Pregnancy Tests
Overview
Pregnancy testing in research studies is conducted to protect potential research subjects and any developing fetus from exposure to investigational drugs, procedures, or interventions that may pose a risk during pregnancy.
The purpose of this guidance is to provide investigators with a clear standard for when and how pregnancy testing is used appropriately to protect research subjects and adhere to regulatory compliance.
When Pregnancy Testing is Required
Pregnancy testing should be included when:
- The study involves interventions with potential risk to a fetus (e.g., drugs, radiation, invasive procedures).
- Research subjects include individuals of childbearing potential.
- There is insufficient evidence confirming safety during pregnancy.
How to handle positive results?
- The research subjects should be informed immediately, privately, and sensitively.
- Study participation may be paused or discontinued depending on protocol risks.
IRB Application Expectations
When submitting a study involving females of childbearing potential, investigators should clearly describe the following:
Section: Data Collection
Q: What methods will you use to collect data? (check all that apply)
- The protocol should include biospecimens collection (urine or blood).
Section: Research Procedures
Q: What are you asking subjects to do?
- Investigators should inform the participants that the use of pregnancy test is required for the study.
- Include what type of pregnancy test to be used.
- Include who will administer or interpret the test and where the testing will occur (e.g. clinic, laboratory, or research setting).
Q: When will participants do the procedures?
- Depending on the study, you need to sometimes indicate that a pregnancy test is typically required at screening and/or baseline before study enrollment.
Section: Subject Enrollment
Q: List the specific criteria that make someone eligible for this study. Identify the population you intend to study. Your study should include those who are able to participate and those who represent the population where your study is relevant.
Pregnancy testing may be used as part of the eligibility screening process to determine whether individuals of reproductive potential meet the study’s inclusion or exclusion criteria prior to enrollment or initiation of study procedures.
For example:
- Individuals who are pregnant at the time of screening will be excluded from participation when study-related procedures or interventions may pose potential risks to a developing fetus.
- The study population should include individuals of reproductive potential for whom the research question is relevant and who are able to safely participate in the study based on all protocol requirements.
Section: Risks
Investigators should evaluate the probability, magnitude, duration, and reversibility of these risks based on the study design and the research subjects' population.
A. Physical
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Research subjects may experience temporary physical discomfort, including:
- Temporary Discomfort from blood collection, if serum testing is used.
- Minor bruising, bleeding, or dizziness associated with venipuncture.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation:
- Provide appropriate post-procedure care and instructions.
- Use trained and qualified personnel to perform blood collection procedures.
- Use the least invasive testing method appropriate for the study (e.g., urine testing when applicable and scientifically acceptable)
B. Psychological
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Research subjects may experience the following:
- Anxiety, emotional distress, or discomfort related to testing.
- Stress associated with unexpected or undesired pregnancy results.
- Feelings of embarrassment or stigma.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation:
- Inform research subjects during the consent process about the purpose of pregnancy testing and possible outcomes.
- Conduct testing and result disclosure in a private, respectful, and sensitive manner.
- Allow research subjects to ask questions and discuss concerns before testing.
- Provide referrals to appropriate healthcare providers, counseling services, or support resources when needed.
- Remind research subjects that they may withdraw from the study at any time without penalty, unless pregnancy testing is required for safety-related eligibility.
C. Social Risks
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Research subjects may experience the following:
- Discrimination or other adverse social consequences resulting from disclosure of pregnancy status.
Q: Provides the measures you will use to minimize reputational harms.
The following are suggested risk mitigation:
- Maintain strict confidentiality of pregnancy test results.
- Conduct testing and communication of results in a private setting.
- Share pregnancy-related information only with authorized personnel directly involved in the study.
- Limit the research personnel who will process the test.
D. Privacy Risks
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research.
Research subjects may experience the following:
- Pregnancy status constitutes sensitive personal health information and it may not be anticipated.
- Unauthorized disclosure of pregnancy status or breach of confidentiality.
Q: Provides the measures you will use to minimize risks and to monitor subjects’ comfort level.
The following are suggested risk mitigation:
- Limit access to pregnancy test results to authorized research personnel with a need to know.
- Store records securely using password-protected electronic systems and/or locked filing cabinets.
- Use identification codes rather than names whenever possible.
- Follow all applicable privacy, confidentiality, and data security requirements.
- Disclose results only to the participant unless additional disclosure is required by law or authorized by the subject.
- Build in methods so the subject can take the test in private and have a sealed, secure way they can dispose of the test and leave the site without explanation.
Section: Consent Documentation/Waivers
Consent language should clearly explain:
- That pregnancy testing is part of the screening process.
- Whether testing is mandatory for participation or condition of continued involvement.
- The consequences of declining testing, including potential ineligibility enrollment.
- The purpose of testing and how the results will be communicated.
- An explicit assurance that results of the pregnancy test will not be disclosed outside the research including the Honors Office.
References
45 CFR § 46.202(f)
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