​Ethics

Any research involving the exposure of humans to ionising radiation must carry out the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) (ARPANSA Radiation Protection Series No. 8) (the Code) .

Please see section 2.1.7 of the Code for information on the requirements of the Human Research Ethics Committee (HREC).

Submission to HREC involves the following steps:

1. Completion and submission to the NSLHD Radiation Safety Officer (RSO) NSLHD-RNS-RPO@health.nsw.gov.au, of a NSLHD Radiation Research Study Request(accessible only through NSLHD intranet).

2. Once the Radiation Research Study Request has been processed and signed by the RSO, the submission to the HREC must include the following;

(​a) A copy of the NSLHD Radiation Research Study Request which will give:

- the​ reasons why it is necessary to expose research participants to ionizing radiation for the purpose of the research (Section 11 of the Form),

- the precautions to be taken to keep ra​​diation exposure to a minimum (Section 12 of the Form)

- a statement confirm​​​ing that the site(s) at which the examination or procedure will be performed is actively involved in a relevant quality assurance program; Section 9 of the Form)

- for novel uses of radiation, the arrangements for a review of radiation doses actually ​received and the arrangements for retention of dose records (Section 19 of the Form)

(b) The radiation dose assessment and risk assessment obtained from the RSO;

(c) The written information to be given to research participants relating to the doses and risks associated with the radiation exposure.

3. Submission to the HREC must be via REGIS.

Governance

Investigators conducting research at a NSLHD site involving the use of ionising radiation must follow the below guidance;

When the radiation use does not exceed standard care:

• ​The Principal Investigator must complete and sign a   Radiation in Research Notification to Research Governance and submit it with the governance application in REGIS.

When the radiation use does exceed standard care:

When LEAD HREC is not NSLHD

• Please submit the HREC approved Radiation Risk Report, Protocol and Participant Information Sheet and Consent Form to the NSLHD Radiation Safety Officer (RSO), NSLHD-RNS-RPO@health.nsw.gov.au and request endorsement.
• Please submit the HREC approved Radiation Risk Report with evidence of NSLHD RSO endorsement of this report into REGIS with the site specific governance application.

When Lead HREC is NSLHD

Upload the NSLHD HREC approved Radiation Risk Report into REGIS with the site specific governance application.