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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

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. For project proposals with the intention of experimenting on non-human primates however, the ethical review process must at least have been initiated by the project application’s deadline. In practice, this is evidenced by uploading either the ethical approval for the intended experiments, or the acknowledgement of receipt of your request for ethical advice by the Ethics Committee on Animal Testing together with your project proposal. In any case, FWO must be in the possession of the ethical approval for performing research on non-human primates at the time of the rebuttal, or, if no rebuttal is foreseen in the procedure of the subsidy channel concerned, at the latest 1 month before the start of the evaluation panels. Please contact MED@fwo.be if you need additional information.

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.

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

Attention points

Clinical trial transparency

From an ethical and public health perspective as well as within the context of efficient use of research resources, it is essential that clinical trials are conducted openly and transparently and that their conclusions are made available to the research community and society within a reasonable period of time. Not disclosing results of clinical trials leads to a systematic skewing of the medical knowledge base, creates scientific gaps and exposes subjects to unnecessary risks by research being unknowingly duplicated. Publications in journals, which typically tend to favour positive research results, lead to systematic overestimation of the efficacy of drugs, medical devices or clinical interventions and underestimation of their potential harms. The combination of blind spots in knowledge and bias in the reporting of clinical trials undermines proper regulatory decision-making, balanced health technology assessment and the development of robust clinical guidelines. In addition, it obstructs public health and individual treatment recommendations. This means that it also ultimately undermines public confidence in clinical scientific research.

For these reasons, the prior registration of clinical trials and the publication of clinical research methods and results in public trial registries, in addition to reporting in (specialised) journals, constitutes a universal necessity that is also set out in the World Medical Association's Declaration of Helsinki. Furthermore, at least for certain types of clinical studies, this is a legal requirement in several jurisdictions, including the European Union (European Regulation No 536/2014).

Pursuant to this European regulation, the FWO requires that funded clinical trials are registered in a recognised public clinical trials registry (e.g. https://www.clinicaltrials.gov), prior to the start of the trial. For the purposes of registration, a clinical study or clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials include interventions such as, but not restricted to, drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.

Where necessary, the information in the public clinical trial registry should be kept up to date during the course of the study. A sufficiently detailed clinical study protocol, statistical analysis plan and summarised study results must be made publicly available through the same registry within 12 months (six months for paediatric studies) of the end of the data analysis.

Publishing data from the trial in a (specialised) journal is a mandatory part of the project activities as well. For clinical trials, the FWO requests compliance with relevant reporting guidelines that have been developed specifically to improve the design, analysis and reporting of experiments, so that readers can assess the robustness of the findings and reproduce the work should they wish to do so. Randomised clinical trials should comply with the CONSORT guidelines.

The mandatory registration and publication of clinical trials also applies to FWO projects that were terminated early or did not lead to the desired outcome. Disclosing details about a clinical trial in a public trial registry does not adversely affect the ability to publish the same results in a peer-reviewed journal at a later point. In fact, the identifier from the clinical database should be reproduced in all specialised publications on the clinical trial in order to link scientific publication (with details on research methods and results) to the registration in the public clinical trial registry. Please note that the FWO follows an Open Access publication policy.

European Regulation No 536/2014 also applies to clinical trials completed before 2014. Therefore, beneficiaries of FWO grants must also deposit clinical trials not yet registered and/or complete any missing data and study results in a public clinical register.

Where appropriate, openness around clinical trial data provides the basis for sharing anonymised data of participants for further medical research and public health policy in line with FAIR principles and current legislation (including GDPR).

In summary, transparency around clinical trials thus includes not only the registration of the trial with the addition of the protocol and summary results in a searchable public registry but also the publication of a clinical research report in a specialised Open Access journal, regardless of the outcome of the trial. Reporting by means of a trial registry is considerably faster than the usual publication timelines in peer-reviewed medical journals and so compliance with these rules contributes to accelerating medical progress.

Once the first patient has been enrolled, the beneficiary must notify the FWO of the study start date and the clinical trial registration number in the database. Verifying compliance with FWO regulations and those of European Regulation No 536/2014 forms an intrinsic part of the evaluation of a final report of an FWO-funded project and its conclusions may be considered by the expert panels during the deliberations of future grant applications

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.

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.

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.