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Research exposure

North Western Medical Physics, Christie Hospital NHS Foundation Trust, Withington, Manchester M20 4BX, UK

Correspondence: Anne Walker, North Western Medical Physics, Christie Hospital NHS Foundation Trust, Withington, Manchester M20 4BX, UK. E-mail: Anne.Walker{at}physics.cr.man.ac.uk

Imaging is often an essential tool within modern research studies. Such imaging, if it involves the use of ionising radiation, is associated with an increased likelihood of stochastic effects. It is, therefore, important that any such imaging is carefully considered and justified, especially if it is extra to that required for the management of a patient's condition and hence has no direct benefit to the patients involved.

In the UK, the provision to Research Ethics Committees (RECs) of information concerning radiation exposures undertaken as part of a research protocol has undergone a major overhaul in the past few years. Before the introduction of the electronic submission form devised by the Central Office of Research Ethics Committees (COREC; now called the National Research Ethics Service (NRES)), there was little consistency and often no guarantee that correct information on research exposures would be available. A variety of submission forms was in use and advice on dose levels was rarely asked of Medical Physics Experts. In particular, one form that some British Institute of Radiology (BIR) members will have seen throughout the 1990s required the signature of the "Radiation Safety Officer" — a term that became obsolete in 1986 when the first set of the Ionising Radiation Regulations (IRR85) [1] came into force. In general, the use of a national format for submissions was greatly welcomed, as this ensured that RECs received information about research exposures, the related dose and the associated risk, and so would be able to take this into account in their ethical considerations. However, as Andy Rogers points out in his Commentary in this edition, there has been conflict between the requirements of the Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER) [2] and the COREC/NRES submission processes. Although there have been attempts to bring the two processes into line in editions 5.0, 5.1 and 5.2 of the form, further problems continue to surface and the whole process often seems overly bureaucratic. The continued lack of clarity was very apparent at the BIR meeting entitled "Radiation, research and risk" held on 9 November 2006. It is pleasing to see that the Commentary makes several excellent suggestions for how things might be taken forward, as well as providing the background to the present situation and an outline of the current problems.

In particular, any moves to simplify the information provided to the RECs, whilst still providing them with sufficient information to be able to consider the ethics of the exposure to radiation, are very much to be welcomed. It is hoped that NRES, in conjunction with the professional bodies concerned, will continue to work to achieve this aim. Standardization in the way dose and risk is derived and explained would help Ethics Committee members in making ethical judgements based on the given information.

In addition, the suggestion to remove the IRMER term "dose constraint" from the submission form might well remove some possible sources of conflict. However, we must not forget that, in order to comply with IRMER, dose constraints will still need to be set at a local level; further guidance on what is meant by target doses and dose constraint in this context, and how dose constraints can be "adhered to", would be of great benefit.

As clinical radiation professionals, it is important that we all take part in the debate to ensure the development of efficient systems for dealing with research exposure, which allows fully informed ethical decisions to be made.

Received for publication August 16, 2007. Revision received August 28, 2007. Accepted for publication August 30, 2007.

References

1. The Ionising Radiations Regulations 1985 (S.I. 1985 No 1333). London, UK: Her Majesty's Stationery Office; 1985
2. Ionising Radiation (Medical Exposure) Regulations 2000 (SI 2000 No1059). London, UK: The Stationery Office; 2000

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This Article Full Text (PDF) Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Walker, A Search for Related Content PubMed PubMed Citation Articles by Walker, A