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

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; (794/2010) “

HUS (Helsinki University Hospital) ethics committees will review Aalto University’s medical research projects . You will need to ask for an Ethics 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 ethical evaluation. HUS 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 an 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 minimize the likelihood of risks materializing if you are prepared and have taken the time to recognize them. 

Aalto University has a Research Ethics Committee which handles ethics statement requests on research with human participants

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

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.

• 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" twice a year in English and once in Finnish. 

If you work with gene manipulated test animals you need permission from Board of Gene technology. 

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

Often an Ethical Review is required when doing research with animals. Aalto University collaborates with University of Helsinki on these Ethical Reviews. For test animals the review is conducted by the HUS ethics committees, and for other animal involvement University of Helsinki Viikki Campus Research Ethics Committee

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)

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 Ethical Reviews in both locations. You also need to carefully assess the risks for your research staff as well as the local participants. Pay attention especially 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​
• ​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.   

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.

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

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 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. 

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 applied 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)” (ref Horizon 2020 Guidance — How to complete your ethics self-assessment)

Guidelines and support on the topic are currently being developed, and more information is forthcoming.

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  (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 safe. Sometime appointing ethics/security advisor or advisory board might be in need. Also, you need to pay special attention to data security.

See:

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

More information forthcoming.