agency. The sex ratio of referrals was two men to one woman; the sex ratio of the study population was 1 3 men to one woman. Referrals were made to general practitioners (37); dentists ( 15) for atlantoaxial x ray examination (10-ILeicester hosted the Special Olympics last year, and many Down's syndrome patients wanted to participate); ophthalmologv (nine); physiotherapy, speech therapy, and occupational therapy (six); geneticists, chiropodists, dietitians, and orthopaedic surgeons (six). In those referred to general practitioners 33 medical problems were diagnosed: raised blood pressure (four), glycosuria (three), proteinuria (two), hypothyroidism (three), hyperthyroidism (one), skin lesions (eight), anxiety (one), depression (one), obesity (two), weight loss (one), heart failure (one), heart defect (one), wax in ears leading to hearing loss (three). Seven patients required surgerv: three for hernia, two for undescended testicles, one for subluxation of the hip, and one for a septic bunion. Four patients were advised on
contraception. No patient complained or had svmptoms. Rarely the family and sometimes staff reported a change in behaviour. The need for routine medical examinations seems self evident. It is effective to use clinical medical officers, who are accustomed to assessing potential in those without speech, flexible in their approach to different venues, and accustomed to liaison within a health care team. For the patients, being examined in a familiar setting with the reassuring presence of their community nurse is non-threatening. For carers, the long appointment encourages useful dialogue with the clinical medical officer and communitv nurse, which, it is hoped, reduces the burden on them-and on the state. MAUREEN BEAUCHAMP
leiceseirshire Area Health Authorit%, I.cester LEI 6TY I Ashley-Miller M. Community care. Br Medj 1990;300:487-8.
V24 February.i
2 Bicknell J. (Consent and people with mcntal handicap. Br Medj 1989;299:1176-7. I I November.;
Research ethics committees SIR,-I sympathise with Dr Ann Cartwright's view that researchers using samples taken from public records should not be required to submit their protocols to district health authority ethics committees.' I disagree, however, with her assertion that when considering sociological studies ethics committees should confine themselves to questions of confidentiality of data and not question the design of the study. Most of the protocols that ethics committees see concern research on NHS patients. As a patient representative I want the committees to examine the quality of all the research they are asked to approve, but as a former lay member of a research ethics committee I know that they are woefully inadequate to do this. They are not required to have a social scientist as a member-an important omission in the Department of Health's draft guidelines. Their ignorance of another discipline does not prevent medical members, who are in the majority, from thinking that they know how such research should, or should not, be done. I have seen studies either go through on the nod because it was wrongly assumed that there were no ethical issues involved or be criticised in a way that could damage carefully structured questionnaires. There is an increasing volume of research in nursing and midwifery exploring issues that are of great value to patients, yet researchers are deprived of informed and educational advice by the ethics committees that look at their projects. I have no doubt that there are issues of major ethical importance in approval or amendment of
BMJ VOLUME 300
7 APRIL 1990
these studies, and it mav be that they should go to separate committees that are not primarily medical. One problem at present is that proposals from a medical source are more likely to be approved - yet some of such "sociological" research published in medical journals is of such poor quality that no social science based ethics committee would have passed it and no decent sociological journal would have published it. Doctors seem unaware that questions asked before and after patients have left hospital are likely to get different answers and that being interviewed by or receiving a questionnaire from a doctor, nurse, or medical student may affect the patient's reply. Patients who know or suspect that their doctors will see their replies are unlikely to be critical -but the advantage to the doctors is that the "survey" shows how much patients like their care. Many doctors and research ethics committees seem unaware that the abilitv to design and analyse questionnaires does not come automatically with a medical degree. Future management of patients mav be based on the results of such "studies"; poor quality protocols are dangerous to patients and we have a right to be protected from them. The only question is whether the present ethics committees can be trained to do the job or whether we need different committees for social science research.
seem unequivocal about the need for separate submissions to local committees.' On the other hand, the recently published guidelines from the Royal College of Physicians on the practice of ethics committees acknowledges that multiple applications may be impracticable "so that research that is valuable to the community can be impeded or may even not be undertaken."4 The confusing nature of the present situation is thus all too evident. The articles, commentaries, and letters published over the past few months have revealed a range of serious problems. So far, these have not been debated sufficiently thoroughly around the same table by those concerned. T W MEADE
MRC Epidemiology and Medical Care Unit, Northwick Plark Hospital, Harrow, Middlesex HAl 3UJ I Drury Mi. Research ethics committees. Br Med7 1990;300:608. (3 March.) 2 Meade IW. Research ethics committees. Br Alcd J 1990;300: 396. (10 February., 3 Marshall T, Moodie P. Research ethics committees revisited. BrMed] 1989;299:1419-20. (9 December.) 4 Royal College of Physicians. Guidelintes on the practice o ethift/s commtttees tn medical research involving human subjects. 2nd cd. London: Royal College of Physicians, 1 99.
JEAN ROBINSON
()xford (X2 7ti' I Cartwright A. Research ethics committces. Br lcdj 1990;300: 607. (3 March.)
SIR,-The establishment of a clinical trials ethics committee by the Royal College of General Practitioners referred to by Sir Michael Drury in his letter' is, I think, another indication that some kind of central committee is needed, though for several reasons I am not confident that it solves the problems I was referring to.Firstly, many multicentre studies are, of course, carried out through hospitals. Rather than having to rely on yet another "central" committee on these occasions-set up, for example, by the Royal College of Physicians or the Royal College of Surgeons-it would be much better to have a single committee responsible for all multicentre studies, however they were conducted. Secondly, our own experience of local reactions to an arrangement similar to the committee described by Sir Michael was not encouraging. In 1988, at the suggestion of the Department of Health, we planned a feasibility study of anonymous HIV testing. To allow an early start and also because of the special considerations involved we approached the convener of the committee on ethical issues in medicine of the Royal College of Physicians (and I am grateful to Sir Douglas Black for agreeing that I may refer to our exchange). He consulted the then president and another member of the committee and approved our proposal. When the general practitioners in our study consulted their nine local ethical committees, however, these committees nearly all asked for separate submissions even though they knew the work had been approved centrally. If the decisions of any future national committee were not binding on local committees, the undoubted problems of multiple applications to separate committees would therefore remain. Eventually, the local committees also accepted the HIV study-with one exception, which illustrates the potential for idiosyncratic decisions. That particular committee declined the proposal on the grounds that anonymous testing would leave subjects positive for HIV unidentified and uncounselled, even though the national scheme for anonymous testing had been announced and was about to start. Finally, the Department of Health guidelines that you referred to in the BMJ's news section
Bovine spongiform encephalopathy SIR,-In his editorial Professor W B Matthews discusses bovine spongiform encephalopathy.' The publicity given to this disease and its possible public health implications has prompted a reexamination of the relation between it and similar diseases found in humans and other animals-the transmissible dementias (box).'
The transmissible dementias Disease
Animal affected
Scrapic
Sheep, goats Mink M\ule deer, elk Cattle Humanis
Transmissible mink encephalopathy Chronic wasting disease Bovine spongiform encephalopathy Sporadic Creutzfeldt-Jakob disease Familial Creutzfeldt-Jakob disease
Gerstmann-Straussler svndrome Kuru
Humans Humans Humans
All of the transmissible dementias share a common factor-the involvement of an aberrant isoform of prion protein.' This protein is the product of a highly conserved gene found in organisms as diverse as the fruit fly and humans.' The abnormal isoform of prion protein is present in brain extracts from patients with transmissible dementias and is the main constituent of the amyloid plaques in these patients.3-6 Its presence distinguishes transmissible dementias from conditions such as Alzheimer's disease and can be regarded as diagnostic of transmissible dementias.4i Distinct prion gene alleles are associated with long and short disease incubation times in mice, and linkage between the GerstmannStraussler syndrome and both a base substitution' and an insertion in the prion gene"" has been shown. The evidence suggests that in all animals the aberrant isoform of prion protein has a central and possible causal role in the genesis and pathology of transmissible dementias. Over the past two years we have screened patients with a wide range of familial dementias and ataxias and those with apparently sporadic symptoms to determine whether these diseases are in fact part of the prion disease range. Using both immunocytochemical and molecular biological techniques we have shown that several families labelled as having atypical dementias were suffering from variants of prion disease. "'
943
contraception. No patient complained or had svmptoms. Rarely the family and sometimes staff reported a change in behaviour. The need for routine medical examinations seems self evident. It is effective to use clinical medical officers, who are accustomed to assessing potential in those without speech, flexible in their approach to different venues, and accustomed to liaison within a health care team. For the patients, being examined in a familiar setting with the reassuring presence of their community nurse is non-threatening. For carers, the long appointment encourages useful dialogue with the clinical medical officer and communitv nurse, which, it is hoped, reduces the burden on them-and on the state. MAUREEN BEAUCHAMP
leiceseirshire Area Health Authorit%, I.cester LEI 6TY I Ashley-Miller M. Community care. Br Medj 1990;300:487-8.
V24 February.i
2 Bicknell J. (Consent and people with mcntal handicap. Br Medj 1989;299:1176-7. I I November.;
Research ethics committees SIR,-I sympathise with Dr Ann Cartwright's view that researchers using samples taken from public records should not be required to submit their protocols to district health authority ethics committees.' I disagree, however, with her assertion that when considering sociological studies ethics committees should confine themselves to questions of confidentiality of data and not question the design of the study. Most of the protocols that ethics committees see concern research on NHS patients. As a patient representative I want the committees to examine the quality of all the research they are asked to approve, but as a former lay member of a research ethics committee I know that they are woefully inadequate to do this. They are not required to have a social scientist as a member-an important omission in the Department of Health's draft guidelines. Their ignorance of another discipline does not prevent medical members, who are in the majority, from thinking that they know how such research should, or should not, be done. I have seen studies either go through on the nod because it was wrongly assumed that there were no ethical issues involved or be criticised in a way that could damage carefully structured questionnaires. There is an increasing volume of research in nursing and midwifery exploring issues that are of great value to patients, yet researchers are deprived of informed and educational advice by the ethics committees that look at their projects. I have no doubt that there are issues of major ethical importance in approval or amendment of
BMJ VOLUME 300
7 APRIL 1990
these studies, and it mav be that they should go to separate committees that are not primarily medical. One problem at present is that proposals from a medical source are more likely to be approved - yet some of such "sociological" research published in medical journals is of such poor quality that no social science based ethics committee would have passed it and no decent sociological journal would have published it. Doctors seem unaware that questions asked before and after patients have left hospital are likely to get different answers and that being interviewed by or receiving a questionnaire from a doctor, nurse, or medical student may affect the patient's reply. Patients who know or suspect that their doctors will see their replies are unlikely to be critical -but the advantage to the doctors is that the "survey" shows how much patients like their care. Many doctors and research ethics committees seem unaware that the abilitv to design and analyse questionnaires does not come automatically with a medical degree. Future management of patients mav be based on the results of such "studies"; poor quality protocols are dangerous to patients and we have a right to be protected from them. The only question is whether the present ethics committees can be trained to do the job or whether we need different committees for social science research.
seem unequivocal about the need for separate submissions to local committees.' On the other hand, the recently published guidelines from the Royal College of Physicians on the practice of ethics committees acknowledges that multiple applications may be impracticable "so that research that is valuable to the community can be impeded or may even not be undertaken."4 The confusing nature of the present situation is thus all too evident. The articles, commentaries, and letters published over the past few months have revealed a range of serious problems. So far, these have not been debated sufficiently thoroughly around the same table by those concerned. T W MEADE
MRC Epidemiology and Medical Care Unit, Northwick Plark Hospital, Harrow, Middlesex HAl 3UJ I Drury Mi. Research ethics committees. Br Med7 1990;300:608. (3 March.) 2 Meade IW. Research ethics committees. Br Alcd J 1990;300: 396. (10 February., 3 Marshall T, Moodie P. Research ethics committees revisited. BrMed] 1989;299:1419-20. (9 December.) 4 Royal College of Physicians. Guidelintes on the practice o ethift/s commtttees tn medical research involving human subjects. 2nd cd. London: Royal College of Physicians, 1 99.
JEAN ROBINSON
()xford (X2 7ti' I Cartwright A. Research ethics committces. Br lcdj 1990;300: 607. (3 March.)
SIR,-The establishment of a clinical trials ethics committee by the Royal College of General Practitioners referred to by Sir Michael Drury in his letter' is, I think, another indication that some kind of central committee is needed, though for several reasons I am not confident that it solves the problems I was referring to.Firstly, many multicentre studies are, of course, carried out through hospitals. Rather than having to rely on yet another "central" committee on these occasions-set up, for example, by the Royal College of Physicians or the Royal College of Surgeons-it would be much better to have a single committee responsible for all multicentre studies, however they were conducted. Secondly, our own experience of local reactions to an arrangement similar to the committee described by Sir Michael was not encouraging. In 1988, at the suggestion of the Department of Health, we planned a feasibility study of anonymous HIV testing. To allow an early start and also because of the special considerations involved we approached the convener of the committee on ethical issues in medicine of the Royal College of Physicians (and I am grateful to Sir Douglas Black for agreeing that I may refer to our exchange). He consulted the then president and another member of the committee and approved our proposal. When the general practitioners in our study consulted their nine local ethical committees, however, these committees nearly all asked for separate submissions even though they knew the work had been approved centrally. If the decisions of any future national committee were not binding on local committees, the undoubted problems of multiple applications to separate committees would therefore remain. Eventually, the local committees also accepted the HIV study-with one exception, which illustrates the potential for idiosyncratic decisions. That particular committee declined the proposal on the grounds that anonymous testing would leave subjects positive for HIV unidentified and uncounselled, even though the national scheme for anonymous testing had been announced and was about to start. Finally, the Department of Health guidelines that you referred to in the BMJ's news section
Bovine spongiform encephalopathy SIR,-In his editorial Professor W B Matthews discusses bovine spongiform encephalopathy.' The publicity given to this disease and its possible public health implications has prompted a reexamination of the relation between it and similar diseases found in humans and other animals-the transmissible dementias (box).'
The transmissible dementias Disease
Animal affected
Scrapic
Sheep, goats Mink M\ule deer, elk Cattle Humanis
Transmissible mink encephalopathy Chronic wasting disease Bovine spongiform encephalopathy Sporadic Creutzfeldt-Jakob disease Familial Creutzfeldt-Jakob disease
Gerstmann-Straussler svndrome Kuru
Humans Humans Humans
All of the transmissible dementias share a common factor-the involvement of an aberrant isoform of prion protein.' This protein is the product of a highly conserved gene found in organisms as diverse as the fruit fly and humans.' The abnormal isoform of prion protein is present in brain extracts from patients with transmissible dementias and is the main constituent of the amyloid plaques in these patients.3-6 Its presence distinguishes transmissible dementias from conditions such as Alzheimer's disease and can be regarded as diagnostic of transmissible dementias.4i Distinct prion gene alleles are associated with long and short disease incubation times in mice, and linkage between the GerstmannStraussler syndrome and both a base substitution' and an insertion in the prion gene"" has been shown. The evidence suggests that in all animals the aberrant isoform of prion protein has a central and possible causal role in the genesis and pathology of transmissible dementias. Over the past two years we have screened patients with a wide range of familial dementias and ataxias and those with apparently sporadic symptoms to determine whether these diseases are in fact part of the prion disease range. Using both immunocytochemical and molecular biological techniques we have shown that several families labelled as having atypical dementias were suffering from variants of prion disease. "'
943
