Guides, templates & forms
- Online Forms: application and file upload – guidance
- Online Forms: requests and approvals – guidance
- Cultural questions – guidance
- Participant information sheet templates
- Potentially vulnerable study participants – guidance
- Recruitment and advertising materials – guidance
- Scientific peer review submissions – guidance
- Health information and data use – guidance
- Human tissue use – guidance
- Ethical standards for health and disability research
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
one or more of the statutory exceptions to the need to gain informed consent applies as set out at section 20(f) of the Human Tissue Act 2008 (or Right 7(10)(c) of the Code of Health and Disability Services Consumers’ Rights 1996).
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consent in the future (Note: If the samples are identifiable or potentially identifiable they should be able to be withdrawn.)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.’
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:
- Storing human tissue beyond the end of a specified study, read Future unspecified use of tissue – guidance.
- Studies involving the use of Māori human tissue:
In this section
- Participants in a research project may be offered the opportunity to consent to their tissue being used in future unspecified research. – Read more
- Studies that involve storing human tissue for use beyond a specified research project must store that tissue in an HDEC-registered tissue bank. – Read more
- Guidance for studies involving human tissue – mandatory and optional procedures. – Read more