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Obtaining approval from a human research ethics committee or endorsement from a specialist college

3 July 2017

Medical practitioners seeking to become Authorised Prescribers need to have their application either approved by an human research ethics committee (HREC) or endorsed by a specialist college. The approval or endorsement should be made in writing.

Under the Therapeutic Goods Act 1989, an ethics committee must be constituted and operating in accordance with National Health and Medical Research Council guidelines and have notified its existence to the Australian Health Ethics Committee.

Medicines and biologicals

For a medical practitioner engaged in clinical practice in a hospital, the ethics committee of that hospital should provide the approval.

For medical practitioners engaged in clinical practice outside of a hospital setting, an appropriate ethics committee will be one that has relevant expertise relating to the use of the unapproved good.

If the medical practitioner does not have access to an appropriate ethics committee, then they may seek endorsement from a specialist college that has expertise relevant to the use of the medicine or biological (as applicable).

Medical devices

For a medical practitioner engaged in clinical practice in a hospital, the ethics committee of that hospital should provide the approval.

For medical practitioners engaged in clinical practice outside of a hospital, an appropriate ethics committee will be one which both has relevant expertise in the use of the unapproved good and conducts its activities in the geographical area where the medical practitioner intends to use the unapproved good. If the medical practitioner does not have access to an appropriate ethics committee, then they may seek endorsement from a specialist college that has expertise relevant to the use of the medical device.

For example a medical practitioner in private practice may obtain approval from an ethics committee at a hospital where they have admitting rights or the Area Health Service in which they practice. Alternatively, a medical practitioner could be endorsed by a specialist college having expertise relevant to the treatment of the condition for which use of the product is being sought.

The TGA may consult with independent expert advisory committees to determine the appropriateness of the endorsement.

It is recommended that the HREC letter of approval or Specialist College letter of endorsement include:

  • a clear statement that the approval or endorsement is being given for the purpose of the medical practitioner becoming an authorised prescriber
  • the name of the medical practitioner being endorsed
  • the medicine, biological or medical device and indication/use for which endorsement has been given
  • the site(s) at which use is covered by the endorsement
  • any conditions the ethics committee has imposed on the endorsement
  • the signature of the chairman of the HREC over his/her official title.