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I have an Applied Biomedical Research with a Primary Social finality projects

The programme Applied Biomedical Research with a Primary Social finality (TBM) aims at contributing in the long term to the implementation of (new) therapies, diagnostic techniques and preventive methods, which, without government funding, would not make it to the patient due to a lack of industrial interest.

Information

The programme Applied Biomedical Research with a Primary Social finality (TBM) aims at contributing in the long term to the implementation of (new) therapies, diagnostic techniques and preventive methods, which, without government funding, would not make it to the patient due to a lack of industrial interest.

This webpage is designed to present all essential practical and administrative information for the benefit of the beneficiaries of a TBM project grant.

Contract

Shortly after the award decision, the Research Coordination/Contract Management department of your research institution will receive the contract agreement from the FWO and have them signed by all the contracting parties. The FWO regulations TBM projects and the FWO general regulations form an integral part of the contract.

The awarded grant will be available as from 1 October of the year of the grant. The approved funding can be used throughout the approved project period (typically 4 years). The FWO provides for an additional phase-out period of 2 years during which all approved funding can be used. The grant is guaranteed so long as that the FWO regulations are complied with at all times.

Cooperation agreement

For any project involving cooperation between several beneficiaries, you must provide the FWO (via tbm@fwo.be) with a cooperation agreement signed by all involved parties within a period of 4 months from the official project start date (as specified in the agreement with the FWO). The receipt of this cooperation agreement by the FWO is a prerequisite for the further payment of the grant.

Contact your Tech Transfer Office for support with the IP arrangements between the TBM consortium partners. When drafting such a cooperation agreement, the regulatory provisions of the TBM programme with regard to the use of the results must be taken into account (Article 24 et seq. of the TBM regulations).

Advisory committee

If an advisory committee was established, a meeting of its members shall be organised at least once a year. During this meeting, the feasibility of the innovation objective will be discussed as well as the need for adjustments to the approach and the actions already taken or planned to ensure the future utilisation of the results.

The FWO shall be invited in advance and in a timely manner to the meeting (via tbm@fwo.be) and may attend the annual meeting. The supervisor shall in any case forward the minutes of the meeting to the FWO (via tbm@fwo.be). These minutes are an integral part of the mandatory reporting. In the subject line, always state the project number (TXXXXXXN) and the current project year.

Transparent clinical trials

If your project involves a clinical trial, the trial must be registered in a public clinical trial registry (e.g. https://www.clinicaltrials.gov)) prior to the start of the trial (see Article 4 §2 of FWO’s General Regulations). For these purposes, a clinical trial is any research study in which human participants or groups of human participants are prospectively assigned to receive one or more health-related interventions in order to assess the effects on health outcomes.. Clinical trials include interventions such as, but not limited to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, changes in care processes, preventive care, etc. This definition includes phase I to phase IV trials.

When the first patient is enrolled, the FWO must be informed (via tbm@fwo.be) of the start date of the trial (first patient in) and the registration number of the clinical trial. The data in the registry must be kept up to date for the duration of the trial and, within one year of the end of the clinical trial (six months for paediatric trials), a full descriptive clinical study protocol and a summary of the trial results must be added to the same registry, regardless of whether the trial results were negative, inconclusive or positive. For more background information, see Research Foundation - Flanders - Research Ethics (fwo.be)/Attention points/1. Transparent clinical trials.

Reporting

Information concerning FWO’s reporting policy can be found on a dedicated webpage.

Progress and utilisation reports 

Progress and utilisation report

For projects of three years or longer, both a progress report and a utilisation report must be submitted after the second year. The progress report must include a report on the progress of the research, the project activities still to be carried out, and, where appropriate, a list of scientific publications and other realisations. The utilisation report describes the utilisation-oriented efforts made or still to be made, the utilisation already achieved and/or the expected utilisation of the project results in the short term.

Final and utilisation reports

For each project a scientific final report and utilisation report is required at the end of the project.

The reports must be drawn up using the following template and must be submitted to the FWO by the supervisor of the TBM project. This template contains a detailed guide on the reporting, the modalities and the reporting timelines.

Financial reporting

The acceptable costs are determined upon approval of the project. Detailed cost information can be found in the TBM cost model.

Each year a financial report must be submitted. Upon completion of the project (including the phase-out period, if applicable), the final financial account is calculated based on all the declarable acceptable costs. The financial reports must be submitted by the Finance department of your research institution.

Utilisation follow-up

Approval of the scientific, utilisation and financial final report marks the completion of the project implementation. However, the FWO expects that reasonable efforts will continue to be made towards the maximum utilisation of the project results. The FWO may ask for an additional utilisation report to be submitted for up to 5 years after completion of the TBM project.

Notification duty

The actual project implementation may, to some extent, differ from the original plan. This is acceptable so long as the grant is used towards the achievement of the contractually specified innovation goal. However, should circumstances arise that differ substantially from the starting points that were known at the time of approval of the support (e.g. major changes in the budget or the work, budget shifts between parties or any events that have a great impact on the implementation of the project or the subsequent utilisation of the results), the FWO must be notified immediately via tbm@fwo.be.

Budget changes

Shifts within the budget of a contracting party

In practice, the course of a project may vary from the initially planned course. To achieve the project objectives, each contracting party is free to optimally deploy their resources and, where necessary, shift them between cost items (personnel costs, consumables, equipment). However, the maximum project budget per contracting party may not be exceeded.

Budget shifts between research partners of different legal persons

Any shifts between budgets of different legal persons must be requested in advance from the FWO and substantiated by current figures (old versus new situation). All involved parties must sign the request. After approval by the FWO, the updated budget is attached as an addendum to the contract. The payment scheme is adapted accordingly. The total accepted project budget may not be exceeded.

Miscellaneous

Open access

Holders of an FWO TBM project are required to deposit their publications, realised in whole or in part with TBM resources, in a public “Open Access” database no later than one year after publication. Further information can be found on the website.

Data Management Plan

The FWO expects to receive a completed Data Management Plan (DMP) no later than 6 months after the start date of the TBM project. More information about the procedure, the DMP standard model and the contact details within our research institutions for questions and support, can be found via our website.

Research ethics

In the application form for your project you also completed a questionnaire on the ethical aspects. If you answered affirmatively to a question with an asterisk, you are required by law to obtain ethical approval from the competent ethics committee of your main host institution before undertaking the relevant research activities. For the other questions institutional obligations may apply. For questions without asterisk you are also expected to consider any ethical aspects that could be related to the subject matter, the research approach or the consequences of the results, and, where necessary, take appropriate precautions.

Please consult the Guidelines on the FWO’s ethics checklist for help and background information.

The required ethical approval must be obtained before you start working on the associated work package. For project proposals aimed at performing experiments on non-human primates you have to be in possession of an approval by the relevant ethical committee already at the time of evaluation of the proposal by the FWO.

The supervisor-spokesperson shall submit the certificates of the ethics committee to the research coordination department of the main institution, where they are stored and can be retrieved by the FWO if necessary. For details see our research ethics webpage.

Scientific integrity

Beneficiaries of FWO funds undertake to ensure the scientific integrity of the research practice and outcomes.

Vacancies

Vacancies linked to research projects can be posted via the FWO website. You can forward the vacancy notice to the FWO via communicatie@fwo.be. Additionally, it is highly recommended to publish such notices via the Euraxess website of the European Commission: http://ec.europa.eu/euraxess/.

Acknowledgement of funding source

The FWO must always be acknowledged as grant giver in publications or other relevant communication about your project (results).

Contact

For questions regarding the TBM grant programme you can always contact us at tbm@fwo.be. Please make sure to always state the project number.

Reservation concerning applicable regulations

In the event of any discrepancy between the general information or this webpage and the provisions in the contract of your TBM project (including FWO general regulations, TBM regulations and cost model), the latter shall prevail at all times.

Exceptional renewal due to COVID-19

The TBM program has been hit exceptionally hard by the COVID-19 pandemic. During this crisis, hospitals were forced to postpone regular care for the most critical services. As a result, it was impossible for some ongoing TBM projects to recruit sufficient patients within the proposed time frame. Certain TBM project leaders or personnel also had to prioritize acute care tasks, as a result of which the TBM project was postponed or delayed.

The FWO wants to offer the affected researchers the opportunity to bring their TBM project to a successful conclusion. To this end, the FWO will allow a renewal of one year under certain conditions, possibly with additional funding. These renewals will be funded from the budget for the new TBM call.

Renewal without additional funding

Conditions

  • The project plan was drawn up before the outbreak of the COVID-19 pandemic and therefore the impact of this could not be taken into account in the work schedule. Concretely, this concerns projects started in 2017, 2018, 2019 and 2020.
  • The utilization targets can no longer be achieved within the original project period, including the regular extension period of two years.
  • The reason that the utilization targets cannot be achieved is a demonstrable and direct consequence of the COVID-19 pandemic.
  • It is highly likely that the objectives will be achieved with the additional time provided by the renewal.
  • The researchers have held preliminary consultations with the FWO administration.

Procedure

  • The application is submitted in the first regular extension year of the TBM project. Projects that qualify for the call of 2024 therefore have the application number Txxxx19N.
  • The supervisor submits a pre-proposal by e-mail (to tbm@fwo.be) at the latest on Monday 4 March 2024 at 17:00.
  • Before submitting the application for renewal, a mandatory preliminary discussion will take place with the FWO administration at the latest on Monday 4 March 2024.
  • The supervisor submits a brief application for renewal by e-mail (to tbm@fwo.be) using the available template and no later than Monday 18 March 2024 at 17:00.
  • After an eligibility check by the FWO administration, the FWO Board of Directors decides on the granting of the renewals.
  • The results will be announced on 27 June 2024.
  • The duration of the renewal is at most one year after the regular extension period has ended.

Renewal with additional funding

Conditions

  • The project plan was drawn up before the outbreak of the COVID-19 pandemic and therefore the impact of this could not be taken into account in the work schedule. Concretely, this concerns projects started in 2017, 2018, 2019 and 2020.
  • The utilization targets can no longer be achieved with the required budget within the original project period, including the regular extension period of two years. To this end, in the first extension year the host institution must provide a financial report.
  • The reason that the utilization targets cannot be achieved is a demonstrable and direct consequence of the COVID-19 pandemic.
  • The researchers have no other options to successfully complete the project.
  • The additional resources allocated are only used to achieve the original objectives.
  • It is highly likely that the objectives will be achieved effectively with the additional time and resources provided by the renewal.
  • The researchers have held preliminary consultations with the FWO administration. A budget check will also take place prior to submission.

If the application volume exceeds the available budget for the renewals, the following selection criteria will also be taken into account:

  • The impact of the project objectives for the individual patient and for general healthcare in Flanders, based on the most recent insights.
  • The cost efficiency of the proposed additional activities.

Procedure

  • To ensure continuity of funding, the application is submitted in the first regular extension year of the TBM project. Projects that qualify for the call of 2024 therefore have the application number Txxxx19N.
  • The supervisor submits a pre-proposal by e-mail (to tbm@fwo.be) at the latest on Monday 4 March 2024 at 17:00.
  • Before submitting the application for renewal, a mandatory preliminary discussion will take place with the FWO administration at the latest on Monday 4 March 2024.
  • The host institution provides a financial report at the latest on Monday 4 March 2024 at 17:00.
  • The supervisor submits an application for renewal by email (to tbm@fwo.be) using the available templates, including budget table, and no later than Monday 18 March 2024 at 17:00.
  • The application is evaluated by a panel of scientific experts. If necessary, the applications for renewal will be ranked by the evaluators for selection.
  • The Board of Directors of the FWO decides on the granting of the renewals based on the advice of the expert panel and taking into account the available budget for renewals and new TBM applications. This ensures that the success rate for new TBM applications is always at least 20%.
  • The results will be announced on 27 June 2024.
  • The duration of the renewal is at most one year. The budget per application is not capped, because feasibility is the main priority. However, cost efficiency is a selection criterion and the original project budget and corresponding expenses will be taken into account during the evaluation.

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