Tissue banks – guidance

Studies that involve storing human tissue for use beyond a specified research project (future unspecified use of tissue) must store that tissue in a Health and Disability Ethics Committees (HDECs) registered tissue bank.

When HDEC review is required

An application for HDEC review of a tissue bank is required for:

• studies that are unable to use an already established HDEC registered tissue bank for storing human tissue beyond the end of a specified research project
• those seeking to establish a tissue bank.

How to submit a tissue bank application

Steps to follow:

1. Set up your online account

If you do not have an Ethics Review Manager (ETHICS RM)(external link) account, please create one as this is required for creation of a Tissue Bank application.

2. Complete the HDECs Tissue bank application form

Create an HDEC Tissue Bank application in ETHICS RM. 
Check that your application clearly states:

• the name of your tissue bank
• how the governance arrangements for your tissue bank ensure that robust and appropriate processes are in place for all aspects of tissue storage, management and use
• how your organisation will:
  • be seeking consent from potential donors
  • collect, transport and store tissue samples
  • cultural issues associated with storing and using tissue from Māori (and other relevant population groups)
• the circumstances in which tissue stored in your tissue bank may be provided to researchers, including:
  • the types of activity for which the stored tissue may potentially be made available
  • how your organisation will check that research projects using the tissue bank samples are scientifically valid
  • any other conditions under which the tissue samples will be made available
• where relevant, details of whether and how your organisation will provide donors and their relatives with clinically significant information arising from research on their tissue.

3. Include other relevant information

Include any supporting information with your application form, such as:

• a covering letter
• a participant information sheet
• a consent form
• the terms of reference for your tissue bank and advertising
• data and tissue management plan
• the name and email address for the ETHICS RM(external link) account that you will use to submit this application.

4. Submit your application

Click Submit once completed as per any other HDEC application.

Further information:

• For more information about HDEC review of tissue banks, please read Section 13 of Standard Operating Procedures for HDECs(external link).
• Consent requirements for collecting tissue for future unspecified research: Future unspecified use of tissue – guidance(external link)(external link)
• He Tangata Kei Tua: Guidelines for Biobanking with Māori – University of Waikato website (external link)