ICRP Task Group 126 questionnaire on human medical research using ionizing radiation

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Question Title

* 1. Introduction - Please state which country and, if applicable, state/province your institution is in:

Country

State/Province

Institution

Question Title

* 2. Introduction - How are you involved in studies applying ionizing radiation to human volunteers at your institution? (Please mark all that apply)

Performing studies

Reviewer of studies, e.g. as member of institutional review board (IRB) or ethics committee

Manager at the institution

Regulator/inspector

Not directly involved

Other (please specify below)

Question Title

* 3. Legislative / regulatory issues - What level and structure of requirements on the use of ionizing radiation in biomedical research exists in your country? (Please mark all that apply)

Specific requirements through laws or regulation

General guidelines from authorities/professional bodies

Recommendation by regulatory authorities for voluntary reporting of incidents

Policy/guidelines from my own institution

No requirements/guidelines

Other (please specify below). Optional: If possible, please provide the reference or link to the law/regulation/guideline.

Question Title

* 4. Legislative / regulatory issues - Do requirements/guidelines recommend which level of doses to the human volunteer is justified based on the benefit expected from a research project?

Info: Standards could be based for instance on ICRP 62, NCRP 185 or US Code of Federal Regulations (21CFR361.1, FDA).

Yes, for healthy volunteers

Yes, for patient volunteers

Yes, for both healthy and patient volunteers

Question Title

* 5. Legislative / regulatory issues - What, if any, constraints on the radiation doses allowed in biomedical research exist in your country or at your institution for each category of human volunteer subjects?

	For patient volunteers	For healthy volunteers	For pregnant volunteers	For children
No constraints	No constraints For patient volunteers	No constraints For healthy volunteers	No constraints For pregnant volunteers	No constraints For children
Constraint on the dose to the human volunteer in each Individual study	Constraint on the dose to the human volunteer in each Individual study For patient volunteers	Constraint on the dose to the human volunteer in each Individual study For healthy volunteers	Constraint on the dose to the human volunteer in each Individual study For pregnant volunteers	Constraint on the dose to the human volunteer in each Individual study For children
Constraint on the combined dose to the human volunteer from all studies over certain time period, e.g. during one year	Constraint on the combined dose to the human volunteer from all studies over certain time period, e.g. during one year For patient volunteers	Constraint on the combined dose to the human volunteer from all studies over certain time period, e.g. during one year For healthy volunteers	Constraint on the combined dose to the human volunteer from all studies over certain time period, e.g. during one year For pregnant volunteers	Constraint on the combined dose to the human volunteer from all studies over certain time period, e.g. during one year For children
Other	Other For patient volunteers	Other For healthy volunteers	Other For pregnant volunteers	Other For children
Unknown/not applicable	Unknown/not applicable For patient volunteers	Unknown/not applicable For healthy volunteers	Unknown/not applicable For pregnant volunteers	Unknown/not applicable For children

If other, please elaborate. Or add further comments:

Question Title

* 6. Legislative / regulatory issues - Are the constraints on the radiation doses allowed in biomedical research (cf. answers provided to question 5) set through national regulation or by rules of your institution?

Through regulation

By your institution

Both (regulation and institution)

Other (please specify)

Question Title

* 7. Legislative / regulatory issues - How is the adherence to specific guidelines issued by regulatory bodies/professional bodies monitored? (mark all that apply)

By a board set up within the institution, e.g. institutional review board (IRB)

By regulatory inspections

By professional bodies via accreditation

Other (please specify)

Question Title

* 8. Legislative / regulatory issues - Are the general guidelines (such as radiation protection knowledge on institutional review boards, IRBs) by professional bodies in your country/region strictly followed?

	1 (Totally disagree)	2	3	4	5 (Totally agree)
Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree)	Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree) 1 (Totally disagree)	Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree) 2	Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree) 3	Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree) 4	Indicate agreement on a scale from 1 (totally disagree) to 5 (totally agree) 5 (Totally agree)

Comments:

Question Title

* 9. Management issues - Is a medical physicist and/or a radiation safety specialist required in the review and approval of research proposals that involve ionizing radiation by regulations/guidelines?

Always

Depends on the type of study, e.g. including expected doses

Other (please specify)

Question Title

* 10. Management issues - Are there special requirements for departments/facilities that carry out imaging or radiotherapy research of human volunteers in your country?

None

Specific license or similar from a government agency is required

Researchers are required to undergo regular training in human subjects’ research ethics, e.g. prior to research and every 2-3 years

Other. Please specify in the box below

Question Title

* 11. Human volunteer-related issues - Are volunteers in biomedical research receiving any financial reward?

No, never

Usually not, possible in certain studies

In most studies, but not always

Yes, always

I do not know

Please provide details on the financial reward or on other types of incentives in the box below:

Question Title

* 12. Human volunteer-related issues - How is the radiation dose and radiation safety of the human volunteers evaluated in the process of setting up biomedical research involving exposure to ionising radiation? Evaluated by (mark all that apply)

general (e.g. national or regional) ethics committee for clinical research, with radiation experts on the committee

general ethics committee for clinical research, where external radiation experts can be consulted

local ethics committee (e.g. IRB) for clinical research, with radiation experts on the committee

local ethics committee for clinical research/trial protocols, where external radiation experts can be consulted

general/local ethics committee for clinical research/trial protocols, without involvement of radiation experts

a separate radiation safety committee (e.g. part of the radiation protection authority)

Not routinely evaluated

Comment:

Question Title

* 13. Human volunteer-related issues - What kind of information on radiation dose and associated risk is provided as part of the process of obtaining informed consent? (mark all that apply)

Informed consent specific to radiation is not required

Estimated radiation exposure (doses for the research and for any routine imaging required for the study)

Estimated radiation exposure and associated potential risk

Balance of risk including radiation risk and expected benefit from research

Other (please specify)

Question Title

* 14. Please provide any further comments or information:

Question Title

* 15. Optional: please provide contact details (name, email address, and affiliation) in case of follow-up questions.
Thank you very much for your participation.

Name

Affiliation

Email Address

ICRP Task Group 126 questionnaire on human medical research using ionizing radiation

Question Title

* 1. Introduction - Please state which country and, if applicable, state/province your institution is in:

Question Title

* 2. Introduction - How are you involved in studies applying ionizing radiation to human volunteers at your institution? (Please mark all that apply)

Question Title

* 3. Legislative / regulatory issues - What level and structure of requirements on the use of ionizing radiation in biomedical research exists in your country? (Please mark all that apply)

Question Title

Question Title

* 5. Legislative / regulatory issues - What, if any, constraints on the radiation doses allowed in biomedical research exist in your country or at your institution for each category of human volunteer subjects?

Question Title

* 6. Legislative / regulatory issues - Are the constraints on the radiation doses allowed in biomedical research (cf. answers provided to question 5) set through national regulation or by rules of your institution?

Question Title

* 7. Legislative / regulatory issues - How is the adherence to specific guidelines issued by regulatory bodies/professional bodies monitored? (mark all that apply)

Question Title

* 8. Legislative / regulatory issues - Are the general guidelines (such as radiation protection knowledge on institutional review boards, IRBs) by professional bodies in your country/region strictly followed?

Question Title

* 9. Management issues - Is a medical physicist and/or a radiation safety specialist required in the review and approval of research proposals that involve ionizing radiation by regulations/guidelines?

Question Title

* 10. Management issues - Are there special requirements for departments/facilities that carry out imaging or radiotherapy research of human volunteers in your country?

Question Title

* 11. Human volunteer-related issues - Are volunteers in biomedical research receiving any financial reward?

Question Title

* 12. Human volunteer-related issues - How is the radiation dose and radiation safety of the human volunteers evaluated in the process of setting up biomedical research involving exposure to ionising radiation? Evaluated by (mark all that apply)

Question Title

* 13. Human volunteer-related issues - What kind of information on radiation dose and associated risk is provided as part of the process of obtaining informed consent? (mark all that apply)

Question Title

* 14. Please provide any further comments or information:

Question Title

* 15. Optional: please provide contact details (name, email address, and affiliation) in case of follow-up questions.Thank you very much for your participation.

* 15. Optional: please provide contact details (name, email address, and affiliation) in case of follow-up questions.
Thank you very much for your participation.