3.10 Pregnancy Testing

4.0 ProceduresGeneral Requirements

• 4.1. Protocols that describe pregnancy as an exclusion criterion must describe how pregnancy status will be determined.
• 4.2. Protocols that include an intervention considered potentially harmful to a fetus must include pregnancy testing prior to initiating the intervention(s).intervention.
• 4.3. If pregnancy testing is required (as indicated in Section 4.2 above), testing should be performed on urine unless blood is being drawn for another reason. In that case, serum qualitative pregnancy testing can be performed.
  • 4.3.1. Quantitative testing is not indicated for the purposes of this policy.
  • 4.3.2. Acceptable test results are those performed at Nebraska Medicine, BMC, CHMC, or a documentedhealthcare resultfacility from(including practitioner’s office).
  • 4.3.3. Depending on the subject’steratogenic provider.
  risk
  • of 4.3.3.the Homeintervention, home pregnancy test resultsmay arealso notbe acceptable.acceptable at the discretion of the IRB and/or IRB Executive Chair or designee.
• 4.4. Protocols that describe pregnancy as an exclusion criterion, but are not expected to cause fetal harm, may use subject self-report of pregnancy status.
• 4.5. A negative pregnancy test within 7 days prior to the intervention of interest should be considered current, consistent with Nebraska Medicine Pregnancy Testing Policy (MS72).current. For ongoing interventions or exposures, testing should be done at a frequency consistent with clinical practice (and notreflecting morethe oftenteratogenic thanpotential monthly).of the intervention.
• 4.6. The informed consent/assent process and the ICF must include:
  • 4.6.1. How often pregnancy testing will be done.
  • 4.6.2. How often subjects will be informed of results.
  • 4.6.3. Whether subjects will be removed from the study if they become pregnant.
• 4.7. Minor subjects should be informed during the consent/assent process and in the ICF that theirpregnancy parent/guardiantest results will be informedshared ofwith thetheir test results.parent/guardian.
• 4.8. Subjects should be informed of whether they will be charged for pregnancy testing:
  • 4.8.1. For protocols that require pregnancy testing, but are not expected to cause fetal harm, subjects may not be charged for pregnancy testing.
  • 4.8.2. The IRB strongly discourages pregnancy testing of females who are NOT of childbearing potential. However, if such subjects will be tested, they may not be charged for this test.
• 4.9.7. Subjects should be given pregnancy test results privately. Minors should be given pregnancy test results privately followed by disclosure by the research team to the subject’s parent or parent/guardian.
• 4.8. Subjects should be informed of whether they will be charged for pregnancy testing.
  • 4.8.1. For protocols that require pregnancy testing, but are not expected to cause fetal harm, subjects may not be charged for pregnancy testing.
  • 4.8.2. The IRB strongly discourages pregnancy testing of persons who are NOT of childbearing potential. However, if such persons will be tested, they may not be charged for this test.
• 4.9. Subjects should be informed during the consent process and in the ICF (1) how often pregnancy testing will be done, and (2) whether subjects will be removed from the study if they become pregnant.
• 4.10. Any subject with a positive pregnancy test should be referred to hertheir primary care physician to review the positive test result. Subjects should be offered to have study information sent to their primary care physician if the subject received any intervention prior to the positive pregnancy test.