The new regulations require explicit consent from every patient. Explicit consent is appropriate for the use of emotionally important samples such as post-mortem tissue, but the new regulations also apply to all samples from living patients, including resected tumours, tiny biopsies, even blood and urine.
Although this takes due account of the autonomy of the few who object, it is now inhibiting work done for the good of everyone and has other ethically undesirable consequences, says Professor Peter Furness, in this week's BMJ.
Recording the wishes of all patients whenever samples are taken would resolve this problem but this has major resource implications, he writes. So is implied consent - asking the few who object to make their wishes known a reasonable possibility for the use of tissue from living patients for research?
Implied consent was recommended by the Nuffield Council on Bioethics in 1995, but has since been rejected by the Medical Research Council, despite evidence that patients thought it was appropriate. The Department of Health for England has so far taken a similar line to the MRC.
"If we are serious about empowering patients to control the use of their tissue samples, resources must be allocated irrespective of whether implied or explicit consent is regarded as appropriate," says the author. "Without such resources our laboratories are forced into paralysis or continuing paternalism. At present we have both."