NHMRC – Attachment B

Update on NHMRC initiatives

The update below relates to the work of the NHMRC’s Australian Health Ethics Committee (AHEC). AHEC is a principal committee of the NHMRC and is established to develop human research guidelines and promote discussion on ethical issues relating to human health.

Relevant guidelines include:

  1. National Statement on Ethical Conduct in Human Research (http://www.nhmrc.gov.au/guidelines/publications/e72);
  2. Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (http://www.nhmrc.gov.au/guidelines/publications/e78); and
  3. The Australian Code for the Responsible Conduct of Research (http://www.nhmrc.gov.au/guidelines/publications/r39).

Human biospecimens

During the 2009 – 2012 triennium, 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 identified inconsistencies between the two chapters and gaps in the ethical guidance which was compromising the integrity of the National Statement and the ethical review process. The issues were:

  • Chapter 3.6 is out-of-date as stem cell research had developed as a research field since the National Statement was issued in 2007.
  • Chapter 3.6 deals 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 is unnecessary.
  • The exemption from ethical review in Chapter 3.6 for collections of non-identifiable data involving negligible risk is 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 has resulted in confusion about the level of ethical review required and an inconsistent application of the National Statement.
  • That there is not enough ethical guidance around the importation of stem cell lines used in Australia for research and there is no ethical guidance on the exportation of stem cell lines which have been derived in Australia.

Following two public consultations, AHEC has drafted a revised Chapter 3.4: Human biospecimens in laboratory based research to bring together the current Chapters 3.4 and 3.6. The revised Chapter 3.4:

  • 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:

a)  the harvesting of embryonic stem cells and the derivation of embryonic stem cells (governed by the RIHE Act and the ART Guidelines), and

b)  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 a low-risk pathway of ethical review where:
    • the tracing of the human biospecimens back to the donor(s) is not practical,
    • there has been appropriate ethical review prior to the collection and/or derivation of those human biospecimens, and
    • the subsequent use is consistent with the earlier consent.
  • Provides clear ethical guidance on the requirements for the exportation and importation of biospecimens to and from international sources.

The revised Chapter 3.4 is currently being considered by the NHMRC CEO. It is anticipated that this chapter will be issued by the CEO in late 2013.

 

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