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Human tissue use – guidance

Most studies involving the collection, use, or storage of human tissue must be reviewed by the Health and Disability Ethics Committees (HDECs).

When HDEC review is required

Any collection, use, or storage of human tissue without informed consent, and use of stored tissue samples, for study purposes other than the original specified purpose must be reviewed by Health and Disability Ethics Committees (HDEC).

Any HDEC study application must clearly detail how the use of tissue for the study meets legal and ethical requirements. If informed consent will not be obtained, the reasons and justification for not obtaining consent must be included in the HDEC study application.

When HDEC review is not required

HDEC review is not needed if:

  • informed consent (which may include informed consent to future unspecified research) has already been obtained for such use, and
  • the tissue will not be made available to researchers in a form that could reasonably be expected to identify the individual(s) concerned

or:

Informed consent

Participant information sheet

When obtaining informed consent to use human tissue in studies, the participant information sheet should clearly state:

  • what tissue will be collected
  • any risks associated with collecting that tissue (such as bruising from blood draws)
  • where the tissue will be stored in New Zealand or overseas (and if overseas where)
  • how it will be disposed of (including any cultural protocols that apply)
  • what tests will be done on the tissue
  • how long the tissue might be stored
  • whether the tissue will be stored in an identifiable form
  • whether participants can withdraw their consent in the future (Note: If the samples are identifiable or potentially identifiable they should be able to be withdrawn.)
  • in the case of the use of Māori human tissue, a specific statement recognising cultural values. The HDECs recommend the following statement:

‘You may hold beliefs about a sacred and shared value of all or any tissue samples removed. The cultural issues associated with sending your samples overseas and/or storing your tissue should be discussed with your family/ whānau as appropriate.
There are a range of views held by Māori around these issues; some iwi disagree with storage of samples citing whakapapa and advise their people to consult before participating in research where this occurs. However, it is acknowledged that individuals have the right to choose.’

Cultural concerns

Māori consider the body to be tapu. Any health or medical research that involves the body or any part of the body, such as organs, blood, hair, saliva and/or other tissue, must be conducted in a respectful manner. The collection of human tissue from a deceased person is a particularly sensitive area for Māori.

For more information

Useful web resources on the following topics:

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