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Common consent

Scientists hope to have access to the material described in a published research paper, so they can verify the results and build on the conclusions. But, as the corrigendum on page 1044 of this issue shows, the work of research and the ethics of the field of study are not always synchronous, which can introduce unfortunate – and unacceptable – restrictions.

Corrigendum is related to a paper that describes making pluripotent germline stem cells from human testicular tissue (S. Conrad et al. Nature 456, 344–349; 2008). As with all materials or data reported in a Nature research paper, these cells should be shared with the research community upon publication.

However, as a corrigendum details, none of the pluripotent cell lines are currently available due to restrictions in the consent forms of the donors, which limit distribution and promise that cells can be destroyed after a certain time in culture. will be done. The authors have since contacted donors and obtained permission to develop some of the lines for distribution. They are also building new lines for distribution from other donors.

Such failures to deliver cell lines are inconsistent with Nature journal policies and the efficient advance of scientific knowledge. The corrigendum alerts investigators to this situation and the steps being taken to rectify it. This particular case illustrates how, when clinicians, researchers and their local ethics boards follow internal procedures that promote both donor safety and medical research, serious problems can arise.

The community was not as surprised by the situation – six out of seven researchers contacted by Nature thought it might happen again.

Researchers developing cell lines should investigate 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 have multiple legal rights. come from the area. If a scientist needs to create a cell line that can be used for yet unexpected purposes, only tissue with no restrictions should be used.

An article published earlier this year helpfully suggested that scientists receiving human tissue may agree to some common procedures (such as sharing cell lines with other investigators) and by including requests to contact donors. Mentioning can alleviate most of the issues from the very beginning. again if their research takes an unexpected direction (K. Aalto-Setala et al. PLOS Biol. 7, e100042; 2009).

Journals may remind authors in their policy guidelines that authors of submissions that include consent forms should inform editors of any limitations that may result from those forms. The Nature journal will revise its policies to clarify this.

More importantly, patients, researchers, clinicians and review and ethics boards around the world need to agree on conventions that are acceptable to most parties under most circumstances. Internationally standardized consent forms for human tissue donation should include new uses, genomic comparisons, patents and product development, and should discourage limited access or lifespan.

Ethics and review boards are set up to protect individuals, but can go much further to promote research. No one can deny that donors need to understand the risks and benefits of a procedure, test or donation. However, it seems most ethically responsible, given the value of the research, to interpret the results to boards that restricted access and time limits can have on the value of a donor’s tissue.

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