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

As the Finnish national guidelines and processes in research ethics differ in medical and non-medical research with human participants, we will first present the guidelines for doing medical research with human participants. Here you will also find the guidelines on research on Human Organs, Tissues and Cells

Medical researchmeans 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; (794/2010) “

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

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

More information:

• Declaration of Helsinki 1964  https://www.who.int/bulletin/archives/79(4)373.pdf
• Medical research ethics in Finland: https://vastuullinentiede.fi/en/planning/medical-research-ethics-finland
• Law on medical research https://www.finlex.fi/fi/laki/ajantasa/1999/19990488

Research on Medical Use of Human Organs, Tissues and Cells usually follows similar path as medical research in terms of Research Ethical Review. HUS Research Ethics Guidelines (in Finnish). https://www.hus.fi/tutkijalle/tutkimuslupa/kudos-ja-nayte/Sivut/default.aspx

You need to explain what is the material that you use, where you obtained it and how you will handle it. In addition, you may need a Research Ethics Review. 

More information: 

• Act of the Medical Use of Human Organs and Tissues (101/2001, amended 547/2007, 778/2009, 653/2010, 336/2011, 689/2012, 277/2013)
• The EU 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 risk could be physical social and psychological. 

Familiarize yourself and comply with personal data regulations.

You may not be able to prevent all risks from happening, but you can minimize the likelihood of risks materializing by being prepared, and by having taken the time to recognize them. 

Aalto University has a Research Ethics Committee, which handles Request for Research Ethical Review on research with human participants for Aalto researchers.

More information: 

• Aalto University Research Ethics Committee: https://www.aalto.fi/en/services/research-ethics-committee
• How to handle personal data in research:   https://www.aalto.fi/en/services/how-to-handle-personal-data-in-research 
• TENK guidelines on ethical principles for research with human participants and ethical pre-evaluation in human sciences(link)  https://www.tenk.fi/sites/tenk.fi/files/Ihmistieteiden_eettisen_ennakkoarvioinnin_ohje_2019.pdf

Note that are are also focused guidelines available on different research areas e.g. research on immigration and refugees, and on specific methodologies such as ethnography/anthropology.  

Processing of personal data has 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 age, profession and their employer. Personal data can e.g. be 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 the data processing, data quality and confidentiality. More information and support: 

How to handle personal data in research: https://www.aalto.fi/en/services/how-to-handle-personal-data-in-research 

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) GDPR), you need to make a request for Research Ethical Review  (see chapter before)  

More information: 

Aalto University Research Ethics Committee: https://www.aalto.fi/en/services/research-ethics-committee

When animals are involved in your research, you need to comply with several guidelines and acquire permissions for such research. 

You need a permission to work with test animals from local Regional State Administrative Agency. The space/laboratory/project  needs to have a license to acquire, breed, keep and take care of animals for scientific or educational purposes. Remember to indicate the project number and PI when applying the permissions so they are detectable within Aalto processes. 

• https://www.avi.fi/web/avi/elainkokeet-ja-koe-elainlaitokset (in Finnish). 
• contact in Southern Finland/Etelä-Suomessa läänineläinlääkäri Tapani Parviainen 

• https://www.avi.fi/web/avi/elainkoelautakunta-ella (in Finnish) 

In addition all the personnel involved in working with test animals need to have appropriate education. Laboratory Animal Centre in University of Helsinki, Viikki campus arranges a Function A & D course for researchers "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 gene manipulated test animals you need permission from the Board of Gene Technology. 

• https://geenitekniikanlautakunta.fi/suljettukaytto/elaimet (in Finnish) 

A Research Ethical 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 Research Ethical Review is conducted by the University of Helsinki Viikki Campus Research Ethics Committee (you need a co-researcher from the University of Helsinki)

More information on use of animals in research in Aalto 

More information:

• Laboratory/test animals - Ministry of Agriculture and Forestry (in Finnish)
• Committee for animal protection in the context of animals in research and education 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 animals but NOT  as test animals, please contact the Aalto University Research Ethics Committee secretary to discuss how to proceed with 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 Ethical Reviews 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​
  • Note that you need Research Ethical Review 

  • More information: Aalto University Research Ethics Committee: https://www.aalto.fi/en/services/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 
  • My course: Research ethics for Doctoral students

    • "..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.

      For more information on transfers outside of the EU or the EEA, see: https://ec.europa.eu/info/law/law-topic/data-protection/data-transfers-outside-eu_en."

Cultural traditions must be respected and the benefits of the research work shared.

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 (for more information see; Forthcoming; Aalto University support and guidelines are being currently developed.

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 you research group and students, upon your potential outcomes, and e.g. how the new technologies impact the environment.

The European Commission also requires that you follow the do no significant harm -principle  which means that you research should no do any harm against any of the EU sustainability activities, namely the six environmental objectives covered by the Taxonomy Regulation:

1. harm to climate change mitigation, leading to significant greenhouse gas (GHG) emissions;
2. harm to climate change adaptation  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. harm to the sustainable use and protection of water and marine resources, being 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. harm to the circular economy, including waste prevention and recycling, leading 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. harm to pollution prevention and control leading to a significant increase in emissions of pollutants into air, water or land;
6. harm to the protection and restoration of biodiversity and ecosystems, being 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. (c2021_1054_en.pdf (europa.eu))

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

You also need to bear in mind the safety and security issues for your research and other staff. Aalto university has several instructions and training on safety at work and waste management.

More information: 

Research projects and support for safety and security:  https://www.aalto.fi/en/service-entities/research-projects-and-support-for-safety-and-security

Cyber Security for research: https://www.aalto.fi/en/cyber-security/cyber-security-for-research

This section concerns projects with activities involving the development or/and use of artificial intelligence (AI)-based systems or techniques. 

The ethical questions relate to 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) 

It is recommended to name and Ethics Advisor or an Ethical Board with relevant competences to advise and reflect 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.

It is recommended to engage an experienced Ethics Adviser from the field in question, to help you to deal with ethical issues and put appropriate procedure in place. If your project contains several ethical concerns you should appoint an Ethics Advisory Board with several experts with varied expertise.

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

Aalto University Research Ethics Committee: https://www.aalto.fi/en/services/research-ethics-committee

In many cases the research outcomes have several potential uses. It is advisable that you reflect upon the potential dual 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 the negative impacts. Please consult an Ethical Advisor or an Advisory Board to help you throughout the research project. 

(This question in addressed in Security table of the form)

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, going into 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 what are the best procedures to keep your research ethically justifiable. Sometime appointing and Ethics or Security advisor or and Advisory Board might be in need. Also, you need to pay special attention to data security when dealing with research approaching areas where misuse is a risk.

More information:

• Research projects and support for safety and security:  https://www.aalto.fi/en/service-entities/research-projects-and-support-for-safety-and-security
• Cyber Security for research: https://www.aalto.fi/en/cyber-security/cyber-security-for-research

Note that regulations on dual use have been moved to the Declarations part. Hence by applying for funding Aalto University and you as the researcher commit to following the dual use/export control regulations. Please note that failure to follow the regulation 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  “In 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 are currently being developed, and more information is forthcoming.