Delegate An officer who has been authority by the Minister or Secretary to exercise a power, which the Act or Regulations confer on the Minister/Secretary. Ethics Committee see Research Ethics Committee’, below ‘Human Exempt Goods Relates to the provisions of Chapters 3 or 4 of the Act, and covers that are exempted from the requirement to be included in the Register of Therapeutic Goods or are exempted from licensing requirements. Formulation A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch. Gene and Related Therapies Research Advisory Panel (GTRAP) A subcommittee of the Research Committee, established in 1994 to provide HRECs with advice about medical, scientific, ethical and safety issues related to gene therapy protocols. It provides advice to researchers to facilitate design of protocols for gene therapy and maintains a register of human gene therapy trials undertaken in Australia. Membership of GTRAP includes gene therapy, xenotransplantation and human stem cell research experts, members of the Gene Therapy Technical Advisory Committee (GTTAC), a representative from the TGA, an ethicist and a lawyer. Gene Therapy and Related Therapies As originally conceived, gene therapy is the introduction of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) into the cells of humans using a gene carrier or 'vector' to carry a gene into cells with a view to integration of the gene into chromosomal DNA and its long term expression. The NHMRC considers introduction of DNA or RNA into somatic (nonreproductive) cells to be ethically acceptable. However, it considers the introduction of DNA or RNA into germ (reproductive) cells to be ethically unacceptable since there is insufficient knowledge about the possible consequences including hazards and effects on future generations. HRECs would not be expected to receive, and should not approve, research proposals for germ cell gene therapy. Recent novel and varied methodologies for introducing and modifying gene expression overlap with the traditional concept of gene therapy. These include modifications to immunisation strategies, in which DNA, rather than protein is used to generate an immune
Delegate An officer who has been authority by the Minister or Secretary to exercise a power, which the Act or Regulations confer on the Minister/Secretary. Ethics Committee see ‘Human Research Ethics Committee’, below Exempt Goods Relates to the provisions of Chapters 3 or 4 of the Act, and covers that are exempted from the requirement to be included in the Register of Therapeutic Goods or are exempted from licensing requirements. Formulation A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch. Gene and Related Therapies Research Advisory Panel (GTRAP) A subcommittee of the Research Committee, established in 1994 to provide HRECs with advice about medical, scientific, ethical and safety issues related to gene therapy protocols. It provides advice to researchers to facilitate design of protocols for gene therapy and maintains a register of human gene therapy trials undertaken in Australia. Membership of GTRAP includes gene therapy, xenotransplantation and human stem cell research experts, members of the Gene Therapy Technical Advisory Committee (GTTAC), a representative from the TGA, an ethicist and a lawyer. Gene Therapy and Related Therapies As originally conceived, gene therapy is the introduction of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) into the cells of humans using a gene carrier or 'vector' to carry a gene into cells with a view to integration of the gene into chromosomal DNA and its long term expression. The NHMRC considers introduction of DNA or RNA into somatic (nonreproductive) cells to be ethically acceptable. However, it considers the introduction of DNA or RNA into germ (reproductive) cells to be ethically unacceptable since there is insufficient knowledge about the possible consequences including hazards and effects on future generations. HRECs would not be expected to receive, and should not approve, research proposals for germ cell gene therapy. Recent novel and varied methodologies for introducing and modifying gene expression overlap with the traditional concept of gene therapy. These include modifications to immunisation strategies, in which DNA, rather than protein is used to generate an immune
clinical-trials-guidelines.docx