Demanding informed consent for research on tissue stored in ‘biobanks’ is hindering science and should be abandoned, according to a Sweden-based team.
In a new paper, they argue that, although brought in with good intentions, rules requiring informed consent in countries such as Sweden and the United Kingdom are inappropriate and could safely be replaced with the oversight of an ethics board.
“Often the question of consent is portrayed as protecting the rights of the individual against the public good,” says lead author on the paper, Joanna Forsberg, of the Centre for Research Ethics and Bioethics at Uppsala University. “The other thing to weigh against it is the self interest that the patient has in optimizing [their] health care.”
In the British Medical Journal, Forsberg and colleagues argue that, as well as the public good of medical science, the individuals themselves have a direct or indirect benefit from improving the healthcare system. With proper data protection and ethical approval being required from ethics boards, the risks of abandoning informed consent would be minimal, they say.
This would free up money now spent chasing down the patients that samples such as tumour cells originally came from if researchers years down the line were to decide they wanted to study them. The team cites examples of studies being hindered and even abandoned because of problems with the present system of informed consent.
“Leftover material, stored tissue samples, and associated data can be used without consent, after approval by and ethics review board, because the minimal risk of harm is clearly outweighed for each individual by the increased chance of benefiting, directly or indirectly, from healthcare,” says the paper.
As the paper notes, such a system would appear to go against both the UNESCO International Declaration on Human Genetic Data and guidelines from the Council for International Organizations of Medical Sciences, which call for informed consent.
“In a way that is the purpose of the paper: to question those guidelines,” Forsberg told Nature.
She says she believes researchers “in general agree with me” about the need for change.