One-time general consent for research on biological samples: Good idea, but will it happen?BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7542.665-a (Published 16 March 2006) Cite this as: BMJ 2006;332:665
EDITOR—Wendler's advocacy of one-time consent for research use of biological samples that would otherwise be discarded as clinical waste is welcome and would be ethically sound and financially efficient.1 But this suggestion is not new. The Royal College of Pathologists advocated exactly this five years ago, at the height of the organ retention controversy, stating that in relation to tissue removed from living patients: “we suggest that as a minimum it should be possible to record consent or objection to ‘generic’ research use, as outlined above, and to teaching and quality control. Consent or objection should be assumed to refer to all samples from that patient, unless otherwise specified.”2
However, the college also stated that it was “gravely concerned about implementation, and the speed at which it will occur. We believe it highly unlikely that NHS trusts will act with sufficient urgency…We therefore urge the Departments of Health to distribute appropriate instructions.”
Since then the introduction of the Human Tissue Act 2004 puts the onus on researchers to obtain consent, even for tissue, blood, and urine which would otherwise be disposed of as waste, even though the patients concerned have usually gone home long before the need for consent is recognised. The act does permit the use of tissue in research without consent, but only if samples are anonymised (which makes crucial clinical correlation difficult or impossible) and if a research ethics committee has approved (and experience suggests that many such committees will regard this as inappropriate and demand consent anyway).
The college showed that to ask for consent every time a sample is taken would be absurdly expensive and that staff not involved in research would not do it. So it argued for one-time consent during the development of the act—without success. It is not part of the act. It has not been advocated by the Department of Health or (yet) by the new Human Tissue Authority. But no workable alternative has been proposed.
As Wendler shows, the autonomous wish of the vast majority of patients is that their surgical waste should be available for the benefit of mankind, rather than being incinerated. At present, most patients are never asked, so this wish is ignored.
Failing to ask empowers no one. Is such disrespect for patient autonomy not an ethical outrage?
Competing interests PNF is a histopathologist and chaired the working group which wrote the royal college report cited.