Many subjects in trial were not asked for consent

BMJ 1996;312:509 (24 February)

Letters

Many subjects in trial were not asked for consent

In the UKCCCR multicentre randomised controlled trial of oneand two view mammography in breast cancer screening, only oneout of the nine breast screening centres that took part soughtinformed consent before randomisation from the 40 163 womenattending their first breast screening examination who participatedin this trial.¹ The remainder sought consent after randomisationand only from those women who had been allocated to either ofthe two view arms (ratio 1:1:2)--that is, a quarter of the womenin eight out of nine centres did not know they were in a trial.

Might it be assumed that the trial working party decided thisbecause consent is not sought from women "invited" for breastscreening? Presumably it was deemed to be unjust to those millionsof women who have attended for mammographic screening withoutbenefit of the provision of adequate balanced information thatinformed consent would confer. Should we not now be asking ifit was unjust and unethical for those women in this trial notasked for consent, particularly as the stated conclusion that"two view mammography is medically more effective than one view:it detects more cancers and reduces recall rates; it is alsosimilarly cost effective financially" could hardly be said tobe counter intuitive?² ³ ⁴ ⁵

Is it not time that all women who attend for screening are presentedwith proper, balanced information and asked for consent? Itwould be particularly interesting to know the opinion of the9000 or so unsuspecting women who unknowingly participated inthis trial. Such better informed women would be better placedto enter into the debate concerning the value (economicallyand psychologically) of screening in terms of reducing the morbidityand mortality of women with breast cancer.

31 Regent Street, Rowhedge, Colchester CO5 7EA

Hazel Thornton

Wald NJ, Murphy P, Major P, Parkes Cl, Townsend J, Frost C. UKCCCR multicentre randomised controlled trial of one and two view mammography in breast cancer screening. BMJ 1995;311:1189. (4 November.) [Abstract/Free Full Text]
Anderson I, Hildell J, Muhlow A, Petterson H. Number of projections in mammography: influence on detection of breast disease. AJR 1978;130:349-51. [Abstract]
Anderson I. Radiographic screening for breast carcinoma. III. Appearance of carcinoma and number of projections used at screening. Acta Radiol 1981;22:407.
Sickles EA, Weber WN, Galvin HB, Ominsky SH, Sollitto RA. Baseline screening mammography: one vs two views per breast. AJR 1986;147:1149-53. [Abstract/Free Full Text]
Bassett LW, Bunnell DH, Jahanshahi R, Gold RH, Arndt RD, Linsman J. Breast cancer detection: one versus two views. Radiology 1987;165:95-7. [Abstract/Free Full Text]

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