The review of National Statement Chapters 3.4 & 3.6 and the development of Chapter 3.4

During the 2009 - 2012 triennium, the Australian Health Ethics Committee (AHEC) commenced a review of Chapter 3.4: Human tissue samples and Chapter 3.6: Human stem cells of the National Statement on Ethical Conduct in Human Research, 2007 (National Statement) in response to concerns about inconsistencies between the two chapters and perceived gaps in the ethical guidance. The issues were:

  • Chapter 3.6 was out-of-date as stem cell research had developed as a research field since the National Statement was issued in 2007.
  • Chapter 3.6 dealt with the derivation of embryonic stem cell lines which is also governed by the Research involving Human Embryos Act 2002 (RIHE Act), and the Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research, 2007 (ART Guidelines). Having this information in two different documents was unnecessary.
  • The exemption from ethical review in Chapter 3.6 for collections of non-identifiable data involving negligible risk was misleading as human stem cell lines do not meet the definition of ‘non-identifiable data’ (as outlined in Chapter 3.2 of the National Statement) and therefore do not satisfy the criteria to be exempt from ethical review. This resulted in confusion about the level of ethical review required.
  • That there was not enough ethical guidance around the importation of stem cell lines used in Australia for research and there was no ethical guidance on the exportation of stem cell lines which have been derived in Australia.

The revised Chapter 3.4: Human biospecimens in laboratory based research brings together current Chapters 3.4 and 3.6, which:

  • Recognises human stem cells and human tissue as “human biological specimens” (biospecimens).
  • Clarifies that the chapter is applicable to laboratory use of human biospecimens, i.e. the chapter is not applicable to therapeutic uses.
  • Makes a clear distinction between:
  1. the harvesting of embryonic stem cells and the derivation of embryonic stem cells (governed by the RIHE Act and the ART Guidelines), and
  2. the research use of established embryonic stem cells and stem cell lines.
  • Provides clear guidance on the requirements of informed consent from donors of biospecimens, or where a waiver of consent may be ethically permissible.
  • Provides clear ethical guidance on when an HREC must review proposed research using biospecimens.
  • Provides for a low-risk pathway of ethical review.
  • Provides clear ethical guidance on the requirements for the exportation and importation of biospecimens to and from international sources.

Drafts of the revised Chapter 3.4 underwent two separate public consultations:

  • 16 November 2011 – 11 January 2012 - 21 submissions were received
  • 4 September 2012 – 18 October 2012 - 32 submissions were received

Non-confidential submissions are available from the NHMRC Public Consultation website.

Contact

Postal address Project Officer - Human Biospecimens

Health and Research Ethics

NHMRC

GPO Box 1421

Canberra ACT 2601
Email address ethics@nhmrc.gov.au