Research Ethics Committee

The application for obtaining an opinion on the research by the University of Lodz Research Ethics Committee should be prepared on the form attached as Annex 3 to the Rules. Before filling out the application, we encourage you to review the FAQ section, which contains answers to the most frequently asked questions.

The application must be accompanied by a completed consent form (Annex 2 to the Rules) – in the case when the research data is collected directly from a study participant.

The completed, signed and scanned application with the annex (consent form) should be sent only via e-mail to the following e-mail address: komisja.etyka@uni.lodz.pl.

In case of doubts, the information shall be provided by: komisja.etyka@uni.lodz.pl 

In accordance with the principles of open science, databases should not be deleted, and the researcher should allow other researchers to reuse the database by making it available (e.g., by uploading the data to an open repository or storing it on an online drive and making it available upon request). Such a database should be anonymized before being made available, i.e., any information that could identify the research participants—such as geolocation data, computer IP addresses, first and last names, etc.—should be removed. If such information was not collected (i.e., the database is anonymous and does not require anonymization), the database should be stored and made available in its complete, unaltered form.

Paper-based study documentation (e.g., consent forms, paper-and-pencil questionnaires) should be retained for a minimum of 5 years. If such documentation contains information that allows for the identification of participants (e.g., signatures on consent forms, interview transcripts from which it is clear who gave the interview), it must be specially secured (e.g., stored in a secure room) or anonymized (e.g., names on consent forms must be redacted or obscured)

Pursuant to § 3(5) of the Rules of Procedure of the Committee on Research Ethics at the University of Łódź, the Committee’s jurisdiction does not extend to matters which, by law, fall within the jurisdiction of other bodies, in particular the bioethics committees referred to in Article 29 of the Act of December 5, 1996, on the professions of physician and dentist. Bioethics committees, on the other hand, issue opinions on proposed medical experiments. The Committee on Research Ethics at the University of Łódź therefore has no jurisdiction in such matters. The regulations do not define the concept of a medical experiment, although the aforementioned Act identifies two types: therapeutic and research experiments. The former are conducted to introduce new or only partially tested diagnostic, therapeutic, or preventive methods and aim to achieve a direct benefit to the patient’s health. Research experiments, on the other hand, are primarily aimed at expanding medical knowledge and may be conducted on both sick and healthy individuals. Furthermore, pursuant to Article 21(4) of the aforementioned Act, a medical experiment also includes the examination of biological material, including genetic material, collected from a person for scientific purposes. The concept of biological material has not been defined by law, although it can be assumed that it refers to a biological sample collected from a human being for the purpose of conducting scientific research. For example, this category includes blood, tissue samples collected during surgery, saliva, and bodily secretions. However, it is essential that the material be collected from a living person. Therefore, this group does not include tissues and cells collected from cadavers, e.g., during an autopsy. Furthermore, the collection must be intentional, i.e., the material must be intended for scientific purposes. It does not matter, however, whether the material was collected by the researcher or provided by the study participant—for example, a strand of hair cut off by the participant themselves. The scope of the provision in question also does not cover material derived from a human but not collected from them, such as medical waste. 

If the applicant is planning a project that meets the criteria of a medical experiment, they must comply with the requirements set forth in Chapter Four of the aforementioned Act, in particular by seeking an opinion from the competent bioethics committee. This also applies to the aforementioned biological material collected for scientific purposes. In such cases, the University of Łódź Research Ethics Committee will not be competent to review the application. 

Yes—as a general rule, research tools must be included. This is because the Ethics Committee must be able to realistically assess what the research participants will be “exposed to” during their participation in the study.
By reviewing the tools, the Committee can verify whether the scope and nature of the questions are appropriate for the study’s purpose and whether the potential costs (e.g., emotional, cognitive, time-related) borne by the research participant have been properly described in the informed consent form. Without access to the tools, such verification is not possible.
This applies to both standardized and proprietary instruments, as well as qualitative methods such as interviews or focus groups. For qualitative research, the research plan and the interview script—or at least an outline of it—along with sample questions must be provided.
If, for any reason, it is not possible to provide the full version of the tool (e.g., due to licensing restrictions), it is necessary to provide a detailed description of the tool and present sample questions. The description should be sufficiently comprehensive to allow the Committee to assess the nature of the study and its potential impact on participants.

Please also indicate whether the researcher has the right to use the tools (e.g., purchased the right to use them, obtained the authors’ consent to use them in the planned format, such as online, or is using tools that are openly available).

The description of the research tools should be detailed enough to allow the Commission to understand exactly what the phenomenon in question will be measured by and how the study will be conducted.
In particular, you should indicate who developed the tool and whether it is a standardized or proprietary tool. If the tool has been adapted into Polish, it is worth providing information about this adaptation. You should also describe the structure of the tool, including the number of items and the general thematic scope of the questions.
Formal issues are also very important. The applicant should clearly indicate whether they have permission to use the tool in question or that such permission is not required. In the case of online research, it should additionally be noted that the use of the tool in this form is permissible and does not infringe on anyone’s copyright.

The research may begin only after receiving a favorable opinion from the Research Ethics Committee to ensure its compliance with ethical principles and the protection of participants. When specifying the research duration, the application may include the following statement: “upon receiving a favorable opinion from the Research Ethics Committee” and indicate the planned completion date of the research.

The applicant should keep in mind that the information they provide is not intended for the members of the University of Łódź Research Ethics Committee, but for the study participants. In most cases, these participants do not possess specialized knowledge. Therefore, care must be taken to ensure that the message is accessible and understandable. The applicant should therefore avoid scientific terminology, technical jargon, abbreviations, and acronyms, as well as, in particular, the names of the tests being used. Such terminology will not convey meaningful information to the participants. It is better to describe what the test entails and what it is intended to assess. Furthermore, it must be taken into account that the information may be addressed to children and individuals with limited cognitive abilities. In such cases, the message should be adapted to the participant’s age and cognitive abilities. In summary, the information should be worded in such a way that a person without specialized knowledge can understand, with insight, what their participation in the study will entail, as well as its risks and benefits, and on this basis make an informed decision about their participation. 

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