- Email: [email protected]
CONSENT TO MEDICAL EXPERIMENT
642
Points of View CONSENT TO MEDICAL EXPERIMENT MUCH of the scientific and technological progress of Medicine in the past fifty years has been accompanied or preceded by increasingly sophisticated animal experiments and clinical trials. The very word "experiment", used in the context of the human body, produces strong emotional responses in some people and especially in those for whom the word means only some sort of voyage into the unknown. In popular usage the word "experiment" is given its tertiary meaning of : "An action or operation undertaken in order to discover something unknown ..." For the doctor and scientist, the secondary meaning of the word is far more appropriate : "A tentative procedure ... a method or course of action adopted in uncertainty whether it will answer its purpose."* It seems in the highest degree unlikely that any medical experiment falling strictly within the former definition has ever been undertaken in this country. On the other hand, the latter definition is apt to describe a vast range of interventions designed to alleviate suffering in cases where established treatment has failed. *
*
*
It is a major concern of any system of law to control the activities of members of the community towards one another. A first step in exercising control is to declare *Oxford
that every human being is to have his or her body intact. interference with it against his will is characterised as an assault and treated as a criminal offence. This concept is reflected in the title of the Offences against the Person Act, 1861, much of which is still in force. Yet that integrity, valuable as it is, we are prepared to surrender daily in a thousand ways, ranging from the affectionate and acceptable hand on the shoulder to a boxing glove on the nose. The essence of the surrender is consent, express or implied. Consent is a concept of great complexity: but for most of us it means an agreement to a course of action based on full information, free of constraint and given in words or writing. In the field of dayto-day medicine, a consent in the terms of that definition can hardly ever be given. It is seldom that the patient can be as fully informed as the doctor and it might be bad for him if he were; he is never free from the constraint of his illness and he is often unconscious or too ill to express his feelings. In the last instance his consent may have to be implied from his circumstances, as in the case of someone admitted to an accident unit. The range of medical interventions for which consent is or may have to be implied is vast, reaching from the taking of the pulse by silent accord at one extreme to prefrontal leucotomy at the other. In the case of the sane and adult person, there is no practical alternative to the familiar form of written consent when he is conscious and to the judgment of the doctor, perhaps with the help of a close relation, when he is not. It is not practicable to measure the quality of each patient’s consent by testing his comprehension of the proposed treatment or the degree to which his freedom of decision is overborne by his anxiety to get well. However, where part of a patient’s treatment is embodied in a clinical trial, it is usual to give him rather more
Any
English Dictionary, Ill, 930.
DR IRVINE: REFERENCES
Rimoin, D. L. Med. Clins N. Am. 1971, 55, 807. Solomon, I. L., Blizzard, R. M. J. Pediat. 1963, 63, 1021. 3. Irvine, W. J., Stewart, A. G., Scarth, L. Clin. exp. Immun. 1967,2, 31. 4. Nerup, J. Immunity and Autoimmunity in Diabetes Mellitus (edited by P. A. Bastenie and W. Gepts); p. 149. Amsterdam, 1974. 5. Irvine, W. J., Barnes, E. W. in Clinical Aspects of Immunology (edited by R. R. A. Coombs, P. H. Gell and P. Lachmann); Oxford, 1975. 6. Irvine, W. J., Clarke, B. F., Scarth, L., Cullen, D. R., Duncan, L. J. P. Lancet, 1970, ii, 163. 7. Nerup, J., Andersen, O. O., Bendixen, G., Egeberg, J., Gunnarsson, R., Kromann, G., Poulsen, J. E. Proc. R. Soc. Med. 1974, 67, 506. 8. MacCuish, A. C., Jordan, J., Campbell, C. J., Duncan, L. J. P., Irvine, W. J. Diabetes, 1974, 23, 693. 9. Irvine, W. J., MacCuish, A. C., Campbell, C. J., Duncan, L. J. P. Acta endocr., Copenh. 1976, suppl. 205, 65. 10. MacCuish, A. C., Jordan, J., Campbell, C. J., Duncan, L. J. P., Irvine, W. J. Diabetes, 1975, 24, 36. 11. Bottazzo, G. F., Florin-Christensen, A., Doniach, D. Lancet, 1974, ii, 1279. 12. MacCuish, A. C., Barnes, E. W., Irvine, W. J., Duncan, L. J. P. ibid. p. 1. 2.
1529. on Endocrinology, (Hamburg, 1976); p. 525, Amsterdam. Irvine, W. J. Proceedings 9th Congress of the International Diabetes Federa-
13. Irvine, W. J. Proceedings 5th International Congress 14.
tion, Delhi, 1976. 15. Irvine, W. J., McCallum, C. J., Gray, R. S., Campbell, C. J., Duncan, L. J. P., Farquhar, J. W., Vaughan, H., Morris, P. J. Diabetes, 1977, 26, 138. 16. Irvine, W. J., Gray, R. S., McCallum, C. J. Lancet, 1976, ii, 1097 17. Gamlen, T. R., Aynsley-Green, A., Irvine, W. J. Clin. exp. Immun. (in the
press). Huang, S.-W., MacLaren, N. K. Science, 1976, 192, 64. 19. Irvine, W. J. Proc. R. Soc. Med. 1974, 67, 548 20. Singal, D. P., Blajchman, M. A. Diabetes, 1973, 22, 129. 21. Nerup, J., Platz, P., Andersen, O. O., Christy, M., Lyngsøe, J., Poulsen, J. E., Ryder, L. P., Staub Nielsen, L., Thomsen, M., Svejgaard, A. Lancet, 1974, ii, 864. 18.
J., Vaughan, H., Irvine, W. J., McCallum, C. J., Gray, R. S., C. J., Duncan, L. J. P., Farquhar, J. W. ibid. 1976, ii, 652. 23. Lendrum, R., Walker, G., Cudworth, A. G., Woodrow, J. C., Gamble, D. R. Br. med. J. 1976, i, 1565. 24. Gamble, D. R., Taylor, K. W. ibid. 1969, iii, 631. 25. Adams, S. F. Archs intern. Med. 1926, 37, 801. 26. Craighead, J. E., McLane, M. F. Science, 1968, 162, 913. 27. Craighead, J. E. Progr. med. Virol. 1975, 19, 161. 28. Gamble, D. R., Taylor, K. W. Acta endocr., Copenh. 1976, suppl. 205, 161. 29. Gamble, D. R., Kinsley, M. L., FitzGerald, M. G., Bolton, R., Taylor, K.W. Br. med. J. 1969, iii, 627 30. Coleman, T. J., Gamble, D. R., Taylor, K. W. ibid. 1973, iii, 25. 31. Lancet, 1976, ii, 28. 32. Craighead, J. E., Higgins, D. A. J. exp. Med. 1974, 139, 414. 33. Menser, M A., Forrest, J. M., Honeyman, M. C., Burgess, J. A. Lancet, 1974, ii, 1509. 34. Rolles, C. J., Rayner, P. H. W., Mackintosh, P. ibid. 1975, ii, 230. 35. Irvine, W. J. Q. Jl. exp. Physiol. 1964, 49, 324. 36. Felix-Davies, D. Lancet, 1958, i, 880. 37. Gepts, W. Diabetes, 1965, 14, 619. 38. Le Compte, P. M. Archs Path. 1958, 66, 450. 39. Mayenburg, H. Schweiz. med. Wschr. 1940, 21, 554. 40. Stansfield, O. H., Warren, S. New Engl. J. Med. 1928, 198, 686. 41. Le Compte, P. M., Legg, M. A. Diabetes, 1972, 21, 762. 42. Doniach, II, Morgan, A. G. Clin. Endocr. 1973, 2, 233. 43. Crome, L., Erdohazi, M., Rivers, R. P. A. Archs dis. Childh. 1967, 42, 677 44. Cudworth, A. G. Br. J. Hosp. Med. 1976, 16, 207. 45. Bottazzo, G. F., Doniach, D. Lancet, 1976, ii, 800. 46. Goldstein, D. E., Drash, A., Gibbs, J., Blizzard, R. J. Pediat. 1970, 77, 304. 47. Whittingham, S., Matthews, J. D., Mackay, I. R., Stocks, A. E., Ungar, B., Martin, F. I. R. Lancet, 1971, i, 763. 48. Nerup, J., Platz, P., Andersen, O. O., Christy, M., Egeberg, J., Poulsen, J. E., Ryder, L. P., Thomsen, A., Svejgaard, A. Genetics of Diabetes Mellitus (edited by W. Creutzfeldt, J. Köbberling, J. V. Neel); p. 106. Berlin. 22.
Morris,
P.
Campbell,
1976. 49.
Rubinstein, P., Suciu-Foca, N., Nicholson, J. F., Fotino, M., Molinaro, A.. Harisiadis, L., Hardy, M. A., Reemtsma, K., Allen, F. H. J. exp. Med 1976, 143, 1277.
643
information about the tentative nature of the treatment proposed than if he were being offered some well-established and familiar intervention. This accords with common sense but in no way differs in principle from the course adopted with regard to well-known medical or surgical procedures. The difference is merely one of degree, recognising the importance of obtaining as real a consent as possible. The existing practice with respect to obtaining the consent of sane adults has been followed for many years and there is no reason to suppose that it requires closer control. *
*
A real difficulty arises in the cases of children and the mentally ill. The judgment of both these groups is impaired, in the one instance through immaturity and in the other by the nature of the disease. Society has therefore always been anxious to ensure that children and the mentally ill receive a special degree of protection, because of their inability to give a truly voluntary consent, and this concern is by no means confined to the
field of medical treatment. In the case of both these groups it is necessary to supplant, or at least supplement, the judgment that goes to form a consent. So far as children are concerned, there is always someone in loco parentis, natural or adoptive parents, a guardian or the local authority, whose ability to judge the child’s interests can be used to replace or augment his own. As children grow older, the sufficiency of a purely proxy consent may itself be called in question. For example, when it is suggested that a healthy child of 14 or 15 years should donate a kidney to a twin, it would hardly be satisfactory for the decision to be taken solely by those having the legal custody of the donor. The proper course is to consult both child and parent, so that consent, if given, will be as nearly voluntary as possible. This illustration is also an example of the rare case in which a healthy person may be asked to consent to an intervention on his own body with a view to treating someone else’s. The principle is not different, but the degree of care in making the decision to consent must obviously be much greater. Neither for donor nor recipient is a kidney transplant a medical experiment, except within the strict limits of the secondary definition given above. Nor is there any reason to suppose, at any rate in this country, that the combined care of doctor and parent is not a sufficient safeguard for the child. *
*
*
The mentally ill, and especially those who must be detained in secure hospitals, present a special problem. Male psychopaths are quite often aware of their intense and dangerous urges to physical or sexual violence and long to be freed from the suffering involved. Attempts have been made to relieve these damaging and uncontrollable impulses by leucotomy and hormone implants, well
as by more conventional treatment. Many of the suffering from these disorders (there seem to be very few women) consent to these comparatively novel procedures, in so far as they are capable of doing so; but such consents must be closely scrutinised. No doubt the Department of Health and Social Security does and should keep a close watch on these developments, which
as
men
ample powers to control. The Mental Health Act, 1959, provides for the protection of the detained patient
it has
by forms of independent guardianship, but offers no safeguards specifically directed to innovatory treatment for mental illness. There is, however, no ground at present for supposing that the treatments given were not primarily and specifically designed for the relief of the subjects’ own suffering and in the hope that they would "answer the purpose". *
*
*
It is against this background that the Medical Experimentation Bill, now before Parliament, should be viewed. The emotional origins of this Bill are fairly obvious and the clumsiness of the law as a means of fine control of human endeavour is well demonstrated. As drafted, the Bill will do little to clarify the subtle issues which have to be resolved from time to time as medical knowledge advances. It might well have the effect of making a doctor hesitate in adopting as a last resort some relatively untried expedient. This would be a pity, for yesterday’s "experiment" is today’s treatment of choice. The definition in the Bill of "medical experiment" seems unlikely to curtail any practice now current in this country, being confined to the administration or withholding of drugs or processes "not specifically and primarily designed for his [i.e., the patient’s] own therapy." By this definition it would not be necessary even to ask a mental patient’s consent to a leucotomy which was designed specifically and primarily for his own therapy. There is good reason for saying that a mental patient ought to be asked to give whatever consent he is capable of giving, unless no intelligible answer at all can be obtained from him, and that in any case the person having the legal guardianship of his affairs should be asked as well. To fetter the doctor’s discretion on the one hand and to absolve him from the need to consider the issue on the other seems a crude and insensitive tinkering with a delicate problem. The Bill further proposes to make it impossible for persons under 18 years of age and prisoners to consent to a "medical experiment"-i.e., a drug or process not specifically and primarily designed for their own therapy. This would seem to have the effect, perhaps inadvertent, of forbidding those two categories of people to donate an organ or to participate in a clinical trial. This is arguably an unnecessary deprivation of liberty for people who may, despite youth on the one hand and a criminal record on the other, genuinely wish to make some contribution to society. As it stands, the Bill would prevent these two groups from giving a pint of blood. Enough has been said to show how unhappy may be the results of carrying control by legislation to extremes. It is impossible to devise a legal formula which would fit the facts of every case which might arise in this difficult field. We might do better to concentrate on preserving and strengthening a medical profession conspicuous for its competence and integrity, one which will accurately reflect our common instinct in ethical matters. Already the General Medical Council and the courts lie in wait for those doctors who fail to measure up to our expectations. Goldsmith
Building,
Temple, London EC4Y 7BL
C. M. CLOTHIER
Points of View CONSENT TO MEDICAL EXPERIMENT MUCH of the scientific and technological progress of Medicine in the past fifty years has been accompanied or preceded by increasingly sophisticated animal experiments and clinical trials. The very word "experiment", used in the context of the human body, produces strong emotional responses in some people and especially in those for whom the word means only some sort of voyage into the unknown. In popular usage the word "experiment" is given its tertiary meaning of : "An action or operation undertaken in order to discover something unknown ..." For the doctor and scientist, the secondary meaning of the word is far more appropriate : "A tentative procedure ... a method or course of action adopted in uncertainty whether it will answer its purpose."* It seems in the highest degree unlikely that any medical experiment falling strictly within the former definition has ever been undertaken in this country. On the other hand, the latter definition is apt to describe a vast range of interventions designed to alleviate suffering in cases where established treatment has failed. *
*
*
It is a major concern of any system of law to control the activities of members of the community towards one another. A first step in exercising control is to declare *Oxford
that every human being is to have his or her body intact. interference with it against his will is characterised as an assault and treated as a criminal offence. This concept is reflected in the title of the Offences against the Person Act, 1861, much of which is still in force. Yet that integrity, valuable as it is, we are prepared to surrender daily in a thousand ways, ranging from the affectionate and acceptable hand on the shoulder to a boxing glove on the nose. The essence of the surrender is consent, express or implied. Consent is a concept of great complexity: but for most of us it means an agreement to a course of action based on full information, free of constraint and given in words or writing. In the field of dayto-day medicine, a consent in the terms of that definition can hardly ever be given. It is seldom that the patient can be as fully informed as the doctor and it might be bad for him if he were; he is never free from the constraint of his illness and he is often unconscious or too ill to express his feelings. In the last instance his consent may have to be implied from his circumstances, as in the case of someone admitted to an accident unit. The range of medical interventions for which consent is or may have to be implied is vast, reaching from the taking of the pulse by silent accord at one extreme to prefrontal leucotomy at the other. In the case of the sane and adult person, there is no practical alternative to the familiar form of written consent when he is conscious and to the judgment of the doctor, perhaps with the help of a close relation, when he is not. It is not practicable to measure the quality of each patient’s consent by testing his comprehension of the proposed treatment or the degree to which his freedom of decision is overborne by his anxiety to get well. However, where part of a patient’s treatment is embodied in a clinical trial, it is usual to give him rather more
Any
English Dictionary, Ill, 930.
DR IRVINE: REFERENCES
Rimoin, D. L. Med. Clins N. Am. 1971, 55, 807. Solomon, I. L., Blizzard, R. M. J. Pediat. 1963, 63, 1021. 3. Irvine, W. J., Stewart, A. G., Scarth, L. Clin. exp. Immun. 1967,2, 31. 4. Nerup, J. Immunity and Autoimmunity in Diabetes Mellitus (edited by P. A. Bastenie and W. Gepts); p. 149. Amsterdam, 1974. 5. Irvine, W. J., Barnes, E. W. in Clinical Aspects of Immunology (edited by R. R. A. Coombs, P. H. Gell and P. Lachmann); Oxford, 1975. 6. Irvine, W. J., Clarke, B. F., Scarth, L., Cullen, D. R., Duncan, L. J. P. Lancet, 1970, ii, 163. 7. Nerup, J., Andersen, O. O., Bendixen, G., Egeberg, J., Gunnarsson, R., Kromann, G., Poulsen, J. E. Proc. R. Soc. Med. 1974, 67, 506. 8. MacCuish, A. C., Jordan, J., Campbell, C. J., Duncan, L. J. P., Irvine, W. J. Diabetes, 1974, 23, 693. 9. Irvine, W. J., MacCuish, A. C., Campbell, C. J., Duncan, L. J. P. Acta endocr., Copenh. 1976, suppl. 205, 65. 10. MacCuish, A. C., Jordan, J., Campbell, C. J., Duncan, L. J. P., Irvine, W. J. Diabetes, 1975, 24, 36. 11. Bottazzo, G. F., Florin-Christensen, A., Doniach, D. Lancet, 1974, ii, 1279. 12. MacCuish, A. C., Barnes, E. W., Irvine, W. J., Duncan, L. J. P. ibid. p. 1. 2.
1529. on Endocrinology, (Hamburg, 1976); p. 525, Amsterdam. Irvine, W. J. Proceedings 9th Congress of the International Diabetes Federa-
13. Irvine, W. J. Proceedings 5th International Congress 14.
tion, Delhi, 1976. 15. Irvine, W. J., McCallum, C. J., Gray, R. S., Campbell, C. J., Duncan, L. J. P., Farquhar, J. W., Vaughan, H., Morris, P. J. Diabetes, 1977, 26, 138. 16. Irvine, W. J., Gray, R. S., McCallum, C. J. Lancet, 1976, ii, 1097 17. Gamlen, T. R., Aynsley-Green, A., Irvine, W. J. Clin. exp. Immun. (in the
press). Huang, S.-W., MacLaren, N. K. Science, 1976, 192, 64. 19. Irvine, W. J. Proc. R. Soc. Med. 1974, 67, 548 20. Singal, D. P., Blajchman, M. A. Diabetes, 1973, 22, 129. 21. Nerup, J., Platz, P., Andersen, O. O., Christy, M., Lyngsøe, J., Poulsen, J. E., Ryder, L. P., Staub Nielsen, L., Thomsen, M., Svejgaard, A. Lancet, 1974, ii, 864. 18.
J., Vaughan, H., Irvine, W. J., McCallum, C. J., Gray, R. S., C. J., Duncan, L. J. P., Farquhar, J. W. ibid. 1976, ii, 652. 23. Lendrum, R., Walker, G., Cudworth, A. G., Woodrow, J. C., Gamble, D. R. Br. med. J. 1976, i, 1565. 24. Gamble, D. R., Taylor, K. W. ibid. 1969, iii, 631. 25. Adams, S. F. Archs intern. Med. 1926, 37, 801. 26. Craighead, J. E., McLane, M. F. Science, 1968, 162, 913. 27. Craighead, J. E. Progr. med. Virol. 1975, 19, 161. 28. Gamble, D. R., Taylor, K. W. Acta endocr., Copenh. 1976, suppl. 205, 161. 29. Gamble, D. R., Kinsley, M. L., FitzGerald, M. G., Bolton, R., Taylor, K.W. Br. med. J. 1969, iii, 627 30. Coleman, T. J., Gamble, D. R., Taylor, K. W. ibid. 1973, iii, 25. 31. Lancet, 1976, ii, 28. 32. Craighead, J. E., Higgins, D. A. J. exp. Med. 1974, 139, 414. 33. Menser, M A., Forrest, J. M., Honeyman, M. C., Burgess, J. A. Lancet, 1974, ii, 1509. 34. Rolles, C. J., Rayner, P. H. W., Mackintosh, P. ibid. 1975, ii, 230. 35. Irvine, W. J. Q. Jl. exp. Physiol. 1964, 49, 324. 36. Felix-Davies, D. Lancet, 1958, i, 880. 37. Gepts, W. Diabetes, 1965, 14, 619. 38. Le Compte, P. M. Archs Path. 1958, 66, 450. 39. Mayenburg, H. Schweiz. med. Wschr. 1940, 21, 554. 40. Stansfield, O. H., Warren, S. New Engl. J. Med. 1928, 198, 686. 41. Le Compte, P. M., Legg, M. A. Diabetes, 1972, 21, 762. 42. Doniach, II, Morgan, A. G. Clin. Endocr. 1973, 2, 233. 43. Crome, L., Erdohazi, M., Rivers, R. P. A. Archs dis. Childh. 1967, 42, 677 44. Cudworth, A. G. Br. J. Hosp. Med. 1976, 16, 207. 45. Bottazzo, G. F., Doniach, D. Lancet, 1976, ii, 800. 46. Goldstein, D. E., Drash, A., Gibbs, J., Blizzard, R. J. Pediat. 1970, 77, 304. 47. Whittingham, S., Matthews, J. D., Mackay, I. R., Stocks, A. E., Ungar, B., Martin, F. I. R. Lancet, 1971, i, 763. 48. Nerup, J., Platz, P., Andersen, O. O., Christy, M., Egeberg, J., Poulsen, J. E., Ryder, L. P., Thomsen, A., Svejgaard, A. Genetics of Diabetes Mellitus (edited by W. Creutzfeldt, J. Köbberling, J. V. Neel); p. 106. Berlin. 22.
Morris,
P.
Campbell,
1976. 49.
Rubinstein, P., Suciu-Foca, N., Nicholson, J. F., Fotino, M., Molinaro, A.. Harisiadis, L., Hardy, M. A., Reemtsma, K., Allen, F. H. J. exp. Med 1976, 143, 1277.
643
information about the tentative nature of the treatment proposed than if he were being offered some well-established and familiar intervention. This accords with common sense but in no way differs in principle from the course adopted with regard to well-known medical or surgical procedures. The difference is merely one of degree, recognising the importance of obtaining as real a consent as possible. The existing practice with respect to obtaining the consent of sane adults has been followed for many years and there is no reason to suppose that it requires closer control. *
*
A real difficulty arises in the cases of children and the mentally ill. The judgment of both these groups is impaired, in the one instance through immaturity and in the other by the nature of the disease. Society has therefore always been anxious to ensure that children and the mentally ill receive a special degree of protection, because of their inability to give a truly voluntary consent, and this concern is by no means confined to the
field of medical treatment. In the case of both these groups it is necessary to supplant, or at least supplement, the judgment that goes to form a consent. So far as children are concerned, there is always someone in loco parentis, natural or adoptive parents, a guardian or the local authority, whose ability to judge the child’s interests can be used to replace or augment his own. As children grow older, the sufficiency of a purely proxy consent may itself be called in question. For example, when it is suggested that a healthy child of 14 or 15 years should donate a kidney to a twin, it would hardly be satisfactory for the decision to be taken solely by those having the legal custody of the donor. The proper course is to consult both child and parent, so that consent, if given, will be as nearly voluntary as possible. This illustration is also an example of the rare case in which a healthy person may be asked to consent to an intervention on his own body with a view to treating someone else’s. The principle is not different, but the degree of care in making the decision to consent must obviously be much greater. Neither for donor nor recipient is a kidney transplant a medical experiment, except within the strict limits of the secondary definition given above. Nor is there any reason to suppose, at any rate in this country, that the combined care of doctor and parent is not a sufficient safeguard for the child. *
*
*
The mentally ill, and especially those who must be detained in secure hospitals, present a special problem. Male psychopaths are quite often aware of their intense and dangerous urges to physical or sexual violence and long to be freed from the suffering involved. Attempts have been made to relieve these damaging and uncontrollable impulses by leucotomy and hormone implants, well
as by more conventional treatment. Many of the suffering from these disorders (there seem to be very few women) consent to these comparatively novel procedures, in so far as they are capable of doing so; but such consents must be closely scrutinised. No doubt the Department of Health and Social Security does and should keep a close watch on these developments, which
as
men
ample powers to control. The Mental Health Act, 1959, provides for the protection of the detained patient
it has
by forms of independent guardianship, but offers no safeguards specifically directed to innovatory treatment for mental illness. There is, however, no ground at present for supposing that the treatments given were not primarily and specifically designed for the relief of the subjects’ own suffering and in the hope that they would "answer the purpose". *
*
*
It is against this background that the Medical Experimentation Bill, now before Parliament, should be viewed. The emotional origins of this Bill are fairly obvious and the clumsiness of the law as a means of fine control of human endeavour is well demonstrated. As drafted, the Bill will do little to clarify the subtle issues which have to be resolved from time to time as medical knowledge advances. It might well have the effect of making a doctor hesitate in adopting as a last resort some relatively untried expedient. This would be a pity, for yesterday’s "experiment" is today’s treatment of choice. The definition in the Bill of "medical experiment" seems unlikely to curtail any practice now current in this country, being confined to the administration or withholding of drugs or processes "not specifically and primarily designed for his [i.e., the patient’s] own therapy." By this definition it would not be necessary even to ask a mental patient’s consent to a leucotomy which was designed specifically and primarily for his own therapy. There is good reason for saying that a mental patient ought to be asked to give whatever consent he is capable of giving, unless no intelligible answer at all can be obtained from him, and that in any case the person having the legal guardianship of his affairs should be asked as well. To fetter the doctor’s discretion on the one hand and to absolve him from the need to consider the issue on the other seems a crude and insensitive tinkering with a delicate problem. The Bill further proposes to make it impossible for persons under 18 years of age and prisoners to consent to a "medical experiment"-i.e., a drug or process not specifically and primarily designed for their own therapy. This would seem to have the effect, perhaps inadvertent, of forbidding those two categories of people to donate an organ or to participate in a clinical trial. This is arguably an unnecessary deprivation of liberty for people who may, despite youth on the one hand and a criminal record on the other, genuinely wish to make some contribution to society. As it stands, the Bill would prevent these two groups from giving a pint of blood. Enough has been said to show how unhappy may be the results of carrying control by legislation to extremes. It is impossible to devise a legal formula which would fit the facts of every case which might arise in this difficult field. We might do better to concentrate on preserving and strengthening a medical profession conspicuous for its competence and integrity, one which will accurately reflect our common instinct in ethical matters. Already the General Medical Council and the courts lie in wait for those doctors who fail to measure up to our expectations. Goldsmith
Building,
Temple, London EC4Y 7BL
C. M. CLOTHIER