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Unprecedented insights into the biology of cancer cells are coming
from research using recently developed methods such as global gene
expression analysis.1 In clinical oncology, the
benefits of these advances are likely to be significant in the
diagnostic classification of tumours and informed design of novel
anticancer agents. However, for this potential to be realised, the
molecular analysis of large numbers of tumours is required, which in
turn is dependent on the availability of collections of
well-preserved and well-characterised tumour tissue for research.
Coincident with increased need for human tissue specimens in cancer
research is the increased complexity of the attending ethical
issues. Ironically, it is the power of modern genetic analysis that
creates the most difficult ethical dilemmas. The potential for
discovering inherited genetic lesions that confer an increased risk
of developing cancer (eg, a mutation in the breast cancer
susceptibility gene BRCA1) has led to concern that "genetic
research" may uncover information that is unwanted by the patient,
has implications for family members and could potentially lead to
discrimination.2
Serious ethical questions are also raised by the involvement of
commercial interests in human-tissue-based research, in
particular relating to potential conflicts of interest and the
distribution of financial benefits.2,3 Moreover, these ethical
issues must be negotiated in the current climate of public concern
following recent media reporting on the retention of human organs
following autopsy.4,5
Cancer remains a leading cause of morbidity and mortality in our
community and the continued need for research into its nature and
treatment is undisputed. It is also clear that society's view on
involvement of individuals in all aspects of their healthcare has
changed, resulting in the expectation of a more stringent regulatory
environment for the conduct of research. This is reflected in a number
of initiatives relevant to the collection and use of human tissue. In
1999, the National Health and Medical Research Council (NHMRC)
issued updated guidelines for the conduct of ethical
research involving humans.6 The guidelines
incorporate the internationally accepted principles of
integrity, respect for persons, beneficence and justice in the
conduct of research, and reaffirm the crucial role of independent
human research ethics committees (HRECs) to review and regulate
research in specific institutions.
Recently, the necessity for legislation on these issues has been
considered, with a proposed review of the Human Tissue Act
1983 (NSW)7 and a joint inquiry into
protection of human genetic information by the Australian Law Reform
Commission and the Australian Health Ethics Committee of the
NHMRC.8
The supply of human tissue for cancer research requires an integrated
system of safeguards to protect the rights of patients, allow
research that may benefit the wider community to continue, and offer a
workable framework for hospitals, and, in particular, pathology
departments, to support the process. Increasingly, tumour banks are
emerging as an appropriate response to the concerns of involved
parties. A tumour bank is an independent facility that collects
samples of surgical specimens removed in the course of usual
treatment from cancer patients who have given informed consent for
their removal and use in research. The tissue taken is in excess of
requirements for histopathological assessment and may include both
cancer and normal tissue. The tumour bank also includes a database of
relevant demographic, clinical and follow-up
information.9
Researchers may apply to the tumour bank for samples to use in projects
that have appropriate HREC approval. The decision to supply samples
is generally made by a committee, comprised of clinicians and
scientists, on the basis of scientific merit, available resources
and the extent of collaboration with groups involved in collection of
tumour bank specimens.
The key safeguard in the conduct of ethical research is the
involvement of an HREC, and the most important issues for the HREC to
oversee in relation to a tumour bank pertain to donor consent and
privacy protection.6 The informed consent
process relating to tumour banks does not involve supply of the
specific details of research projects, as these may not be known at the
time of sample collection. The non-specific nature of this consent
needs to be taken into account by the HREC when researchers proposing
to use tumour bank specimens submit projects for review.6
The extent to which research participants are identifiable is an
important factor. Tumour banks maintain links between donor
identity and tissue samples, but supply samples to researchers
without identifying information.9 The benefits of this system
are that the privacy of donors is protected while maintaining the
capacity to collect valuable follow-up information and to recontact
donors if necessary. In the event that research studies uncovered
information that might be relevant to the wellbeing of a donor, the
HREC would play a pivotal role in consideration of the issues.
Establishment and management of a tumour bank is a long-term
commitment requiring substantial resources and secure funding.
However, these costs must be met to ensure that progress in cancer
research continues, ethical challenges posed by new investigative
technology are met and public confidence in the conduct of research is
maintained.
Rosemary L Balleine
Staff Specialist
Karen E Humphrey
Senior Tumour Bank Officer
Christine L Clarke
NHMRC Senior Research Fellow, and Department Head
Department of Translational Oncology, Westmead and Nepean
Hospitals
Westmead, NSW
rosemary_balleineATwmi.usyd.edu.au
- Marx J. DNA arrays reveal cancer in its many forms. Science
2000; 289: 1670-1672.
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Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic
research: disclosure and informed consent. Nat Genet 1997;
15: 16-20.
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Magnusson RS. The use of human tissue samples in medical research:
legal issues for human research ethics committees. J Law Med
2000; 7: 390-403.
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Jacobsen G. Morgue chief removed over "sickening" tests.
Sydney Morning Herald 2001; 19 March; 3.
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Retention of organs after necropsy. Lancet 2001; 357: 157.
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National Health and Medical Research Council. National statement
on ethical conduct in research involving humans. Commonwealth of
Australia, 1999. Available at:
<http://www.nhmrc.gov.au/publications/pdf/e35.pdf>.
Accessed 14 August 2001.
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Review of the Human Tissue Act 1983 (NSW). Discussion paper. Organ
and tissue donation and use and post mortem examination. October
1999. Available at
<http://www.health.nsw.gov.au/csd/llsb/organ/issuespaper.pdf>.
Accessed 7 August 2001.
-
Protection of human genetic information. A joint inquiry of the
Australian Law Reform Commission and Australian Health Ethics
Committee of the National Health and Medical Research Council.
Commonwealth of Australia, February 2001. Available at:
<http//:www.alrc.gov.au/current/genetic/overview.htm>.
Accessed 14 August 2001.
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Grizzle WE, Aamodt R, Clausen K, et al. Providing human tissues for
research: how to establish a program. Arch Pathol Lab Med
1998; 122: 1065-1076.
©MJA 2001
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