Informed consent for cord blood donation. A theoretical and empirical study.
OBJECTIVE
Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network.


METHODS
The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the "NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration".


RESULTS
Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects.


CONCLUSIONS
Italian forms for CB collection, storage and use need standardisation to meet international criteria.
Bioethics Unit, Office of the President, Italian National Institute of Health, Rome.
Carlo
C
Petrini
Michele
M
Farisco
D026688:Bioethical Issues; D001771:Blood Banks / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000458:organization & administration; D001782:Blood Donors / Q000941:ethics* / Q000331:legislation & jurisprudence; D001793:Blood Preservation / Q000941:ethics* / Q000379:methods; D032962:Consent Forms / Q000941:ethics* / Q000592:standards; D005312:Fetal Blood; D006801:Humans; D007558:Italy; D000094902:Blood Banking / Q000379:methods
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19802029
Bone Marrow Transplant. 2009 Nov;44(10):621-6
19802032
Bone Marrow Transplant. 2009 Nov;44(10):653-9
19802021
Bone Marrow Transplant. 2008 Apr;41(8):687-705
18084334
N Engl J Med. 1999 May 13;340(19):1521-4
10320393
N Engl J Med. 1989 Oct 26;321(17):1174-8
2571931
Vox Sang. 2008 Nov;95(4):335-48
19138265
BMJ. 2006 Oct 14;333(7572):801-4
17038739
Bone Marrow Transplant. 2009 Nov;44(10):635-42
19802017