How to make an ethics self-assessment in research projects – Aalto support and guidelines

As the Finnish national research ethics guidelines and processes differ for medical and non-medical research with human participants, we will first discuss the guidelines for medical research with human participants. This section also includes guidelines on research on human organs, tissues and cells.

‘Medical research means research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general, and which is not a clinical trial as defined in the Clinical Trials Regulation’ (Medical Research Act (488/1999), Section 2(1) as amended by the Act 984/2021, see also below).

Note: this is an unofficial translation based on the latest version of the Medical Research Act. In case of discrepancies between the language versions, the Finnish and Swedish versions shall prevail. An earlier translation which does not include the latest amendments is available on Finlex: Medical Research Act (pdf, in English).

The HUS (Helsinki University Hospital) ethics committees review Aalto University’s medical research projects. You need to ask for a research ethics review and follow the proper processes indicated. 

Note that you also need to apply for the relevant research permits for your research. 

More information:

• Declaration of Helsinki 1964 (who.int, pdf)
• Medical research ethics in Finland (vastuullinentiede.fi):
• Medical Research Act (488/1999): an up-to-date version in Finnish (Finlex.fi)
• English translation: Medical Research Act (488/1999) (Finlex.fi, pdf). Please note that the latest amendments are not included in this translation.
• Clinical Trials Regulation (eur-lex.europa.eu) : The Clinical Trials Regulation defines ’clinical trial’ as follows: ‘“[C]linical trial” means a clinical study which fulfils any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned; (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects’ (Regulation (EU) No 536/2014 of the European Parliament and of the Council, Article 2(2)(2)).

Research on the Medical Use of Human Organs, Tissues and Cells usually follows a similar path as medical research in terms of the research ethics review. See the HUS Research Ethics Guidelines (hus.fi, in Finnish).

You need to explain what materials you will use, where you have obtained it and how you will handle it. In addition, you may need a research ethics review. 

More information:

• Act on the Medical Use of Human Organs, Tissues and Cells (101/2001, amended 547/2007, 778/2009, 653/2010, 336/2011, 689/2012, 277/2013)
• Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).

Think of all the risks which may occur to your research participants and how to mitigate them. The risks could be physical, social and psychological.

Familiarise yourself and comply with personal data regulations.

You may not be able to prevent all risks but you can minimise their likelihood by being prepared and by having taken the time to recognise them.

Aalto University has a Research Ethics Committee which handles Aalto researchers’ requests for research ethics reviews for research projects with human participants.

More information: 

• Aalto University Research Ethics Committee | Aalto University  
• How to handle personal data in research | Aalto University
• Finnish National Board on Research Integrity (TENK): The ethical principles of research with human participants and ethical review in the human sciences in Finland (tenk.fi, pdf)

Note that there are specific guidelines available for different research areas, e.g. research on immigration and refugees, and on specific methodologies such as ethnography or anthropology.

The processing of personal data is subject to specific regulations regardless of the method used (e.g. interviews, questionnaires, direct online retrieval etc.). Personal data is any data or information relating to an identified or identifiable natural person. A person may be identifiable directly, e.g. by their name, or indirectly by combining data such as their age, profession and employer. Personal data can also consist of the opinions or recorded speech of the identifiable person. Personal data must be processed in accordance with certain principles and conditions which aim to limit any possible negative impact on the persons concerned and ensure fairness, transparency and accountability of data processing, and data quality and confidentiality. More information and support: 

How to handle personal data in research (aalto.fi)

Note that if your research data includes special categories of personal data (formerly known as ‘sensitive data’), personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orient at ion (Article 9(1) of the GDPR), you need to make a request for a research ethics review (see the chapter above)  

More information: 

Aalto University Research Ethics Committee | Aalto University

If your research involves animals, you need to comply with several guidelines and obtain permits for such research.

You need a permit to work with test animals from your local Regional State Administrative Agency. The space/laboratory/project needs to have a licence to acquire, breed, keep and take care of animals for scientific or educational purposes. Remember to indicate the project number and the name of the principal investigator (PI) when applying for the permit to enable it to be tracked during its processing.

Regional State Administrative Agency: Laboratory animals: authorisations and enforcement

All projects involving the use of animals require prior authorisation from the Project Authorisation Board (avi.fi) working under the Regional State Administrative Agency

In addition, all the personnel working with test animals need to have appropriate training. The Laboratory Animal Centre of the University of Helsinki, Viikki campus, arranges a Function A & D course for researchers under the title ֥‘The use of animals in research: the course for  people carrying out procedures on animals’. The course takes place twice a year in English and once in Finnish. 

If you work with genetically manipulated test animals, you need a permit from the Board for Gene Technology. 

• Board for Gene Technology: Contained use of genetically modified animals (geenitekniikanlautakunta.fi)

A research ethics review is often required when doing research with animals. For test animals, the review is conducted by the HUS ethics committees. For other animal involvement, a research ethics review is conducted by the University of Helsinki Research Ethics Committee on Animal Research.  (you need a co-researcher from the University of Helsinki)

More information on the use of animals in research at Aalto.

More information:

• Laboratory/test animals - Ministry of Agriculture and Forestry (in Finnish)
• Council on the protection of animals used for scientific or educational purposes: Tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelun neuvottelukunta TOKES (in Finnish)

It is always recommended to create a communication plan when doing research with animals. 

If your research involves test animals/animals and you conduct the research outside Finland, please conact Aalto Unversity Research Ethics Committee secretary (Annukka Jyrämä) 

If your research involves animals but NOT as test animals, please contact the Aalto University Research Ethics Committee secretary to discuss how to proceed with the research ethics review (Annukka Jyrämä).

When doing research in non-EU countries, it is important to acknowledge the need to comply with both the target country and EU legislation. It is also recommended to have research ethics reviews conducted in both locations. You also need to carefully assess the risks for your research staff as well as the local participants. Please pay special attention to the following issues:

·                  Humans and vulnerability: communities, subjects and vulnerabilities, agency distribution, power dynamics​

·                  Materials of historical value: architecture, historical landmarks, cultural sensitivity, intangible cultural heritage​

·                  ​Sensitive topics: genetic, health, sexual, lifestyle, ethnicity, political opinion, religious or philosophical conviction, value conflicts​

o        Note that you need a research ethics review

o        More information: Aalto University Research Ethics Committee

·                  ​Benefit-sharing / capacity-building: responsiveness to local needs and priorities, IPR issues, skills development, agency ​

·                  ​Safety and security: safety measures, political risks, social risks, environmental considerations and travel issues of all involved participants (researchers and locals)

·                  Import/export regulations (see more forthcoming)

·                  Regulation on sharing personal data outside EU 

•  
  • MyCourses: Materials on research ethics
    • ‘…if you wish to transfer personal data outside of the EU or the EEA, the transfer requires additional safeguards. The additional safeguards must be put in place before transfer of any personal data outside of the EU or the EEA can be effected. If the European Commission has made an adequacy decision with respect to the country of the transferee, no further safeguards are required. Another example of additional safeguards under which transfer may be possible is the agreement to the standard contractual clauses by the transferee.’ (Materials on research ethics (aalto.fi)

For more information on transfers outside of the EU or the EEA, see: International dimension of data protection | European Commission

Cultural traditions must be respected and the benefits of the research work shared. Read the Ethical Guidelines for Global South Academic Partnerships here.

Aalto University has experienced researchers in this field who can help you. Please contact the Aalto Global Impact team for more information and training on the topic.   

It is also important to check if import/export regulations apply to your research setting. See more: Responsible internationalisation – Export control and sanctions compliance at Aalto University | Aalto University

More information

• Aalto Global Impact
• Travel safety 
• TRUST Guide on Involving Vulnerable Populations in Research
• Global Code of Conduct for Research in Resource-Poor Settings 
• Equitable Research Open Source Book
• Research Fairness Initiatives
• European Commission ethics for researchers, p. 21 on research involving developing countries

Your research should not cause any harm to the environment, fauna, plants etc. Please reflect, for example with your research group and students, on your potential outcomes, and e.g. how new technologies will impact the environment.

The European Commission also requires that you follow the ‘do no significant harm’ principle whichmeans that your research should not do any significant harm against any of the six environmental objectives covered by the Taxonomy Regulation (2020/852).

Point 1 of Commission Notice on the technical guidance on the application of ‘do no significant harm’ under the Recovery and Resilience Facility Regulation defines what constitutes ‘significant harm’ for the six environmental objectives:

1. An activity is considered to do significant harm to climate change mitigation if it leads to significant greenhouse gas (GHG) emissions;
2. An activity is considered to do significant harm to climate change adaptation if it leads to an increased adverse impact of the current climate and the expected future climate, on the activity itself or on people, nature or assets;
3. An activity is considered to do significant harm to the sustainable use and protection of water and marine resources if it is detrimental to the good status or the good ecological potential of bodies of water, including surface water and groundwater, or to the good environmental status of marine waters;
4. An activity is considered to do significant harm to the circular economy, including waste prevention and recycling, if it leads to significant inefficiencies in the use of materials or in the direct or indirect use of natural resources, or if it significantly increases the generation, incineration or disposal of waste, or if the long-term disposal of waste may cause significant and long-term environmental harm;
5. An activity is considered to do significant harm to pollution prevention and control if it leads to a significant increase in emissions of pollutants into air, water or land;
6. An activity is considered to do significant harm to the protection and restoration of biodiversity and ecosystems if it is significantly detrimental to the good condition and resilience of ecosystems, or detrimental to the conservation status of habitats and species, including those of Union interest.

More information: EU taxonomy for sustainable activities | European Commission (europa.eu)

You also need to bear in mind any safety and security risks to your research and other staff. Aalto university has many sets of instructions and training available on safety at work and waste management.

More information: 

Research projects and support for safety and security | Aalto University

Cyber Security for research | Aalto University

This section addresses projects involving the development and/or the use of systems or techniques based on artificial intelligence (AI).

The ethical questions in this area include several topics such as: 

• Human agency and oversight
• Privacy and data governance
• Fairness, diversity and non-discrimination
• Accountability 
• Transparency
• Societal and environmental well-being (impact) 

We recommend that you name an ethics advisor or an ethics board with relevant competences to provide advise and reflections on these questions throughout the project. 

More information: Ethics guidelines for trustworthy AI | Shaping Europe’s digital future (europa.eu)

Your project may raise new ethical issues and concerns which are currently not identified in the ethics self-assessment list of issues. If you already know of them, please describe them and explain how you plan to mitigate them.

We recommend that you engage an experienced ethics advisor from the field in question, to help you to deal with ethical issues and put appropriate procedures in place. If your project involves several ethical concerns, you should appoint an ethics advisory board with several experts with varied expertise.

If you are unsure of the likelihood of ethical issues or need help in finding an ethics advisor, please contact the Aalto University Research Ethics Committee (secretary).

Aalto University Research Ethics Committee | Aalto University

In many cases, research outcomes have several potential uses. It is advisable to reflect on the potential dual use or misuse of your research outcomes. Could your results be applied to terrorist or military use? You need to consider the risks and think of ways to mitigate negative impacts. Please consult an ethics advisor or an advisory board to help you throughout the research project. 

(This question in addressed in Horizon funding application form in the Security table.)

Misuse looks at the potential unethical use of your research in broad perspective. What can you do to avoid any of your research materials (e.g. biological, chemical, radiological and nuclear security-sensitive materials and explosives) or outcomes from being used for unethical purposes, ending up in the wrong hands, or for example being used to violate human rights or to undermine democratic processes (e.g. in on surveillance technologies, new data-gathering and data-merging technologies/ the context of big data)? Think of the risks and the best procedures to keep your research ethically justifiable. Sometimes it may be necessary to appoint an ethics or security advisor or an advisory board. Also, you need to pay special attention to data security when dealing with research approaching areas where a risk of misuse exists.

More information:

• Research projects and support for safety and security | Aalto University
• Cyber Security for research | Aalto University

Note that regulations on dual use have been moved to the Declarations part. By applying for funding, Aalto University and you as the researcher commit to following dual-use/export control regulations. Please note that failure to follow regulations may lead to criminal prosecution.

Dual use regulations concern research involving goods, software and technologies which are covered by the EU Export Control Regulation No 482/2009. These dual-use items are normally used for civilian purposes but they may additionally be applicable to military purposes, or they may contribute to the proliferation of weapons of mass destruction. Export regulations concern all activities of Aalto University from research to education, as well services such as HR and procurement, IT licenses etc. Note that according to the Horizon 2020 Programme Guidance on how to complete your ethics self-assessment (pdf), ‘[i]n certain exceptional cases, publication of research findings (e.g. a scientific article in a journal published both outside or inside the EU) may be classed as an intangible technology transfer (ITT) and may require an authorisation (which is not always granted).’

Guidelines and support on the topic: Responsible internationalisation – Export control and sanctions compliance at Aalto University | Aalto University