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The study will be conducted in accordance with the Declaration of Helsinki in its latest form. The study will be submitted to and approved by a Regional Multicentre Research Ethics Committee (MREC) and the local Research Ethics Committee (LREC) of each participating centre prior to entering patients into the study. The NYCTRU will provide the LREC with a copy of the final protocol, patient information sheets and consent forms.

The conduct of the trial will be monitored by a Trial Steering Committee consisting of an independent Chair and two independent advisors as well as the project team (Appendix H).

Note this statement acknowledges that the trial development team are aware of potential updates of the Declaration of Helsinki. This will also be the case for any of the regulatory and other codes of practice that may pertain, as these too are continually being revised to meet new circumstances. However, if regulatory changes are made, they may or may not be invoked for ongoing protocols that have current approval status.

A major ethical requirement is to ensure that the potential participants in trials understand that participation is voluntary, and that they are free to withdraw their consent at any time and that doing so will not in any way compromise the future treatment that they will receive.