Is it Time to Change the Model for Tissue Donation?
Shifting from a Consent Model to a Gift Model
SOURCE: AP/Steve Helber
A technician measures a donated bisected patellar ligament. The use of human tissue is necessary to advance medical research, the consent model often limits what researchers are able to do with it.
My University of Pennsylvania colleague Art Caplan and I argue in the medical journal The Lancet (subscription required) this week that it is time to reconsider the idea that informed consent should be required for tissue donation to medical research.
Informed consent protects the rights of people who participate in research studies. Research subjects may be medically, psychologically, and socially vulnerable, and they are therefore entitled to have their personal autonomy respected by providing them with the information they need to decide whether or not to participate in the research.
Informed consent historically grew out of scandals and tragedies during human experiments from the 1960s and 1970s. But it’s now being applied to the collection of human tissues for laboratory research in a way that may not make sense and interferes with promising medical science.
Two recent cases illustrate the problem: an Arizona Native American group that objected to the medical use of anonymous blood samples for research purposes other than that specified in the original consent form; and embryonic stem cell consent forms that, again, specified only research on a certain disease. The materials in the first case were returned to the tribe, and in the second the National Institutes of Health is not permitting research funding on the cell lines affected by the consent restrictions.
We don’t advocate violating the consent forms once they are in place, but it is more appropriate going forward to treat these materials as gifts. The donors would have no ongoing rights and the materials would not be restricted in their research uses. Donors would still have the possible lab uses of their tissues explained to them, but with the provision that they understand they are giving them to science rather than “consenting” under the conditions of a form.
A gift model has another important advantage over a consent model: It would be clearer to donors that they would not stand to gain in any commercial value that might come from products of work with their tissues.
Of course, all the needed privacy conditions would also apply so that the researchers would not be able to trace the materials back to the donors. There is no reason that a gift approach can’t be just as ethical as an informed consent model of tissue donation.
The idea of informed consent for these kinds of donations seems to have grown up accidentally as part of the medical research system in a similar way to clinical trials. But it seems to us that it’s time to revisit the reasoning behind this system since a tissue donor is not directly involved in the research and the system is often impeding important medical studies.
Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.
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