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3.10 Pregnancy Testing

Last Revised: 7/9/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for determining how and when pregnancy testing should be performed on subjects who are of childbearing potential enrolled in protocols that describe pregnancy as an exclusion criterion.

2.0 Policy

It is the policy of the Organization that

  • 2.1. When persons of childbearing potential are enrolled in protocols which include a pregnancy exclusion criterion, the protocol must have procedures in place for either pregnancy testing or self-reporting depending on the teratogenic risk.

3.0 Definition

  • 3.1. Persons of childbearing potential (POCBP) are individuals who have begun menstruating and not entered menopause. Persons who are sterile due to lack of functioning uterus or ovaries are not considered persons of childbearing potential for the purposes of this policy.
  • 3.2. Menopause for the purpose of this policy is defined as lack of menses for 12 months in the absence of any reversible medical condition which could produce amenorrhea.

4.0 General 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.
  • 4.3. If pregnancy testing is required (as indicated 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 a healthcare facility (including practitioner’s office).
    • 4.3.3. Depending on the teratogenic risk of the intervention, home pregnancy test may also be 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. For ongoing interventions or exposures, testing should be done at a frequency consistent with clinical practice and reflecting the teratogenic potential of the intervention.
  • 4.6. Minor subjects should be informed during the consent/assent process and in the ICF that pregnancy test results will be shared with their parent/guardian.
  • 4.7. 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/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 their 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.

DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 1/8/2018 - revision not documented

 Revised 10/30/2024 – Revised to use gender neutral language; clarified allowable methods of pregnancy testing; deleted reference to MS72; clarified that testing should be done at a frequency consistent with clinical practice and reflecting the teratogenic potential of the intervention” (section 4.5); stylistic changes.

 Revised 1/24/2025 – confirmed section 4.6 with NU GC office, comment added

 Revised 7/9/2025 – removed comment regarding section 4.6.

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