Leucine and ACE inhibitors as therapies for sarcopenia: a two by two factorial randomised placebo controlled trial

More information - 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 Trust.

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 test results 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 Act 1998.

The research blood tests will be analysed by our colleague Dr Paul Kemp in his laboratory in London. Some of the tests will include tests for differences in genes that control muscle function. One blood sample will be sent to the USA to be analysed by a company called Regeneron; they will destroy the sample after they have finished analysing it, and they will not have access to any of your personal information or other information collected during the trial. After the tests are complete, we will, with your permission, store the spare blood samples so that we can perform further tests on them in future as we learn more about muscle function in older people.