Suppose a group of researchers is interested in investigatin…
Suppose a group of researchers is interested in investigating whether a new type of chemotherapy is safe for breast cancer patients who are pregnant. Initially the researchers plan to conduct a randomized controlled trial in which they randomly assign pregnant patients to the intervention group, in which they receive the new chemotherapy, or to the control group, in which they receive usual care. Before the researchers start their randomized controlled trial, they submit their study protocol to the institutional review board. However, the institutional review board decides to disapprove the study and advises the researchers to change their study design into an observational study design. Why did the institutional review board disapprove this study? (max. 6 points).
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