SPECIAL REPORT
Family donor care management: principles and recommendations
SM van Walraven
1
, G Nicoloso-de Faveri
2
, UAI Axdorph-Nygell
3
, KW Douglas
4
, DA Jones
5
, SJ Lee
6
,
M Pulsipher
7
, L Ritchie
8
, J Halter
9
and BE Shaw
8,10
, on behalf of the WMDA Ethics and Clinical
working groups
1
Department of Pediatric Stem Cell Transplantation, Leiden University Medical Centre, Leiden, The Netherlands;
2
Swiss Blood Stem
Cells, Bern, Switzerland;
3
Clinical Immunology/Transfusion Medicine, Karolinska University Hospital, Stockholm, Sweden;
4
Scottish
National Blood Transfusion Service, Glasgow, UK;
5
NHS Blood and Transplant, Sheffield, UK;
6
Clinical Research Division, Fred
Hutchinson Cancer Research Centre, Seattle, WA, USA;
7
Division of Hematology/BMT, University of Utah, School of Medicine,
Salt Lake City, UT, USA;
8
Section of Haemato-Oncology, Royal Marsden NHS Foundation Trust, London, UK;
9
Division of
Hematology, University Hospital Basel, Basel, Switzerland and
10
Anthony Nolan Trust, London, UK
The World Marrow Donor Association (WMDA) is
an international organization fostering collaboration
in clinical transplantation and promoting the interests
of unrelated stem cell donors. The WMDA has developed
standards for the recruitment, counseling, work-up and
subsequent donations to protect the interests of donors.
Although the care of family donors has been carefully
considered and managed in transplant centers (TCs)
internationally over numerous years (and increasingly
TCs are facing accreditation programs, which address this
issue) there is currently a lack of standardized guidelines
for the management of family donors. The underlying
principles of family donor care are in many ways identical
to those concerning unrelated donors, although key ethical
considerations differ. Although the WMDA is primarily
involved in the field of unrelated donors, we believe that
it is important to collaborate with those involved with
family donors, to standardize the care. This document
hopes to encourage increased collaboration between those
caring for related and unrelated donors, and build on the
extensive work, which has already been undertaken in this
field to homogenize care. We recognize that there will be
financial, regulatory and logistic differences in different
countries and that the manner in which these principles are
achieved may vary.
Bone Marrow Transplantation advance online publication,
21 December 2009; doi:10.1038/bmt.2009.354
Keywords: family donors; stem cell donation; unrelated
donors; donor care management
Introduction
The dynamics of care management for hematopoietic stem
cell family donors differ substantially from unrelated donor
care, although there are overlapping aspects to both
procedures. A survey carried out by the European Group
for Blood and Marrow Transplantation (EBMT) Nurses
Group/Late Effects working party showed that at present
there is a lack of recognized standardized guidelines for the
management of family donors.
1
The World Marrow Donor
Association (WMDA) was established to foster international
collaboration to facilitate the exchange of high-quality
hematopoietic stem cells for clinical transplantation world-
wide and to promote the interests of donors.
2
In former years,
working groups of the WMDA have set up guidelines for the
recruitment, counseling, work up and informed consent
procedures, subsequent donations and transport of stem cell
products to protect volunteer stem cell donors. Since the
establishment of Bone Marrow Donors Worldwide (BMDW)
in 1989 is worldwide, over 13 million volunteers have been
registered as stem cell donors,
3
of whom over 80 000 have
actually donated stem cells for an unrelated recipient. A
substantial proportion of SCTs are also carried out with stem
cells from family donors (for example, family members of the
patient). In many countries transplantation centers (TC) are
obliged to conform to an accreditation program such as the
Joint Accreditation Committee ISCT & EBMT (JACIE) or
the Foundation for the Accreditation of Cellular Therapy.
These factors have led to demands for new guidelines for the
care management of family donors. JACIE requires written
criteria for stem cell donation to protect the donors’ safety.
Related stem cell donation presents substantial ethical
challenges, which differ from those associated with unrelated
donation. Although the WMDA is primarily involved in the
care of volunteer donors, the Ethics Working Group and the
Clinical Working Group of the WMDA determined that care
for family donors is of critical importance, and as such
formed a subcommittee to establish recommendations for this
particular group of donors. In this paper, the different steps in
the donor care process will be explained, discussed and
recommendations for family donor care will be given.Received 28 October 2009; accepted 15 November 2009
Correspondence: Dr SM van Walraven, Department for Pediatric Stem
Cell Transplantation, Willem Alexander Children & Youth Centre,
Leiden University Medical Centre, Albinusdreef 2, J6-S-221, PO Box
9600, Leiden 2300RC, The Netherlands.
E-mail: s.m.van_walraven@lumc.nl
Bone Marrow Transplantation (2009), 1–5
& 2009 Macmillan Publishers Limited All rights reserved 0268-3369/09 $32.00
www.nature.com/bmt

Donor recruitment
Traditionally, the health-care professional of the recipient
was also responsible for the donor. Although there is no
substantiating evidence, it would seem rational that from
time to time divided loyalties and conflicts of interest could
arise, more often to the disadvantage of the donor than the
recipient. To avoid these potential problems and to assure
maximal donor protection and integrity of the transplant
program, it is important that the donor is assessed
by a practitioner who is not directly involved in the
recipient’s care. The practitioner does not necessarily have
to be geographically dislocated and may even be in the
same hospital. It is important that the practitioner has an
understanding of donor rights and that they can advocate
for the donor. In some TCs, this may be achieved by
dedicated specialist personnel for donor care management,
while in others, members of the transplant team may be
identified and empowered to fulfill the donor advocate role.
As there is a need for information before consent, we
recommend donor counseling before tissue typing. In this
way any obvious reluctance to donate, or any medical
problems precluding donation, can be identified, which
will allow for deferral of unwilling or unable donors
before establishing a full HLA match. As donors may
be physically distant from the TC, an assessment and
counseling may need to be carried out by telephone or
email and it is important that good donor information,
which can supplement such discussions, should be avail-
able. Whereas volunteer donors decide for themselves
whether to join the register or not, family donors do in
fact not have the anonymous choice whether to become a
donor or not. They are directly approached with the
request for HLA compatibility typing for their relative,
often at the same time the recipient is identified as a
candidate for transplantation. Even in the case of donor
drives, volunteer donors always have the choice to join or
not whereas relatives often feel coerced by the knowledge of
a relative in need of SCT.
4
It is therefore important to give
family donors a fair chance to decide whether or not to
become a donor. A positive balance has to be found
between risks for the donor/benefit for the recipient, but
also benefit for the donor/risks for the patient, both
physically and emotionally.
5
Unrelated donors are provided with independent donor
advocacy, confidentiality and protection by the stem cell
donor registry. It is an important requirement that
unrelated donors always have a specified independent
donor advocate to discuss any doubts they have regarding
the donation procedure, and that they can make a decision
to proceed, or not, without coercion. Independent donor
assessment is equally necessary for family donors and
involvement of an independent committee or independent
counseling (psychologist, donor’s advocate) should be
considered. The role of this person is to perceive any
coercion during the information/pre donation process and
to assist the donor to overcome any barriers to donation.
This person should have knowledge of the risks and side
effects of any type of stem cell donation and transplanta-
tion outcome to fulfill this role. Despite this it has to be
accepted that by its nature, the possibility of familial
pressures/guilt in the family context will never be com-
pletely eliminated. The requirement for an independent
donor advocate has been recognized by some countries/
TCs and has been introduced by some centers. The optimal
donor advocate will have a primary role distinct from the
transplant team. Alternatively, this could be a member of
the transplant team who is identified as undertaking this
role, is trained in donor rights and who is not involved
in the care of that donor’s recipient (that is, will advocate
for the donor in an unbiased manner). TCs must have
policies for dealing with situations wherein a conflict of
interest between the family donor and others may arise.
These should include an independent advocate acting in
the interests of the family donor. It is recognized that, for
smaller TCs with limited finances and limited suitable
expertise, appointing a donor advocate may be challenging.
In these situations, adequate procedures to document and
address potential conflicts of interest are even more
important.
Children acting as donors require further consideration.
Laws and regulations governing minors acting as a donor
for a sick sibling, differ from country to country. Indeed, in
some countries a court of law now has to make the final
decision to permit a pediatric stem cell donation.
6
Further-
more, children need a special approach. Guidelines for
child donor counseling and clearance need to be separately
established. For children who cannot consent, the need
for advocacy to protect their interests is essential, especially
as a parent who is signing consent may have conflicting
feelings because of their need to be involved in decisions
concerning the welfare of both the patient and the donor.
Rarely, adult donors with severe developmental or
psychological problems rendering them mentally incapable
of informed consent are considered as stem cell donors for
a relative. These can be either donors who have always been
mentally challenged (for example, Down’s syndrome) or
donors who are suffering from a psychiatric illness. It is
advised to first establish whether the aspirant donor could
endure the donation procedure (both physically and
mentally), before performing HLA testing.
7,8
Again, some
countries have decided to enforce the rule of the law courts
to decide on suitability for donation in case of mentally
incapable donors who cannot decide for themselves.
Informed consent procedures
Volunteer donors give their (written) informed consent
when they sign up for the registry. Whenever an unrelated
donor registry receives a request for confirmatory typing
or high-resolution typing, they ask the donor yet again
for informed consent, according to the WMDA recom-
mendations.
9
Before asking for informed consent, family
donors should be informed carefully regarding risks and
benefits of and alternatives to the donation procedure.
Although TCs usually have a preference for the source
of stem cells for transplantation, volunteer donors are given
the choice whether to donate BM or stimulated PBSCs. At
present, it is unclear to what extent family donors have the
opportunity to choose between forms of donation. Ideally,
we recommend that the information procedure should be
Family donor care management
SM van Walraven et al
2
Bone Marrow Transplantation