Download Use of Ionising Radiation for Research in Humans

ACT Health
Human Research Ethics Committee
Use of Ionising Radiation for Research in Humans
To submit your Radiation Safety Application please email this form with the following documents

Study Protocol (eg Ethics application and investigation schedule)

Participant Information Sheet and Consent form
to the Radiation Safety Officer (RSO) at [email protected] and [email protected]
Note: As of June 2005, the radiation dose to a participant from exposures additional to standard clinical care must
be assessed or verified by a medical physicist approved by the regulatory authority. If this dose exceeds the levels in
the ARPANSA Code of Practice Exposure of Humans to Ionising radiation for research purposes [rps8] – see part E
below – the proposal must be assessed by a second medical physicist independent of the study and the HREC may
seek further authoritative advice.
Glossary
ARPANSA
Australian Radiation Protection and Nuclear Safety Agency
Medical physicist
A person qualified to perform radiation dosimetric calculations, measurements and monitoring and that
has been approved by a regulatory authority to make estimates in a speciality relevant to the research
project.
Participant
A person taking part in a research project.
Radiation Safety
Officer (RSO)
The responsible person at an institution for safety of radiation sources and the use of radiation at the
institution.
Volunteer
A participant that receives no benefit from radiation exposure incurred in the course of a research project
and where such exposure does not form part of their standard clinical care.
PI
PICF
Primary Investigator
Participant Information and Consent Form
Definitions (Typical ionising radiation procedures encountered in research)
Bone Scan
A bone scan is a test that is performed by injecting an unsealed radioactive substance (radiolabeled
substance) into a vein. This substance is preferentially absorbed by bone, particularly by areas of high
bone activity.
CT
Computed tomography: scans involving a 360-degree rotation of an x-ray beam and the computer
generation of images. These scans allow for cross-sectional views of body organs and tissues.
DEXA or DXA
Dual Energy X-ray Absorptiometry (uses X-rays to provide a quantitative assessment of bone density)
MUGA
Multiple Gated Acquisition Scan; A technique used to evaluate the heart's ability to respond to physical
stress. Uses unsealed radioactive substances in the diagnosis.
Nuclear Medicine
Nuclear medicine is the branch of medicine that uses unsealed radioactive substances in diagnosis and
therapy.
Positron Emission
Tomography (PET)
Uses an injected unsealed radioactive substance to produce a three-dimensional image of functional
processes in the body.
Skeletal Survey
Uses X-rays to image the body to review the skeleton of the volunteer.
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SECTION 1: Applicant to complete
Item A - APPLICANT DETAILS
(a)
Primary investigator Contact details
Name
Position
Email
Phone (Business)
Phone (Mobile)
Co-ordinator Name
Co-ordinator Email
Co-ordinator Phone
(b)
Research Project Details
Institution/Hospital
Project Title
Reviewing HREC
HREC Ref Number
New/ amended protocol
Choose an item.
Study Protocol Number
List of participating facilities
Study commencement date
Duration of a volunteer’s participation in research (average transit time
of an individual through research) (years and months)
(c)
Average
Maximum
Principal Investigator (PI) Declaration
I accept responsibility for the conduct of this research project according to the principles of the National Statement
on Ethical Conduct in Human Research published by the National Health & Medical Research Council (March 2007),
the requirements of the ‘Code of Practice - Exposure of Humans to Ionising Radiation for Research (2005)’
published by ARPANSA and the recommendations of the medical physicist.
Name
PI Signature
Date
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Item B - RADIATION IMAGING SITE DETAILS
Please contact the Radiation Imaging Site Licensee(s) for the following information.
(a) Radiation Licensee – Facility 1
Name of Facility
Name of Licensee
Licence Number and type
Date of Expiry (dd/mm/yy)
Are the proposed procedures (Section E) covered in the site license conditions?
Choose an item.
What Quality assurance programs is the site is actively involved?(eg RANZCR, ANZAPNM)
Site Contact Name
Position
Email
Phone (Business)
Phone (Mobile)
Licensee Signature
Date
(b) Radiation Licensee – Facility 2 (If applicable)
Name of Facility
Name of Licensee
Licence Number and type
Date of Expiry (dd/mm/yy)
Are the proposed procedures covered in the site license conditions?
Choose an item.
Which quality assurance programs is the site is actively involved?(e.g RANZCR)
Site Contact Name
Position
Email
Phone (Business)
Phone (Mobile)
Licensee Signature
Date
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Item C - CLASSIFICATION OF PARTICIPANT RADIATION EXPOSURE
Please provide details about the classification of radiation exposure those participants (including volunteers)will
receive.
(a) If a participant was not enrolled in this clinical trial, would they still receive the same number of procedures
involving the use of ionising radiation at the specified intervals as stated in the research protocol?
Yes
(i)
(Refer to (i))
No
(Refer to (ii))
If Yes, then these examinations are considered to be standard care for the participant.
For ionising radiation protection deemed to be standard clinical care:
Standard clinical care is defined as the typical or routine management of the patient with a recognised medical condition.
When considering whether the management is standard clinical care the following items need to be taken into account:

The type and number of radiation procedures being performed.

The frequency or time interval between the radiation procedures.

The body part being exposed to radiation.
It is only when the above points are equivalent regardless of the persons involvement in the research that the
procedures are deemed to be standard clinical care.
In this instance the following sections MUST be completed :



Classification
Participants
Procedures.
It is the responsibility of the researcher to ensure their interpretation is accurate. If any doubts or concerns exist an
approved medical physicist should be consulted.
(ii)
If No, these procedures would be deemed to be in addition to standard clinical care.
For ionising radiation procedures deemed to be in addition to standard clinical care:
Any exposure to ionising radiation beyond that considered standard clinical care of the condition being treated.
Radiation exposure that is requested specifically for research purposes only, for example use of different modalities to
perform imaging (i.e. CT instead of general X-ray), increased frequency of radiological examinations being performed,
additional ionising radiation procedures to monitor adverse outcomes (e.g. heart conditions), examinations being
performed solely to exclude a volunteers participation in a clinical trial, or imaging of additional body regions.
In this instance the following sections MUST be completed:









Classification
Participants, Procedures
Radiation Assessment
Procedure Description
Categories of Risk & Dose
Expected Societal Benefit
Participant Information Risk Statements
Regulatory Details
Certification.
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Item D - PARTICIPANT INFORMATION
(a)
Are all radiation procedures and/or therapies part of ‘standard clinical care’?
(b)
How many participants will be included in this research proposal (both experimental and controls)?
(c)
Are there any specific exclusions from study (both experimental and controls)?
(d)
What is the minimum age of participants irradiated?
Yes
No
(i) If the study involves participants under the age of 18, please justify
(e)
Will women who are pregnant or breastfeeding be irradiated in this research?
Yes
No
Yes
No
(i) If the study involves pregnant or breastfeeding women, please justify
(f)
Will babies, infants or foetuses be irradiated in this research?
(i) If Yes, provide a detailed justification.
(Note that research projects involving irradiation of babies, infants or foetuses are generally not justified unless
the information sought is essential and cannot be obtained by other means.)
(g)
Is the median life expectancy of the participants less than five years?
Yes
No
(i) If Yes, state median life expectancy
(h)
Benefit to participate (please select one of the following options)
Persons with no known or relevant disease who are unlikely to benefit from participating in the study
Persons with relevant disease who are unlikely to benefit from participating in the study
Persons with relevant disease who may benefit from participating in the study
(i) Please explain the benefit(s) for the individual and society that can be expected to accrue from this research
and why the radiological investigations are required. This information should be provided to the medical
physicist to assist in the preparation of the report.
(i)
What is the expected median age of the participants?
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Item E - PROCEDURES INVOLVING THE USE OF IONISING RADIATION
List all procedures involving ionising radiation in your project. Include and identify procedures deemed to be
‘standard care’ and those procedures that are ‘additional to standard care’ and are required because of the
participant’s inclusion in the research. Add rows for projects involving more than eight different types of ionising
radiation procedures.
(a)
Detail the type, number and frequency of ionising investigations
Type of Procedure
Number
Performed per
year*
Facility
Example: CT exam of chest
x3
Deemed to be:
(please mark one only)
Additional to
Standard
Standard
Care
Care
1
2
3
4
5
6
7
8
*Where the exact number of procedures is not known, please indicate the anticipated average and maximum
number likely to be performed over the duration of the research. Indicate “(Avg)” & “(Max)” next to value stated.
(i) Additional Comments (if necessary)
(b)
Procedure Details
Please list all of the procedures involving radiation that are additional to ‘standard clinical care’ in your project.
(Please duplicate table if necessary)
Type of Procedure
1
2
3
4
5
(c)
Procedure 1
Procedure 2
Procedure 3
Type of investigation
Will all participants undergo this investigation?
Institution at which the Procedure will be performed?
Radionuclide
Activity to be administered [MBq]
Please provide details of machine/s protocols screening time and other technique factors for exposures,
sufficient to estimate the radiation dose (eg, CT: Manufacturer, Model Number, CTDI, DLP)
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(d)
Please provide details of RADIOPHARMACEUTICAL and administered activity for exposures, sufficient to
estimate the radiation dose
(e)
Please identify the precautions which will be taken to ensure radiation exposures are kept to the minimum,
particularly for procedures in children, adolescents and women of reproductive capacity
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Section 2: MEDICAL PHYSICS TO COMPLETE
Item A - RADIATION ASSESSMENT
(a)
Has an approved medical physicist assessed the application and written a report on the doses and risks
involved?
Yes
No
(i) If Yes, provide the medical physicist’s details and complete the written report in the form appendix.
Medical Physicist
Institution
(ii) If No, please organise to have an assessment carried out in order for it to be forwarded to the HREC
Secretary.
Note: The ARPANSA Code of Practice – Exposure of Humans to Ionising Radiation for research Purposes,
Radiation Protection Series Publication No. 8 (May 2005) requires that:
 The investigators submit to HREC calculations of the total effective dose, relevant organ doses and
associated risk information for provision to participants.
 Dose calculations and risk assessments submitted to HREC’s must be independently verified by a medical
physicist (approved to perform that type of assessment by the NSW EPA, Hazardous Materials, Chemicals
and Radiation Section).
 Verification of the doses by a second medical physicist must also be obtained where doses are in excess of
the dose constraints.
(iii) Medical physicist’s written report (see appendix).
(iv) Have the dose constraints been exceeded?
Yes
No

If Yes, provide the details of the second medical physicist that has verified the initial dosimetry
calculations performed.
Second Medical Physicist
Institution
(b)
Certification by an approved medical physicist
I have reviewed the information in Sections Participants and Radiation Assessment and I am satisfied that the
information is accurate and that it complies with the recommendations of:
(ARPANSA) RPS 8. Code of Practice – Exposure of Humans to Ionising Radiation for Research Purposes Radiation
Protection Series Publication No. 8 (May 2005).
Medical Physicist Name
Signature of Medical Physicist
Date
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Item B – RADIATION DOSE AND RISK ASSESSMENT
(a) Estimation of radiation dose for those procedures which are required for both research and standard clinical
care: (see appendix below for calculations).
(i) Standard Care Procedures
Procedure (eg. CT, DEXA)
Max no. for any participant in 1
year
Max no. for any participant over 5
years
Effective Dose per examination
(mSv)
Effective Dose per year
Effective Dose over 5 years
Dose to significant organ(s)
Total Effective Dose per year
Total Effective Dose over 5 years
(ii) Research Procedures
Procedure (eg. CT, DEXA)
Max no. for any participant in 1
year
Max no. for any participant over 5
years
Effective Dose per examination
(mSv)
Effective Dose per year
Effective Dose over 5 years
Dose to significant organ(s)
Total Effective Dose per year
Total Effective Dose over 5 years
(b)
Please identify the precautions that are required keep radiation exposures to the minimum
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Item C - CATEGORIES OF RISK AND DOSE
This section is for ionising radiation ‘additional to standard clinical care’ only.
(a)
Please choose the level of dose and risk from the table below. The medical physicist will provide advice.
Level of risk
Minimal
Risk category
Effective Dose
range (mSv)
Expected benefit to
society
< 0.2
Minor
(~ 10-5 or less)
I
Very Low
IIa (~ 10-5 to 10-4)
≥ 0.2 𝑎𝑛𝑑 < 2
Intermediate
Low
IIb (~ 10-4 to 10-3)
≥ 2 𝑎𝑛𝑑 ≤ 20
Moderate
> 20
Substantial
Moderate
III
(~ 10-3 or more)
Total Radiation
Risk (please tick
one box)
(b) Please complete the table below. Risk estimates by age and gender can be found in Annex 1, table 2, RPS
No.8.
Age of participants
Risk Male (Deaths (10-2 Sv-1)
Risk Female (Deaths (10-2 Sv-1)
Median =
< 20 yrs
> 50 yrs
(c)
Please provide a description of radiation dose and risk for the Participant Information Sheet:
Dose constraints: An effective dose of 5 mSv in any year for all persons, except for persons of any age with a life
expectancy of less than 5 years, then the risk constrain is set at an effective dose of 50 mSv. The effective dose
constraint for up to 5 years is 10 mSv. See Ref Table 1 RPS No. 8.
(d) Certification by an ACPSEM registered Medical physicist
Medical Physicist Name
Signature of Medical Physicist
(e)
Date
Please provide an additional signature if the protocol requires the review of a second ACPSEM registered
medical Physicist
Medical Physicist Name
Signature of Medical Physicist
Date
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Item D - RADIATION SAFETY OFFICER TO COMPLETE
(a)
Date application received (dd/mm//yy) : __/__/__
(b)
Radiation dose and risks have been assessed or verified by approved medical physicist
Yes
(c)
The dose estimates are within the dose constraints of the ARPANSA Code of Practice
Yes
(d)
No
The dose estimates have been verified by second independent medical physicist
Yes
(e)
No
No
The Participant Information Statement contains an appropriate description of radiation risk
Yes
No
(f)
The researcher should include in Progress Reports to the Ethics Review Committee the actual radiation doses
received by participants
Yes
No
(g)
Additional Comments:
(h)
Radiation Safety Officer Certification
RSO Approval
Yes
No
Radiation Safety Officer Name
Signature
Date
RSC review Date
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Appendix - MEDICAL PHYSICS CALCULATIONS
Please provide your calculations for each of the following:
(a)
Max no. for any participant in 1 year
(b)
Max no. for any participant over 5 years
(c)
Effective Dose per examination (mSv)
(d)
Effective Dose per year
(e)
Effective Dose over 5 years
(f)
Dose to significant organ(s)
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(g)
Total Effective Dose per year
(h)
Total Effective Dose over 5 years
(g)
Please provide a list of your references:
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