• Section 1 - Purpose
• Section 2 - Scope
• Section 3 - Principles
• Project Description
• Information and Consent
• Commercialisation 
• Section 4 - Procedures
• Section 5 - Definitions

Section 1 - Purpose

(1) This Policy meets the direction within the National Statement on Ethical Conduct in Human Research (Chapter 3.2 Human biospecimens in laboratory based research) that institutions should develop a policy for the collection, storage, use and disposal of human tissue in research.

(2) This Policy sets out the requirements for forensics-related research, experiments or teaching including the use of human tissue within the University of Canberra (University).

(3) This Policy is to be used in conjunction with the approvals procedures of the Human Research Ethics Committee (HREC), all information requested on the University’s Research Ethics Online Application Form and all requirements under the National Statement on Ethical Conduct in Human Research.

Section 2 - Scope

(4) This Policy is restricted to the use of human tissue for forensics-related research, experiments or teaching in which there is no diagnostic component with respect to the donor.

(5) This Policy does not cover the use of human tissue for any medically-related diagnostic research.

(6) This Policy covers the use of all human tissue with the exclusion of gametes and embryos.

(7) This Policy is aligned with the National Statement on Ethical Conduct in Human Research and is a supplementary policy which does not replace any other requirements under the National Statement on Ethical Conduct in Human Research.

Section 3 - Principles

Project Description

(8) Where a proposed research or teaching project is to be conducted at the University and/or involving University staff utilising human tissue, it must be submitted as a comprehensive project description and application to the CEHR and approval received before the research can commence.

(9) The project description must outline the source of human tissue samples.

(10)  If samples are to be sourced from an external party, the arrangements and written agreements involved in provision of material and any regulations enforced by the external party on use of the material must be detailed within the application. If needed, legal authorisation from the University should be sought in advance of ethics approval.

(11)  If University staff are to be involved in sample collection their actions must be in accordance with the ACT Transplantation and Anatomy Act 1978 which legislates for donation of tissue by living persons, effects of consents and authorities, revocation of consent or agreement, donations of tissue after death, donations for anatomical purposes and regulations for schools of anatomy.

(12) The project description must outline method(s) of transport of the materials to and from the University.

(13) The project description must outline the method and location of storage for the human tissue samples including management of access to samples in storage. Appropriate record-keeping must be in place and access must be restricted to research personnel directly involved in the project.

(14) The project description must outline the method of disposal of human tissue samples, long-term storage of samples or components of samples or return of samples to external source on completion of research project.

(15) The project description must outline the management of confidentiality and privacy issues with regard to samples. Sample identification methods must be comprehensively outlined whether donor identity is known or unknown.

(16) The project description must contain a detailed protocol for use of human tissue samples during the research project and information on the appropriate dissemination of results arising from use of these samples. Donor confidentiality must be specifically addressed.

Information and Consent

(17) Requirements with regard to participant and or donor consent must be in alignment with the National Statement on Ethical Conduct in Human Research Chapter 2.2 General requirements for consent and Chapter 2.3 Qualifying or waiving conditions for consent.

Commercialisation 

(18) There should be no trade in human tissue for research purposes.

Section 4 - Procedures

(19)  Nil.

Section 5 - Definitions