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(1) What is the likely fate of cord blood donations?
- In order for parents to make an informed decision about
donating their child's cord blood to the National Cord Blood Program,
they have the right to know what is the liekly disposition of their donation.
What is the likelihood that their child's stem cells will be
archived for transplant, versus the likelihood that the stem cells
will be given to a research program, or the likelihood
that the stem cells will be discarded? Will parents have any role
in deciding the disposition of their child's stem cells?
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(2) What are the criteria for cord blood storage?
- What criteria will the National Cord Blood Program use to define
a cord blood unit which is suitable to be archived for transplant?
At present, public banks reject a large fraction
of the cord blood donations they receive.
However, the majority of these rejections are based on "low" volume,
not the presence of infectious disease or contamination.
It could be argued that the smaller units are still usable,
either by in vitro cell expansion or in combination with other units,
and the volume standard should be open to reconsideration.
What procedures will be used to periodically re-evaluate storage criteria,
and who will participate in the evaluation?
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(3) What are the criteria for research donations?
- If some of the donations to the National Cord Blood Program
may be used for research, under what circumstances could that occur?
For example, would the cord blood be assigned to research only if
it is unsuitable for transplant, only if the parents
signed a release, or at the discretion of the bank?
If the parents sign a consent for research use of their child's cord blood,
how much will they be told about the nature of the research
before they give "informed consent"?
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(4) What are the standards for participating research programs?
- If the National Cord Blood Program releases some cord blood donations
to research programs, what standards will be applied to those programs?
Must they be operating an FDA-approved clinical trial?
Must they agree to publish their results in a peer-reviewed journal?
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(5) What business models will be accepted for participating banks?
- If a cord blood bank which participates in the National Cord Blood Program
is allowed to release cord blood units for research, will there be any
restrictions on the financial terms of the release?
ie: Will they be required to donate the cord blood for free,
or will they be allowed to charge a price for it?
Will participating banks be required to operate as non-profit institutions?
Specifically, will the national program allow the participation of for-profit
donor banks, which look to maximize their income from blood sales,
and thus to sell as many units as possible and/or
charge as much per unit as possible?
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(6) What level of education will constitute "Informed Consent" of the donor family?
- When parents are recruited to donate to the National Cord Blood Program,
what educational material and counseling will be provided to them?
How late in gestation or labor may the family be approached with an appeal to donate?
Will the National Cord Blood Program require uniformity of educational materials
and legal consent forms across all participating banks?
Will banks that focus on donation be required to provide completely unbiased information,
and inform parents of the option to privately store cord blood for autologous or family use?
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(7) How will the program ensure that the donor recruitment process
is equitable for, and inclusive of, all families?
- What effort will be made to ensure that the recruitment of donors for the
National Cord Blood Program provides a comparable level of Informed Consent
to all donor populations,
regardless of educational level, ethnic background, or native language?
Given the great need to diversify the existing pool of blood cell donors, and the
recognition that cord blood is valuable for this purpose, it is particularly
important to ensure that the National Cord Blood Program exercises
high standards of cultural competency at all levels of operations.
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(8) What record of donor identity will be preserved by the bank?
- At present, public cord blood banks do not have a provision to
connect back a donated cord blood unit to the donor from which it came.
The anonymous storage of donated cord blood is contrary to the standard practices
in unrelated blood, marrow, and organ donation, where donor identity is preserved
and kept confidential.
The National Cord Blood Program should apply the same standards that
are currently used to preserve and safeguard the identity of unrelated donors
of blood, marrow, and solid organs. These procedures are already in compliance
with federal laws regarding privacy of medical information.
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(9) Will donor families be able to access their own donation in the future?
- In the event that a close relative of the donor develops a disease
treatable by transplant, what provision will be made so that
donor families can retrieve their child's cord blood from the
National Cord Blood Program, if it has not yet been used?
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(10) Will cord blood donors be given any special considerations?
- What compensation, if any, will donor families receive if they
donate their child's cord blood to the National Cord Blood Program,
and later have a medical need for the stem cells, but can no longer
retrieve their child's cord blood unit?
Should donors to the National Cord Blood Program be accorded higher priority
in the allocation of cord blood units for transplant?
For example, it is current practice in the United States to give
living organ donors priority if they later need a transplant.
Will special considerations be extended to close relations of the donor?
Should donors to the National Cord Blood Program be given financial assistance,
in the event that they need a stem cell transplant?
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(11) Will donor status change when a cord blood donor becomes an adult?
- Medical research suggests that cryogenically preserved
cord blood has a shelf life of decades.
After 18 years have passed, the cord blood donor will be a legal adult.
At that time, if the stored cord blood is a perfect match for a transplant patient,
the ability to locate the living donor would give the patient
additional transplant options (eg., bone marrow, peripheral blood cells, etc.)
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(12) Are there any provisions to track the health of cord blood donors?
- If, during the testing of donated cord blood, it is discovered
that the baby and/or parent(s) has a previously undiagnosed condition,
what is the responsibility of the National Cord Blood Program
to inform the donor family?
Does the program have any responsibility to help the family arrange for treatment?
Would this responsiblity extend years out, if a new diagnostic test discovers
a condition in cord blood that is being readied for transplant?
Conversely, what is the responsibility of the donor to inform the
National Cord Blood Program upon being diagnosed as a carrier
of an inherited disorder? For example, the European Union requires donors
to inform their bank of such a diagnosis. Again, new markers
for inherited disorders may be discovered years after the original donation.
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(13) What could happen to the archived cord blood if there is little demand for transplants?
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The main premise for the establishment of the National Cord Blood Program
is that large numbers of cancer patients cannot find matching blood and marrow donors.
If and when targeted cancer therapies become so effective that cancer patients
no longer need stem cell transplants, then the choice between
bone marrow and cord blood will be a moot point.
At that time, we can stop recruiting blood and marrow transplant donors.
But what would happen to cord blood that is already cryogenically archived?
Apart from cancer therapy, in the future there will probably be a high
demand for stem cells for regenerative medicine. Because stored cord blood
has a long shelf life, the National Cord Blood Program must consider how the medical
demand for cord blood may evolve over time. While it may be impossible to
predict future medical research, it is possible to draft the legal and
ethical protections for donor rights in such a way as to cover future
circumstances.
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(14) What could happen to the archived cord blood if the National Cord Blood Program
runs out of money?
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If the National Cord Blood Program is financially constructed to be
self-supporting, based on the price charged when units are released for transplant
and the frequency of transplants, then a drastic drop in transplantation rates could
undermine the financial viability of the program.
Even if the National Cord Blood Program is federally funded, its fiscal allocations
could drop as national priorities change.
Yet, the ongoing maintenance of cryogenic storage carries baseline costs.
Are there any provisions for the disposal of the cord blood archives, in the
event that the National Cord Blood Program does not have enough funding to maintain them?
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