ment is that donors of samples have interests related to the donation and use of samples as well as to
E-mail address: Mats.Hansson@bioethics.uu.se
Stud. Hist. Phil. Biol. & Biomed. Sci. 37 (2006) 520–532
www.elsevier.com/locate/shpsc
Studies in History
and Philosophy of
Biological and
Biomedical Sciences1369-8486/$ - see front matter  2006 Elsevier Ltd. All rights reserved.the use of the results of the research, that is, new medical products and treatments. They have a role
both as donors or participants in research and as end users of the research. I conclude that if (i)
access to information acquired through biobank research is strictly limited to researchers, (ii) the
information is protected by secrecy safeguards through coding and (iii) the procedures governing
the research are open to public and democratic control, then most research using human biobanks
may be carried out on the basis of making general information available when collecting biological
samples, without further contact with participants.
 2006 Elsevier Ltd. All rights reserved.
Keywords: Biobanks; Ethics; Integrity; Informed consentCombining efficiency and concerns about
integrity when using human biobanks
Mats G. Hansson
Centre for Bioethics at Karolinska Institutet and Uppsala University,
Department of Public Health and Caring Sciences, Uppsala Science Park, SE-75185 Uppsala, Sweden
Abstract
In the debate about human bio-sampling the interests of patients and other sample donors are
believed to stand against the interests of scientists and of their freedom of research. Scientists want
efficient access to and use of human biological samples. Patients and other donors of blood or tissue
materials want protection of their integrity. This dichotomy is reflected in the Swedish law on bio-
banks, which came into effect 1 January 2003. In this article I argue that if the basic interest of sci-
entists using human biological samples is in increasing knowledge and developing better treatments,
and if the concept ‘integrity’ is properly understood, then sample donors should also be interested in
promotion of efficiency as well as in the protection of their integrity. The basic premise of this argu-doi:10.1016/j.shpsc.2006.06.006

M.G. Hansson / Stud. Hist. Phil. Biol. & Biomed. Sci. 37 (2006) 520–532 5211. The dual interests of patients and other donors of biological samples
The aim of the new Swedish Biobanks (Health Care) Act (2002:297), which came into
effect 1 January 2003, is to facilitate access to human biological material for health care
purposes and for medical research. Cell, blood and tissue samples need to be stored in
order to protect the interests of continuing diagnosis and treatment of patients. The
new law also acknowledges the need of biobanks for development of new treatment oppor-
tunities through research (Proposition 2001/02:44, pp. 18 ff., 29, 67, 70 ff.). At the same
time the Biobanks Act lays down the provisions for an appropriate protection to privacy
of individuals concerned. The law is intended to cover all samples taken and stored for
more than two months in association with health care practice. For each sample taken
an explicit and specified informed consent must be obtained and appropriately docu-
mented. The individual donor of a sample has a right to revoke his consent at a later time.
The sample must then either be destroyed or stripped of all personal identification mark-
ers. The Biobanks Act has been criticized for being compromised by inconsistencies, gen-
eral obscurities and other shortcomings (Rynning, 2003, p. 121). The strict requirement of
informed consent has had the effect that those individuals incapable of providing such a
consent—for example, incompetent adults are less protected, since the law does not allow
samples from them, to be stored. Their security with regard to diagnosis and treatment is
jeopardized. With regard to research the new Swedish Ethical Review Act (2003:460),
which came into effect 1 January 2004, assigns the task of selection of appropriate infor-
mation and consent procedures to the new ethical review boards.
It should be observed that Swedish law recognizes treatment and research interests as
well as the interests of integrity. Patients and sample donors have dual interests. They want
to be protected from illegitimate intrusions into their private lives, but they also want to
benefit from new medical diagnosis and treatment opportunities. The Swedish Federation
of County Councils has organized a comprehensive national scheme with information and
consent procedures, a common nomenclature for samples and lab reports, and common
requirements for quality assurance governing all biobanks in Sweden. The scheme is nec-
essary in order to fulfill the requirements laid down on all health care professionals by the
law, but also to ensure that human biological material is taken care of and being used in an
efficient way, with the best interest of the patient in mind. In this article I acknowledge the
fundamental concern reflected both in the Biobanks Act and by different authorities
responsible for the practical implementation of the law, that there is a dual interest of effi-
ciency and integrity that should be appropriately recognized.
For the purpose of this article I will use ‘efficiency’ in a broad and general sense. It cov-
ers efficient procedures with regard to sampling, storage and testing, as well as efficient
procedures for linking information obtained from the sample with DNA information
and information from different medical registries. It indicates also an ambition to guaran-
tee researchers and industry a favourable climate with ready access to research material
and not too many cumbersome restrictions. Excessively onerous requirements may pre-
vent the development of better treatment methods for future patients. Basically, efficiency
is related to the end, the output of the biobank practice in terms of improved opportunities
for diagnosis, treatment and health care. With this end in mind the patient donating a
sample wants health care professionals and medical researchers to be careful as well as cre-
ative concerning the means they choose for storing and testing, but he may also acknowl-edge the importance of creating biobanks as generic research resources for promoting that