BiCARB Study - Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis?

What are my rights?

If you have a complaint about your participation in the study you should first talk to a researcher involved in your care. You can ask to speak to a senior member of the research team or the Complaints Officer for your NHS hospital.

In the event that something goes wrong and you are harmed during the study there are no special compensation arrangements.  If you are harmed and this is due to someone’s negligence then you may have grounds for a legal action for compensation against the University of Dundee or your NHS Trust but you may have to pay your legal costs.  The normal National Health Service complaints mechanisms will still be available to you (if appropriate.)

Will my GP know about this research project?

With your permission we will inform your GP of your participation, any clinical results, and of any new medical problem we find as a result of your participation in the study.

Will my taking part in this study be kept confidential?

All the information that is collected about you during the course of this study will be kept strictly confidential. There will be two sets of information obtained during the study. One set will be routine blood tests analysed by local NHS laboratories and the other, the research data obtained from research blood samples and study procedures. The routine blood tests obtained will be stored indefinitely using your name and unique hospital record number within the NHS clinical system and can be made available to specialist doctors for your future health care needs.

Your research data will be stored using a unique study code which is non-identifiable. All written information will be kept in a locked filing cabinet in a locked room.  Any web-based data will be stored in a secure password protected central database at Health Informatics Centre, University of Dundee.  Only individuals directly involved with the study will have access to this information.  It is a requirement of the regulators that your records in this study, together with any other relevant medical records, be made available for scrutiny by appropriate monitors from Tayside Medical Science Centre (TASC) and the Regulatory Authorities. This procedure is routine and carried out by fully qualified officials, and data confidentiality is preserved at all times.

At the end of the study the confidential records will be kept for 15 years and then destroyed. The confidential handling, processing, storage and disposal of data are in accordance with the Data Protection Act1998.