Nature 461, 593 (1 October 2009) | doi:10.1038/461593c; Published online 30 September 2009

Consent: a need for guidelines to reflect local considerations

Wendy Lipworth1, Rob Irvine1 & Bronwen Morrell1

  1. Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building, University of Sydney, NSW 2006, Australia


As you point out in your Editorial (Nature 460, 933; 2009) on the distribution of human cell lines, withholding scientific material from the broader research community contravenes the basic norms of science. We do not believe, however, that standard international consent guidelines for tissue donors are the solution to this problem, and suggest that these should instead be devised on a local scale, in collaboration with ethics committees.

Far from research being "hindered by restrictions from donors" as you suggest, people are generally willing to donate tissue for research, and even to give open-ended consent to unspecified future applications. This willingness is underpinned by donors' faith in medical research and in their right to protection and confidentiality; the assumption is that their tissue will be used only for 'ethical' investigations.

But problems can arise, for example, over whether consent covers the proposed usage (at present there are many different models of consent, ranging from specific to general), and when and how tissue should be discarded (K. Aalto-Setälä et al. PLoS Biol. 7, e42; 2009).

The answers may not always be obvious, and ethics committees (in collaboration with donors or their representatives) need to take into account the type of tissue involved, as well as the demographics and potential vulnerability of the donor or donor community, in judging the acceptability of a research proposal.

None of this precludes distribution of tissue in the name of scientific progress, nor should it if the wishes of donors are to be respected. However, it does challenge any unqualified presumption among researchers about access to human material; it also calls into question the ethical acceptability of using internationally standardized consent forms, as recommended in your Editorial. Rather, we would argue for international standards to ensure that tissue distribution is not thwarted by ethics committees, accompanied by a plurality of local approaches to obtaining consent.

This strategy would address the problems you outline, while demonstrating respect for moral decisions made by individuals and groups and preserving donors' trust in biological medicine.

See also Consent: criteria should be drawn up for tissue donors.

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  1. #69731
    2017-04-29 03:26 PM
    Refugia Cottie said:

    Science will always be the first when it is about providing things (buyinstfollowers.

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