formqradiation-uthscsa（10页）.doc

Study Title: IRB Information about the Use of Radiation in Human Research Studies Index (Click link to go to section) I. Guidelines for Radiation Risk Statements II. Radiation Exposure Worksheet o Table I Effective Dose Equivalents for Routine Diagnostic X-Ray Procedures o Table II Effective Dose Equivalents for Routine Diagnostic Nuclear Medicine Procedures III. Calculate Radiation Dosimetry Totals for Routine and Non-Routine Procedures and Identify Risk Category IV. Suggested Comparative Risk Statements o Table A Descriptions of Risk as Applied to Effective Dose o Table B Descriptions of Risk of an Individual Dying (D) in any one year or developing an Adverse Response  Study Title: IRB Information about the Use of Radiation in Human Research Studies (Click here to return to Index) I. Guidelines for Radiation Risk Statements for Clinical Investigation Projects Involving Human Subjects When a participant in a research study is to be exposed to ionizing radiation (other than that which is part of the accepted management of the participant’s medical condition) the consent form must make a disclosure of the type of radiation and its risks. a. It must also include an explanation as to whether the ionizing radiation exposure (dose) will come from an external source or by the administration of radioactive materials. b. For subjects who will not benefit from participation in the study, it must include a statement regarding the long term risks of low dose radiation. The appropriate risk statement should be based on both the effective dose equivalent, HE, (the average effective radiation dose to the total body) and calculated organ dose equivalents (WTHT, where WT = organ weighting factor and HT = organ dose) (see Radiation Exposure Worksheets for further instructions). c. Based on these calculations, the dose due to radiation exposure will be given a category designation. Three (3) categories have been defined using a combination of c