For women of childbearing potential (defined as from the onset of menstruation through menopause), a pregnancy test must be conducted prior to research-related radiation exposure except as provided below:
a. Exceptions
- Women declaring they are one year post menopause, or over 60 years of age, or have had a hysterectomy are not required to have a pregnancy test. The Medical Radiation Protection Committee (MRPC) recommends the investigator documents the subject’s response.
- Pregnancy testing is not required where fetal exposures are expected to be below 1 mrem. Radiation procedures that would be expected to yield fetal doses less than 1 mrem include dental X-rays, X-rays of the extremities (excluding legs above the knee), and peripheral DEXA bone mineral scans. The MRPC requires that the patient be asked whether she has reason to believe she might be pregnant, document that this question has been asked, and record her response. If the patient believes she might be pregnant, a pregnancy test must be administered. If the pregnancy test is positive, the patient is no longer eligible to participate in the research project.
- The MRPC requires that the investigator provide a documented fetal dose estimate and also requires the investigator provide abdominal shielding for all female participants.
b. No additional pregnancy test will be required prior to irradiation if the protocol:
- Requires a pregnancy test for participating in the research, and
- There is a requirement for the use of an effective means of birth control included in the informed consent, and
- There is a stipulation in the consent form that the investigator should be told immediately if the subject has reason to believe she is pregnant.
- Neither the MRPC nor the Institutional Review Board (IRB) will require special procedures or training for performing pregnancy tests since the technology is essentially “off-the-shelf.” The pregnancy testing and recording of results can be performed by a member of the research team or other appropriate clinical staff designated by the PI. The results of the test must be maintained in the research record subject to standard human subject record retention requirements (see UI Investigator’s Guide for Human Subjects Research).
- The IRB will assume the responsibility for assuring that the protocol includes the testing as outlined above. In situations where the conditions of a protocol necessitate safety measures beyond those outlined above, the MRPC will communicate these needs to the IRB as a part of the MRPC review process.
Policy Version Date: 2/2014