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DR IRVINE: REFERENCES

1. Rimoin, D. L. Med. Clins N. Am. 1971, 55, 807.2. 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., Kro-

mann, 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.

1529.

13. Irvine, W. J. Proceedings 5th International Congress on Endocrinology,(Hamburg, 1976); p. 525, Amsterdam.

14. Irvine, W. J. Proceedings 9th Congress of the International Diabetes Federa-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, 109717. Gamlen, T. R., Aynsley-Green, A., Irvine, W. J. Clin. exp. Immun. (in the

press).18. Huang, S.-W., MacLaren, N. K. Science, 1976, 192, 64.19. Irvine, W. J. Proc. R. Soc. Med. 1974, 67, 54820. 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.

22. Morris, P. J., Vaughan, H., Irvine, W. J., McCallum, C. J., Gray, R. S.,Campbell, 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, 62730. 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, 67744. 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 Mel-litus (edited by W. Creutzfeldt, J. Köbberling, J. V. Neel); p. 106. Berlin.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. Med1976, 143, 1277.

Points of View

CONSENT TO MEDICAL EXPERIMENT

MUCH of the scientific and technological progress ofMedicine in the past fifty years has been accompanied orpreceded by increasingly sophisticated animal experi-ments and clinical trials. The very word "experiment",used in the context of the human body, produces strongemotional responses in some people and especially inthose 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 : "Anaction or operation undertaken in order to discover

something unknown ..." For the doctor and scientist,the secondary meaning of the word is far more appro-priate : "A tentative procedure ... a method or courseof action adopted in uncertainty whether it will answerits purpose."* It seems in the highest degree unlikelythat any medical experiment falling strictly within theformer definition has ever been undertaken in this

country. On the other hand, the latter definition is aptto describe a vast range of interventions designed to alle-viate suffering in cases where established treatment hasfailed.

* * *

It is a major concern of any system of law to controlthe activities of members of the community towards oneanother. A first step in exercising control is to declare

*Oxford English Dictionary, Ill, 930.

that every human being is to have his or her body intact.Any interference with it against his will is characterisedas an assault and treated as a criminal offence. This con-

cept is reflected in the title of the Offences against thePerson Act, 1861, much of which is still in force. Yetthat integrity, valuable as it is, we are prepared to sur-render daily in a thousand ways, ranging from the affec-tionate and acceptable hand on the shoulder to a boxingglove on the nose. The essence of the surrender is con-sent, express or implied. Consent is a concept of greatcomplexity: but for most of us it means an agreement toa course of action based on full information, free of con-straint and given in words or writing. In the field of day-to-day medicine, a consent in the terms of that definitioncan hardly ever be given. It is seldom that the patientcan be as fully informed as the doctor and it might bebad for him if he were; he is never free from the con-straint of his illness and he is often unconscious or tooill to express his feelings. In the last instance his consentmay have to be implied from his circumstances, as in thecase of someone admitted to an accident unit. The rangeof medical interventions for which consent is or mayhave to be implied is vast, reaching from the taking ofthe pulse by silent accord at one extreme to prefrontalleucotomy at the other. In the case of the sane and adultperson, there is no practical alternative to the familiarform of written consent when he is conscious and to the

judgment of the doctor, perhaps with the help of a closerelation, when he is not. It is not practicable to measurethe quality of each patient’s consent by testing his com-prehension of the proposed treatment or the degree towhich his freedom of decision is overborne by his

anxiety to get well.However, where part of a patient’s treatment is embo-

died in a clinical trial, it is usual to give him rather more

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information about the tentative nature of the treatment

proposed than if he were being offered some well-estab-lished and familiar intervention. This accords with com-mon sense but in no way differs in principle from thecourse adopted with regard to well-known medical orsurgical procedures. The difference is merely one ofdegree, recognising the importance of obtaining as reala consent as possible. The existing practice with respectto obtaining the consent of sane adults has been followedfor many years and there is no reason to suppose thatit requires closer control.

* *

A real difficulty arises in the cases of children and thementally ill. The judgment of both these groups is im-paired, in the one instance through immaturity and inthe other by the nature of the disease. Society has there-fore always been anxious to ensure that children and thementally ill receive a special degree of protection,because of their inability to give a truly voluntary con-sent, and this concern is by no means confined to thefield of medical treatment. In the case of both these

groups it is necessary to supplant, or at least supple-ment, the judgment that goes to form a consent. So faras children are concerned, there is always someone inloco parentis, natural or adoptive parents, a guardian orthe local authority, whose ability to judge the child’s in-terests can be used to replace or augment his own. Aschildren grow older, the sufficiency of a purely proxyconsent may itself be called in question. For example,when it is suggested that a healthy child of 14 or 15years should donate a kidney to a twin, it would hardlybe satisfactory for the decision to be taken solely bythose having the legal custody of the donor. The propercourse is to consult both child and parent, so that con-

sent, if given, will be as nearly voluntary as possible.This illustration is also an example of the rare case inwhich a healthy person may be asked to consent to anintervention on his own body with a view to treatingsomeone else’s. The principle is not different, but thedegree of care in making the decision to consent mustobviously be much greater. Neither for donor nor reci-pient is a kidney transplant a medical experiment,except within the strict limits of the secondary definitiongiven above. Nor is there any reason to suppose, at anyrate in this country, that the combined care of doctorand parent is not a sufficient safeguard for the child.

* * *

The mentally ill, and especially those who must bedetained in secure hospitals, present a special problem.Male psychopaths are quite often aware of their intenseand dangerous urges to physical or sexual violence andlong to be freed from the suffering involved. Attemptshave been made to relieve these damaging and uncon-trollable impulses by leucotomy and hormone implants,as well as by more conventional treatment. Many of themen suffering from these disorders (there seem to bevery few women) consent to these comparatively novelprocedures, in so far as they are capable of doing so; butsuch consents must be closely scrutinised. No doubt theDepartment of Health and Social Security does andshould keep a close watch on these developments, which

it has ample powers to control. The Mental Health Act,1959, provides for the protection of the detained patientby forms of independent guardianship, but offers no

safeguards specifically directed to innovatory treatmentfor mental illness. There is, however, no ground at pres-ent for supposing that the treatments given were not pri-marily and specifically designed for the relief of the sub-jects’ own suffering and in the hope that they would"answer the purpose".

* * *

It is against this background that the Medical Experi-mentation Bill, now before Parliament, should beviewed. The emotional origins of this Bill are fairlyobvious and the clumsiness of the law as a means of finecontrol of human endeavour is well demonstrated. Asdrafted, the Bill will do little to clarify the subtle issueswhich have to be resolved from time to time as medical

knowledge advances. It might well have the effect ofmaking a doctor hesitate in adopting as a last resortsome relatively untried expedient. This would be a pity,for yesterday’s "experiment" is today’s treatment ofchoice.The definition in the Bill of "medical experiment"

seems unlikely to curtail any practice now current inthis country, being confined to the administration orwithholding of drugs or processes "not specifically andprimarily designed for his [i.e., the patient’s] own thera-py." By this definition it would not be necessary even toask a mental patient’s consent to a leucotomy which wasdesigned specifically and primarily for his own therapy.There is good reason for saying that a mental patientought to be asked to give whatever consent he is capableof giving, unless no intelligible answer at all can beobtained from him, and that in any case the person hav-ing the legal guardianship of his affairs should be askedas well. To fetter the doctor’s discretion on the one handand to absolve him from the need to consider the issueon the other seems a crude and insensitive tinkeringwith a delicate problem.The Bill further proposes to make it impossible for

persons under 18 years of age and prisoners to consentto a "medical experiment"-i.e., a drug or process notspecifically and primarily designed for their own thera-py. This would seem to have the effect, perhaps inadver-tent, of forbidding those two categories of people todonate an organ or to participate in a clinical trial. Thisis arguably an unnecessary deprivation of liberty for

people who may, despite youth on the one hand and acriminal record on the other, genuinely wish to makesome contribution to society. As it stands, the Bill wouldprevent 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 fitthe facts of every case which might arise in this difficultfield. We might do better to concentrate on preservingand strengthening a medical profession conspicuous forits competence and integrity, one which will accuratelyreflect our common instinct in ethical matters. Alreadythe General Medical Council and the courts lie in waitfor those doctors who fail to measure up to our expec-tations.

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