The FWO takes great care to ensure that all research funded with its resources is carried out in accordance with ethical standards. Some of these are imposed by law, others are generally accepted as being part of (international) scientific practice.
Researchers funded by the FWO are required to identify any ethical aspects in their research using the questionnaire that is included in the application forms. This may also involve a legal requirement to submit the research proposal to an ethical committee, as specified in the questionnaire. Other aspects will at least constitute points of interest for the applicants and the evaluators of the application. (See general regulations.) Applicants may also contact the research coordination department of their main host institution for any questions on this issue.
Please note that where no ethical advice is required for the research itself, such advice may be necessary when you want to use your data for publications. That is why, in the questionnaire, the requirement to request advice sometimes has a slightly broader scope than is strictly legally required for the research itself, so as to avoid problems later.
Scientific experiments involving humans, human material, animals and often also scientific research having a broader impact on people and their environment are governed by legislation at national and European level. The European and Belgian legislation, which is binding for researchers in Belgium, is summarised below for the categories of human subjects, embryos and human material, personal data, and animal subjects. This overview is not exhaustive. For European legislation, it is limited to regulations, because these automatically apply to all member states of the European Union and therefore do not need to be transposed in national legislation. European directives, by contrast, first have to be transposed in national legislation and as such are already incorporated in Belgian law, so they are not included in the overview.
- European legislation
- Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
- Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
- Belgian legislation
- Human subjects
- Law of 7 May 2004 concerning experiments on the human person
- Royal Decree of 30 June 2004 establishing measures for the implementation of the law of 7 May 2004 concerning experiments on the human person with regard to clinical trials on medicinal products for human use
- Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004 establishing measures for the implementation of the law of 7 May 2004 concerning experiments on the human person with regard to clinical trials on medicinal products for human use
- Royal Decree of 04 April 2014 establishing measures for the implementation of the law of 7 May 2004 concerning experiments on the human person, with regard to the ethical committee
- Embryos and human material
- Law of 11 May 2003 concerning research on embryos in vitro
- Law of 19 December 2008 regulating the procurement and use of human tissues and cells for medical application in humans or scientific research
- Royal Decree of 28 September 2009 setting standards of quality and safety in relation to the donation, harvesting, procurement, testing, processing, storage and distribution of human tissues and cells, with which human tissue banks, intermediary structures for human tissues and cells, and production establishments must comply
- Personal data
- Law of 8 December 1992 on the protection of privacy with regard to the processing of personal data ('Privacy Act')
- Royal Decree of 13 February 2001 implementing the law of 8 December 1992 on the protection of privacy with regard to the processing of personal data
- Animal subjects
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines
- Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (2010)
- Scientific Integrity
Also guidelines on scientific integrity may prove relevant for more specific ethical issues, as indicated here.
The application form for an FWO fellowship or project includes the section 'Ethics'. This section contains a number of questions relating to ethical aspects of the proposed research, which are based on the ethical questionnaire of the European Research Framework Programme.
- For questions marked with *, when answered in the affirmative, ethical advice must be obtained from the relevant ethical committee as required by law or by the main host institutions.
- For all other questions the applicant and the evaluation panel are invited to reflect on the issue and take appropriate precautions as necessary.
Also the panel responsible for evaluation of the application may indicate that ethical advice is required or formulate comments and advice for specific aspects.
The fellow or supervisor of a research project must, no later than at the start of the fellowship or project, submit the ethical advice to the main host institution, which will forward it to the FWO. If the advice relates to a work package that is planned only for a later stage of the fellowship or project, it may be submitted just before the start of that part of the research. The FWO will in any case monitor the delivery of the advice at the agreed time in close collaboration with the main host institutions.
For ethical advice related to FWO research the FWO's standard form should be used. The ethical committee may come to one of three conclusions: 'approved', 'approved but subject to conditions' or 'rejected'. In the last case, the research can only be started if the researcher makes the necessary changes to the proposal so that it can as yet be approved by the ethical committee.
If the relevant ethical committee uses its own model form, the FWO form should be attached to it. The FWO form may also have been incorporated into that of the main host institution.
For information about the ethical committees of the main host institution and the local procedure for requesting ethical advice, you may contact the research department of the relevant institution.
- KU Leuven:
Vlerick Business School: