Human Tissue and Genetics

Research involving human tissue, especially genetic research, carries specific obligations and raises sensitive issues for many New Zealanders.

For many Māori, there are additional aspects to consider specifically when carrying out studies involving human tissue and/or genetics, particularly if tissue is being sent out of New Zealand, or may be used for future purposes.

Ancestry and ethnicity are different concepts. In studies which include components of genetic research, ethnicity cannot be used as a proxy for ancestry. It is important to be clear about these definitions and to use the appropriate concept.

Definition of Ancestry

Ancestry is appropriate when family history or lineage is being considered in the research hypothesis. Because ancestry is aligned with whakapapa, further consultation may be necessary with relevant iwi, hapū and whānau groups.

• You must specify in your proposal and in the consent form how you plan to manage human tissue and DNA. This will involve clarity about how tissue will be stored, whether it will be used for any future purpose and how it will be destroyed. For an example, see below.
• Some iwi do not support storage of tissue and blood samples because of collective whānau, hapū, iwi and whakapapa implications, and advise members to consult prior to participation in research where this occurs. However, it is acknowledged that individuals have a right to make their own decision to participate. If in doubt please discuss this with Te Ira Kawai (Auckland Regional Biobank).
• If study samples are being sent overseas for analysis and/or storage they move beyond the jurisdiction of New Zealand law. This is a point of significant sensitivity to some Māori. It can be somewhat mitigated if the overseas laboratory is quality assured according to internationally agreed standards.
• Some Māori whānau consider that the rights and protections of tissue extend to the data generated from this tissue - including genetic data. These issues need to be clarified during the consultation and consenting process.  

Example - Data and Sample Collection, Storage and Confidentiality

An example of how you may cover these issues in your proposal

• Blood and/or serum samples will be collected, prepared and stored [specify site/relevant staff].
• Data held at Auckland University will be initially identified according to [e.g. patient’s NHI] and given a unique study number for the purposes of anonymised data entry and sample identification.
• The data and the blood will be transported to the [specify site] according to [specify as relevant e.g. IATA international] guidelines for the transport of tissue.
• Data will be stored in a locked room and secured within a locked cabinet. [Specify staff] will have access to the data.
• All laboratory specimens, evaluation forms, reports, and other records that leave the site will be identified by coded number only to maintain subject confidentiality.
• All computer entry and networking programs will be done with coded numbers only.
• Clinical information will not be released without written permission of the subject. Subjects must not be identifiable by name or personal details on any report forms or published material.
• The data will be held for [specify] years and destroyed by [specify eg university shredding] procedures at the end of the statutory period.
• Samples will be tested at [specify laboratory] and any remaining after the specified testing will be destroyed according to [specify] procedures for destruction of biological samples.
  

This is an issue which will be very carefully evaluated by ethics committees, as it carries unquantifiable but potentially high risks for the participant.

Consent to the future unspecified use of a person’s tissue samples must be distinct from consent to collect the sample and distinct from consent to use the sample in specified research.

Consent may be given for the unidentified or de-linked use of the donor’s tissue sample. However, in such situations, the donor must be informed that they will not be able to withdraw their consent in the future.

“Different cultural views may inform choice about donation of human tissue” (Ministry of Health, 2007). Some Māori will consider that human tissue contains genetic material that is collectively “owned” by whānau, hapū and iwi, and may wish to discuss this with their whānau, hapū or iwi.​​​​​​​

See also:

Part 5, pg 30-32 in Guidelines for the Completion of the National Application Form for Ethical Approval of a Research Project NAFG-2009-v1