Research ethics

Consider that ethics issues arise in many areas of research. Apart from the obvious example, the biomedical and health field, involving (unborn) human beings, human material or animals, research topics and methodology in social sciences, ethnography, psychology, environmental studies, security research, etc. may involve e.g. the participation of research subjects, the collection of personal and sensitive data, have an international dimension, create risk for research participants, researchers and uninvolved third parties, etc. In addition, ethical concerns may arise from the results of your research, i.e. the potential for misuse or dual use, or the impact on environment, health, safety or human rights.

The FWO aims to do everything in its power to ensure that research funded with its resources is carried out in accordance with the highest ethical standards. Some of these values are imposed by European and national law, others are generally accepted as being part of good (international) scientific practice.

Hereto, researchers that seek funding from FWO are required to go through an ‘ethics clearance’ procedure before initiating their research activities.

Overview FWO’s ethics approval procedure

  1. Application phase: the ethics checklist

As part of their project proposal, applicants must truthfully complete an ethics checklist, in the form of a questionnaire. This section, based on the ethics questionnaire of the EU Framework Programme for Research & Innovation, contains a number of questions relating to ethical aspects of the proposed research topic, methodology as well as potential applications.

An affirmative answer to  the questions marked with an asterisk triggers the legal obligation to obtain ethics approval from the appropriate ethics committee, before initiating any of the research activities concerned.

In case questions without asterisks are ticked, institutional obligations apply and/or applicants are invited to reflect on ethical aspects that may relate to the subject, study approach and/or result’s consequences and applications. Take precautions if necessary or desirable.

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

No ethical approval is required at this stage, except for project proposals with the intention of experimenting on non-human primates. The applicant of the latter type of projects should be in possession of an approval from the competent ethics committee at the moment (s)he submits the application for review by the FWO. The proof of such ethical approval must be uploaded to the E-Loket when submitting the project proposal.

  1. Review phase

The peer reviewers and/or expert panel assesses the submitted ethics checklist and may impose ethics advice and/or formulate concerns, advice, preventive and/or corrective measures for specific ethical aspects.

  1. Project execution phase

In case funding is assigned to your project proposal, the ethics checklist (and possible addenda of the review panel) becomes part of your grant agreement with FWO which gives rise to binding obligations: The beneficiary of FWO funding, irrespective of whether it concerns a personal grant or a project subsidy, must now, for the aspects identified in the questionnaire, request ethics approval to the ethical committee that is responsible for overseeing the intended type of research within its host institution.

Ethically sensitive project activities should not under any circumstances be initiated before all required approvals have been obtained from the ethics committee(s) and, if applicable, from other regulatory authorities. In case you plan experiments involving human embryo’s, foetuses, embryonic stem cells or non-human primates, you must have obtained ethical approval before the start of the research project as a whole. Please keep in mind that the ethical authorisation procedure may take some time and that therefore you should submit your application for ethical authorisation to the local ethics committee well in time.

The FWO does not take an ethical position but follows the decision of the competent local ethics committee, provided it is in accordance with the legislation in force in Flanders. The FWO or its assignees may request the ethics approvals ad hoc or during sample audits from the applicant’s host institution, and this at any time during the project period up to and including 5 years after their completion.

At any time during the project period, researchers must carefully consider ethical issues that may arise from their research topic, methodology and results. They shall act in accordance with responsible research practices as laid down in, amongst others, the European Code of Conduct for Research Integrity (ALLEA) and other deontological declarations and protocols.

At all times, your research, methodology, resources and technology must, aside with ethics legislation, also comply with institutional policies and applicable international, European and national law.

Ethical guidance

Your first source for information and primary point of contact about the ethics matters, committees and the local procedure for requesting ethics advice lays within your host institution.

KU Leuven

UAntwerpen

UGent

UHasselt:

VUB:

Vlerick Business School

Attention points

1. Clinical trial transparency

From an ethical and public health perspective, but also in view of an efficient use of research resources, it is essential that clinical trials are conducted in an open and transparent manner and that the findings are made available to the whole research community and society. Transparency regarding clinical trials includes thus as a minimum the publication of the summary results for non-experts and of a clinical research report in a (specialized) journal describing design, methodology and outcome. Openness regarding clinical trials sets, where appropriate, the base for sharing anonymized data from participants for further medical research and public health policy, in accordance with FAIR principles and current legislation (including GDPR).

Since July 2014, European Regulation No. 536/2014 stipulates that a summary of the results for non-experts are to be published in a public registry (e.g. https://www.clinicaltrialsregister.eu) within 12 months of the completion of the clinical trial (six months for pediatric trials). This Regulation also applies to studies completed before 2014 and applies regardless of whether the results of a study were positive or negative and / or findings were published in specialized scientific journals.

FWO therefore requires clinical trials to be registered in a public clinical database at the very beginning. The summary results are to be made public within 12 months of completion. The clinical database concerned and identification code is to be included in all specialized publications on the clinical trial concerned in order to link scientific publications (with details regarding research methods and results) with the public registry’s entry. Beneficiaries of FWO grants must also deposit clinical trials that were not yet registered and / or fill out missing data and trial outcome(s) in a public clinical register.

The registration of clinical trials must be reported to the FWO in the course of the project period and the completeness of this information can be taken into account by the expert panels when deliberating on assigning future grant applications.

2 Ethics dumping

The continuing globalization of research activities increases the risk that collaborative but ethically sensitive research is conducted abroad in a manner that would not be tolerated from an ethical point of view in Flanders (= Ethics dumping). At the other hand, the unilateral imposition of norms and values ​​from a dominant ethical and / or legal perspective often contradicts with the equal, respectful and mutually beneficial partnership with local scientific and social stakeholders, a requirement for international research (http://www.globalcodeofconduct.org/).

A double verification procedure for ethically sensitive research outside Europe should contribute to the prevention of ethics dumping while respecting differences in ethical standards, regulations and human practices. For EU countries, ethical approval in the country where de research is conducted suffices, given that across Europe, EU ethics regulations guides national legislation.

  1. Ethical approval must be obtained in the non-EU country where the project is to be executed and for clinical and animal testing necessary governance structures have to be in place locally. Also for other types of research involving human participants (e.g. behavioral or sociological research) require institutional, regional or national consent (whether or not by an ethics committee) and / or community-level consent.
  2. Simultaneously, the responsible ethics committee of the Flemish or European research institution must assess whether the proposed research complies with the fundamental ethical principles (such as for example for human experiments contained in the 'Declaration of Helsinki ') and the spirit and principles of the national / European regulations in force.

If one of the parties involved believes that there is a risk of opportunistic shifting of ethically inadmissible, problematic or controversial practices and / or if it cannot sufficiently guaranteed that the research can be carried out in an acceptable manner, the proposed research cannot take place with support of FWO funds. It is advisable to conduct research within the EU if there is no specific need to carry it out outside the EU for a particular reason.

Research activities that require ethical approval in Belgium may under no circumstances be initiated before permission has been obtained in both the non-EU country and within the EU. The responsible researcher (coordinator) of the FWO project is requested to provide the supporting documents from the non-EU country to its host institution’s responsible service, where they are kept at the disposal of the FWO. In accordance with FWO procedures, researchers wishing to conduct or commission tests on non-human primates must already be in possession of double ethical approval at the moment of submitting the grant proposal for assessment at the FWO.

3. Dual and military use

Research proposals that in full and unambiguously aim for military applications with an offensive character are not eligible for funding. Projects involving research into technologies and products that could be used for both civilian and defensive military purposes may be eligible for support provided there is a clear justification for which civilian uses the technology or product will be used. The participation of military partners or the development of generic technologies, products or knowledge that may meet the needs of both civil and military end-users (known as 'dual-use' goods or technologies) is a priori not ruled out for funding, provided that the research itself has a clear focus on development or improvement of goods, software, methodology and technologies for civil applications. See for more information: VLIR brochure dual use.

Legal and regulatory basis

Below, a non-exhaustive overview is given of the legal basis for several ethical issues arising in research projects. Many of these aspects are governed by legislation at national and European level, and are thus binding on researchers in Belgium. For European legislation, the list is limited to ‘regulations’, since these automatically apply to all member states of the European Union without the need to be transposed in national legislation. European directives, by contrast, first have to be transposed in national legislation. Therefore, reference is made to Belgian law. Needless to say your research should also comply with all applicable institutional policies.

Human embryos, fetuses and human embryonic stem cells

Human beings

Human cells or tissues

Personal data

Animals

International collaboration

Dual and military use/misuse of research results

Other guidelines

Research Integrity

Also guidelines on scientific integrity may prove relevant for more specific ethical issues. See for more information:

Disclaimer

Any of the above information should be interpreted as non-binding assistance and no rights can be derived from this information. FWO cannot be held responsible for parts or information that is incorrect, incomplete and/or outdated.