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3.10 Pregnancy Testing

Last Revised: 1/8/20187/9/2025

1.0 Purpose

The purpose of this policy and procedure 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

when
women2.1. 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. WomanPersons of childbearing potential (WOCBP)POCBP) forare the purpose of this policy is a womanindividuals who hashave begun menstruating and not entered menopause. WomenPersons who are sterile due to historylack of hysterectomy,functioning bilateral oophorectomy,uterus or radical pelvic irradiationovaries are not considered femalespersons of childbearing potential.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 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.

        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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