Consent to using human tissue

Human tissue is vital for teaching, laboratory quality control, and research—work done for the good of all. Consent is required to legitimise such use. But how should consent be sought?

Dramatic recent publicity about inadequate consent procedures for autopsy has engendered new regulations that have been applied to all human samples—surgical resections, biopsies, blood, urine, even sputum.1 As an example of the consequences an international study of a rare form of kidney disease has recently been abandoned because the requirement for central review of microscope slides—which contain micrograms of human tissue—was deemed to require explicit consent from patients in the United States and the United Kingdom. The situation in other European countries is varied, but none has regulations as restrictive as the United Kingdom.

Is the United Kingdom leading the way or overreacting? Autopsy specimens have great emotional importance, but patients rarely regard tissue that has been removed for therapeutic purposes in the same light.2 The experience of the Peterborough tissue bank emphasises this. Of 3140 patients 98.8% (3102) gave consent for surgically resected tissue to be used in research by commercial organisations, which is usually thought to be more troubling to patients than other sorts of research. …