Ethics Committee

The Ethics Committee is responsible for the review and approval of research involving human participation or addressing ethically sensitive areas, especially when it concerns research that includes:

- biomedical research involving simple medical or physiotherapy procedures, the use of approved nursing methods, non-invasive interventions, alternative or integrative medicine, and other biomedical approaches that do not fall under the jurisdiction of the Medical Ethics Committee of the Republic of Slovenia (KME RS);

- psychological research involving psychological tests, interviews, observation of behavior, or interventions that may affect the psychological well-being of participants;

- social and social science research based on surveys, interviews, observation, or other methods of collecting data on social behavior;

- research involving vulnerable groups (e.g. children under 15, older adults, persons with disabilities), where no medical interventions are involved;

- research dealing with sensitive topics (e.g. violence, trauma, discrimination);

- educational research focusing on educational processes, programs, or policies and involving pupils, secondary school students, university students, or teachers;

- research in the field of information technology involving the collection and processing of personal data, privacy issues, or data security;

- research in the humanities when it involves direct human participation or raises important ethical issues;

- research in business and economics involving the participation of individuals or organizations, especially through interviews, surveys, or analysis of business practices.

In borderline cases, the Ethics Committee itself assesses whether approval by a national-level ethics committee is also required. In cases where review by the Medical Ethics Committee of the Republic of Slovenia (hereinafter: KME RS) is clearly required, the Ethics Committee will directly refer the application to KME RS.

Review by national or specialized ethics committees (e.g. the Medical Ethics Committee of the Republic of Slovenia (hereinafter: KME RS)) is mandatory when the research:

• includes biomedical research, medical procedures, or healthcare interventions involving humans;
• tests medicines, food supplements, or medical devices;
• includes genetic testing, biobanks, or the collection and storage of biological samples (blood, tissue, DNA, etc.);
• uses invasive or risky methods;
• includes clinical research or animal research for which approval by a special committee is legally required (e.g. the Committee for Animal Experiments);
• includes international cooperation where the rules of partners or funders require national review.

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• When you have already obtained approval from the ethics committee of the institution in Slovenia where you are conducting the research;
• When the research does not involve sensitive or ethically controversial content (in accordance with the Rules on the Operation of the Ethics Committee and the Code of Ethics of Alma Mater Europaea University).

If the data are not personal and are anonymized, a review is generally not required, but consultation with the committee is recommended.

No. Any research requiring an ethical review may only begin after written approval has been obtained from the university ethics committee.

If a student will conduct research at an institution abroad and has already obtained approval from that institution’s ethics committee, an additional ethical review at Alma Mater Europaea University is generally not required, provided that the research does not involve additional procedures, data, participants, or activities within our university. However, in such a case, the student must submit a copy of the obtained approval to the Ethics Committee for recognition. If the Ethics Committee finds that the review criteria are not comparable or cannot be clearly determined, it may conduct the review itself or, at its discretion, require the student to submit the application for ethical review to the Medical Ethics Committee of the Republic of Slovenia.

If the student, within the framework of Alma Mater Europaea University:

• includes participants from Slovenia (e.g. interviews with Slovenian residents or students),
• processes sensitive personal data obtained at Alma Mater Europaea University,
• conducts part of the research on the premises of Alma Mater Europaea University (e.g. laboratories, test groups),
• conducts procedures involving our employees, students, or other participants,
• must submit an application to the Ethics Committee even if they already have an ethical review from abroad. The application must also include:
• a copy of the already obtained ethical review (in English or translated into Slovenian),
• an activity plan (description of the methodology) to be carried out at our institution,
• informed consent forms.
  
  

The researcher must strictly comply with all procedures and guidelines applicable to research work at Alma Mater Europaea University.

Informed consent is the participant’s voluntary and conscious agreement based on clear information about the research: its purpose, course, duration, risks, benefits, and the manner in which personal data will be protected. It is a fundamental ethical requirement that enables the participant to decide on participation with an understanding of what the research entails. It ensures that the participant is informed about and understands the key elements of the research before deciding to take part. In this way, the rights, well-being, and autonomy of participants are protected, which is the basis of ethical research work. Informed consent must be obtained before the start of the research and the collection of data from participants. Participation and the research may not begin if the participant has not given valid consent on the prescribed informed consent form.

Research involving the processing of personal data must comply with Regulation (EU) 2016/679 (GDPR) and applicable national legislation.

The processing of personal data must be based on a lawful legal basis (Article 6 GDPR) and carried out in accordance with the principles of lawfulness, fairness, and transparency, purpose limitation, data minimization, accuracy, storage limitation, and integrity and confidentiality.

Only personal data necessary for carrying out the research may be processed. Special categories of personal data (Article 9 GDPR) may be processed only with the individual’s explicit consent or on another appropriate legal basis.

Access to personal data is restricted to authorized members of the research team in accordance with the principle of least privilege.

Where possible, personal data are processed in pseudonymized or anonymized form. Data are stored under codes, while identifying information is kept separately and subject to additional protective measures. A deadline for data de-identification must be specified.

Personal data are retained only for as long as necessary for the purpose of the research, after which they are permanently deleted or physically destroyed in a manner that prevents further processing or identification.

Researchers must ensure appropriate technical and organizational measures for the security of personal data and define procedures for handling personal data protection breaches.

The Ethics Committee assesses the compliance of research with personal data protection requirements and may require additional protective measures as a condition for approval of the research.

Anonymization means that data are processed in such a way that an individual can no longer be identified by any available means, which means that these data are no longer personal data and the GDPR no longer applies to them.

Pseudonymization, on the other hand, means that identifiers are replaced with codes or ciphers, but with additional information it is still possible to link the data to a person, which is why these data remain personal data and are still protected by the GDPR.

Pseudonymization is used when it is still necessary to link data to participants (e.g. for follow-up measurements or audits), while at the same time reducing the risk of identity disclosure. The data remain subject to the GDPR and must be appropriately protected.

Anonymization, on the other hand, is used when identification is no longer necessary for the research. The data are permanently altered so that it is no longer possible to identify any individual, and the GDPR no longer applies to them, enabling their safer and broader use.