No restrictions on tissue distribution
The distribution of human cell lines used in research should not be hindered by restrictions from donors, states an Editorial in Nature last week (460, 933; 2009 ; free to access online). The occasion of the Editorial is a Corrigendum relating to a paper published in the journal last year ('Generation of pluripotent stem cells from adult human testis' by
S. Conrad et al., Nature 456, 344-349; 2009). In the Corrigendum, the authors explain how the original patient consent forms to collect the material used to derive the pluripotent stem cells precluded distribution to third parties under the regulations of the relevant hospital ethics committee. (The authors also explain that they are going to cultivate new cells, under different terms of consent, which they can then distribute upon request.)
As the Editorial points out, failures to distribute cell lines are incompatible with Nature journal policies and with the efficient progression of scientific knowledge. The Corrigendum alerts investigators to this situation and the steps being taken to rectify it. Even when clinicians, researchers and their local ethics board follow internal procedures that promote both donor safety and medical research, serious problems can arise regarding the unhindered distribution of samples.
Here is a slightly shortened version of the rest of the Editorial:
The community was not that surprised by this situation — six of seven researchers contacted by Nature thought this could happen again. Researchers developing cell lines must investigate the restrictions associated with the human tissue they are using, particularly if someone else collected the samples, if the samples come from multiple clinical sources or if they come from several legal jurisdictions. If a scientist needs to create cell lines that might be used for as-yet-unforeseen purposes, only tissue with no restrictions should be used.
Journals can remind authors in their policy guidelines that authors of submissions that involve consent forms must make editors aware of any limits that result from those forms. The Nature journals will be revising their policies to make this clearer.
Most importantly, patients, researchers, clinicians, and review and ethics boards worldwide need to agree on conventions that are acceptable to most parties under most circumstances. Internationally standardized consent forms for the donation of human tissue should cover new uses, genomic comparisons, patents and product development, and should discourage limiting access or lifespan.
Ethics and review boards are set up to protect individuals, but can also go much further to promote research. No one can deny that donors need to understand the risks and benefits of a procedure, trial or donation. However, it seems most ethically responsible, given the value of research, for the boards to explain the consequences that restricted access and time limits can have on the value of a donor's tissue.
