Tumour banks: providing human tissue for cancer 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

1. Marx J. DNA arrays reveal cancer in its many forms. Science 2000; 289: 1670-1672.
2. Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic research: disclosure and informed consent. Nat Genet 1997; 15: 16-20.
3. 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.
4. Jacobsen G. Morgue chief removed over "sickening" tests. Sydney Morning Herald 2001; 19 March; 3.
5. Retention of organs after necropsy. Lancet 2001; 357: 157.
6. 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.
7. 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.
8. 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.
9. 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.

Make a comment