Human
Research
MUSC Radiation Safety Office
Guidelines for Human Subject Research Involving Radiation
Investigators who wish to enroll human subjects in research studies that involve the use of radiation producing machines and radioactive material are required to obtain written approval from the MUSC Institutional Review Board (IRB). The instructions and forms required to apply for approval to conduct human research studies are available on the IRB Web Site. Section III, Special Concern Research Areas, of the IRB Human Research Review Application requires investigators using radiation in their study to indicate whether the use of radiation in the protocol is non-routine or routine use.
Routine Radiation Use for Research Purposes
Routine radiation exposure consistent with the standard of care includes studies where the research subject's radiation exposure would be the same, regardless of their participation in the research. Radiation exposure to research subjects that undergo standard diagnostic and therapeutic radiation procedures for patient care purposes in conjunction with the research protocol is considered routine use of radiation. Since the radiation procedure is standard of care and is medically indicated, only IRB approval is required. Investigators must still include a general explanation of the risk of radiation in the consent form.
Non-Routine Radiation Use for Research Purposes
Research protocols involving the non-routine use of radiation require the approval of the MUSC Radiation Safety Office in addition to the IRB. All radiation exposures to research subjects that are not considered standard of care, do not directly benefit the subject and are not medically indicated are considered non-routine. The non-routine use of radiation includes experimental radioactive drugs, experimental radiologic device, FDA approved radiopharmaceuticals or radiologic devices that are used in a manner not specified on the package insert labeling and protocols involving atypical research subject populations. It is the investigator's responsibility to gain approval from both the IRB and the Radiation Safety Office prior to enrolling any research subjects.
To receive authorization to conduct human research studies involving radiation you must:
- Review the Online Training Course for Human Research Investigators
- Complete the Radiation Safety Test for Human Research Investigators
- Submit the Radiation Safety Test to the Radiation Safety Office (301 HOT)
- Complete an IRB Human Research Application found on the IRB Web Site
- For studies that only involve the routine use of radiation, submit the application to the IRB
- For studies that involve the non-routine use of radiation, copies of the protocol and consent form must be submitted to the Radiation Safety Office in addition to submitting the application to the IRB.
Online Training Course for Human Research Investigators
This training course is designed to provide basic radiation safety training to individuals that use radioactive material or radiation producing machines for research in human subject studies. The training includes instruction on obtaining Institutional Review Board and Radiation Safety Office approval for human research studies involving radiation as well as general instruction on radiation protection principles. The Radiation Safety Test for Human Research Investigators is accessed through the last slide of the training course. You must answer at least 75% of the test questions correctly to pass the test. The Radiation Safety Office will notify you of your score once you submit the test. Be sure to complete the information at the top of the test so that we may contact you. To begin the Online Training Course for Human Research Investigators click the link in the menu at the left.