title: Position statement on ethics, equipoise and research on charged particle radiation therapy.
abstract: The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research.
authors.affiliation: The Ethox Centre, University of Oxford, Oxford, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Sheehan
authors.affiliation: Particle Therapy Cancer Research Institute, University of Oxford, Oxford, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Timlin
authors.affiliation: Particle Therapy Cancer Research Institute, University of Oxford, Oxford, UK.
authors.forename: Ken
authors.initials: K
authors.lastname: Peach
authors.affiliation: Rotman Institute of Philosophy, University of Western Ontario, London, Canada.
authors.forename: Ariella
authors.initials: A
authors.lastname: Binik
authors.affiliation: Gray Institute for Radiation Oncology and Biology, University of Oxford, Oxford, UK.
authors.forename: Wilson
authors.initials: W
authors.lastname: Puthenparampil
authors.affiliation: International Network for Cancer Treatment and Research UK, Oxford, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Lodge
authors.affiliation: School of Cancer Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Sean
authors.initials: S
authors.lastname: Kehoe
authors.affiliation: Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, London.
authors.forename: Michael
authors.initials: M
authors.lastname: Brada
authors.affiliation: Department of Oncology, University of Cambridge, Cambridge, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Burnet
authors.affiliation: Centre for Applied Philosophy and Public Ethics, Charles Sturt University, Canberra, Australia.
authors.forename: Steve
authors.initials: S
authors.lastname: Clarke
authors.affiliation: St James' Institute of Oncology, St James's University Hospital, Leeds, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Crellin
authors.affiliation: The Ethox Centre, University of Oxford, Oxford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Dunn
authors.affiliation: National Center for Oncological Hadron Therapy (CNAO), Pavia and Dipartimento di Scienze della Salute, University of Milano, Italy, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Fossati
authors.affiliation: Particle Therapy Cancer Research Institute, University of Oxford, Oxford, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Harris
authors.affiliation: Oxford NIHR Biomedical Research Centre, Oxford University Hospitals Trust, Oxford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Hocken
authors.affiliation: The Ethox Centre, University of Oxford, Oxford, UK.
authors.forename: Tony
authors.initials: T
authors.lastname: Hope
authors.affiliation: Centre for Biomedical Ethics, University of Birmingham, Birmingham, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Ives
authors.affiliation: Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kamada
authors.affiliation: Center for Ethics and Policy, Department of Philosophy, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA.
authors.forename: Alex John
authors.initials: AJ
authors.lastname: London
authors.affiliation: Department of Radiation Oncology and Proton Beam Therapy Program, Mayo Clinic, Rochester, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Miller
authors.affiliation: The Ethox Centre, University of Oxford, Oxford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Parker
authors.affiliation: Maastricht Radiation Oncology (MAASTRO) Clinic, Maastricht, The Netherlands.
authors.forename: Madelon
authors.initials: M
authors.lastname: Pijls-Johannesma
authors.affiliation: Oxford Uehiro Centre for Practical Ethics, Faculty of Philosophy, University of Oxford, Oxford, UK.
authors.forename: Julian
authors.initials: J
authors.lastname: Savulescu
authors.affiliation: Leeds Institute of Molecular Medicine, St James University Hospital, Leeds, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Short
authors.affiliation: Melbourne Law School, University of Melbourne, Australia.
authors.forename: Loane
authors.initials: L
authors.lastname: Skene
authors.affiliation: Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Tsujii
authors.affiliation: National Center for Oncological Hadron Therapy (CNAO), Pavia and Dipartimento di Scienze della Salute, University of Milano, Italy, Italy.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Tuan
authors.affiliation: Rotman Institute of Philosophy, University of Western Ontario, London, Canada.
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
mesh_terms: D032921:Consensus; D003245:Consensus Statements as Topic; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000941:ethics; D019317:Evidence-Based Medicine; D006801:Humans; D009369:Neoplasms / Q000532:radiotherapy* / Q000628:therapy; D017410:Practice Guidelines as Topic; D011879:Radiotherapy Dosage; D011882:Radiotherapy, High-Energy / Q000941:ethics* / Q000379:methods; D012107:Research Design; D057212:Therapeutic Equipoise; D016896:Treatment Outcome
keywords: Clinical Trials; Position Statements (of organizations/groups); Radiology; Research Ethics