Planning Supporting Material

Codes of ethics in Estonia and Europe

 

Research ethics are a set of principles that researchers refer to during the process of carrying out their research. When formulating a research plan it is important to make sure that the research that is being carried out adheres to the various commonly accepted and practiced rules, norms, and principles. This also means that the researchers must be aware of and refer to the codes of ethics of their field of expertise. In Europe, the most widely used guideline for research ethics is the European Code of Conduct for Research Integrity, which has been formulated by ALLEA (All European Academies) and is available in English, Estonian and various other languages. The Estonian researchers in ALLEA are represented by the Estonian Academy of Sciences (Eesti Teaduste Akadeemia). The responsibility to practice good science is shared among the entire research community. Contributing to the acknowledgement of this responsibility and providing a supporting framework for the self-regulation of the research community is the primary goal and function of the European Code of Conduct for Research Integrity. For any researchers working on projects funded by the European Commission, following this code is also a requirement.

 

Many establishments and institutions have adopted their own codes of conduct, but all the larger universities and research institutions in Estonia have also signed the Estonian Code of Conduct for Research Integrity in 2017. This agreement is a framework document with the purpose of providing support for learning good research practices, embracing them, and entrenching them in the Estonian research community. Tallinn University bases its research activity on both the European and the Estonian Code of Conduct for Research Integrity, and various other field-specific codes of conduct or similar agreements.

 

For other codes of conduct for research integrity and ethics used in Estonia or elsewhere around the world, you may refer to the Tartu University “Eetikaveeb” (ethics web).

 

Evaluation and review by the ethics committee

 

In certain cases, it may be necessary to undergo an ethics review. The necessity of a review by the ethics committee and their evaluation depend on many factors, among which are relevant national laws, agreed-upon norms in a specific field, internal regulations in a research institution, provisions and terms set by the funding party and/or publisher, and the risk-factors emanating from the research. Different countries, institutions and fields have differing standards and rules for research ethics and, as such, it is necessary to be informed about all such factors to make an informed decision. In this complicated situation saturated by information, it is reasonable for a researcher to start by getting acquainted with the rules of their institution and, if necessary, consult with colleagues, supervisors, or an ethics committee.

 

According to their handbook, the Tallinn University ethics committee mainly reviews in-university research, pertaining fields such as humanitarian, social or natural sciences, which has at least one of the following risk-factors associated with it:

 

  • Subjects of the research include persons, who have been included without following the principle of conscious consent.

  • Subjects of the research include underaged persons (meaning persons under the age of 18 years), if they have been included in active data gathering without asking for prior consent from their legal parents or guardians in a way, where they have the power to decline or obstruct the involvement of their child in the research.

  • Carrying out the research may pose a danger to the physical, mental and/or emotional wellbeing of those participating in the research (including the researchers) or people close to them.

  • Participation in the research brings with it the effect of significantly increased or intensified stimulus to the subjects.

  • The topic of research is categorized as sensitive.

  • The research is based on different kinds of personal data, which may be used to identify the associated subject, or if big data is used and there is a risk of this data being deanonizable, or being used to indirectly identify the subjects.

 

A review by the ethics committee is not necessary, if the research is being carried out in the fields of humanitarian, social or natural sciences but is not associated with the aforementioned risk-factors. An exception to this is if the funder and/or potential publisher of the research require an evaluation by the ethics committee.

 

If the research includes procedures, that have the characteristics of pharmaceutical, medicinal or genetic research, procedures, which may significantly endanger human health, or procedures, which involve testing on animals, then it is necessary to refer to an international ethics committee or council. If the research requires human testing, then it would be appropriate to turn to the Ethics Committee for Human Research at the National Institute for Health Development or the University of Tartu. Besides the two mentioned previously, there is also the Estonian Bioethics and Human Research Council, called together by the Ministry of Social Affairs, which has the responsibility of evaluating research on gene banks and the operation of the health information system or the use of data therein. If the research pertains the use personal data or data, which may be used to identify the subject, but there is no ethics committee associated with the associated field or institution, then it is also possible to turn to the Data Protection Inspectorate for approval. If the study involves one or more animal experiments, permission must be sought from the Animal Experimentation Project Authorization Committee (link in Estonian). 

 

Impact of the research

 

When planning a study, it is also important to analyse what the intended purpose of the research is and what the wider ramifications for it in society would be. Research should strive towards the greater good, benefit society and take all observable pros and cons into account. If the research involves risks, then these must be mitigated and justifiable by the objectives of the research. As research ethics (and ethics in general) are mostly situational, the researcher must be sensitive to context and choose the most appropriate approach to ensure the ethical integrity of their specific study. Since perfect and universally applicable ethical solutions are rare, if not non-existent, it is reasonable to request assistance or advice from other researchers or institutions to help notice and acknowledge risks and/or consequences and mitigate them most effectively.

 

In the planning phase, it is also important to take the choice of methodology into account – the choice of method and sample should be optimal for achieving the goals of the study, meaning the inclusion of vulnerable groups or persons should be thoroughly justified.

 

Risk prevention and analysis

 

Research is based on uncertainty – answers to unanswered questions are sought, and the results of the research are thus unpredictable. This means, that the research may entail unforeseen risks to the participants, society at large, or even the environment. It is therefore necessary, that the research is conducted in an ethical fashion and that the researchers act responsibly towards participants, colleagues, towards their society and its heritage, and towards their environment. When analysing the risks, one tries to bring attention to the parts of the process which may be detrimental, who they may affect, and how. Then preventative measures are formulated to remove the risks completely, or at least minimise them as much as possible.

 

The most risk is associated with children, patients, vulnerable social groups, the use of stem cells, privacy and data protection issues, animal trials, and the environmental effects or consequences of any relevant activities. It is important to note that factors such as age, sex, culture, religion, ethnical heritage, or social class may classify the sample as vulnerable, and participation in the research may endanger or otherwise affect their health, safety or wellbeing. The participants of a study have a right to their privacy, the protection of their personal data, the preservation of their dignity, a right to equal treatment and the protection of their health and safety. It may therefore be necessary to provide subjects with confidentiality and anonymity, meaning that no subjects (including individuals or organisations) can be recognised or identified based on the information provided in the research report. It may also be prudent to consider, whether the beneficiaries of the research are the subjects or another party.

Risks are also prevented, if any misconduct, such as forgery or plagiarism, is avoided during the research practice. Another method of risk prevention is to be proficient in the chosen methodology and to use it professionally.

 

While working through ethical issues, one may find, that they are putting themselves, their colleagues, the subjects or their environment into danger and the research becomes unethical as a result. It is also possible, that the necessity to discuss the research design with someone or to look for an expert opinion is discovered during risk analysis. Based on the analysis, the research design (eg method or sample) may also be modified to ensure the safety of the research and the protection of participants' values, rights, and interests.

 

During the planning phase, one should also consider whether researchers, research institutions or funders may have a conflict of interest in relation to the research.

Data management

 

Regarding issues pertaining data management, they should also be reviewed as soon as during the planning phase and the relevant principles should subsequently be added to the study report. Data management refers to both the collection of data and the use thereof during the research process. This also includes access regulation and delegation of responsibility for the data itself and for what is done with it after the study has ended.

 

Some institutions may require a data management plan, which includes aspects such as: what data is created during the research; what requirements are associated with this data; how is the data documented, secured, saved and stored; who is the data shared with and who has access to it; possibility of reuse for the data.

 

The data is kept both as public as possible and as secure as possible (in line with the FAIR principles :  Findable, Accessible, Interoperable and Re-usable). Research practices are moving towards open data, which is open for future use in repositories/data warehouses and this data is subsequently assembled into registries (ie OpenAIRE).