Meeting Report (Lisa Devereux)
Australian Institute of Health Law and Ethics:
“TISSUE OWNERSHIP: IMPLICATIONS FOR POLICY, PRIVACY AND
Royal Adelaide Hospital for Women and Children
May 31st, 2005
This document is a collection of notes taken at the 2005 AIHLE conference, and is
not necessary an accurate description of proceedings. For more information, please
contact Lisa Devereux at Lisa.Devereux@petermac.org .
1. Are ‘Genetic’ samples a Special Case? Loane Skene, University Melb. Law
Examine the nature of genetic samples and the relationship between genetic samples
and genetic information
Evaluate arguments about the ‘special’ characteristics of genetic samples/information
and ‘genetic essentialism/exceptionalism’ viewpoints as well as the counter
Explore what protection genetic samples currently do/should have.
-Genetic information is ‘familial’ so need to acknowledge that we are treating
families, not just the individual. E.g. in Familial Adenomatous Polyposis the record
keeping is held in families.
-Ownership rights are ‘bundled’ rights: *access to tissue with respect to mutation
*bequeath property to ‘son’
*share in profits
*negligence cases (medical)
*theft of tissue (can hospital claim on property insurance)
*fire (can claim be made by hospital on insurance policy)
England/Australia- no-one owns a corpse. Proprietary right is held by executor for
the purposes of securing the body for burial (public hygiene and respect for dead).
Tissue was considered ‘property’ for purposes of access for paternity testing, Roche v
Douglas (2000) WASC 146. Court didn’t say who owned the tissue only that it was
-‘State of Play’:- 1908: can gain an interest in a corpse by ‘work and skill’. 1974/6:-
urine/blood can be stolen.
-Loane Skene’s view: Personal right to control use of tissue. Should be exercisable
by others on your behalf. It is trespass to remove tissue without consent. No property
rights for donors.
Hospitals should have property rights by virtue of lawful acquisition (consent) then
expenditure of effort (research and development). Limited to use of tissue connected
to the purpose for which tissue originally taken. E.g. medical research on tissue
acquired in hospital setting.
-medical records are owned by the person who compiled them, e.g. doctor or hospital.
This law should hold for tissue.
Use of tissue in research: Surgically removed tissue should be regarded as
‘abandoned’. Use should be monitored by HREC. Hospital should be regarded as
‘owning’ the tissue, ‘intellectual property’. Access by relatives for their purposes
should be allowed.
Family history taking is allowed by a ‘public interest determination’ to be compliant
with the Privacy Legislation.
• NSW Health- categorizes the different format of tissues re: genetic info.
Available on website.
2. Are Pathology Samples Anyone’s Property. Cameron Stewart, Division of Law,
Do pathology samples belong to the person from whom they originated; in a legal
context, are they the person’s (or anyone’s) property?
If they are not legally the donor’s property, and the samples are re-classified as health
information, does that confer privacy rights over the donor’s samples even though
they don’t own them?
-Can property be transferred or assigned with respect to tissue? Assignability does
not necessarily come with property. ‘Property’ is inextricably linked with principals
of relationships and equity.
-Should responsibility for disseminating information re: familial disease mutations be
given to the tested individual?
3. The implications of classifying tissue and blood samples as information. Jean
Murray, Principal Consultant, Ethico Legal Reform, Dept of Health, SA.
It has been proposed that pathology samples should be considered as health
information. This proposition arose because genetic information can be derived from
tissue and blood samples. This would classify a tissue or blood sample as a health
record, and would encompass all pathology samples not just those destined for genetic
testing. However, the quality and confidentiality requirements imposed on pathology
samples are not the same as those for health records. Also, genetic information is not
easily derived from samples. Such classification has wide-reaching practical and
regulatory implications and privacy concerns would be better addressed by other
-Blood taken for biochemistry test is same as that for BRCA1 test, therefore all path
samples could be considered medical information. NPAAC standards state that lab
reports and records should be kept for 3 years, specimens should be kept for 7 days or
2 days after report is issued, histopathology blocks, slides, sections and records must
be kept for 20years after report is issued.
NPAAC standards for genetic tests: reports must be kept indefinitely and Guthrie
cards be kept for 18+7 years.
-Guthrie cards in SA, the format is a sample combined with a request form. As such,
the SA Health Records Act states that Guthrie cards are considered permanent and it
cannot be destroyed or altered. Therefore, technically, the extraction of the last spot
of blood from a Guthrie card would constitute destruction of a health record. Use of
genetic and other path samples are not regulated currently by privacy legislation but
their use, storage and disposal are extensively regulated by: NPAAC, TGA, laboratory
standards, etc. etc.
4. Property and Privacy Issues for the Familial Cancer Service. Graeme Suthers,
Head, Familial Cancer Unit, SA Clinical Genetics Service.
We frequently seek pathology reports and tissue samples from people who are
deceased. Who should control access to these samples and data? If they are regarded
as property then the executor of the estate would be the appropriate person to provide
permission. However, biologically speaking, it would make more sense to seek
access from a biological relative. Should the degree of relationship provide a ranking
of those suitable to provide permission?
- Integrating deceased individual records/samples for benefit of living relatives,
who should approve this? In SA executor of the estate has principal authority
or if unavailable, then spouse, child, parent, sibling (in this order but this is
- NSW Act states that if the person died more than 30yrs ago, the medical
record without consent (although practically, this has not been the experience
of some research projects!)
5. Case Study: Newborn Screening Cards. Janice Fletcher, Head, Newborn
Screening Program SA.
Newborn blood screening cards will be discussed from the viewpoints expressed in
the presentations above. If they are classified as information questions to be
considered are: for what will they be used?
What are they legally?
To what have parents consented?
Should consent be obtained at all?
Should it be opt-out consent only?
- Guthrie cards began in Australia in mid 1960’s for PKU testing. Congenital
hypothyroidism was screened for commencing 1977. Cystic fibrosis screening
- Consent is recorded in the patient file by the midwife but no written consent
doc. is obtained. Only when parents elect not to have a Guthrie card collected
are they required to sign a ‘non-consent’ document in SA.
- Look at site (Westmead Children’s) for further information about the
collection and use of Guthrie cards, a good summary.
6. Hospital Research Ethics Committees as Regulators of Access to Tissue
Samples. Michael James, Chairman, Research Ethics Committee, Royal
Adelaide Hospital SA.
Research Ethics Committees (REC) are charged with reviewing research proposals
from an ethics viewpoint, taking into consideration the research ethics principles
provided in the NHMRC National Statement on Ethical Research in Humans. While
performing that traditional and expected function, an additional expectation has
developed that REC also are regulators of privacy. Privacy issues may arise when an
REC considers access to patient material for research purposes. Could it make a
difference to REC deliberations if pathology samples were reclassified as health
-The discussion centered around the fact that HRECs have become drug regulators as
they are often the first committee to see drug trial studies, they are regulators of
hospital resources and risk, regulators of radiation use (mSv limit on radiation
exposure to study participants, etc. etc) and Privacy regulators. The resources of the
REC to perform all these functions were discussed.
-Royal Adelaide Hospital surgical consent form includes the statement that the patient
agrees for any excess tissue taken to be used in research.