SIXTY-THIRD WORLD HEALTH ASSEMBLY
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WHA63.22
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Agenda
item 11.21
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21 May
2010
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The Sixty-third
World Health Assembly,
Recalling
resolutions WHA40.13, WHA42.5 and WHA44.25 on organ procurement and
transplantation and WHA57.18 requesting an update of the Guiding Principles on
Human Organ Transplantation;
Aware of the
growing magnitude and utility of human cell, tissue and organ transplantation
for a wide range of conditions in low-resource as well as high-resource
countries;
Committed to the
principles of human dignity and solidarity which condemn the buying of human
body parts for transplantation and the exploitation of the poorest and most
vulnerable populations and the human trafficking that result from such
practices;
Determined to
prevent harm caused by the seeking of financial gain or comparable advantage in
transactions involving human body parts, including organ trafficking and
transplant tourism;
Convinced that
the voluntary, non-remunerated donation of organs, cells and tissues from
deceased and living donors helps to ensure a vital community resource;
Sensitive to the
need for post-transplantation surveillance of adverse events and reactions
associated with the donation, including long-term follow up of the living
donor, processing and transplantation of human cells, tissues and organs as
such and for international exchange of such data to optimize the safety and
efficacy of transplantation,
1. ENDORSES the
WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation;
(1)
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to implement the Guiding Principles on Human Cell, Tissue and Organ
Transplantation in
the formulation and enforcement of their own policies, laws and legislation
regarding human
cell, tissue and organ donation and transplantation where appropriate;
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(2)
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to promote the development of systems for the altruistic voluntary
non-remunerated
donation of cells, tissues and organs as such, and increase public awareness
and understanding
of the benefits as a result of the voluntary non-remunerated provision of
cells, tissues and
organs as such from deceased and living donors, in contrast to the physical,
psychological and
social risks to individuals and communities caused by trafficking in material
of human origin
and transplant tourism;
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(3)
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to oppose the seeking of financial gain or comparable advantage in
transactions involving
human body parts, organ trafficking and transplant tourism, including by
encouraging healthcare
professionals to notify relevant authorities when they become aware of such
practices in
accordance with national capacities and legislation;
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(4)
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to promote a system of transparent, equitable allocation of organs, cells
and tissues,
guided by clinical criteria and ethical norms, as well as equitable access to
transplantation
services in accordance with national capacities, which provides the
foundation for public
support of voluntary donation;
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(5)
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to improve the safety and efficacy of donation and transplantation by
promoting
international best practices;
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(6)
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to strengthen national and multinational authorities and/or capacities to
provide oversight,
organization and coordination of donation and transplantation activities,
with special attention
to maximizing donation from deceased donors and to protecting the health and
welfare of living
donors with appropriate health-care services and long-term follow up;
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(7)
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to collaborate in collecting data including adverse events and reactions
on the practices,
safety, quality, efficacy, epidemiology and ethics of donation and transplantation;
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(8)
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to encourage the implementation of globally consistent coding systems for
human cells,
tissues and organs as such in order to facilitate national and international
traceability of
materials of human origin for transplantation;
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(1)
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to disseminate the updated Guiding Principles on Human Cell, Tissue and
Organ
Transplantation as widely as possible to all interested parties;
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(2)
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to provide support to Member States and nongovernmental organizations in order
to ban
trafficking in material of human origin and transplant tourism;
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(3)
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to continue collecting and analysing global data on the practices,
safety, quality, efficacy,
epidemiology and ethics of donation and transplantation of human cells,
tissues and organs;
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(4)
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to facilitate Member States’ access to appropriate information on the
donation, processing
and transplantation of human cells, tissues and organs, including data on
severe adverse events
and reactions;
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(5)
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to provide, in response to requests from Member States, technical support
for developing
national legislation and regulation on, and suitable and traceable coding
systems for, donation
and transplantation of human cells, tissues or organs, in particular by
facilitating international
cooperation;
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(6)
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to review the Guiding Principles on Human Cell, Tissue and Organ
Transplantation
periodically in the light of national experience with their implementation
and of developments
in the field of transplantation of human cells, tissues and organs;
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(7)
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to report to the Health Assembly, through the Executive Board, at least
every four years
on actions taken by the Secretariat, as well as by Member States, to
implement this resolution.
Eighth
plenary meeting, 21 May 2010
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WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN
TRANSPLANTATION1
PREAMBLE
1. As the Director-General’s report to the Executive Board at its Seventy-ninth
session pointed out, human organ transplantation began with a
series of experimental studies at the beginning of the
twentieth century. The report drew attention to some of the major
clinical and scientific advances in the field since Alexis
Carrel was awarded the Nobel Prize in 1912 for his pioneering work.
Surgical transplantation of human organs from deceased, as well
as living, donors to sick and dying patients began after the
Second World War. Over the past 50 years, the transplantation of human
organs, tissues and cells has become a worldwide practice
which has extended, and greatly enhanced the quality of,
hundreds of thousands of lives. Continuous improvements in medical
technology, particularly in relation to organ and tissue
rejection, have led to an increase in the demand for organs and
tissues, which has always exceeded supply despite substantial
expansion in deceased organ donation as well as greater
reliance on donation from living persons in recent years.
2. The shortage of available organs has not only prompted many
countries to develop procedures and systems to increase supply
but has also stimulated commercial traffic in human organs,
particularly from living donors who are unrelated to recipients.
The evidence of such commerce, along with the related traffic
in human beings, has become clearer in recent decades. Moreover, the
growing ease of international communication and travel has led
many patients to travel abroad to medical centres that
advertise their ability to perform transplants and to supply donor
organs for a single, inclusive charge.
3. Resolutions
WHA40.13 and WHA42.5 first expressed the Health Assembly’s concern
over commercial trade in organs and the need for global
standards for transplantation. Based on a process of
consultation undertaken by the Secretariat, the Health Assembly then
endorsed the WHO Guiding Principles on Human Organ
Transplantation in resolution WHA44.25. Over the past 17 years the
Guiding Principles have greatly influenced professional codes and
practices as well as legislation around the world. In the
light of changes in practices and attitudes regarding organ and
tissue transplantation, the Fifty-seventh World Health
Assembly in resolution WHA57.18 requested the
Director-General, inter alia, “to continue examining and collecting
global data on the practices, safety, quality, efficacy and
epidemiology of allogeneic transplantation and on ethical issues,
including living donation, in order to update the Guiding
Principles on Human Organ Transplantation”.
4. The
following Guiding Principles are intended to provide an orderly,
ethical and acceptable framework for the acquisition and
transplantation of human cells, tissues and organs for therapeutic
purposes. Each jurisdiction will determine the means of
implementing the Guiding Principles. They preserve the essential
points of the 1991 version while incorporating new provisions in
response to current trends in transplantation, particularly
organ transplants from living donors and the increasing use of
human cells and tissues. The Guiding Principles do not apply to
transplantation of gametes, ovarian or testicular tissue, or
embryos for reproductive purposes, or to blood or blood constituents
collected for transfusion purposes.
Cells,
tissues and organs may be removed from deceased and living persons
for the purpose of transplantation, only in accordance with the
following Guiding Principles.
1As
endorsed by the sixty-third World Health Assembly in May 2010, in
Resolution WHA63.22
Guiding Principle 1
Cells, tissues and organs may be removed from the
bodies of deceased persons for the purpose of transplantation if:
(a) any consent required by law is obtained, and
(b) there
is no reason to believe that the deceased person objected to such
removal.
Commentary on Guiding Principle 1
Consent
is the ethical cornerstone of all medical interventions. National
authorities are responsible for defining the process of obtaining
and recording consent for cell, tissue and organ donation in the
light of international ethical standards, the manner in which
organ procurement is organized in their country, and the practical
role of consent as a safeguard against abuses and safety breaches.
Whether consent to procure organs and tissues from deceased
persons is “explicit” or “presumed” depends upon each country’s
social, medical and cultural traditions, including the manner in
which families are involved in decision-making about health care
generally. Under both systems any valid indication of deceased
persons’ opposition to posthumous removal of their cells, tissues or
organs will prevent such removal.
Under a regime of
explicit consent – sometimes referred to as “opting in” – cells,
tissues or organs may be removed from a deceased person if the
person had expressly consented to such removal during his or her
lifetime; depending upon domestic law, such consent may be made
orally or recorded on a donor card, driver’s license or identity
card or in the medical record or a donor registry. When the deceased
has neither consented nor clearly expressed opposition to organ
removal, permission should be obtained from a legally specified
surrogate, usually a family member.
The alternative, presumed
consent system – termed “opting (or contracting) out” – permits
material to be removed from the body of a deceased person for
transplantation and, in some countries, for anatomical study or
research, unless the person had expressed his or her opposition
before death by filing an objection with an identified office, or
an informed party reports that the deceased definitely voiced an
objection to donation. Given the ethical importance of consent, such
a system should ensure that people are fully informed about the
policy and are provided with an easy means to opt out. Although
expressed consent is not required in an opting-out system before
removal of the cells, tissues or organs of a deceased person who
had not objected while still alive, procurement programmes may be
reluctant to proceed if the relatives personally oppose the
donation; likewise, in opting-in systems, programmes typically
seek permission from the family even when the deceased gave
pre-mortem consent. Programmes are more able to rely on the
deceased’s explicit or presumed consent, without seeking further
permission from family members, when the public’s understanding and
acceptance of the process of donating cells, tissues and organs is
deep-seated and unambiguous. Even when permission is not sought
from relatives, donor programmes need to review the deceased’s medical
and behavioural history with family members who knew him or her
well, since accurate information about donors helps to increase
the safety of transplantation.
For tissue donation, which
entails slightly less challenging time constraints, it is recommended
always to seek the approval of the next of kin. An important
point to be addressed is the manner in which the appearance of
the deceased’s body will be restored after the tissues are removed.
Guiding Principle 2
Physicians determining that a
potential donor has died should not be directly involved in cell,
tissue or organ removal from the donor or subsequent
transplantation procedures; nor should they be responsible for
the care of any intended recipient of such cells, tissues and organs.
Physicians determining that a potential
donor has died should not be directly involved in cell, tissue or
organ removal from the donor or subsequent transplantation
procedures; nor should they be responsible for the care of any
intended recipient of such cells, tissues and organs.
Commentary
on Guiding Principle 2
This Principle is designed to avoid
the conflict of interest that would arise were the physician or
physicians determining the death of a potential donor to be
responsible in addition for the care of other patients whose
welfare depended on cells, tissues or organs transplanted from that
donor. National authorities will set out the legal standards for
determining that death has occurred and specify how the criteria
and process for determining death will be formulated and applied.
Guiding Principle 3
Donation from
deceased persons should be developed to its maximum therapeutic
potential, but adult living persons may donate organs as
permitted by domestic regulations. In general living donors
should be genetically, legally or emotionally related to their
recipients.
Live donations are acceptable when the donor’s
informed and voluntary consent is obtained, when professional care
of donors is ensured and follow-up is well organized, and when
selection criteria for donors are scrupulously applied and
monitored. Live donors should be informed of the probable risks,
benefits and consequences of donation in a complete and understandable
fashion; they should be legally competent and capable of
weighing the information; and they should be acting willingly, free
of any undue influence or coercion.
Commentary on
Guiding Principle 3
The Principle emphasizes the importance
both of taking the legal and logistical steps needed to develop
deceased donor programmes where these do not exist and of making
existing programmes as effective and efficient as possible.
While favouring the maximal development of transplant programmes
that avoid the inherent risks to live donors, the Principle also
sets forth basic conditions for live donation. A genetic relationship
between donor and recipient may be therapeutically advantageous
and can provide reassurance that the donor is motivated by
genuine concern for the recipient, as can a legal relationship (such
as that between spouses). Many altruistic donations also originate
from emotionally related donors, though the strength of a
claimed connection may be difficult to evaluate. Donations by
unrelated donors have been a source of concern, though some such
cases are unexceptionable, such as in hematopoietic stem cell
transplantation (where a wide donor pool is therapeutically
advisable) or when an exchange of kidneys is made because the
donors are not immunologically well matched with the recipients to
whom they are related.
With live donation, particularly
by unrelated donors, psychosocial evaluation is needed to guard
against coercion of the donor or the commercialism banned by
Principle 5. The national health authority should ensure that the
evaluation is carried out by an appropriately qualified, independent
party. By assessing the donor’s motivation and the donor’s and
recipient’s expectations regarding outcomes, such evaluations may
help identify – and avert – donations that are forced or are
actually paid transactions.
The Principle underscores the
necessity of genuine and well-informed choice, which requires full,
objective, and locally relevant information and excludes
vulnerable persons who are incapable of fulfilling the
requirements for voluntary and knowledgeable consent. Voluntary
consent also implies that adequate provisions exist for
withdrawal of consent up until medical interventions on the recipient
have reached the point where the recipient would be in acute
danger if the transplant did not proceed. This should be
communicated at the time of consent.
Finally, this Principle
stresses the importance of protecting the health of living donors
during the process of selection, donation, and necessary aftercare
to ensure that the potential untoward consequences of the
donation are unlikely to disadvantage the remainder of the donor’s
life. Care for the donor should match care for the recipient, and
health authorities have the same responsibility for the welfare
of both.
Guiding Principle 4
No
cells, tissues or organs should be removed from the body of a living
minor for the purpose of transplantation other than narrow
exceptions allowed under national law. Specific measures should be
in place to protect the minor and, wherever possible the minor’s
assent should be obtained before donation. What is applicable to
minors also applies to any legally incompetent person.
Commentary
on Guiding Principle 4
This Principle states a general
prohibition on the removal of cells, tissues or organs from legal
minors for transplantation. The major exceptions that may be
authorized are familial donation of regenerative cells (when a
therapeutically comparable adult donor is not available) and kidney
transplants between identical twins (where avoiding
immunosuppression represents a benefit to the recipient adequate to
justify the exception, in the absence of a genetic disorder that
could adversely affect the donor in the future).
While the
permission of the parent(s) or the legal guardian for organ removal
is usually sufficient, they may have a conflict of interest if
they are responsible for the welfare of the intended recipient. In
such cases, review and approval by an independent body, such as a
court or other competent authority, should be required. In any
event, a minor’s objection to making a donation should prevail over
the permission provided by any other party. The professional
counselling provided to potential living donors in order to
assess, and when needed, address any pressure in the decision to
donate, is especially important for minor donors.
Guiding
Principle 5
Cells, tissues and organs should
only be donated freely, without any monetary payment or other
reward of monetary value. Purchasing, or offering to purchase, cells,
tissues or organs for transplantation, or their sale by living
persons or by the next of kin for deceased persons, should be
banned.
The prohibition on sale or purchase of cells, tissues
and organs does not preclude reimbursing reasonable and verifiable
expenses incurred by the donor, including loss of income, or paying
the costs of recovering, processing, preserving and supplying
human cells, tissues or organs for transplantation.
Commentary
on Guiding Principle 5
Payment for cells, tissues and
organs is likely to take unfair advantage of the poorest and most
vulnerable groups, undermines altruistic donation, and leads to
profiteering and human trafficking. Such payment conveys the idea
that some persons lack dignity, that they are mere objects to be
used by others.
Besides preventing trafficking in human
materials, this Principle aims to affirm the special merit of
donating human materials to save and enhance life. However, it allows
for circumstances where it is customary to provide donors with
tokens of gratitude that cannot be assigned a value in monetary
terms. National law should ensure that any gifts or rewards are not,
in fact, disguised forms of payment for donated cells, tissues or
organs. Incentives in the form of “rewards” with monetary value that
can be transferred to third parties are not different from
monetary payments.
While the worst abuses involve living
organ donors, dangers also arise when payments for cells, tissues
and organs are made to next of kin of deceased persons, to vendors
or brokers, or to institutions (such as mortuaries) having charge
of dead bodies. Financial returns to such parties should be
forbidden. This Principle permits compensation for the costs of
making donations (including medical expenses and lost earnings
for live donors), lest they operate as a disincentive to donation.
The need to cover legitimate costs of procurement and of ensuring
the safety, quality and efficacy of human cell and tissue
products and organs for transplantation is also accepted as long as
the human body and its parts as such are not a source of
financial gain.
Incentives that encompass essential items which
donors would otherwise be unable to afford, such as medical care
or health insurance coverage, raise concerns. Access to the highest
attainable standard of health is a fundamental right, not
something to be purchased in exchange for body parts. However, free
periodic medical assessments related to the donation and insurance
for death or complications that arise from the donation may
legitimately be provided to living donors.
Health
authorities should promote donation motivated by the need of the
recipient and the benefit for the community. Any measures to
encourage donation should respect the dignity of the donor and foster
societal recognition of the altruistic nature of cell, tissue and
organ donation. In any event, all practices to encourage the
procurement of cells, tissues and organs for transplantation should be
defined explicitly by health authorities in a transparent
fashion.
National legal frameworks should address each
country’s particular circumstances because the risks to donors and
recipients vary. Each jurisdiction will determine the details and
method of the prohibitions it will use, including sanctions which
may encompass joint action with other countries in the region.
The ban on paying for cells, tissues and organs should apply to all
individuals, including transplant recipients who attempt to
circumvent domestic regulations by travelling to locales where
prohibitions on commercialization are not enforced.
Guiding
Principle 6
Promotion of altruistic
donation of human cells, tissues or organs by means of advertisement
or public appeal may be undertaken in accordance with domestic
regulation.
Advertising the need for or availability of cells,
tissues or organs, with a view to offering or seeking payment to
individuals for their cells, tissues or organs, or, to the next of
kin, where the individual is deceased, should be prohibited.
Brokering that involves payment to such individuals or to third
parties should also be prohibited.
Commentary on
Guiding Principle 6
This Principle does not affect general
advertisements or public appeals to encourage altruistic donation
of human cells, tissues or organs, provided that they do not subvert
legally established systems of organ allocation. Instead, it
aims to prohibit commercial solicitations, which include offering to
pay individuals, the next of kin of deceased persons, or other
parties in possession (such as undertakers), for cells, tissues
or organs; it targets brokers and other intermediaries as well as
direct purchasers.
Guiding Principle 7
Physicians
and other health professionals should not engage in transplantation
procedures, and health insurers and other payers should not cover
such procedures, if the cells, tissues or organs concerned have
been obtained through exploitation or coercion of, or payment to, the
donor or the next of kin of a deceased donor.
Commentary
on Guiding Principle 7
Health care professionals should only
proceed with the removal, intermediate management or implantation
of cells, tissues or organs when donations are unpaid and truly
voluntary. (In the case of live donors, a psychosocial evaluation
of the donor is usually indicated, as described in Guiding
Principle 3). Failing to ensure that the person consenting to the
donation has not been paid, coerced or exploited breaches
professional obligations and should be sanctioned by the relevant
professional organizations and government licensing or regulatory
authorities.
Physicians and health care facilities should
also not refer patients to transplant facilities in their own or
other countries that make use of cells, tissues or organs obtained
through payments to donors, their families or other vendors or
brokers; nor may they seek or accept payment for doing so.
Post-transplant care may be provided to patients who have
undergone transplantation at such facilities, but physicians who
decline to provide such care should not face professional sanctions
for such refusals, provided that they refer such patients
elsewhere.
Health insurers and other payers should reinforce
adherence to high ethical standards by refusing to pay for
transplants that violate the Guiding Principles.
Guiding
Principle 8
All health care facilities and
professionals involved in cell, tissue or organ procurement and
transplantation procedures should be prohibited from receiving any
payment that exceeds the justifiable fee for the services rendered.
Commentary on Guiding Principle 8
This provision
reinforces Guiding Principles 5 and 7 by forbidding profiteering in
cell, tissue and organ recovery and implantation. Health
authorities should monitor the fees charged for transplantation
services to ensure that they are not disguised charges for the cells,
tissues or organs themselves. All persons and facilities
involved should be accountable for all payments for transplantation
services. A medical or other health care practitioner uncertain
whether a fee is justifiable should seek the opinion of an
appropriate licensing or disciplinary authority before proposing or
levying the fee. Fees charged for similar services may be used as a
reference.
Guiding Principle 9
The
allocation of organs, cells and tissues should be guided by clinical
criteria and ethical norms, not financial or other
considerations. Allocation rules, defined by appropriately
constituted committees, should be equitable, externally justified,
and transparent.
Commentary on Guiding Principle 9
Where donation rates do not meet clinical demand, allocation
criteria should be defined at national or subregional level by a
committee that includes experts in the relevant medical specialties,
bioethics and public health. Such multidisciplinarity is important
to ensure that allocation takes into account not only medical
factors but also community values and general ethical rules. The
criteria for distributing cells, tissues and organs should accord
with human rights and, in particular, should not be based on a
recipient’s gender, race, religion, or economic condition.
This
principle implies that the cost of transplantation and follow-up,
including immunosuppressive treatment where applicable, should be
affordable to all patients concerned — that is, no recipient
should be excluded solely for financial reasons.
The concept
of transparency is not exclusive to the allocation process but is
central to all aspects of transplantation (as is discussed in the
commentary on Guiding Principle 11, below).
Guiding Principle
10
High-quality, safe and efficacious
procedures are essential for donors and recipients alike. The
longterm outcomes of cell, tissue and organ donation and
transplantation should be assessed for the living donor as well
as the recipient in order to document benefit and harm.
The
level of safety, efficacy and quality of human cells, tissues and
organs for transplantation, as health products of an
exceptional nature, must be maintained and optimized on an ongoing
basis. This requires implementation of quality systems including
traceability and vigilance, with adverse events and reactions
reported, both nationally and for exported human products.
Commentary on Guiding Principle 10
Optimizing the
outcome of cell, tissue and organ transplantation entails a
rules-based process that encompasses clinical interventions and ex
vivo procedures from donor selection through long-term
follow-up. Under the oversight of national health authorities,
transplant programmes should monitor both donors and recipients
to ensure that they receive appropriate care, including information
regarding the transplantation team responsible for their care.
Evaluation of information regarding the long-term risks and
benefits is essential to the consent process and for adequately
balancing the interests of donors as well as recipients. The benefits
to both must outweigh the risks associated with the donation and
transplantation. Donors should not be permitted to donate in
clinically hopeless situations.
Donation and transplant
programmes are encouraged to participate in national and/or
international transplant registries. All deviations from accepted
processes that could elevate the risk to recipients or donors, as
well as any untoward consequences of donation or transplantation,
should be reported to and analysed by responsible health
authorities.
Transplantation of human material which does not
involve maintenance treatment may not require active, long-term
follow-up, though traceability should be ensured for the anticipated
lifetime of the donor and the recipient. Internationally agreed
means of coding to identify tissues and cells used in
transplantation are essential for full traceability.
Guiding
Principle 11
The organization and execution
of donation and transplantation activities, as well as their clinical
results, must be transparent and open to scrutiny, while
ensuring that the personal anonymity and privacy of donors and
recipients are always protected.
Commentary on Guiding
Principle 11
Transparency can be summarized as maintaining
public access to regularly updated comprehensive data on
processes, in particular allocation, transplant activities and
outcomes for both recipients and living donors, as well as data
on organization, budgets and funding. Such transparency is not
inconsistent with shielding from public access information that could
identify individual donors or recipients while still respecting
the necessity of traceability recognized in Principle 10. The
objective of the system should be not only to maximize the
availability of data for scholarly study and governmental
oversight but also to identify risks – and facilitate their
correction – in order to minimize harm to donors or recipients.
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