Opinion of the Bioethics Committee
Scientific research involving humans, due to issues related to legal requirements, can be divided into research that is a medical experiment or research that is not a medical experiment.
This division is based solely on Polish legal requirements that must be met for the research to be conducted legally.
A medical experiment of a research nature is intended to explain a specific scientific problem and expand medical knowledge. Conducting such a study is subject to the regulations of the Act on the medical and dental professions of 5 December 1996 (Journal of Laws 2023, item 1516, consolidated text), which obliges the researcher to obtain a positive opinion on the project issued by an independent bioethics commission.
Therefore, scientific research that is a medical experiment, conducted by PhD students and employees of Gdańsk University of Technology, requires the approval of the Bioethics Committee at the District Medical Chamber in Gdańsk.
Pursuant to the above, the study of biological material collected from a person for scientific purposes, including all genetic tests, also constitutes a medical experiment.
In the case of research that is a medical experiment, but conducted by Gdańsk Tech employees in cooperation with employees of the Medical University of Gdańsk or the University Clinical Center in Gdańsk, an application for an opinion should be submitted to the Independent Bioethics Committee for Scientific Research of the Medical University of Gdańsk.
Other tests such as:
- epidemiological research,
- surveys and questionnaires,
- retrospective studies,
- observational studies,
- research involving the use of biological samples remaining after medical treatments/tests, constituting the so-called medical waste,
- research involving the use of materials from deceased persons.
require the consent of the Research Ethics Committee of Gdańsk University of Technology.
Information regarding the study
Regardless of applicable legal requirements, but primarily in order to provide the research participant with the information necessary to make an informed decision about participating in the study and from the point of view of the possibility of using the results of this study (including biological samples, audio-video recordings, photos etc.) in the future, it is important to inform the research participant about:
Ensuring the confidentiality of the research participant's personal data may be achieved by pseudonymizing or anonymizing this data. Under the GDPR, personal data should be pseudonymized in such a way that it can no longer be associated (or "assigned") to a single data subject (the user) without the use of additional data.
This additional data should be stored separately from the pseudonymized data and should be subject to technical and organizational measures to make it difficult to link the data to someone's identity.
Anonymization is the permanent removal of personal data, which does not allow the identification of the data subject (user). Anonymized data is not personal data and is not subject to the processing rules of the GDPR.
It seems necessary to inform the participant that for re-use the data will be stored in the Research Data Catalog - MOST Wiedzy and managed in accordance with the Data Management Plan. Stored data available for re-use will or will not (optionally selected by the research participant) contain information that allows identification of the user. Re-use of data will only be permitted after obtaining a positive opinion from the ethics committee that the new use of the data meets the requirements of ethical assessment.
To obtain detailed information, please contact the Gdańsk Tech Personal Data Inspector.
The researcher is obliged to inform the research participant about the method of making research data (results) public, e.g. in the form of scientific publications or conference presentations.
If data collected from people has been fully anonymized, consent is not needed to share it, but it is good practice to inform study participants how the data will be used.
The research participant may express his/her will to share data after anonymization, as follows:
"I understand that personal data, including special category personal data, and biological material (audiovisual recording*) collected from me in this study will be retained and made available in an anonymized form so that they can be reused by others for scientific purposes."
*Audiovisual recordings or photographs may be made available on the basis of the same principles as consents to share personal data and biological samples. From the point of view of future use of research data containing personal data, it is important to obtain the so-called extended consent.
By giving extended consent, the participant agrees that his/her data, as part of a larger data set (information collected for this project), may be re-used in other projects that are: an extension of the project in which he/she is currently participating, closely related to this project in the same research area (e.g. oncology), conducted by another research group in the same research area, etc.
In the Information for the research participant, mainly participating in a medical experiment, it is necessary to inform them about the possibility of the so-called incidental results.
An incidental finding is unexpected information discovered during testing or medical care that may have social or psychological consequences for a research participant. This is when, for example, we learn that a child's biological father is someone other than the presumed father, or that a person being tested for one disease or disorder has or is at risk of developing another disease.
The research participant should have the opportunity to express his or her declaration of will to be informed or to inform his or her family members about such results.
Moreover, at every stage of the project, a research participant has the right to withdraw from participating in the research, as well as to order the withdrawal of his or her personal data.
