When working with research that involves human embryos created by assisted reproductive technology (ART), it can be difficult to determine if a licence is required for training and quality assurance activities. The attached documents provide information and helpful links to help identify legislative requirements.

 

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The Research Involving Human Embryos Act 2002 (RIHE Act) regulates some uses of human embryos created by assisted reproductive technology (ART).  Some activities may be conducted as part of clinical practice. Some activities using ‘excess ART embryos’ may only be conducted under licence.  Other activities are prohibited by the RIHE Act or the Prohibition of Human Cloning for Reproduction Act 2002.

The way the legislation applies to training and/or quality assurance activities conducted in the clinical context may be less obvious than for research activities. The NHMRC Licensing Committee has developed a framework and supporting information to help ART clinics decide whether their training and/or quality assurance activities require a licence. 

The information is presented in several formats to assist users to answer their specific questions.

  • Training and QA - Information from ERLC. This document outlines how the legislative framework applies to training and/or quality assurance activities
  • When is a licence required. This contrasts activities that don’t require a licence with activities that need a licence and those that are completely prohibited

It can be difficult to determine the circumstances under which a particular embryo may or may not be used for training and/or quality assurance activities.  The key question is whether the embryo is an excess ART embryo.  The time when consent is obtained for the use of the embryo is critical for determining whether the embryo is an excess ART embryo. This in turn determines whether its use requires a licence.

  • A decision tree has been developed to assist ART clinics to determine how and when a specific ART embryo can be used in training and/or quality assurance activities. 
  • A flowchart outlines training and/or quality assurance activities that do not require a licence
  • Case studies apply the framework to typical scenarios

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Case studies117.21 KB
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Decision tree130.03 KB
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