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Future unspecified use of human tissue – guidance

Participants in a research project may be offered the opportunity to consent to their tissue being used in future unspecified research.

What 'unspecified use' includes

Unspecified research is any research not part of a specific research project with defined tests, goals and purposes.

Storage of tissue

Any human tissue stored in New Zealand beyond a specified research project must be stored in a Health and Disability Ethics Committees (HDEC) registered tissue bank. Read the guidance on tissue banks.


Consent to store human tissue for use in future projects must be separate from consent to participate in a specified research project. This reduces the burden for participants who are taking part in the main research project. It also helps clarify the compulsory aspects of the main study.

Information that must be provided to a tissue donor participant when seeking consent for future unspecified use of their tissue sample includes:

  1. an indication of the type and nature of the study to be carried out; its implications for the tissue donor (where possible); an explanation of why they are being approached for their tissue and the specific tissue sought from that donor

  2. known possible researchers or institutions that might use the tissue sample

  3. the possibility of the tissue sample being sent overseas and (where possible) to what country or countries

  4. acknowledgement that all future unspecified research in New Zealand may be subject to ethical review but that any tissue sample sent overseas (unless it is sent in conjunction with a New Zealand research project) is likely to be considered by an overseas ethics committee without New Zealand representation

  5. whether the tissue donor’s identity and details will remain linked with the sample or whether the sample will be de-linked. Read the guidance on data identifiability.

  6. how tissue donor confidentiality will be maintained

  7. a statement acknowledging that if a tissue donor consents to a tissue sample being unidentified or de-linked, they relinquish their right to withdraw consent in the future

  8. whether the tissue donor may be contacted in the future about their tissue sample and under what circumstances information about the future unspecified research will be made available to the donor and/or (where relevant) their clinician

  9. acknowledgement that the tissue donor will not own any intellectual property that may arise from any future research

  10. whether a tissue donor can withdraw their consent for using their samples in the future (Where they can withdraw consent, only samples that exist at the time of a request to withdraw and any information held for future unspecified research may be withdrawn. Tissue samples or information used in research before the request to withdraw is received are unlikely to be able to be returned or destroyed.)

  11. acknowledgement that the tissue donor’s decision around consent for future unspecified use of their tissue sample will in no way affect the quality of their current or future clinical care

  12. where and for how long a tissue sample will be stored, how it will be disposed of and whether there is a cultural protocol for its disposal (for example, information about the institution holding the tissue sample: its aims, research procedures and research governance)

  13. whether tissue samples will be provided to commercial biomedical companies or used in commercial research collaborations (if known)

  14. acknowledgment that different cultural views may inform choice about the donation of tissue samples; for example, for some Māori, human tissue contains genetic material that is considered to be collectively owned by whānau, hapū and iwi

  15. acknowledgement that cultural concerns may arise when tissue samples are sent overseas, including how the samples are stored and disposed of

  16. acknowledgement that donors may want to discuss the issue of tissue donation with those close to them, for example, family, whānau, hapū and iwi.

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