessary efforts must be made to achieve the specified project objectives using the agreed resources through research and development activities and to ensure their utilization in Flanders. All reasonable efforts must be made to achieve the project results within the planned duration of the project.

Art. 20.               

Any animal tests/patient studies/studies on patient material under the project shall not be started up until all required approvals have been obtained from the ethics committee(s)/regulatory authorities for the respective animal tests/patient studies/studies on patient material. If amendments are made to the protocol for these studies that again require the approval of an ethics committee/regulatory authority, the amended protocol shall not be started up until these new approvals have been obtained. Any approval of an ethics committee/regulatory authority must be must be made available to the FWO on request.

Art. 21. (as amended by decision of the board of trustees of 25/05/2022)             

If there are several host institutions, they must sign a mutual cooperation agreement. To qualify for approval by the FWO, this agreement should cover at least the following in sufficient detail:

The cooperation agreement includes a detailed description of the services or products to be provided by each of the consortium members.

The cooperation agreement shall specify the name of a supervisor. The supervisor monitors the provisions of the cooperation agreement for compatibility with the agreement and its implementation modalities.

The cooperation agreement must include all provisions relevant to the cooperation and in particular a regulation governing the mutual arrangements made regarding the implementation of the project and the utilization of the project findings, including the consultations, possibly the decision-making process, the ownership and user rights to the project findings, the confidentiality clause, the reporting obligations, dispute resolution procedure, liability and compensation.

The cooperation agreement must concur with the FWO agreement and the TBM regulations, in particular with the provisions regarding the utilization of the project findings. To this end, this cooperation agreement is subject to approval by the FWO. It must also comply with the regulations of the decrees and the executive decisions regarding the missions of education, research, and social services of universities, university colleges or other research centers. As part of international subsidy programmes, additional conditions may be imposed on the cooperation agreement. These shall then be incorporated into the agreement.

The members of the project consortium must submit the partnership agreement to the FWO within four months of the official start date of the project set out in the agreement with the FWO. The FWO will be deemed as having given its approval if it has not responded within 25 working days after submission of the partnership agreement to the FWO.

Approval by the FWO is also required for amendments to the cooperation agreement during the implementation of the agreement.

Without prejudice to article 34, the FWO may suspend the payment of the grant so long as the cooperation agreement has not been submitted to or approved by the FWO, even if the aforementioned four-month period has not yet expired.

Art. 22.               

If the project proposal is approved, reports on the proper execution and progress of the project must be submitted at regular intervals. This aspect is covered in a separate explanatory document that is available on the website.

Art. 22.1. Involvement of the FWO in the advisory committee, if applicable

If an advisory committee is set up, an annual meeting must be held, to be attended by the members of the advisory committee. The FWO must be invited to this meeting and the minutes of the meeting must be sent to the FWO. These minutes are an integral part of the mandatory reporting.

Art. 22.2. Progress report and final report

For projects with a duration of three years or more, a progress report (including the utilization report, see article 22.3) is required on 1 January of the last year of the agreement. For each project, regardless of the duration, a final report (including the utilization report, see article 22.3) is required at the latest one year after the end date of the agreement.

Art. 22.3. Utilization report

A report on the manner in which the obligations relating to the utilization of the project results as set out in article 29 are being met, must be submitted to the FWO. If a progress report is required, it must also be accompanied by a utilization report. A utilization report must also be submitted at the end of the agreement.

For fully completed projects, a utilization report after a period of 5 years after the end date of the project, may be requested by the FWO.

Art. 22.4. Additional reporting requirements

At the explicit request of and at (a) moment(s) determined by the FWO, additional reports may be requested. Such request and the request for any additional information relevant for assessment of the utilization of the project results, must be answered in the form of a follow-up report, no later than 2 months after the request was made by the FWO. Based on these additional reports and this additional information, the FWO establishes the full or partial performance of the obligations relating to the utilization of the project results. Where appropriate, the FWO applies the provisions of articles 35 and 36 for revision and recovery of the grant.

Art. 23.               

Payment, reporting and auditing are governed by the applicable provisions of the FWO Regulations for research projects, in particular but not exclusively the provisions of the chapters 9, 10 and 11.

Art. 24.               

The project consortium has the obligation to exploit the project findings as broadly as possible in order to achieve maximum added value for the targeted patient group. To that effect, the project consortium must, among other things, disseminate the project findings to a broad target group, among other things by organizing knowledge dissemination activities. When a project includes the development and/or validation of a software application, the applicants must specify a proposed software exploitation route. After completion of the project, the software should be exploited as open source software.

Art. 25.               

The beneficiary[4] of supported projects is the owner of the research results. For a consortium of beneficiaries, each beneficiary is, in principle, the owner of the results of the completed sub-project unless otherwise stipulated in the consortium agreement. Members of the advisory committee or subcontractors, whose contribution is by definition limited to the provision of goods or services, cannot claim any rights of ownership.

If the beneficiary is a university research group, the provisions of article IV.48 of the Higher Education Code of 11 October 2013 shall apply.

The project application should specify how IPR will be handled.

Art. 26.               

The host institution(s) will acquire the project results arising from the research activities. For any transfer of ownership rights and granting of user rights to the project results to companies, the host institution ensures that a fee is received that corresponds to the market price for the use of the relevant project results.

The fee received is considered equivalent to the market price if it ensures the enjoyment of the full economic advantage of the aforementioned rights to the project results referred to above, and one of the following conditions is satisfied:

a. the amount of the fee is set via an open, transparent and non-discriminatory competitive sales procedure, or

b. an assessment by an independent expert confirms that the amount of the fee is at least equal to the market price, or

c. the research center, as seller, can demonstrate that it has effectively negotiated the fee at arm's length conditions in order to obtain the maximum economic advantage at the time of signing the contract, taking its statutory objectives into account, or

d. insofar as the mutual arrangements entitle the cooperating company to a right of first refusal regarding the aforementioned rights to the project results referred to above, the research center has the right to contact third parties for the purpose of obtaining economically more advantageous proposals, so that the cooperating company has to adapt its proposal accordingly.

All income from these activities must be reinvested in the primary activities of the research center, notably education and open research, in accordance with article IV.48 of the Higher Education Code of 11 October 2013.

Art. 27.               

The regulation on ownership and user rights must be fully compliant with the European regulations on government support for research, development and innovation.

Art. 28.               

With any transfer of ownership rights or awarding of user rights to the project results, all potential users within the European Union must be treated in an equal and non-discriminatory manner.

Art. 29.               

Art. 29.1.         

The financing of a project implies that the applicant makes all reasonable efforts to adequately protect the project results and to utilize the project results.

Art. 29.2.         

The financing of a project implies that the applicant makes all reasonable efforts to utilize the project results over a 10-year utilization period after completion of the project, in accordance with the options set out in the project proposal as approved by the FWO and on which the allocation of the grant is based.

In case of utilization of the project results outside of the European Economic Area, the applicant undertakes all reasonable efforts to ensure a significant utilization of the project results within the European Economic Area as well.

Art. 29.3.         

Without prejudice to the provisions in article 30, in case of any transfer of ownership rights or exclusive license to the project results, including in case of bankruptcy, acquisition or merger of the transferee of the project results, the applicant undertakes appropriate measures to ensure compliance with the aforementioned obligations.

Thus it has to be recognized that partial or full transfer of the ownership rights to the project results, including in case of bankruptcy, acquisition or merger of the transferee of the project results, is possible only with the simultaneous transfer of the obligations under the agreement, in particular those relating to the utilization of the project results and taking into account the provision in article 38 and the reference documents mentioned.

Unless expressly decided otherwise in writing by the FWO, such transfer of project results in case of bankruptcy, acquisition or merger of the transferee of the project results also implies the transfer of the obligation to repay the grant if the FWO decides to revise or recover the grant pursuant to articles 35 and 36.

Art. 30.               

In addition to the notification duty explicitly provided for elsewhere in the regulations, the FWO must immediately be notified of the following:

- Any major project change that impacts the anticipated project results.

- Any event or circumstance that may compromise the realization of the project and the anticipated project results, the uninterrupted and proper performance of the agreement and/or the utilization of the project results. In particular, this notification duty shall apply in case of any material change in the management structure or in the regulation concerning ownership and/or exploitation of the project results, cessation of activities, intention to apply for a judicial reorganization, bankruptcy of a host institution, or any other circumstance that could adversely affect the financial situation of the host institution.

- Any delay of more than 4 months in the commencement of the project implementation.

- Any proposal to change the distribution of the grant among the host institutions.

- Any cumulation with other government support pursuant to the applicable decision or the allocation of other support modalities to the project.

- Any change or replacement of the supervisor.

- Intention to proceed with early termination of the agreement.

Art. 31.               

The FWO reserves the right to reassess the further execution of the agreement, where appropriate, taking into account the notification it has made and then to take appropriate measures with regard to the grant, including the application of articles 34, 35 and 36 and consequently suspend, revise and/or recover the grant.

Art. 32.               

The FWO has the right to use the following project-related data for publication: the name of the host institution, the title, the start date, the duration, the amount of the grant, and the name of the supervisor and those of the co-supervisors.

Art. 33.               

Any communication, publication or publicity by the host institution and its employees, relating to the project or the project findings shall refer to the FWO project grant. Ordinary and customary advertising, user manuals or instructions and the like do not fall under this provision.

Art. 34. (as amended by decision of the Board of Trustees of 26/10/2022)           

The registration and publication of clinical trials is mandatory (see general regulations Art. 4 §2). The FWO must be informed of this in due course via tbm@fwo.be.

Art. 35.               

Art. 35.1.         

The FWO will suspend the grant if the conditions and provisions under which the grant has been awarded are not complied with. The FWO may suspend the grant in particular, but not exclusively, in the following cases:

- In case of non-compliance with the obligations relating to notification of information, reporting, assistance with audits by the FWO and publications as set out in articles 30, 32, 33, 34 and 22.

- If, pursuant to article 21, the required cooperation agreement has not been submitted to the FWO within 4 months after the signing of the agreement or if the submitted cooperation agreement is not approved by the FWO.

- In case of a reassessment as referred to in article 31.

- In case the regulations are generally not complied with.

- In case the obligations under other agreements with the FWO are not or inadequately complied with.

Art. 35.2.         

In the event of a suspension, the FWO shall inform the applicant by registered letter about the suspension of payment, the start date of the suspension, the reason for the suspension and the grace period to remedy the breach of the regulations. The suspension period is, in principle, maximum 4 months, unless a different period is fixed by the FWO.

After expiry of the suspension period, the FWO may revise and recover the grant pursuant to article 35 or article 36 or impose additional conditions in accordance with article 31 of these regulations.

Art. 36.               

Art. 36.1.         

The FWO reserves the right to revise the implementation of the grant agreement in whole or in part whenever it has valid grounds to do so, without prejudice to the ownership rights to the project results. The FWO may revise the grant in particular, but not exclusively, in the following cases:

- When the conditions and provisions under which the grant has been awarded, are not complied with.

- In case the applicant fails to comply with its obligations relating to the notification of information, reporting, assistance with audits by the FWO and publications as set out in articles 30, 32, 33, 34 and 22.

- In case of inappropriate use of the grant or of sums paid under the grant.

- When, pursuant to article 22, no effectively incurred costs can be presented or when these costs cannot be approved by the FWO.

- When, for the purpose of obtaining the grant or any other benefit associated with the agreement, incorrect or incomplete statements have been made.

- In case of cumulation with other support as referred to in the applicable Decision.

- In case the obligations under this and/or other agreements with the FWO are not or inadequately complied with.

- In case of early termination, e.g., for technical or economic reasons.

Art. 36.2.         

After a formal notice of default by the FWO via registered letter to remedy the default, the FWO decides to revise the grant. This decision is communicated by registered letter at least one month after the formal notice of default.

Art. 36.3.         

If the grant is revised, the FWO shall, after examining the justification and the insurmountability of the reasons given, determine the amount of the grant as a function of the costs effectively paid or made until the date of receipt of the registered letter containing the decision to revise the grant, and of the costs regularly incurred as obligations until the date of said receipt, and of any termination benefits of staff specifically recruited for the implementation of the project. From receipt of the FWO's registered letter containing its decision to revise the grant, the applicant shall be deemed to immediately take all appropriate measures to mitigate the financial consequences of the obligations entered into and termination benefits.

Art. 36.4.         

Apart from the exceptions referred to in the second paragraph of this article, the applicant may in principle appeal against any decision by the FWO to revise the grant. Such appeal is, however, not possible if the FWO decides to revise the grant on grounds of formal observations by the FWO, such as untimely submission of reports.

An appeal can be lodged by registered letter to be sent to the FWO within 30 working days after notification of the FWO's decision. This letter must at least contain the substantiated objectifiable reasons that are raised against the decision to revise the grant. The FWO shall handle the appeal within 45 calendar days, after which the FWO Board of Trustees may make a new decision.

Art. 37.               

Art. 37.1.         

Without prejudice to the ownership rights to the project results, the FWO will recover the grant in the following cases:

- In case sums other than those due were received from the FWO.

- In case of revision of the grant pursuant to article 35 for those sums of the grant that had already been paid out at the time of the revision.

Art. 37.2.         

The FWO will announce its decision to recover the grant in a registered letter and issue a formal notice of default to the host institution. In case of non-payment within the grace period specified in the letter, default interest shall be due over the period from the demand for payment until the day of effective payment, on the basis of a rate two points higher than the legal interest rate applicable at the time of the formal notice of default.

Art. 38.               

The FWO watches over the scientific integrity from the moment research funding is applied for until
the execution of the research and the publication of the research results. Therefore, researchers benefiting from FWO support as well as their host institutions, (co-)promoters and other
collaborators involved in FWO research are required to adhere to the scientific integrity at all times.

To this end, elementary rules of behavior have been laid down in the Ethical Code for scientific research in Belgium and the European Code of Conduct for Research Integrity. Both documents are an integral part of these regulations and are available on the FWO website. The FWO assumes that each researcher has acknowledged these codes from the moment the application is submitted and undertakes to comply with their provisions in all stages of the proposed research. If there is any doubt about the applicability or implementation of a provision, the host institution and/or the researcher responsible for the project should contact the FWO administration in order to clarify or make concrete arrangements about the relevant provision.