ARTICLE
Potential harms, anonymization, and the right
to withdraw consent to biobank research
Stefan Eriksson*,1 and Gert Helgesson1
1Centre for Bioethics at Karolinska Institutet and Uppsala University, Uppsala Science Park, SE-751 85 Uppsala,
Sweden
This paper discusses the potential harms involved in biobank research and how ethical review, informed
consent, withdrawals, and anonymization of samples should be handled in the light of these harms. There
is less risk involved in biobank research than in human subject research; it should therefore be treated
differently. In our view, anonymization should not be an automatically permissible response to requests for
withdrawal. Nor should a request for withdrawal necessarily stop research on identifiable samples. Apart
from not being particularly appropriate for protecting the interests of individuals, anonymization of
samples has a negative impact on research. We suggest that the current view on withdrawal from research,
supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context
of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach
requires those wishing to withdraw their samples from research to present sufficient reason for doing so.
Our interpretation of ‘sufficient reason’ includes all those involving genuine, deeply felt concerns that are
not based on misconceptions. Still, this underlines the fact that we all share a responsibility for health
research and that no one should take withdrawal from biobank research lightly.
European Journal of Human Genetics (2005) 13, 1071–1076. doi:10.1038/sj.ejhg.5201458;
published online 29 June 2005
Keywords: anonymization; biobank research; harm; informed consent; Nuremberg Code; withdrawal of
consent
Introduction
Risks involved in biobank1 research have been widely
discussed lately. New ethical guidelines have been intro-
duced in order to protect sample donors from harm.2 – 5
New legal regulations have been enacted in, for example,
Iceland, Norway, Sweden, and the UK. Other European
countries, for instance Finland, have adjusted previous
legislation to also cover research on archived biological
material. However, further analysis is needed to clarify
what negative effects biobank research may have and what
recommendations regarding ethical review, informed con-
sent, and procedures for the storage and use of biobank
samples are needed in order to counter or reduce these
risks. Part of such an analysis will be undertaken in this
paper.
A presumption in much of the debate, reflected in legal
regulations and ethical guidelines, is that potential pro-
blems connected with biobank research are related to the
harm that may arise if sensitive personal information ends
up in the wrong hands. When participants wish to
withdraw from a study, de-identification of samples and
data (making them unlinkable to specific individuals) has
therefore been considered a satisfactory solution. On the
contrary, we argue that anonymization should not be an
automatically permissible response to requests for with-
drawal; nor should a request for withdrawal necessarily
stop research on identifiable samples. Apart from not being
particularly appropriate for protecting the interests of
Received 4 March 2005; revised 18 May 2005; accepted 24 May 2005;
published online 29 June 2005
*Correspondence: Dr S Eriksson, Centre for Bioethics at Karolinska
Institutet and Uppsala University, Uppsala Science Park, SE-751 85
Uppsala, Sweden. Tel: þ 46 18 611 22 87; Fax: þ 46 18 50 64 04;
E-mail: Stefan.Eriksson@bioethics.uu.se
European Journal of Human Genetics (2005) 13, 1071–1076
& 2005 Nature Publishing Group All rights reserved 1018-4813/05 $30.00
www.nature.com/ejhg

individuals, anonymization of samples has a negative
impact on research. We suggest that the current view on
withdrawal from research be abandoned in the context of
biobank research and be replaced by an approach inspired
by the Nuremberg Code.
Risks of harm related to biobank research
There is a certain risk of physical harm connected to the
taking of samples, the amplitude depending on the kind of
sample and physical state of the sample donor. Storing a
sample in a biobank or using it for research, however,
involves no risk of direct physical harm. As recognized by the
German Nationaler Ethikrat, bodily risks are precluded
from the outset because the samples used for research have
already been separated from the body.4 In this respect,
there is a difference between biobank research and research
conducted directly on humans. This has often been
overlooked in policy work. Thus, the Declaration of
Helsinki states that medical research involving human
subjects ‘includes research on identifiable human material
or identifiable data’ and makes no distinction between
research of the latter kind and experimental research when
it comes to requirements regarding information and
consent. For instance, according to the declaration, every
research subject has the right to withdraw consent to
participate at any time without reprisal, regardless of
whether the research is conducted on their bodies or on
their stored biological samples.5
Although there is no risk of direct physical harm
involved in biobank research, there is a palpable risk of
indirect physical harm. Most samples are originally collected
in a clinical setting and may turn out to be important for
the future care of the patients. If researchers are granted
unrestricted access, samples may be exhausted completely
or become too sparse for future purposes of care, having
possible negative effects on some participants’ physical
health.
Biobank research may also involve a risk of various forms
of nonphysical harm. Nonphysical harm is usually tied to
sensitive information ending up in the wrong hands and
being used to the disadvantage of a person. This informa-
tion may be either extracted from the samples or tied to
them. As long as safety routines for the biobank and the
data collected therein are satisfactory, informational risk
does exist but is small. The inflicted harm may be social,
psychological, or economical.
For instance, it has been argued that insurance compa-
nies and employers could come to use genetic information
to discriminate against people with certain genetic dis-
positions. This would likely damage the individuals
concerned, both economically and socially.6 When facts
one would like to keep secret (eg regarding paternity or
STDs) are communicated to relatives or partners against
one’s wishes, psychological harm may arise.7 Psychological
harm can also occur, for instance, when patients wrongly
form the belief that there will be personal gain from
participation in research (the ‘therapeutic misconcep-
tion’8). When such expectations are not met, feelings of
anger or hopelessness can result. Much other potential
nonphysical harm is easily imagined in the form of, for
instance, stigmatization and discrimination at work as well
as anxiety and disturbed relationships with spouses,
children, relatives, and friends.
Not all risks of harm are related to specific individuals.9
Samples used in biobank research may harm the group to
which a participant belongs, and thereby harm the
individuals concerned. This harm may arise, for instance,
if people outside the group regard the group in a more
negative way or treat people belonging to that group in a
worse way than others, or by prejudice being spread or
strengthened. The harm may also be due to people in the
group starting to look at themselves in a different, more
negative, way.
Thus, a distinction can be made between external and
internal harm to groups of people. External harm is
connected to factors external to the group, such as changes
in attitudes regarding the group. Such changes can cause
economic harm, for instance more expensive insurance for
group members due to expectations about their behaviour.
Internal harm, on the other hand, is related to internal
changes resulting from the spread of information from
biobank research. Loss of self-esteem is an example of
internal harm, decline in social functions and bonds
another.
Moral harms
The types of harms discussed so far do not exhaust the
possible negative effects of biobank research. Apart from
harming participants, as mentioned above, one may wrong
them by storing or using their samples. In other words, one
may treat an individual in an illegitimate way even if they
are not exposed to any risk of physical, psychological,
social or economic harm. We call this ‘moral harm’. It
should be clear that the category of wrongs is relevant to
the ethics of biobank research.
What kinds of wrongs are there in relation to the storage
and use of biobank samples? In connection to medical
research, as well as the procedures of informed consent
usually treated as absolutely essential to ethically accep-
table research, autonomy, privacy, and personal integrity are
central values at stake. The term autonomy has been used in
different ways. We take it to mean self-governance (self-
determination); that is, deciding for oneself and acting on
these decisions regarding matters affecting one’s own life,
without interference from others. Respecting someone’s
autonomy is respecting that person’s right to decide and
Anonymization and withdrawal from biobank research
S Eriksson and G Helgesson
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European Journal of Human Genetics