Office of Human Research Ethics SOP 4101: Research Involving Radiation

Title

Office of Human Research Ethics SOP 4101: Research Involving Radiation

Research Involving Radiation

Studies involving the use of radiation, such as those requiring patients to be X-rayed, are not eligible for expedited review, even if all of the other procedures in the study have been deemed to pose no more than minimal risk.

Projects in which subjects are exposed to ionizing radiation must receive approval from the Radiation Safety Subcommittee (RSS) of the UNC-Chapel Hill Safety Committee before final IRB approval can be granted. The Application for Human Use of Radiation in Research should be completed and approved by to the Radiation Safety Subcommittee prior to submitting to the IRB.

However, if subjects are 18 years and older and receiving five or fewer of the following views/scans, the RSS has determined that they represent no greater than minimal risk and therefore do not require review and approval by the RSS.

  • DEXA scans
  • Chest x-rays
  • Planar x-rays of extremities (as defined by Nuclear Regulatory Commission) – hands, forearms, elbows, feet, knees, leg below the knees, and ankles)
  • Dental x-rays

It is important to note that one procedure could have multiple views/scans (e.g., AP and Lat view for “chest x-ray”). The following statement must be included in the risk section of the consent form:

This research study involves exposure to radiation from (insert maximum number scans and type of procedure). Please note that this radiation exposure is not necessary for your medical care and is for research purposes only.

For comparison, the average person in the United States receives a radiation exposure of 0.3 rem (or 300 mrem) per year from natural background sources, such as from the sun, outer space, and from radioactive materials that are found naturally in the earth’s air and soil. The dose that you will receive from participation in this research study is less than amount you receive from these natural sources in one year.

The amount of radiation you will receive in this study has a minimal risk and is below the dose guideline established by The University of North Carolina Radiation Safety Committee for research subjects.

For studies that meet the criteria for approval by the Radioactive Drug Research Committee (RDRC), investigators should also submit a UNC RDRC Application. Such studies must be basic research and meet limits on pharmacological dose and radiation dose as specified in the RDRC regulations (21 CFR 361.1).

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879

Details

Article ID: 132259
Created
Thu 4/8/21 9:27 PM
Modified
Fri 9/30/22 4:55 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
06/02/2017 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor
Last Review
Date on which the most recent document review was completed.
03/18/2022 12:00 AM
Last Revised
Date on which the most recent changes to this document were approved.
06/02/2017 12:00 AM
Next Review
Date on which the next document review is due.
07/01/2025 12:00 AM
Origination
Date on which the original version of this document was first made official.
06/02/2017 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-IRB and Human Research Ethics