Ethics: How do I complete the ethics questionnaire for a BOF or IOF application?

These guidelines are designed to help applicants of BOF and IOF funding fill in their ethics questionnaire (see attachment at the bottom of this page). Needless to say, your research should always comply with all applicable EU, (inter)national laws and regulations and Ghent University institutional policies. You may find more information on the university’s ethics policy on our website, including links to the different ethics committees at Ghent University.

 

A. BOF’s ethics authorisation procedure

The application forms for all BOF (and IOF) funding programmes include a section titled ‘Ethics'. This section contains a questionnaire related to ethical aspects of the proposed research topic, methodology and potential applications.

During the review phase the panel responsible for the evaluation of your application reviews the submitted ethics questionnaire and may indicate that ethical advice is required and/or formulate concerns, advice, and preventive and/or corrective measures for specific ethical aspects.

If funding has been granted and an ethical approval is mandatory (mentioned as such in the questionnaire) or recommended, you must submit your application to the ethics committee overseeing the intended type of research.

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 new risks arise during the execution of the project, not covered by the initial application, additional ethics approval might be required.

BOF may request proof of the ethics approval. Approvals may be requested at any time during the project period and up to five years after the end of the project.

 

B. Ethics questionnaire

1. Human embryos and foetuses

This section covers research on human embryos and foetuses, including human embryonic stem cells (hESCs).

What is requested?

If you checked any of the boxes, you must submit your proposal to the Committee for Medical Ethics, as soon as your application has been approved for funding. The project can only start when the committee has formally given an ethical approval of the project.

Additionally, if you checked the box for question 2, research projects using human embryos in vitro require subsequent approval by the Federal Commission for Medical and Scientific Research on embryos in vitro (FCE)

Further information

The Belgian law on research on embryos in vitro in principle allows all types of research directed at therapeutic purposes and at increased medical knowledge. This includes research for germline and somatic gene therapy, therapeutic cloning, and studies that could allow the development of human embryonic stem cell lines from embryos specially created for research, by somatic cell nuclear transfer or from supernumerary non-implanted embryos resulting from in vitro fertilisation. The creation of human embryos for research purposes is only allowed under strict conditions.

Please take note that you must obtain the donor’s free and fully informed consent. Personal data and privacy of donors of embryos for the derivation of the cells is to be protected and no financial inducements may be provided for the donation of embryos.

Activities that are legally prohibited in Belgium are:

  • research activities directed at human cloning for reproductive purposes;
  • sex selection for non-medical reasons;
  • eugenic practices: activities intended to modify the genetic make-up of human beings.

 

2. Human beings 

This section refers to any research involving human study participants, regardless of its nature or topic. It may encompass: (invasive or non-invasive) collection of biological samples, medical interventions, personal data gathering, interviews, observations, tracking, secondary use of information that has been collected for other purposes, officially collected information, information extracted from social media sites, etc. Section 4 on ‘Personal data’ may also apply.

What is requested?

If you checked box 1.a, 1.b, 1.c or 1.d, please note that not every research involving human participants triggers the obligation to request an ethical approval. However, the journal in which you want to publish the results of your research might ask you to submit an ethical approval. For this reason, it might be advisable to request ethical approval anyway before the start of the project from the relevant ethics committee. You can find an overview of the ethics commissions at Ghent University on our website.

If you checked box 1.e, 1.f or 2, you must submit your proposal to the Committee for Medical Ethics, as soon as your application has been approved for funding. The project can only start when the committee has formally given an ethical approval of the project. 

At any time, you must ensure respect for people and for human dignity and try to ensure a fair distribution of the benefits and burdens of research. You must protect the health, rights and interests of the research participants and ensure that your research methodologies do not result in discriminatory practices or unfair treatment. Moreover, you must obtain free and fully informed consent of the research participants. 

Please note that when conducting surveys, interviews or focus groups where personal information is gathered and stored, you must also pay attention to privacy, personal data protection and the wellbeing and safety of participants. If you’re conducting clinical trials, you’ll find more information on legal and ethical considerations on the website of the Health, Innovation and Research Institute of Ghent University Hospital (HIRUZ).

 

3. Human cells and tissues 

This section refers to research collecting, producing or using human cells or tissues. These cells or tissues may be purchased from commercial sources or obtained/derived as part of your research project, from another research project, laboratory or research institution or from a biobank. 

What is requested?

If you checked any of the boxes, you must submit your proposal to the Committee for Medical Ethics, as soon as your application has been approved for funding. The project can only start when the committee has formally given an ethical approval of the project. Moreover, you must keep track of the origin of the cells and tissues you use, produce or collect and must possess free and fully informed consent of the donors.

Beyond ethics aspects, the handling of cells and tissues of human origin is subject to specific rules and (safety) precautions: 

  • Make sure to possess/obtain the necessary accreditation/designation/authorisation/licensing for using, producing or collecting the cells or tissues (e.g., concerning donor selection/protection; accreditation/designation/authorisation/licensing of tissue establishments and tissue and cell preparation processes; quality management of cells and tissues; procurement, processing, labelling, packaging, distribution, traceability, and imports and exports of cells and tissues from and to third countries).
  • Make sure cells/tissues are safe (screened for contagious particles) and lab personal is appropriately protected (by proper equipment, vaccination, …).

Storage and secondary use of human body material

Human cells or tissues which have been derived in a research project or from clinical practice must be accompanied by the donor’s informed consent for the use of the cells or tissues. The consent could be either for specific research or, generally, for any secondary use, or storage of the material for future research. A specific donor’s informed consent is required for the use or storage of human cells or tissues for genetic testing, and for the collection of any additional material or data.

If your research project involves the transfer of cells and tissues from/to non-EU countries, you must comply with the specific provisions on import/export (see also ‘international collaboration’). Moreover, since human cells and tissues constitute personal data, you must also comply with the rules on data transfer to non-EU countries.

Human body material intended for future research should be stored in an established biobank or triggers the obligation to register the storage as a biobank. No samples/data may be registered/placed in the biobank before all appropriate consents and ethics approvals have been obtained and procedures are in place to guarantee data privacy. Refer to our webpage on biobanks for more information.

 

4. Personal data 

This section concerns research which involves processing of personal data, regardless of the method used (e.g. interviews, questionnaires, direct online retrieval, secondary use of personal data). For the aspect ‘personal data collection’, section 2 on ‘Human beings’ may also apply.

Personal data’ means information relating to an identified or identifiable natural living person. Special attention should be paid to special categories of personal data (sensitive data). 

Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or by automatic means. 

What is requested?

If you checked the box, the GDPR General Data Protection Regulation (GDPR) / Algemene Verordening Gegevensbescherming (AVG) applies to your research. This legislation requires that all processing activities at Ghent University are registered in the GDPR register. The registration must be done at the start of each new research project where personal data are processed (or the phase in the project where personal data are processed), and this before the start of the actual data collection/processing. Researchers of Ghent University can register their processing activities in DMPonline.be while creating their data management plan. Check this research tip for more information on how to register personal data processing activities. 

Personal data must be processed in accordance with conditions that aim to limit any possible negative impact on the persons concerned and ensure fairness, transparency and accountability of the data processing, accuracy and confidentiality. Therefore it is important to thoroughly consider and describe how the collection and/or processing of personal data will be handled during the design phase of your research project (privacy by design).

More information on how to be compliant with GDPR in the different phases of your research can be found on our website. Specific questions about the application of the privacy legislation can be directed to privacy@ugent.be.

 

5. Animals

This section refers to all research involving vertebrate animals and cephalopods (such as an octopus or squid), independently feeding larval forms, foetal forms of mammals be it in the last trimester of their normal prenatal development or also in earlier stages if the experiments have consequences in later stages of development and post-partum life.

What is requested?

In case you checked box 1.a, you must have obtained an ethics approval at the time of submitting your proposal for funding. In case you checked box 1.b, 1.c or 1.d, you must submit your proposal to the ethics committee responsible for your faculty as soon as your application has been approved for funding. The project can only start after formal approval of the project by the ethics committee. Please submit your proposal to one of the following ethics committees: 

You must seek alternatives to animal use when possible and implement the ‘three Rs’ principles (replacement, reduction and refinement). If animal experiments are necessary to obtain your scientific goals, you must ensure respect for the animals and animal welfare throughout their life cycle.

Beyond ethical aspects, animal testing is subject to specific rules (including authorisations, restrictions on the use of certain kinds of animals, standards for handling procedures, minimum (training) requirements for personnel, recording and traceability, care, accommodation and imports and exports from and to third countries). Make sure you possess all relevant national authorisations/licensing for experimenting, producing, raising and sourcing the animal species concerned and comply with institutional policies and applicable international, EU and national law.

Check our website for more information. 

 

6. Access and Benefit-Sharing and the Nagoya Protocol 

This section refers to all research involving genetic resources and/or traditional knowledge associated with genetic resources, as covered by the Nagoya Protocol and the related EU legislation.

In the ‘Access and Benefit-Sharing legislation’, more specifically in the EU legislation related to the Nagoya Protocol, ‘genetic resources’ are defined as ‘any material of plant, animal, microbial or other origin containing functional units of heredity and that is of actual or potential value’. ‘Traditional knowledge associated with genetic resources’ means ‘knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources’.

If you checked the box, you must comply with the Nagoya Protocol and EU Regulation 511/2014 before accessing the resources.

What is requested?

You must investigate the conditions for access of the genetic resources and/or associated traditional knowledge in the country of origin. Access might be free, or allowed on the condition of a notification to the Competent National Authority (CNA) of the country. You often must obtain a ‘Prior Informed Consent' (PIC) from the Competent National Authority (CNA) in the country of origin (provider country) prior to the access and utilization of the genetic resources or traditional knowledge. The conditions for utilization, and benefit sharing, must be negotiated and registered in 'Mutually Agreed Terms' (MAT). 

As such, your deadline for compliance is not the start of your project, but the start date of access of the material (sampling, importing, …). Investigation of the country’s access and benefit-sharing (ABS) legislation, contacting the country, and negotiating conditions might take time. So an early start of this process is beneficial to your project.

Researchers have a legal obligation to comply with the Nagoya Protocol. For EU citizens, Regulation (EU) 511/2014 details the rules of compliance. The Protocol applies only to genetic resources and associated traditional knowledge accessed 1) from a country that is party to the Nagoya Protocol and that has access and benefit-sharing (ABS) legislation and 2) for the purpose of ‘utilization of genetic resources’ after 12th October 2014. The protocol applies both to those who obtain genetic resources directly from the country of origin and those who obtain them indirectly from third parties, but does not apply to human genetic resources, genetic resources already governed by specialised international instruments (e.g., the International Treaty on Plant Genetic Resources for Food and Agriculture) nor genetic resources used as traded commodities.

Check our website for more information. You can also consult http://nagoya.vlir.be/ for the checklist to determine whether the Nagoya Protocol applies to the material and get more information on the procedure to follow, if applicable.

If tangible materials are transferred across borders, it may be mandatory under the law of the supplying and/or receiving country to obtain an authorisation for export, respectively import.

 

7. International collaboration

This section concerns research involving non-EU countries. Research in countries that do not fall under Belgian or European laws and standards (including research activities, participants, imported/exported resources) can raise specific ethical issues (particularly in lower and lower-middle income countries), such as:

  • exploitation of research participants;
  • risks to participants and researchers;
  • exploitation of local resources;
  • research that is restricted or prohibited in the EU (ethics dumping).

What is requested?

When accessing or transporting local resources (e.g., animal and/or human tissue samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora samples) from any country, you should comply to all relevant (inter)national legislation. This often includes research permits, access and benefit-sharing (ABS) legislation (see above), and local cooperations. If tangible materials are transferred across borders, it may be mandatory under the law of the supplying and/or receiving country to obtain an authorisation for export, respectively import.

Any use of local resources must show respect for biological diversity, cultural traditions and share benefits (i.e. benefit to local participants and their communities, involvement of local researchers as equal partners and responding to local research needs). This is particularly important for low-income and lower-middle-income countries (see the Global code of conduct for research in resource-poor settings).

A note on ethics dumping

Ethics dumping, or the export of unethical research practices to low- and middle-income countries, where legislation or compliance monitoring may be (much) less stringent, can occur deliberately, on purpose, or even without the knowledge of the responsible of a research project. Naturally, the prevention of ethics dumping is an ethically important issue.

Therefore, ethically sensitive activities must comply with both the legal obligations in the concerned non-EU country, and those in force in Belgium. A double ethics verification procedure is strongly recommended for research in non-EU countries. Research activities in a non-EU country, that would require ethical approval when conducted in Belgium, may under no circumstances be initiated before permission has been obtained in both the non-EU country and at Ghent University. For research in EU countries, ethical approval in the country where the research is conducted suffices.

Whenever possible, ethical approval must be obtained in the non-EU country where the project is to be executed. For clinical and animal testing the necessary governance structures have to be in place locally. Other types of research involving human participants (e.g. behavioural or sociological research) may also require institutional, regional or national consent (whether or not by an ethics committee) and / or community-level consent.

Simultaneously, the relevant ethics committee at Ghent University should assess whether the proposed research complies with fundamental ethical principles 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 be guaranteed that the research can be carried out in an acceptable manner, the proposed research cannot take place using BOF or IOF funding. It is advisable to conduct research within the EU if there is no specific need to carry it out outside the EU.

 

8. Dual-use and military applications 

This section concerns research involving dual-use goods, software, technology or knowledge. These are normally used for civilian purposes but may have partial or full military applications, and/or may contribute to the proliferation of chemical, biological or nuclear weapons of mass destruction.

What is requested?

If you checked any of the boxes, be aware that research proposals with potential military applications or involving dual-use items must comply with Ghent University’s dual-use research policy. Check our website in Dutch or English for more information on this policy. Research proposals of an exclusive military nature are not eligible for BOF or IOF funding.

There is a legal obligation to apply for an export license if goods, software or technical knowledge mentioned on the European Union dual-use control list is shared outside of the EU, be it during the research (e.g. with research partners) or when you’re exploiting the research results. Check our website to determine whether you’re working on technology mentioned on the European Union list. Sharing may include the publication of the research results in scientific journals or papers or during visits abroad. The Dual-Use Contact Point will handle the administration.

The following research or activities must be reported to Ghent University’s Dual-Use Contact Point, using the Dual-Use Notification Form:

  • research or activities with potential military applications, i.e. involving the military or partners active in the defense industry, funded by the military or by partners active in the defense industry, useful for military purposes or for the development or delivery of nuclear, radiological, chemical or biological weapons;
  • sharing goods, software or technical knowledge on the European Union dual-use control list outside the European Union.

The Dual-Use Contact Point checks whether research proposals and/or collaborations are in accordance with legal obligations and the university’s dual-use policy.

There is no obligation to request an ethical approval for every dual-use research project. However, the journal in which you want to publish the results of your research might ask you to submit an ethical approval. For this reason, it might be advisable to request an ethical approval from the Committee on Human Rights Policy and Dual-Use Research anyway before the start of the project. This is also done by reporting your research to the Dual-Use Contact Point, using the Dual-Use Notification Form.

 

9. Misuse and human rights

This section concerns research and collaborations that, although carried out with benign intentions, could be misused for unethical purposes or could harm humans, human rights, animals or the environment. It also refers to collaborations with partners involved in serious or systematic violations of human rights.

What is requested?

If you checked box 1, know that not all potential for misuse of the research results triggers the obligation to request an ethical approval. However, the journal in which you want to publish the results of your research might ask you to submit an ethical approval. For this reason, it might be advisable to request an ethical approval anyway before the start of the project from the relevant ethics committee at Ghent University. 

In order to prevent benefiting from human rights violations, collaborations with external partners are subject to a human rights impact assessment. If it looks like the activity, partner, sector or region is tied to serious or systematic human rights violations, you must check box 2 and submit the intended collaboration to the Committee on Human Rights Policy and Dual-Use Research. Please describe the collaboration you have in mind and what evidence there is of possible human rights violations.

 

10. Environment, health and safety 

This section concerns research that may adversely affect the environment and/or the physical and psychological health and safety of the researchers, research subjects and third parties involved. This may be related to the topic, experimental design of the research and/or research setting and/or undesirable side-effects of the technologies used.

What is requested?

The health and physical and psychological safety of all human participants in research, such as subjects, investigators or uninvolved third parties, must be a priority at all times. At all time, be attentive for the impact gender, religion, sexual orientation, race, ethnicity and disability of the researcher(s) may have on their safety, in particular in certain nations. You must also assess potential risks to the environment and avoid or minimise such risks. Staff should receive adequate training.

Research must comply with applicable institutional policies, international, EU and national laws and regulations, in particular, the precautionary principle and legislation on nature conservation and pollution control. The precautionary principle requires that where there is plausible scientific evidence for serious risks, you must assess that a technology will or will not harm the future users and/or environment.

The handling of environmentally harmful substances while researching is subject to specific health and safety authorisations (e.g., on licensing of establishments, procurement, processing, labelling, packaging, distribution, traceability, public health control and imports and exports of those substances from and to third countries). This is particularly true for activities, installations or products that need to be covered by permits (ionizing radiation, radioactive substances, pharmaceutical products, drug precursors, explosives and precursors, cyanides, GMOs, pathogens, …). Make sure to also possess the necessary environmental authorisations/licensing for using, producing storing and disposal of substances and implement the necessary preventive and curative checks and procedures and training at the workplace.

 

11. Other ethics issues

It may be that your research raises new ethical issues and concerns that are currently not (fully) covered by the ethics checklist. Amongst other may be new developments in the fields of neurobiology, artificial intelligence, man-machine interaction, developments in nanotechnology, genetic enhancement, the creation of androids and cyborgs, design, production, use or governance of artificial intelligence, robots or “autonomous” technology (e.g. self-driving cars and drones, robots in deep sea and space exploration, robotic weapon systems, software agents, deep learning, …).

If you are aware of any such other ethically relevant issues that apply to your project, describe them and explain how you intend to address them. This allows you to alert the expert panel and get appropriate input for addressing them. It could also avoid problems you would encounter if such issues were found out only later (e.g. in the context of publication requirements or audits). Use the ‘ethics by design’ methodology.

 

12. Concluding questions

Perhaps no ethics issues apply to your research proposal. If so, please indicate so. If, on the other hand, ethics issues apply to your research, you must confirm that you shall adhere to all legal and institutional ethical guidelines. If an ethical approval is required for the start of the project or a certain work package, please state which ethics committee will deal with your application.

 

 

 

 

Attachments

Source reference

Translated tip


Last modified Oct. 20, 2021, 3:16 p.m.