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What do you need to do to conduct research involving ionizing radiation and human participants?

You will need to obtain approval from the following organisations:

  1. Approval from Monash University Human Research Ethics Committee
  2. If multi-site, approval from other sites' HRECs
  3. If the project involves radiation doses which exceed the constraints listed in Table 1 (of the code) and where there is no direct benefit to the participant,  the will need approval from Department of Human Services Radiation Advisory Committee.  These approvals can be obtained concurrently.  Do not send your application to DHS.  This will be done for you.

To apply to SCERH for approval, you will also need to submit the following documentation:

  3. Evidence of dose calculations by an independent medical physicist
  4. Letter from individual giving radiation dose stating that they agree to comply with the activities provided to HREC and approved by this HREC

The following is a recommended list of steps to take:

  1. Apply for Human Research Ethics Committee approval

    If the project does not involve sites other than Monash University:

    a. You must obtain approval from the Monash University HREC - Standing Committee on Ethics    in    Research involving Humans (SCERH)
    b. You need to complete Form 1 and the Radiation Module
    c. You will need to submit 1 original and 4 copies of the application form and the Radiation ModuleYou will need to submit an application as per the mandatory submission instructions for Form 1.

    If Multi-site:

    d. You may also need to obtain approval from the HREC at the site at which the research is taking place.
    e. Also submit a letter from the site / letter of approval from the site's HREC stating they will provide the facilities required and that they are actively involved in a relevant quality assurance program.

  2. When you apply to SCERH, SCERH will forward a copy of the Human Ethics application (Form 1) and the Radiation Module to the Monash University Radiation Protection Officer.

  3. The Radiation Protection Officer will review the documentation and if appropriate will approve the project for review by SCERH.

  4. SCERH will seek expert opinion to assist them in the review of the application.

  5. If the project involves radiation doses which exceed the constraints listed in Table 1 and where there is no direct benefit to the participant the project will be sent to DHS for review. The RPO will send all documentation to the Department of Human Services Radiation Advisory Committee.  You will be notified that this has been done by email.

  6. The DHS RAC will communicate directly with the researcher.  Please forward SCERH copy of the letter of approval from the DHS RAC.

  7. SCERH may then grant full approval and advise you in writing.

  8. You must notify SCERH when the project is complete so that we can advise the DHS RAC.