Most people want "private medicine at higher fees for . [financially] privileged citizens." Professor Light's fallacy (one of several in his article) is to equate this with necessarily "rundown facilities on the cheap for the rest." H E EMSON Pathology, Royal University Hospital, Saskatoon, Sk, Canada S7N OXO 1 Light DW. Observations on the NHS reforms: an American perspective. BMJ 1991;303:568-70. (7 September.)
Organising medical aid for the Soviet Union SIR,-Dr D A Gregory is to be praised for his concern with regard to medical provision in the erstwhile Soviet Union and its satellites.' Every effort must be made to assist their progress to a more effective health care system. At a conference of the United Kingdom-Soviet Union Medical Exchange Programme in September this year Stephen Dorrell MP, in an opening address, was satisfied that enough organisations existed to further these aims. Addressing the problem clearly requires detailed knowledge of the countries' system and the utmost care in planning. Initiatives such as International's development of a manuAmprsham factlring base for radioimmunoassay products to help in the aftermath of Chernobyl clearly show the complexity entailed but also that success can be achieved. Dr Harold Lipman is helping to set up a paediatric nurse training programme at the Tushino Hospital in Moscow, which is another fine example of a defined objective. Though much can be learnt from such enterprises, comprehensive progress can be achieved only by bridging the gap between two cultures. The Soviet bloc has an educated medical establishment that is thirsty for knowledge but lacking effective influence. If knowledge is power we, especially in the United Kingdom with our principally state funded health service, are well placed. A vanguard of development is to be the primary care services. The polyclinic and our own general practitioner services have been compared. We have much to contribute. A programme of exchanges and training will enable the countries' doctors to define objectives and requirements. The United Kingdom-Soviet Union Medical Exchange programme is endeavouring to promote medical advances that will have a lasting benefit. It can be contacted at 9d Stanhope Road, London N6 SNE (telephone 081 347 8852). J E HOOD Rothesay Surgery, Bedford MK40 3PX 1 Gregory DA. Organising medical aid for the Soviet Union. BMJ
1991;303:586. (7 September.)
New guidelines for British ethics committees SIR,-I read with interest Jane Smith's comment about new guidelines for local research ethics committees.' Also, I have had a chance to go through the guidelines that have been circulated to the health districts by the Department of Health. This month I have come to the end of my three years' commitment as chairman of the local research ethics committee, which in our district of north west Hertfordshire is a subcommittee of the medical staff committee. The requirements of an ethics committee as enumerated in the guidelines have been scrupulously followed in our district; the committee consists of 11 members, including BMJ VOLUME 303
19
OCTOBER
1991
two lay members. There are representatives from the nursing profession and from pharmacy, medical, and surgical departments. We meet every month and the-researcher has to be present when his or her protocol is being discussed. The protocols are mostly approved, sometimes amended, and occasionally rejected. The reason for rejection is explained to the researcher in writing. At six month intervals the list of the protocols approved is published and sent to the relevant authorities. The DoH guidelines suggest that either the chairman or vice chairman should be a lay person. On this subject Sir Kenneth Robinson commented "this is a thoroughly bad idea which deserves to be strenuously resisted."2 Sir Kenneth should know, for he was minister of health from 1964 to 1968 and is currently a lay member of an ethics committee of a well known teaching hospital. For smooth running of the ethics commuittee, administrative support from the district health authority is absolutely vital. A tremendous amount of secretarial work is involved-photocopying the bulky protocols, arranging meetings, taking minutes, and filing the correspondence. Unfortunately this administrative or secretarial back up is not always forthcoming, and for me it was possible to function smoothly only because of the good will and loyalty of my own departmental secretary. Finally, I find no mention either in the DoH guidelines or in the guidelines from the Royal College of Physicians' of the submission of too many research or drug trial protocols from any particular department. A protocol may be ethically sound, but without a research assistant a consultant in a district general hospital would have difficulty in carrying out the work properly. There should be a limit of two research projects at a given time. M A WAJED
Hemel Hempstead General Hospital, Hemel Hempstead, Hertfordshire HP2 4AD 1 Smith J. New guidelines for British ethics committees. BMJ 1991;303:488. (31 August.) 2 Robinson K. The layman's role in a research ethics committee. JR Coll Physicians Lond 1991;25:43. 3 Royal College of Physicians. Guidelines on the practice of ethics committees in medical research involving human subjects. 2nd ed. London: RCP, 1990.
Another threat to clinical research SIR,-MS Jane Smith's news item mentions, but does not comment on, what may prove to be the most contentious innovation in the Department of Health's guidance on local research ethics committees. ' The second sentence of the document outlines managerial responsibility for research: "The approval of research projects is an important management responsibility involving the availability of resources, financial implications, and ethical issues." The document goes on to mention which NHS bodies will seek advice from local research ethics committees-district and special health authorities, NHS trusts, and family health services authorities-and what sort of research a local research ethics committee must be consulted about. This includes any research involving. NHS patients-past, present, or recently dead -or their records or the use of NHS premises. The guidance then continues: "No NHS body should agree to such a research proposal without the approval of the relevant [local research ethics committee]. No such proposal should proceed without the permission of the responsible NHS body (my italics). Such a requirement is entirely new, with potentially serious consequences for the future of clinical research. The research and development division at the Department of Health has confirmed that this requirement is not accidental but a quite
deliberate change in policy. Yet there was no mention of it in the press release accompanying the new guidance, which was published in mid-August so as, presumably, to arouse least attention. No guidance has been given to NHS bodies on how to decide whether to allow proposed research to go ahead. So, just as the department is trying to make the work of local research ethics committees more uniform it has introduced a totally new layer of required approval, which is likely to be given or withheld for quite as wide a variety of reasons as ethical approval has been. The statement on managerial responsibility indicates that those reasons may include any resource or financial implications, however trivial. As competition between NHS bodies increases they may well decide that clinical research contributes nothing to their short term competitiveness and should be stopped. A requirement that general practitioners must obtain the permission of their family health services authority to do research also seems to raise interesting contractual problems. With medical research already under so much pressure one must ask why the government needs to put yet another obstacle in its path, leading to the possibility of a substantial curtailment of academic freedom. R H NICHOLSON
Editor, Bulletin of Medical Ethics, London EC1V OBX I Smith J. New guidelines for British ethics committees. BMJ 1991;303:488. (31 August.)
Computer aided teaching packages SIR,-We agree with much of the correspondence'43 concerning our article on the use ofcomputer aided teaching packages.4 Dr R L Kennedy and colleagues' may have slightly misunderstood our intention, which was not to belittle the computer's performance (which, incidentally, approximated to the best of the improved clinical figures) but to suggest that for those apprehensive about the real time use of the computer in decision support2 an alternative and possibly preferable mode of operating is available that also seems to be effective. Dr Kennedy and colleagues argue that decision support should be provided in addition for the 25% or so "difficult cases." We completely agree; and it may be of interest that such a system (with answer justification) has already been successfully validated in 1000 cases. A further controlled study is in process. The validity of historical controls is of course doubtful. We point out, however, that the hospitals concerned are in a "no win" situation. Ten or 15 years ago, when relevant projects started, both hospitals were accused (unjustifiably) of achieving improved results through short lived enthusiasm. Now, when the improved performance levels have been maintained for over a decade, the (totally unwarranted) assertion is made that "things must have improved" to account for the current performance levels. (In this connection, incidentally, it is difficult for us to comment on the figures provided by Dr Graham C Sutton2 as they date back to the 1970s and contain no baseline data for unaided clinicians.) These comments, however, elide a fundamental point. The medical course is finite in length. Figures from the Committee of Vice Chancellors and Principals indicate that the medical faculty in the United Kingdom shrank by 9-6% in the 1980s. The amount for students and junior doctors to learn has exploded. The impact of this on clinical performance is not difficult to foresee. Evidence from the recent European Community concerted action, involving over 50 hospitals and over 15 000 patients, suggests that in the United Kingdom performance levels for initial diagnostic accuracy
995
Organising medical aid for the Soviet Union SIR,-Dr D A Gregory is to be praised for his concern with regard to medical provision in the erstwhile Soviet Union and its satellites.' Every effort must be made to assist their progress to a more effective health care system. At a conference of the United Kingdom-Soviet Union Medical Exchange Programme in September this year Stephen Dorrell MP, in an opening address, was satisfied that enough organisations existed to further these aims. Addressing the problem clearly requires detailed knowledge of the countries' system and the utmost care in planning. Initiatives such as International's development of a manuAmprsham factlring base for radioimmunoassay products to help in the aftermath of Chernobyl clearly show the complexity entailed but also that success can be achieved. Dr Harold Lipman is helping to set up a paediatric nurse training programme at the Tushino Hospital in Moscow, which is another fine example of a defined objective. Though much can be learnt from such enterprises, comprehensive progress can be achieved only by bridging the gap between two cultures. The Soviet bloc has an educated medical establishment that is thirsty for knowledge but lacking effective influence. If knowledge is power we, especially in the United Kingdom with our principally state funded health service, are well placed. A vanguard of development is to be the primary care services. The polyclinic and our own general practitioner services have been compared. We have much to contribute. A programme of exchanges and training will enable the countries' doctors to define objectives and requirements. The United Kingdom-Soviet Union Medical Exchange programme is endeavouring to promote medical advances that will have a lasting benefit. It can be contacted at 9d Stanhope Road, London N6 SNE (telephone 081 347 8852). J E HOOD Rothesay Surgery, Bedford MK40 3PX 1 Gregory DA. Organising medical aid for the Soviet Union. BMJ
1991;303:586. (7 September.)
New guidelines for British ethics committees SIR,-I read with interest Jane Smith's comment about new guidelines for local research ethics committees.' Also, I have had a chance to go through the guidelines that have been circulated to the health districts by the Department of Health. This month I have come to the end of my three years' commitment as chairman of the local research ethics committee, which in our district of north west Hertfordshire is a subcommittee of the medical staff committee. The requirements of an ethics committee as enumerated in the guidelines have been scrupulously followed in our district; the committee consists of 11 members, including BMJ VOLUME 303
19
OCTOBER
1991
two lay members. There are representatives from the nursing profession and from pharmacy, medical, and surgical departments. We meet every month and the-researcher has to be present when his or her protocol is being discussed. The protocols are mostly approved, sometimes amended, and occasionally rejected. The reason for rejection is explained to the researcher in writing. At six month intervals the list of the protocols approved is published and sent to the relevant authorities. The DoH guidelines suggest that either the chairman or vice chairman should be a lay person. On this subject Sir Kenneth Robinson commented "this is a thoroughly bad idea which deserves to be strenuously resisted."2 Sir Kenneth should know, for he was minister of health from 1964 to 1968 and is currently a lay member of an ethics committee of a well known teaching hospital. For smooth running of the ethics commuittee, administrative support from the district health authority is absolutely vital. A tremendous amount of secretarial work is involved-photocopying the bulky protocols, arranging meetings, taking minutes, and filing the correspondence. Unfortunately this administrative or secretarial back up is not always forthcoming, and for me it was possible to function smoothly only because of the good will and loyalty of my own departmental secretary. Finally, I find no mention either in the DoH guidelines or in the guidelines from the Royal College of Physicians' of the submission of too many research or drug trial protocols from any particular department. A protocol may be ethically sound, but without a research assistant a consultant in a district general hospital would have difficulty in carrying out the work properly. There should be a limit of two research projects at a given time. M A WAJED
Hemel Hempstead General Hospital, Hemel Hempstead, Hertfordshire HP2 4AD 1 Smith J. New guidelines for British ethics committees. BMJ 1991;303:488. (31 August.) 2 Robinson K. The layman's role in a research ethics committee. JR Coll Physicians Lond 1991;25:43. 3 Royal College of Physicians. Guidelines on the practice of ethics committees in medical research involving human subjects. 2nd ed. London: RCP, 1990.
Another threat to clinical research SIR,-MS Jane Smith's news item mentions, but does not comment on, what may prove to be the most contentious innovation in the Department of Health's guidance on local research ethics committees. ' The second sentence of the document outlines managerial responsibility for research: "The approval of research projects is an important management responsibility involving the availability of resources, financial implications, and ethical issues." The document goes on to mention which NHS bodies will seek advice from local research ethics committees-district and special health authorities, NHS trusts, and family health services authorities-and what sort of research a local research ethics committee must be consulted about. This includes any research involving. NHS patients-past, present, or recently dead -or their records or the use of NHS premises. The guidance then continues: "No NHS body should agree to such a research proposal without the approval of the relevant [local research ethics committee]. No such proposal should proceed without the permission of the responsible NHS body (my italics). Such a requirement is entirely new, with potentially serious consequences for the future of clinical research. The research and development division at the Department of Health has confirmed that this requirement is not accidental but a quite
deliberate change in policy. Yet there was no mention of it in the press release accompanying the new guidance, which was published in mid-August so as, presumably, to arouse least attention. No guidance has been given to NHS bodies on how to decide whether to allow proposed research to go ahead. So, just as the department is trying to make the work of local research ethics committees more uniform it has introduced a totally new layer of required approval, which is likely to be given or withheld for quite as wide a variety of reasons as ethical approval has been. The statement on managerial responsibility indicates that those reasons may include any resource or financial implications, however trivial. As competition between NHS bodies increases they may well decide that clinical research contributes nothing to their short term competitiveness and should be stopped. A requirement that general practitioners must obtain the permission of their family health services authority to do research also seems to raise interesting contractual problems. With medical research already under so much pressure one must ask why the government needs to put yet another obstacle in its path, leading to the possibility of a substantial curtailment of academic freedom. R H NICHOLSON
Editor, Bulletin of Medical Ethics, London EC1V OBX I Smith J. New guidelines for British ethics committees. BMJ 1991;303:488. (31 August.)
Computer aided teaching packages SIR,-We agree with much of the correspondence'43 concerning our article on the use ofcomputer aided teaching packages.4 Dr R L Kennedy and colleagues' may have slightly misunderstood our intention, which was not to belittle the computer's performance (which, incidentally, approximated to the best of the improved clinical figures) but to suggest that for those apprehensive about the real time use of the computer in decision support2 an alternative and possibly preferable mode of operating is available that also seems to be effective. Dr Kennedy and colleagues argue that decision support should be provided in addition for the 25% or so "difficult cases." We completely agree; and it may be of interest that such a system (with answer justification) has already been successfully validated in 1000 cases. A further controlled study is in process. The validity of historical controls is of course doubtful. We point out, however, that the hospitals concerned are in a "no win" situation. Ten or 15 years ago, when relevant projects started, both hospitals were accused (unjustifiably) of achieving improved results through short lived enthusiasm. Now, when the improved performance levels have been maintained for over a decade, the (totally unwarranted) assertion is made that "things must have improved" to account for the current performance levels. (In this connection, incidentally, it is difficult for us to comment on the figures provided by Dr Graham C Sutton2 as they date back to the 1970s and contain no baseline data for unaided clinicians.) These comments, however, elide a fundamental point. The medical course is finite in length. Figures from the Committee of Vice Chancellors and Principals indicate that the medical faculty in the United Kingdom shrank by 9-6% in the 1980s. The amount for students and junior doctors to learn has exploded. The impact of this on clinical performance is not difficult to foresee. Evidence from the recent European Community concerted action, involving over 50 hospitals and over 15 000 patients, suggests that in the United Kingdom performance levels for initial diagnostic accuracy
995
