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Meeting Report (Lisa Devereux)

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  • 1. Meeting Report (Lisa Devereux) Australian Institute of Health Law and Ethics: “TISSUE OWNERSHIP: IMPLICATIONS FOR POLICY, PRIVACY AND USE” 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 School 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 arguments. 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 analysis *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) -Historical 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 ‘property’. -‘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.
  • 2. 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, Macquarie University 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 means. -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.
  • 3. -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 arbitrary). - 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 commenced 1989. - 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. - www.chw.edu/prof/services/newborn
  • 4. 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 information? -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.