National and Provincial Regulations Govern the Use of Radioactive Material and Radiation

1INTRODUCTION

National and provincial regulations govern the use of radioactive material and radiation emitting devices (x-rays). These regulations state that the organization must be in care and control of radioactive material at all times and that all personnel using such material must be properly trained. The organization must also make every effort to reduce radiation exposure to staff, patients and visitors to as low as reasonably achievable in compliance with the regulations. Failure to abide by the regulations can result in loss of licences, jail terms and fines up to $1,000,000.

Research applications must indicate if radioactive material or x-ray devices will be used in the research protocol. The application should also demonstrate that every effort has been made to reduce exposures as low as reasonably achievable and inform the research candidate regarding the procedures they will be receiving. For the most part, there should not be a major impact on research being conducted.

2.RESEARCH GROUPS

There are two main considerations when radiation safety programs group research. Capital Health and Research Ethics Boardpolicies, procedures and guidelines apply to both groups. Additionally, special human research licence requirements apply to research in normal volunteers.

Research in Patients with Pre-existing Conditions: This group refers to patients who already have a medical condition where the procedure that uses radiation devices or nuclear substances forms part of the diagnosis or treatment for that condition. Research in this group does not fall under the human research licence requirement but still must follow all Ethics Board and Radiology Research Office requirements.

Research in Normal Volunteers:Licences issued by the federal government are required for institutions conducting research using nuclear substances on normal volunteers for purposes not connected with the volunteer’s personal medical health. Capital Health policy defines this as administering nuclear substances to a normal volunteer when it is not for the person’s possible examination, diagnosis or treatment. Research in this group must follow all Ethics Board and Radiology Research Office requirements as well as any additional conditions specified in the human research licence issued to the institution.

3.LICENCE /PERMITS

Research should be conducted using established clinical procedures and authorized users under existing licences issued to the institution. Most research involving humans meets this criterion. Any deviation from this practice may require a review of the procedure by the Radiation Safety Committee. This may result in extra conditions placed on the project.

Projects involving the use of radioactive material, where researchers do not have appropriate training or do not use authorized personnel and procedures under an existing licence, may be required to obtain a user permit through the Radiation Safety Committee. The permit authorizes an individual to operate under the authority of the Radiation Safety Committee using an existing Nuclear Substance Licence. Research using established clinical protocols and current authorized users do not generally require a permit. The decision regarding the requirement of a permit rests with the Radiation Safety Committee.

If a user permit is required, the researcher will be required to complete a ‘Radioisotope User Permit Application Form and Guide’. The guide is available from the Radiation Safety Office and provides information on each section of the application form. For more information on the licence process see Section 15 Licence and Permits.

4.ETHICS

Research Ethics Boards

A human research review committee must have the authority and resources to provide protection to participants in research studies. These committees must have a process and criteria by which the human research studies are assessed. Points to be considered are:

• feasibility of the planned research
• applicability and scientific merit of the research
• moral and ethical standards of the research

Where the research involves the use of ionizing radiation, a radiological protection review should be a part of the process to include:

• scrutiny of the potential radiological consequences
• determining effective doses to the participants
• describing the procedure, effective dose and any risks in the consent process
• the ability to hold final approval of research proposals until a radiological review is complete

The radiological review process can have many formats such as:

• application forms, specific to radiological procedures, to accompany the ethics application
• having knowledgeable individuals screen proposals where radiation is used
• having individuals who use radiation sit on the ethics review committee
• ethics review committees seeking advice as needed from the radiation safety committee

5.RADIOLOGICAL PROTECTION REVIEW

For radiation protection purposes, research studies should receive a depth of scrutiny proportional to the potential radiological consequences and reflecting ethical care in the effective radiation dose to participants. Studies using established normal clinical procedures still require a review to determine the amount of radiation exposure a patient may receive above and beyond the normal clinical care they would receive if they were not enrolled in the study.

Determining a Review

A process should determine if any category of review is required. This can include a simple check on an ethics screening form. This is to identify if radioactive material or radiation emission devices are being used as part of the inclusion criteria or during the study.

Sample:

Categories

If a review is required it can be as simple as an administrative review confirming no extra ionizing radiation is being delivered to the patient or a full review requiring a special permit to be issued.

Category A

Administrative Review:

(note: for research on normal volunteers see Category C)

This category includes studies that generally do not deliver any extra ionizing radiation to the patient. They also use authorized staff and established procedures. If an ionizing radiation procedure is required to enroll the patient in the research then a review should be done.

• The number of clinical studies being performed is the same as if the patient was not enrolled in the research study.
• For studies using nuclear substances, such as nuclear medicine procedures or some cancer treatments, the procedures are performed by registered technologists or authorized users under an existing Canadian Nuclear Safety Commission Nuclear Substance Licence.
• Studies using radiation-emitting devices are performed by registered technologists or authorized users as defined under provincial regulations. Such devices include x-ray units;DPX bone density machines some cancer treatments and angiography procedures such as cardiac catheterization and interventional imaging. This does not include Magnetic Resonance Imaging (MRI) or Ultrasound procedures.
• Procedures performed use established department procedures or established clinical practice.
• Equipment is serviced and evaluated according to existing department quality control programs.

Category B

Minimal Radiation Protection Review:

(note: for research on normal volunteers see Category C)

This category includes studies that will require the patient to have more clinical studies or receive more ionizing radiation exposure than if they were not enrolled in the study. The studies also use authorized staff and established procedures. This also includes cases where a clinical radiation procedure is required to enroll the patient in the research. NOTE: If a normal planned clinical procedure is done as enrollment criteria, the study would fall under administrative review unless the time frame of the normal planned clinical study has expired and the patient is required to have it repeated in order to be enrolled.

• The number of clinical studies being performed is more than the number the patient would receive if they were not enrolled in the research study.
• For studies using nuclear substances, such as nuclear medicine procedures or some cancer treatments the procedures are performed by registered technologists or authorized users under an existing Canadian Nuclear Safety Commission Nuclear Substance Licence.
• Studies using radiation-emitting devices are performed by registered technologists or authorized users as defined under provincial regulations. Such devices include x-ray units;DPX bone density machines some cancer treatments and angiography procedures such as cardiac catheterization and interventional imaging. This does not include Magnetic Resonance Imaging (MRI) or Ultrasound procedures.
• Procedures performed use established department procedures or established clinical practice.
• Equipment is serviced and evaluated using existing department quality control programs.
• The consent form conveys the fact that the patient will be receiving more ionizing radiation exposure than if they were not enrolled in the study.
• The organization’s Ethics Board should ensure that an administrative condition is placed on the application until notified all radiation safety issues have been met.
• Radiation safety approval does not mean that the Ethics Board is obligated to approve the proposal. All other issues regarding the proposal are the jurisdiction of the Ethics Board.

Category C

Full Radiation Protection Review:

This category includes studies that are not using established clinical procedures and may require a change to the organizations radiation use licences. The studies may also require a permit to authorize use under an existing licence and training of staff. A full review will require input from the radiation safety committee and radiation safety personnel to ensure all licence criteria and government regulations are met.

• The organization’s Ethics Board should ensure that an administrative condition is placed on the application until notified all radiation safety issues have been met.
• Radiation safety personnel should determine if a user permit is required to meet licence requirements.
• Radiation safety approval does not mean that the Ethics Board is obligated to approve the proposal. All other issues regarding the proposal are the jurisdiction of the Ethics Board.

Research on Normal Volunteers

All research using radioactive material or radiation emitting devices on normal volunteersis classed as Category C (Full Radiation Protection Review) regardless of the amount of radiation used. The process for the review will depend on the classification of the research. The classification, as defined by federal licence criteria, is based on the radiation dose estimate to the volunteer from the study being performed.

Research on normal volunteers is not permitted if the radiation dose estimates exceed 20 mSv.

The Radiology Research Office is responsible for the review of all proposals as well as the consent form wording prior to submission to the Research Ethics Board. Final proposals to the Research Ethics Board must also be reviewed by the Radiology Research Office if any changes have been made to the proposal or consent form.

• Radiology Research Office review of proposal and consent form
• Radiology Research Office review of final submission to Research Ethics Board

• Radiology Research Office review of proposal and consent form
• Consultation with Capital Health Radiation Safety Officer
• Radiology Research Office review of final submission to Research Ethics Board

• Radiology Research Office review of proposal and consent form
• Consultation with Capital Health Radiation Safety Officer
• Review of proposal by Radiation Safety Committee
• Radiology Research Office review of final submission to Research Ethics Board

6.JUSTIFICATION OF PROCEDURES

All radiation use must be optimized and justified as part of the ALARA principle. This principle states that all radiation exposure should be kept as low as reasonably achievable. Medical procedures using ionizing radiation can deliver a significant radiation dose to the patient. While the benefit of diagnosis outweighs the risk for clinical procedures, excessive use of ionizing radiation should be monitored in keeping with the ALARA principle. This is particularly true in research where extra exposure to radiation may not be justified.

Every effort must be made to use procedures or techniques that minimize the use ionizing radiation. Choices to be considered include using ultrasound or MRI over x-rays and CT scans. Other options could include reducing the number of procedures required for the study. Would it be possible, for example, to do one procedure every two months instead of one a month?

Number and Frequency

This category should identify the procedures that would normally be done for the patient condition as well as any extra procedures required for the research study. The frequency can be used to determine the radiation dose to the patient.

Type of Procedures

The type of procedure affects the radiation dose to the patient. Estimates of radiation dose are based on average procedures so it is important to use established clinical procedures using authorized staff. Sample lists of procedures can be provided to assist researchers in determining if a procedure is an ionizing radiation procedure or not.

Radiation Dose Estimates

It is important to obtain an estimate of the radiation dose a patient will be receiving. This will determine the language of the consent form and provide documented information should a review be required. Sample lists of dose estimates for common procedures can be provided to assist researchers in determining a total dose estimate. Medical physicists or radiation safety personnel can also be consulted to provide this information.

VanderbiltUniversity HSRC/RDRC

Radiation Dose Calculator and Consent Language Generator

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This site gives radiation dose estimates for certain radiographic and nuclear medicine procedures, based on literature reported values. Individual organ doses and total body effective doses are given for these specified examinations, and some combinations of examinations. In addition, a short statement is generated, which may be useful as part of a patient consent form document, explaining the radiation doses as numerical values and as equivalent days of exposure to natural background radiation.

SAMPLE OF IONIZING RADIATION PROCEDURES AND DOSE ESTIMATES

(For procedures not listed consult with medical physics or radiation safety personnel)

Common Procedures Requested for Research

actual effective dose varies with individual/technique or dose

6.PATIENT CONSENT

Consent forms should accurately describe any procedure that uses ionizing radiation and also any radiological risk associated with the procedures. The consent process would be different for research patients who already have a medical condition from normal volunteers being asked to undergo procedures using ionizing radiation.

It is difficult to describe every possible combination of procedures but general statements should be made about the amount of ionizing radiation a patient will receive. Consent wording should be described in reference to other procedures the patient may have had, to some radiation limits placed on workers in the medical field, or to background radiation we all receive on a day to day basis. It is up to the researcher to decide the approach they wish to take on the wording.

Sample Wording

The following are a few examples of basic radiation risk statements that can form the basis for a patient consent form.

“You will receive (fill in number) (fill in procedure) procedure(s) in this study. This procedure uses x-rays (or radioactivity) which will expose you to radiation. This radiation is not necessary for your medical care and is for research purposes only. This procedure will be done using established procedures of this institution and be performed by authorized persons. The amount of radiation dose that you will receive is no more than the limits set by government regulations for any member of the general public.