Information sheet for the participants
In this study, in which the Uhasselt is not involved, we would like you to complete an online survey including general questions, your experience and motivation in buying bulk, and your habits in storing and transporting foods. The impact of COVID-19 will also be evaluated. Your participation in this research study is voluntary. You may choose not to participate, or your participation can be withdrawn at any time. It is anticipated that completing the online questionnaire will take about 10 minutes.
Consent and refusal
Participation in this study is entirely voluntary. You can refuse to complete the questionnaire without having to give a reason and without this in any way affecting your further relationship with the researcher.
Participation in this study will probably not bring you any direct benefits. However, the obtained results will allow to evaluate the potential risks for consumers related to buying food in bulk. As a result, additional measures could be introduced to improve the safety of consumers.
Your participation in this study does not entail any additional costs for you, but it also offers no financial benefits.
In accordance with the General Data Protection Regulation (or GDPR) (EU) 2016/679 of April 27, 2016 and the Belgian law of July 30 2018, on the protection of individuals related to the processing of personal data and on the free movement of such data your privacy will be respected. You will be able to access the data collected about you, and each error can be corrected at your request.
Your other rights (i.e. the right to have your data erased in certain circumstances, to withdraw your consent and to lodge a complaint) are also safeguarded.
Your participation in the study means that your data will be processed for the purpose of the study. This processing of data is necessary for the performance of a task carried out in the public interest, as mentioned in article 6, paragraph 1 (e) and is necessary for the purpose of scientific research in accordance with Article 9, paragraph 2 (j) of the General Data Protection Regulation (or GDPR) (EU) 2016/679 of April 27, 2016.
Data Protection Regulation.
The survey does not contain information that will personally identify you. Your responses to the questions will be confidential and de-identified. This study will be pseudonymised (here your data can still be linked to your personal file by means of a code). A code identifier will be used. The key to the codes assigned to you will only be accessible to the investigator or his/her appointed replacement. The electronic data will be password-protected. Only the aggregated data (across participants) will be used in the framework of this project (i.e. TREFCOM 21/4).
Only the pseudonymised data will be used for data analysis and in any documentation, reports or publications (in medical journals or congresses) about the study. Confidentiality of your data will thus be guaranteed at all times.
Both personal data and data concerning your health will be processed and kept for at least 10 years after the end of the study, and for security reasons regarding the study conducted and its follow-up (if any).
The data controller is the institution of the study's principal investigator, Dr Els Van Hoeck (Sciensano). Her research team will have access to your personal data. For data protection purposes, the data will be processed by persons belonging to the research team and designated by and under the responsibility of the principal investigator including internal staff with non-health care professions.
Representatives of the sponsor, auditors, the Medical Ethics Committee and the competent authorities, all bound by professional secrecy, will have direct access to your medical records to check the procedures of the study and/or the data, without breaching confidentiality. This can only be done within the limits permitted by the relevant laws. By agreeing, after prior explanation, to the consent form at the bottom, you consent to this access.
The Belgian supervisory authority responsible for enforcing data protection legislation can be reached via the contact details below:
Data Protection Authority (DPA)
Drukpersstraat 35 – 1000 Brussel
Tel. +32 2 274 48 00
If you have any questions about this study, please contact email@example.com. This study was pre-approved by an independent Medical Ethics Committee affiliated with Ghent University and Ghent University Hospital. The study is conducted according to the guidelines for good clinical practice (ICH/GCP) and the Declaration of Helsinki drawn up to protect people participating in clinical studies.
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THIS FORM WILL BE HELD FOR A PERIOD OF 10 YEARS
Project title: Risks of new trends concerning materials and objects in contact with food (RT 21/4 - TREFCOM)
Name of Researchers: Dr Salvatore Ciano, Mélanie Di Mario, Dr. Stefanie Vandevijvere and Dr. Els Van Hoeck
I have read the instructions; I understand the nature of the research and why I have been invited to participate. I have had the opportunity to ask questions and have them answered to my satisfaction.
- I understand that my participation is entirely voluntary and that I can withdraw from the study at any time without having to provide a justification
- I understand that the research is being conducted by researchers within TREFCOM project, funded by the Federal Public Service Health, Food chain safety and Environment (Grant reference: RT 21/4 TREFCOM)
- I agree to take part in this research and complete the online questionnaire. I understand that I am free to withdraw my participation at any time
- I understand that the researchers guarantee the confidentiality of my results whereby only aggregated comments will be made available to others
- I understand that research data will be pseudonymized and a code identifier will be used and electronic data will be password-protected.
- I understand that pseudonymized data will be kept for 10 years, after which it will be destroyed
- I understand that the summary results of the research may be made available (without any identifying information) in book chapters, journals and conference publications
I, Els Van Hoeck, confirm to have given all necessary explanations about the study. I confirm I have not exercised any pressure on the participant to accept the participation in the study. I confirm to be willing to answer all the additional questions the participant may have.