Scenario: You are a community health worker involved with a nutrition study investigating the effects of a low-sodium diet on women with
high blood pressure. Your responsibilities include recruiting women ages 30-50 who are not pregnant and who do not plan to become
pregnant within the next year. In addition to recruiting and enrolling participants, you will collect measurements every 3 months over the
course of one year. At the end of every completed measurement visit, the participant will receive $50 for their participation. The eligibility
criteria, study activities and incentive payments are explained to the participant at enrollment. During the first measurement session with
a participant you find out that she is 20 weeks pregnant. You wonder if she was unaware of her pregnancy when you enrolled her, or,
perhaps she didn't disclose her pregnancy because she wanted to participate. What should you do?
Let the participant remain in the study and complete all measurements as required. If she hid the pregnancy at enrollment she likely
needs the participation money.
b.
Explain to the participant that she is no longer eligible to take part in the study. Furthermore, participation would require her to
modify her diet, which may be unsafe for her baby's development.
Complete the measurement visit with the participant. Afterwards, check with the study team about whether the participant can
continue in the study since she no longer meets the eligibility criteria.