Research Involving Ionising Radiation

January 2015

Radiation Safety

Ionising Radiation Declaration form.

RESEARCH INVOLVING IONISING RADIATION

Human Participants Only

This form should be completed when a research project involves the use of ionising radiation1 to patients or normal volunteers. After completing the appropriate sections of this declaration, either send a signed copy via internal mail (Radiation Safety Officer, c/o Pathology Department) or email to the Radiation Safety Officer at Omission of information may delay processing.

Applicants should note that the proposal will be assessed against the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Exposure of Humans to Ionizing Radiation for Research Purposes, Radiation Protection Series No. 8 (RPS8) Code of Practice (CoP). Please download the RPS8 CoP for your reference2.

Ionising Radiation Declaration (IRD) Guidelines are available on the intranet.

SECTION 1: APPLICATION SUMMARY

1.  DATE OF APPLICATION:
2.  NAME OF PRINCIPAL INVESTIGATOR:
/ CONTACT DETAILS.:
3.  NAME OF TRIAL COORDINATOR:
/ CONTACT DETAILS.:
4.  DEPARTMENT:
5.  TITLE OF STUDY:
6.  RESEARCH OFFICE REFERENCE: ______/ /______
7.  IS THIS A NEW OR AMENDED PROTOCOL?
8.  IS THIS PART OF A MULTICENTRE TRIAL?
YES NO
IF YES, LIST OTHER AUSTRALIAN PARTICIPATING CENTRES OR ATTACH LIST
9.  WHERE WILL THE PROCEDURES BE CARRIED OUT?
(If any of the procedures will be performed outside of your institution, a statement must be attached from the Director of each site confirming that the site is actively involved in a quality assurance program of the relevant professional body)

1.  A list of CHW ionising radiation applications has been created & is available at Sources of Ionising Radiation - CHW

2.  Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Exposure of Humans to Ionizing Radiation for Research Purposes, Radiation Protection Series No. 8 (RPS8) http://www.arpansa.gov.au/Publications/codes/rps8.cfm

*Note that the ARPANSA Code has suggested wording for patient information, based on expected radiation dose. It is also suggested that, if relevant, additional information be considered regarding the post-discharge period, such as protection of family members, travel, work etc. Assistance can be obtained from the Radiation Safety Officer if needed.

SECTION 2: IONISING RADIATION PROCEDURES

Before filling in the following information, please refer to Table 1 to determine which CHW department performs the required procedures.

Table 1: Ionising Radiation Modalities at CHW by Department

Department / Modalities at CHW
Medical Imaging / ·  Computed Tomography
·  Fluoroscopy
·  X-rays
·  MRI and Ultrasound (non-ionising radiation)
Nuclear Medicine / ·  Bone Mineral Densitometry (BMD and pQCT)
·  Radioisotope/radiopharmaceutical imaging
·  Unsealed radiotherapy
·  PET imaging (conducted at Westmead Adults)
Please confirm individual imaging techniques with Nuclear Medicine staff.
Radiotherapy / ·  All external beam therapies for patients from CHW are performed at CPMCCC Westmead.
·  Unsealed therapies may be performed within Nuclear Medicine at CHW.

MEDICAL IMAGING/RADIOLOGY PROCEDURES

PROCEDURES TO BE PERFORMED:
NO. OF PROCEDURES PER SUBJECT: / Clinical Management/Care:
Research:

HAS THE DEPARTMENT OR PRACTITIONER BEEN INFORMED OF THEIR INVOLVEMENT IN THIS STUDY?

YES NO

PLEASE PROVIDE THEIR CONTACT and RADIATION LICENCE DETAILS.

Contact Name:
Position:
Telephone:
Email:
NAME OF RADIATION LICENSEE(S):
RADIATION LICENCE NUMBER:
DATE OF EXPIRY:
CONDITIONS OF LICENCE (eg IA4):
SIGNATURE OF LICENSEE:

NUCLEAR MEDICINE PROCEDURES

PROCEDURES TO BE PERFORMED:
NO. OF PROCEDURES PER SUBJECT: / Clinical Management/Care:
Research:

HAS THE DEPARTMENT OR PRACTITIONER BEEN INFORMED OF THEIR INVOLVEMENT IN THIS STUDY?

YES NO

PLEASE PROVIDE THEIR CONTACT and RADIATION LICENCE DETAILS.

Contact Name:
Position:
Telephone:
Email:
NAME OF RADIATION LICENSEE(S):
RADIATION LICENCE NUMBER:
DATE OF EXPIRY:
CONDITIONS OF LICENCE (eg IA4):
SIGNATURE OF LICENSEE:

RADIOTHERAPY PROCEDURES

PROCEDURES TO BE PERFORMED:
NO. OF PROCEDURES PER SUBJECT: / Clinical Management/Care:
Research:

HAS THE DEPARTMENT OR PRACTITIONER BEEN INFORMED OF THEIR INVOLVEMENT IN THIS STUDY?

YES NO

PLEASE PROVIDE THEIR CONTACT and RADIATION LICENCE DETAILS.

Contact Name:
Position:
Telephone:
Email:
NAME OF RADIATION LICENSEE(S):
RADIATION LICENCE NUMBER:
DATE OF EXPIRY:
CONDITIONS OF LICENCE (eg IA4):
SIGNATURE OF LICENSEE:

SECTION 3: CHARACTERISATION OF THE STUDY GROUPS

Category of subjects:
  Persons with no known or relevant disease who are unlikely to benefit from participation in the study (including normal volunteers)
  Persons with relevant disease who are unlikely to benefit from participation in the study.
  Persons with relevant disease who may benefit from participation in the study.
*  Total numbers:
*  Age groups:
*  Sex:

SECTION 4: DOSIMETRY

HAS ANY RADIATION DOSIMETRY BEEN PERFORMED?

YES NO

IF YES, PLEASE INCLUDE OR ATTACH DETAILS INCLUDING THE NAME OF THE MEDICAL PHYSICIST

IF THE STUDY INVOLVES A “NOVEL USE OF RADIATION”, DETAIL THE ARRANGEMENTS FOR A REVIEW OF THE RADIATION DOSES ACTUALLY RECEIVED:

For all Human Uses (patient or volunteer)

ARPANSA Code of Practice Requirements (RPS8 paragraph in brackets)

1.  State reasons why it is necessary to expose human participants to ionising radiation for the purpose of this research (eg; to document change, results, child growth etc) (2.1.7(a)).
2.  Please describe the proposed benefits to participants or new information being gained through the use of ionising radiation in this study.
3.  If the investigations are being performed off site to CHW, is that site actively involved in a relevant QA program? Please check with service provider. (2.1.7(c)) and see requirements in Section 1, question 9.
4.  Is the life expectancy of participants less than 5 years? If so, please indicate the section of the protocol to support this.
5.  .SUBMITTED BY: (capacity within study) ______
NAME: ______SIGNATURE: :______
DATE: ______CONTACT No.:______

CHECKLIST:

□ A copy of the study protocol is attached/included

□ A copy of the parent & patient information statement is attached/included – ( See RPS8 section 2.1.7(e), and Annexes 1 and 2 for suggested wording)

□ A copy of the consent form is attached/included

□ A copy of an independent dose assessment is attached, if available (eg from the study sponsor)

□ Quality Assurance documentation (if required)

Radiation Safety Officer to complete: Dosimetry Assessment

TITLE OF STUDY:
DATE RECEIVED: CHW HREC ref No.:
NAME OF THE MEDICAL PHYSICIST PROVIDING THE INITIAL ASSESSMENT:
ARE DOSE CONSTRAINTS EXCEEDED (RPS 8)?
NAME OF THE MEDICAL PHYSICIST PROVIDING THE INDEPENDENT DOSIMETRIC ASSESSMENT:
(Report to be attached)
DOES THE PARTICIPANT INFORMATION SHEET AND CONSENT FORM CONTAIN THE APPROPRIATE DESCRIPTION OF RISK?
ARE NOVEL USES OF RADIATION BEING USED IN THIS RESEARCH?
IF YES, IS THERE A PROCESS FOR RETENTION OF ALL RESEARCH RECORDS?
DOES THIS APPLICATION NEED TO BE SUBMITTED TO THE CHW RADIATION SAFETY COMMITTEE FOR FURTHER REVIEW?
APPROVIAL GIVEN:
COMMENTS/ADDITIONAL INFORMATION FOR THIS APPLICATION:
Signed: ______
Name (RSO): ______
Date: ______

1