INFORMATION BROCHURE FOR PARTICIPANTS

You are invited to participate in a clinical study. Before making the decision to participate in this study, it is important that you understand why this clinical study is undertaken and what this decision exactly implicates. Ask for explanation to a study doctor or study nurse in case something is not clear or if you want some more information. Take the decision to participate after good judgement. This study was investigated and approved by the Ethics Committee of the Ghent University Hospital, that has consulted the Ethics Committees of other involved centres. This approval should not be taken as a stimulus to participate in this study.

The aim of this study is to ….

In order to be included in the study,

Following procedures are study-specific, and will only be performed if you agree to participate in the study:

Voordelen

- The benefits which can be offered by participating at this study are the following:

- The possible risks, connected to this study are …

The researcher will supply a financial compensation and/or medical treatment in case of injury and/or damage which can be ascribed to participation at the study. For this purpose, an insurance with no-fault responsibility has been foreseen in accordance with the Belgian law, concerning experiments on humans (07/05/2004). In this case, your personal data can be transferred to the insurance company.

The decision to participate in this study is completely voluntary. If you decide to participate, you will be asked to sign the accompanying ‘Informed Consent’. You can review your decision any time without argumentation. If you decide not to participate at this study, this decision won’t have any influence on the quality of your current or future medical treatment or on your relationship with the investigators.

In accordance with the Belgian law of 08/12/1992 and the Belgian law of 22/08/2002, your privacy will be respected and you will be granted full access to your personal data. Every fault can be adapted at your request. Representatives of the sponsor, the Commission of Medical Ethics and competent authorities have full access to your medical file in order to control the procedures and/or data, without damaging confidentiality. By signing the Informed Consent, after getting full information, you approve this access to your medical file. If you agree to participate at this study, your personal and clinical data will be collected and coded or anonimized during this study (in this way, your data can always/never be linked back to your file). Reports in which you are identified, will not be accessible in public. If the result of this study will be published, your identity will remain confidential information.

If you want supplementary information about this study or you have any problems or concerns, you can contact one of the following people:

INFORMED CONSENT

Title:

By signing this document – I declare that I have received and read this document in a proper way. I agree with the content of this document and would like to participate in this study.

I received information about the aim, length, and expected effects of this study and about what will be expected from me. The possible risks and advantages of this study have been explained. I was offered the possibility and sufficient time to pose questions about the study, and I received on all my questions a satisfactory answer, also on medical questions.

I agree to collaborate fully with the doctor in charge. I will inform her/him if I would experience unexpected or unusual symptoms. I confirm that I will inform the doctor in charge about medication, of any kind, that I have taken, up to one month ago.

I have been informed about the existence of an insurance policy in case of damage that can be attributed to the participation in this study.


I am aware about the fact that this study has been approved by the independent Commission for Medical Ethics of the University Hospital Ghent and that this study will be executed in accordance with the guidelines for good clinical practice (ICH/GCP) and the declaration of Helsinki, a statement of ethical principles for medical research involving human subjects.

I can withdraw from this study at any time without any reason for this decision and without having any influence on my relationship with the researcher/doctor in charge.

I have been informed about the fact that personal data as well as clinical data will be collected and conserved for at least 20 years. I agree with this and have been informed about the fact that I have full access to these data and have the permission to demand corrections of any fault. As these data are used in the context of a medical-scientific study, I understand that the access to these data can be postponed until finalisation of the study. If I would like to have access to these data, I will make contact to the principal investigator of this study.

I understand that auditors, representatives of the sponsor, the Commission of Medical Ethics or the competent authorities can inspect my data in order to control the collected information. By signing this document, I agree with such a possible control. Moreover, I have been informed about the fact that some data can be transferred to the commissioner, even if this would imply that some of these data would be transferred to another country outside the European Union.

By signing this document, I declare to participate in this study is voluntary:

Name of the participant: ______

Date: ______

Signature: ______

The volunteer agreed to participate in this study by signing and putting the date on this document. I confirm that I explained the aim, length and expected effects of this study to the volunteer, mentioned above:

Name of the person

who informed the volunteer

about the study: ______

Date: ______

Signature : ______

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______

Informed consent version (add version number), dd (add date)