The following advice from the NHMRC is for the preparation and review of research protocols relating to the use of embryonic and non-embryonic human stem cells. It is an update of Human Research Ethics Committee (HREC) Information Sheet 5 (September 2001), which should be discarded . If circumstances change, the NHMRC will issue further advice as required.
Derivation of human embryonic stem cells in Australia
The following legislation and guidelines regulate the derivation of new human embryonic stem cells:
- The Research Involving Human Embryos Act 2002 (the RIHE Act ) Footnote 1.
- The RIHE Act (and corresponding state and territory legislation) establishes a strong regulatory framework for the use of excess Assisted Reproductive Technology (ART) embryos. The RIHE Act also establishes the NHMRC Licensing Committee.
- The RIHE Act requires that all uses of excess ART embryos require a licence issued by the NHMRC Licensing Committee, except for those uses listed as exempt in Section 10(2) of the RIHE Act . A licence is required for the derivation of new embryonic stem cell lines from excess ART embryos.
- Section 21(3)(c) of the RIHE Act states that the NHMRC Licensing Committee must not issue a licence unless it is satisfied that the activity or project proposed in the application has been assessed and approved by an HREC that is constituted in accordance with, and acting in compliance with, the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999).
- Before issuing a licence, the Licensing Committee must be satisfied that a number of statutory requirements are fulfilled, such as processes for obtaining proper consent for the use of the excess ART embryos and HREC approval. In addition, the Licensing Committee must have regard to issues such as restricting the number of embryos used to achieve the goals of the project and the likelihood of a significant advance in knowledge. These requirements are detailed in section 21 of the RIHE Act .
- The Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (NHMRC 2004) (the ART guidelines).
- Paragraphs 17.10 to 17.18 of the ART guidelines provide guidance for research involving excess ART embryos, including requirements for obtaining proper consent.
- The National Statement on Ethical Conduct in Human Research (2007).
It is essential that institutions and researchers wishing to derive new human embryonic stem cell lines have a thorough knowledge of, and comply with, the above legislation and guidelines. Similarly, HRECs must be familiar with, and follow, the responsibilities that the legislation and guidelines impose when considering research proposals that involve the use of human embryos.
The NHMRC Embryo Research Licensing Committee has developed an information kit to assist researchers and Human Research Ethics Committees with applications made under the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. The kit can be accessed here.
Research using human stem cells
There is no legislative framework regulating the research use of human stem cells (embryonic or non-embryonic) after they have been derived. However, the use of human stem cell lines in research must comply with relevant NHMRC guidelines (in particular the National Statement ) and must be approved by an HREC that is constituted in accordance with, and acting in compliance with, the National Statement.
Licences issued by the NHMRC Licensing Committee authorise the defined use of the excess ART embryos, not subsequent research using embryonic stem cells.
To enable HRECs to effectively review research proposals involving the use of existing human stem cell lines, institutions and researchers must provide information to HRECs on all the points below when submitting protocols (common elements span both columns):
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Non-Embryonic Stem Cells |
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1. Evidence that the research proposal complies with the requirements of the National Statement , other relevant guidelines issued by the NHMRC, and prevailing Commonwealth, State and Territory legislation. |
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2. If the human embryonic stem cells were derived in Australia , evidence that the use of embryos for derivation of the stem cells was (or will be) authorised by, and undertaken in accordance with, a licence issued by the NHMRC Licensing Committee. |
2. Evidence that the research to derive the human non-embryonic stem cells complied with the National Statement , other relevant guidelines issued by the NHMRC and relevant Commonwealth and State or Territory legislation. |
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3. If the human embryonic stem cell lines were derived outside Australia and have been imported into Australia , evidence that these imported cell lines were derived using procedures involving embryos that would have complied with the laws in Australia and guidelines issued by the NHMRC. These laws include the RIHE Act, the Prohibition of Human Cloning for Reproduction Act 2002 Footnote 3and corresponding State and Territory legislation, and the Commonwealth Customs (Prohibited Imports) Regulations Footnote 4. |
3. If the proposal involves the use of stem cell lines that have been imported into Australia , evidence that the work to derive these cell lines was undertaken in compliance with comparable standards to those in place in Australia . |
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4. If the proposed research involves the use of stem cell lines (or their products) in humans, evidence that the requirements of the Therapeutic Goods Administration (TGA) have been taken into account. While materials used in initial clinical research are exempt from requirements for Good Manufacturing Practice (GMP), the TGA requires GMP to be implemented for phase 2 and 3 clinical trials Footnote 5. |
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5. As outlined in the National Statement (in particular Chapter 2.1), evidence that assures the HREC that the research proposed will be undertaken by researchers with appropriate experience and using appropriate facilities. |
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Footnotes
1 The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 have been amended by passage of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. The changes come into effect on 12 June 2007.
3 The Prohibition of Human Cloning for Reproduction Act 2002 prohibits, amongst other things, the creation of human embryo clones and the creation of human embryos for purposes other than achieving pregnancy. See also Footnote 1 above.
4 The Customs (Prohibited Imports) Regulations prohibit absolutely the import of viable materials derived from human embryo clones. This includes stem cell lines derived from human embryo clones.
5 The TGA is developing a national regulatory framework for human tissues and emerging biological therapies. It is proposed that this regulatory system will apply to human cells, tissues and cellular and tissue-based products used therapeutically. Various levels of regulation will apply, based on the potential level of risk. A new Code of Good Manufacturing Practice (cGMP) may be developed that is specific to cell and tissue therapies. In due course, researchers will need to become familiar with the requirements of these regulations, as well as any new cGMP, and to demonstrate to the HREC that their proposal takes account of these requirements.