ETHICS
This framework is intended to support and help ensure that the health research conducted within the TTV GUIDE TX project is ethically sound and provides guidance and a review process for research protocols and their refinement.
Report on the inaugural meeting of the Ethical and Governance Council or the TTV GUIDE TX Project.
In the second podcast we explain the process of ‘informed consent’ and offer recommendations how to perform it correctly.
Videos
FAQ about the clinical trial and participation
Do I have to participate in the trial?
No, It is your free decision whether you wish to participate in this study or not. You do not need to give any reasons and you will not suffer any disadvantages
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What is ‘informed consent’?
Informed consent is a process of learning the key facts about a clinical trial before deciding whether to participate or not. In addition, along the study, the participants can ask any information the trial. Potential study participants will be informed about the trial (aims, methods, implications, benefits and risks of the trial, voluntary nature of participation, right to refuse participation, samples and data collection and procedures for unexpected events) in terms they can fully understand, and written informed consent will be obtained prior to inclusion. Members of the research team will explain the details of the study to potential participants, before they decide whether to participate or not. To be valid, the consent must be voluntary, informed and the person consenting should have the capacity to make the decision.
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Who should inform me about the risks and benefits of participating in this research?
All participants will be informed of all the risks, as well as the benefits, of the clinical trial through an informed consent document administered by a medical specialist involved in the research who will be able to answer any question you may have.
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What are my rights as a research participant?
As a participant you have the right to leave the clinical trial at any moment. You also have the right to protection of confidentiality of your identity and medical data.
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What are my benefits?
The results of the study may help to improve the future treatment of patients who have received a kidney transplant. If it turns out that the immunosuppression dosed according to (Torque Teno virus) TTV levels is superior to the standard dosage and you have been assigned to that group, you might have a personal benefit, e.g. through fewer infections or a lower risk of transplant rejection.
Might there be any harm for me?
The scientific data provide evidence, that TTV guided immunosuppression can reduce infections and rejections after kidney transplantation. The risk of harming any participating patient within the trial is very low. However, a remaining risk can never be ruled out and will be assessed thoroughly throughout and after the end of the trial. This risk can include an increase of infection and rejection and other side effects of calcineurin inhibitors - the immunosuppressive drugs guided during the trial.
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What if I want to quit the trial?
You can say NO at any time, immediately or later. You do not need to give any reasons and you will not suffer any disadvantages.
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What is the social or scientific value of this research for the society as a whole?
End stage renal disease (ESRD) causes high socioeconomic burden for citizens and the healthcare system in Europe. Kidney transplantation represents the treatment standard for ESRD. Graft rejection due to inadequate immunosuppression is the leading cause for chronic graft dysfunction and infectious disease due to reduced immune function is a major cause of death. The proposed project has the potential to reduce infection and graft rejection thereby significantly improving graft and patient survival of kidney transplant patients. The improved survival will reduce healthcare costs in the EU.
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Can my health care provider use TTV already?
Yes, there are already some laboratories offering TTV quantification and your health care provider can send your samples there to assess the TTV load. However, the benefit of TTV measurement has not been proven yet and TTV has not entered clinical routine.
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GUIDELINES
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The contemporary bioethical rules and principles, such as autonomy, non-maleficence, justice, freedom etc., are based on a rich philosophical and medical tradition embodied in a number of internationally recognised guidelines and documents. Some of the most important documents on which medical research involving human subjects are based are the following:
Clinical trials - Regulation EU No 536/2014
Convention on Human Rights and Biomedicine
International Ethical Guidelines for Biomedical Research Involving Human Subjects
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