A reply

Abstract

Contrary to a popularly held belief among would-be authors, the Editor and his assessors take no pleasure in rejecting submitted manuscripts or in hindering research but do have a responsibility to ensure that any research has been undertaken in a proper manner. The process of assessment of a submitted manuscript contains several aspects of scrutiny. Almost before anything else, the matter of Ethics Committee approval and informed consent is checked and if there is any ambiguity, the matter is referred back to the author — as in this case. The matter of volunteer studies requiring Ethics Committee approval is well known and forms part of the remit of Local Research Ethics Committees and therefore should not come as a surprise to the researcher. As a general rule, if you are planning to undertake any form of research or audit which, if published, will influence practice, it is prudent to seek advice from the Local Research Ethics Committee beforehand. As to the second matter, which incidentally was not the main reason for the rejection of Dr Ward's manuscript, the point is that following final implementation of the Medical Device Regulations 1994 (SI 1994 no. 3017), the use of a piece of medical equipment for any purpose other than that for which it was designed places the user in a potentially dangerous position. By altering the function of the piece of equipment, the user has effectively invented a new piece of equipment and therefore can be viewed as the manufacturer (with all the concomitant responsibilities). However, there is some protection if the ‘new’ piece of equipment is studied only by the ‘inventor’ (researcher) in a manner acceptable to the Local Research Ethics Committee. If that protection is not present, as was the case here, the researcher could possibly be held liable if another person, having read the published study, were to have an untoward event using the equipment as described. Clearly, the matter is not quite as simple as this and more thorough guidance on the implications of this piece of legislation were contained in an Editorial in last year's volume (Anaesthesia 1998; 53: 13). Thus, rather than being unsympathetic to new ideas, the journal is just fulfilling its responsibility to ensure that research is undertaken in a proper way and that researchers are protected from unanticipated consequences. I can only apologise if this was misinterpreted by Dr Ward and his colleagues.