Human Research Ethics Committees and the therapeutic goods legislation

26 June 2001

This document describes the role of Human Research Ethics Committees (HRECs) in relation to the supply of unapproved therapeutic goods in connection with the operation of the Clinical Trial Notification Scheme, the Clinical Trial Exemption Scheme, the Special Access Scheme, and in the approval of Authorised Prescribers.

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Contents

  • These guidelines
  1. Introduction
  2. Clinical trials
  3. The special access scheme
  4. Authorised prescribers
  5. The criteria used by delegates in deciding whether to approve supply of unapproved therapeutic goods
  6. Informed consent in relation to the use of unapproved products
  • Appendix 1 Excerpts from the legislation
  • Appendix 2 CTN form
  • Appendix 3 CTX form Part 2
  • Appendix 4 HREC letter of endorsement
  • Appendix 5 Consent to treatment and indemnity for use of products derived from human blood or plasma