Our analysis shows that only a few items of the FACT Standards are present in the Italian forms. This does not necessarily mean that the forms do not meet the FACT’s requirements: at least two Italian banks (Milan and Pavia) are FACT accredited. No form contains all the FACT’s points. Indeed, only four items are present in almost all the forms (27 or 28 of the total of 29 forms): (i) informed consent from the mother, (ii) the possible risks of CB collection, (iii) collection of reference and maternal samples for clinical and/or genetic testing and (iv) confidentiality of information. Six other items are included in more than half the forms (between 15 and 22 of the 29 forms: (i) the overall purpose of the collection, (ii) the intent of the donation for either unrelated or directed transplantation, (iii) the mother asked to provide a personal and family medical history, (iv) personnel can review the medical records of the mother and infant donor, (v) reference and maternal samples stored for future testing and (vi) possible uses of the unit for purposes other than clinical transplantation. Thus the majority of voices important, according to FACT, for obtaining consent that is truly informed are present in less than half of Italian consent forms.
On the other hand there are some specific items in Italian forms that are not included in the FACT Standards. Among them, the following seem particularly interesting.
In the forms from 17 banks it is clearly stated that there are no costs for donor, and all the banks declare the donor has no rights to or advantage from the donation; it appears important for Italian banks to clarify donors’ rights and duties.
Another peculiar item of Italian consent forms is the stated possibility, when required by circumstances, to not proceed to the collection even though consent has been expressed (13 banks/18): the bank has no obligation to do it anyway. In 3 forms from 2 banks is also specified that the collection will be made according to the priorities of the delivery room’s staff. It is, therefore, important that the rights and duties of the banks are also expressed.
Two forms (from the same bank) refer to the Convention on Human Rights and Biomedicine (by the Council of Europe), to the Declaration of Helsinki (by the World Medical Association) and to the Universal Declaration of Human Rights. This does not mean that the other banks disregard ethics and human rights. Actually, these documents are very general and do not apply directly to the specific case. Moreover, the Declaration of Helsinki has been developed “for medical research involving human subjects” (art. 1): although the Declaration includes “research on identifiable human material and data” (art. 1) it is not directly enforceable in the case of collection, storage and transplantation for therapeutic purposes.
Only one form outlines the problem of legal ownership of donated CB units and their duration of storage.
In general, little attention is paid to the role of the father, if not requiring his consent to the donation, at least assessing his possible objections to it.
Another important missing item is the time of informed consent, which should be given, according to FACT Standards, during pregnancy, before labour, when the mother can concentrate on information. This is probably taken for granted, like discussing the concepts with the mother in understandable language and giving her the opportunity to ask questions.
All the banks describe the risk of donating CB, but almost none describes the possible benefits or alternatives to collection (2 and 1, respectively).
In brief, the main gaps in Italian consent forms can be divided into two groups: those involving important ethical principles and those involving important formal aspects.
The former group includes:
For these reasons the National Blood Centre, the National Transplantation Centre and the Bioethics Unit of the National Institute of Health are developing, in co-operation with the ITCBN, a standardised informed consent format for the collection, storage and allogeneic use of CB. For samples unsuitable for therapeutic use, the form includes the possibility of donating for research purposes. The aim is to provide all ITCBN banks with a common instrument for assessing the issues analysed above, even though every centre will conserve the faculty to adapt it to its specific situation.