This web-site has been created to offer guidance on Research Ethics Assessment in view of a possible ethics review of research projects by the competent authorities. On this site you can find information on when and how to apply for ethical approval and authorizations, application processes, policies, legislation, guidelines, etc.
Ethics assessment is critical for different research funding bodies. For further questions, please contact the Research Office
The ReO will assist EPFL researchers in completing the ethics component of their H2020 grant applications, the Ethical Issues Table and the Ethics Self-Assessment in particular.
EPFL aims at promoting U.S. Grants submissions. It is however important to take contact with the Research Office as soon as you have a project idea. Indeed, the projects must follow ethical rules fixed by EPFL (FCOI policy) and export law policies fixed by SECO.
The following list present the most common challenges in Research Ethic Assessment. The list is non-exhaustive, thus feel free to contact the Research Office for more information.
- Participation of Third (non EU) and/or Developing Countries.
- No information on handling incidental findings (findings that resulted from the research protocol but were not expected).
- Insurance for participants and/or for researchers.
- Issues related to children (0-17 year): failure to describe if a child obtains a real and direct benefit. If a child is not directly benefited, a minimum risk and minimum burden must be illustrated.
- Clinical research: failure to justify human intervention from an ethical perspective, safeguard data protection, design of informed consent forms.
- Research on animals: failure to describe (i) numbers used; (ii) humane end points; (iii) if non-animal alternatives were sought.
- Data protection and privacy: codification, storage and anonymization of personal data.
(Adapted from: “Ethics Review and the FP7 Framework” by Isidoros Karatzas, Head of the Ethics Sector, European Commission)
This are the criteria examined during an Ethics Review:
- Does the researcher show an understanding of the ethics issues raised by the project.
- Are the relevant national and international legislation taken into account in the design of the proposed research frame.
- Did the applicants sought/ are planning to seek the approval of relevant local/national (ethics) committees and, when appropriate, the relevant competent authorities.
- Does the applicant treats the ethics issues part with due attention and not as an afterthought.
- The Nuremberg Code (1947): States research ethical principles for human experimentation
- The Declaration of Helsinki (1964-2008): Details ethical principles related to the protection of the life, privacy, health and dignity of the human subject
- The Oviedo Convention (1997): Seeks the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine
- The UN Convention on Biological Diversity (1992): Seeks to ensure the conservation and sustainable use of the diversity of species, habitats and ecosystems on the planet
- The Cartagena Protocol on Biosafety (2000): Seeks to protect biological diversity from the potential risks posed by living modified organisms, taking into account human health
- Swiss Federal Act on Research involving Human Beings (2014) – Loi fédérale relative à la recherche sur l’être humain (LRH)
- The European charter of Fundamental Rights (2000): The first formal EU document that tries to combine and declare all the values and fundamental rights (economic and social as well as civil and political) to which EU citizens should be entitled (in particular articles 1,3,7,8,10)
- Kofam, portal for human research in Switzerland
Ethical review by subject
Complete your ethics self-assessment, depending on the subjects involved in your research.
All research involving human subjects must be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and justice (Declaration of Helsinki). It is generally agreed that these guidelines, which in principle have equal moral force, guide the conscientious preparation of proposals for scientific studies.
Furthermore, research involving human subjects should be carried out only by, or strictly supervised by, suitably qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research; the reasons for proposing that it involves human subjects; the nature and degree of any known risks to the subjects; the sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects will be adequately informed and will voluntarily give their consent (Informed Consent). The protocol should be scientifically and ethically established by one or more suitably constituted review bodies, independent of the investigators.
Self-Assesment of your research proposal
You can use the kofam (Swiss Coordination office for research involving humans) Wizard to categorize your research project. The Wizard will tell you what type of research project it is and which category the project or the clinical trial must be allocated to, and which type of authorization must be requested.
This section refers to research in which human cells or tissues are used, produced or collected.
Researchers should give a detailed description of the types of cells/tissues used in their project, together with copies of the accreditation for using, processing or collecting the human cells or tissues.
- For cells/tissues obtained from commercial sources – details on the provider (company or other) and the copies of the import licences need to be provided.
- For cells/tissues obtained from another laboratory/institution/biobank – details on the laboratory/institution/biobank (name, country, legislation number under which the material is stored), consent for secondary use) and copies of the import licences and a statement of the laboratory/institution/biobank that informed consent has been obtained need to be provided.
- For cells/tissues produced or collected during previous research activities of the researcher – details on storage of the cells (name, country, legislation number under which the material is stored, duration of storage) need to be provided.
- For cells/tissues produced or collected as part of the research proposal – details on the duration of storage and fate of the material at the end of the research, together with the Informed Consent Forms and Information Sheets need to be provided.
Animal experiments must be justified on the basis of prevailing values and interests and on based on the principles of replacement, reduction, refinement (3Rs principle):
Researchers are obliged to demonstrate the need for and tenability of all experiments on animals and to carefully verify their ethical justifiability through ethical balancing. The balancing of the ethical issues involved in all animal experiments is the responsibility of the individual researcher and must be justifiable to the consulting cantonal commission for animal experimentation, the authorizing bodies, the ethical committees for animal experimentation, animal welfare officers and the general public. More info on “Federal Food Safety and Veterianary Office FSVO” – Animal Experiments.
The PI and the research team needs to work in conformity with the federal law on animal protection (RS 455, and amendment of June 15, 2012), the federal ordinance on animal protection (RS 455.1), the federal ordinance on animal experimentation, production, and housing (RS 455.163), and in addition with the relevant EU directive (2010/63/EU) for EU funded proposals.
All the experimental procedures on animals within the project will are subject to validation by Cantonal Authorities.
According to the DFE Ordinance 455.109.1, individuals who carry out or supervise animal experiments, must follow the introductory course in laboratory animal science (module 1; section 2: article 23). Supervisors also have to attend a second course (module 2; section 3: article 27) to acquire the expertise and techniques necessary to plan and supervise animal experimental protocols.
Research which involves the collection or processing of personal data, regardless of the method by which they are/were collected should comply with the Federal Act on Data Protection (‘Loi fédérale sur la protection des données’, 235.1). The aim of this Act is to protect the privacy and the fundamental rights of persons when their data is processed. The FDP is currently under revision. The revision of the Act has been motivated by changes in European legislation and by the emergence of new technologies.
As of 25 May 2018, the EU General Data Protection Regulation (EU-GDPR) will enter into force. This Regulation will apply in the EU and it replaces Directive 94/46/EC of the European Parliament and of the Council of 1995. Despite the fact that Switzerland is not a member of the EU, the new EU-GDPR has direct consequences for Switzerland.
For further information on the EU-GDPR, see the EPFL Data Protection web-site.
Ethical clearance of research projects involving personal data:
Research projects involving the processing of (sensitive) personal data may need an authorization from either the cantonal ethics committee (for example, when the project involves health-related data) or the EPFL institutional Human Research Ethics Committee. For more information on how/where to get ethical approval for projects involving personal data, researchers can contact [email protected].
The EPFL Library supports EPFL researchers in the management of their data, provides tools and guidance at any step of the data life cycle. Contact the Research Data Library Team at: [email protected].
Some definitions of the Swiss Federal Act on Data Protection (FDP)
All information relating to an identified or identifiable person.
Any operation with personal data, irrespective of the means applied and the procedure, and in particular the collection, storage, use, revision, disclosure, archiving or destruction of data.
Sensitive personal data
- Religious, ideological, political or trade union-related views or activities.
- Health, the intimate sphere or the racial origin.
- Social security measures.
- Administrative or criminal proceedings and sanctions.
For research that may have a negative impact on the environment or the health and safety of the researchers involved, due to the experimental design of the research itself or due to undesirable side-effects of the technologies used, an assessment of the potential risks to the environment must be provided and the necessary environmental authorisations need to be obtained.
For example: research involving harmful biological agents (pathogenic organisms) or GMOs, research involving harmful chemicals, explosive agents, radioactive agents, research involving harmful equipment such as high-powered laser systems.
Research with Genetically Modified Organisms (GMO): such research requires authorization from the Federal Office for the Environment (FOEN). Potential risks to the environment must be assessed (Risk-benefit analysis) and measures to avoid or minimise such risks should be described.
- Health and Safety
The health and safety of all participants in the research (investigators, subjects involved or third parties) must be a priority in all research projects.
If your research proposal involves the use of elements that may cause harm to humans, a detailed description on the safety procedures you intend to apply and the safety classification of the laboratory need to be provided. Furthermore, copies of the authorisations for the processing or possessions of harmful materials much be obtained. More info: Safety, Prevention and Health Domain (DSPS).
Research in co-operation with developing countries
When research or part of it will be performed in developing countries and/or by partners from developing countries or when the results can be potentially applied in these countries, a description should be provided of the arrangements for
- sharing the benefits and allocation of the intellectual property rights,
- contribution to the capacity building in the developing countries.
Access to Genetic Resources and Associated Traditional Knowledge and Sharing the Benefits arising from their Utilization (ABS)
“The regulations on Access and Benefit-sharing (ABS) of the Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP) apply to all types of research – industrial as well as academic – that make use of genetic resources of plant, animal bacterial or other origin and/or of traditional knowledge associated to these resources.”
EU Regulation on Access and Benefit Sharing
The EU Regulation on Access and Benefit Sharing brings EU law into line with international obligations (Convention on Biological DIversity (CBD) and the Nagoya Protocol).
For more information, please contact the Swiss National Focal Point to the Nagoya Protocol.
By virtue of the Swiss Federal Act on the Control of Dual-Use Goods, Specific Military Goods and Strategic Goods (Goods Control Act, GCA, RS 946.202) and its ordinance (OCB RS 946.202.1), the export of the following goods are subject to the authorization of the Secretary of State for the economy (SECO):
- dual-use goods, components, software, technology and information
- nuclear goods, special military goods, strategic goods and other goods subject to national export controls
- goods that you know or have reason to believe are intended for the development, manufacture, use, passing on or the deployment of nuclear explosive devices, biological or chemical weapons, and their delivery systems (NBC weapons) save where the OCB provides for an authorization exception. For certain categories of nuclear goods, the export authorization is to be requested to the Swiss Federal Office of Energy (SFOE).
Professors and collaborators at EPFL must comply with these legal and regulatory measures (LCB and OCB). This legislation includes penal sanctions in the event of intentional infringement or negligence.
At EPFL, transfer of knowledge, software, demonstrators or prototypes that can fall under the scope of this legislation can occur in the context of technology transfer, international collaborations or research proposals, but also in informal personal contacts.
So, before transmission of information, research results, prototypes etc. to a company, person or entity (even academic) outside of Switzerland, it must be checked whether the data / information / material / software to be transmitted are subject to authorization. To do so, the following annexes to OCB need to be consulted:
- Annex 2 (part 1) – Nuclear Materials, Facilities and Equipment
- Annex 2 (part 2) – Dual-Use Goods
- Annex 3 – Specific Military Goods
- Annex 5 – Weapons and their components – Explosives
EPFL holds a general export license authorizing transfers of dual-use goods (Annex 2, part 2) and goods according to Annexes 3 and 5 to certain countries; the list of these countries appears in Annex 7 to the OCB . Please note: this general license is not valid for certain goods intended for internet or mobile communications surveillance (as defined in the applicable Ordinance, RS 946.202.3), and it does not relieve from the obligation to request an authorization for the export of NBC weapons (see definition above).
OCB and its annexes are available on the SECO web site
In case of doubt, please contact the Legal Team at the Research Affairs: Françoise Chardonnens ([email protected]).
Some foreign laws on export control, including US laws, differ from Swiss laws in that they prohibit not only export to certain countries but also access to certain technologies, software and information for persons of certain nationalities. Professors and researchers at EPFL should therefore be especially cautious in the framework of international collaborations, including with US companies or institutes, and ensure in advance that the foreign legislation on export control is observed.
More detailed information on US and European foreign export control legislation can be found online on the following websites:
- US Export Laws: U.S. Department of Commerce and U.S. Department of State
- European Export Laws: European Commission
Background information about dual-use issues in engineering sciences can be found here.
Potential misuse of research may be defined as: research involving or generating materials, methods or knowledge that could be misused for unethical purposes.
Areas of concern:
- Research involving agents or equipment that could be directly misused for criminal or terrorist purposes: e.g. Does your research involve information on/or the use of biological, chemical, radiological and nuclear sensitive materials and explosives (CBRNE) or means of their delivery?
- Research that creates knowledge that could be used for criminal or terrorist purposes: e.g. infrastructural vulnerability studies, cyber-security related research.
- Research that can result in stigmatization and discrimination: e.g. Does your research involve the development of technologies or the creation of information that could have severe impacts on human rights standards if misapplied?
If your research proposal addresses one of the above-mentioned areas of concern, you must make a risk-assessment and take appropriate measures to avoid abuse.
Ethics Assessment – Information/documents to provide:
- Details on the measures you intend to take to prevent abuse (including training of involved researchers); copies of researchers security clearances
- Details on how your research could affect human rights and details on measures you intend to take to prevent this; copies of ethics approvals if applicable.
(Source: The EU Framework Programme for Research and Innovation Horizon 2020: How to complete your ethics Self-Assessment. Version 1.0. 11 July 2014)