Some new study submissions, in addition to all the usual material, include something called a pregnant partner consent form. These forms are intended to be used if the female partner of a study subject becomes pregnant during the subject’s participation in a clinical trial. They allow sponsors to collect information about the pregnancy and its outcome, which may be important information to have on investigational drug studies. There have been some discussions at IRB meetings and in the IRB office regarding whether these pregnant partners and the babies that result from these pregnancies should be counted as study subjects.
A white paper made available by human research protection consulting and technology provider Kinetiq provides some background about whether pregnant partners should be thought of as subjects. Like so many things in research, the “it depends” answer applies here FDA and OHRP regulations differ in their definitions of subjects, and “IRBs vary in their interpretations of how to apply these regulations,” according to the paper.
In general, pregnant partners and their neonates do not meet the definition of subjects because they neither receive a test article or act as controls (essential to the FDA definition of subjects) and are not systematically studied (OHRP definition of research). Please click on the link above for more discussion and background on this issue.