Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes

Version date: 11/19/2020

Under Wisconsin law, the Department of Health Services (DHS) is charged with regulating the receipt, use, transfer, possession, ownership or acquisition of sources of radiation. Currently, under DHS regulations pertaining to Radiation Protection, no persons may be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts [DHS 157.74(2)(f)]. “Healing arts” means a profession concerned with diagnosis and treatment of human maladies, including the practice of medicine, dentistry, osteopathy chiropractic and podiatry [DHS 157.03(155)]. The deliberate exposure of an individual to useful beam radiation without prior examination disclosing a need for an x-ray procedure and prescription for such a study by a practitioner of the healing arts is prohibited absent a variance from DHS [DHS 157.03(156)].

Research studies which expose subjects to x-ray radiation as part of standard clinical imaging or which are therapeutic in nature (i.e. those which present the prospect of direct benefit to subjects), do not presently require a variance from DHS. Additionally, no variance is required if the exposure to radiation is for the purpose of subject safety (e.g. x-ray to rule out metal in the body prior to a research MRI). However, if the research study is non-therapeutic in nature or enrolls healthy volunteers, a variance must be requested. The information to be submitted by investigators proposing to conduct a non-therapeutic research study or using healthy volunteers wherein such subjects will be exposed to x-ray radiation is set forth in Appendix M to Chapter DHS 157.

This guidance applies to research studies conducted by University of Wisconsin researchers. VA radiation facilities are not subject to WI state inspections, with all radiation safety related issues at the Madison VA Hospital being handled by federal inspectors and oversight groups. Therefore state radiation safety requirements, and related state DHS variances, do not apply at the Madison VA Hospital. Such studies must comply with VA regulations and undergo radiation safety review as part of the Research and Development Committee review process.

Process for obtaining a variance

Effective November 2020, contact Radiation Safety Review personnel in Environment, Health, and Safety regarding variance requests at The HS IRB is no longer involved in the request process, and it is no longer necessary to upload Appendix M in the ARROW application.

More information about radiation safety review is available through the website Human Investigations Involving Radiation.

Keywords:DHS, DHS 157, variance, radiation, x-ray, CT, imaging, healing arts, non-healing arts, therapeutic, non-therapeutic, Appendix M, research   Doc ID:44830
Owner:Monica E.Group:Health Sciences IRBs
Created:2014-11-12 13:02 CSTUpdated:2020-11-19 09:10 CST
Sites:Health Sciences IRBs
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