Radiation exposure of fertile women in medical research studies.

Fertile women may be exposed to ionizing radiation as human subjects in medical research studies. If the woman is pregnant, such exposures may result in risk to an embryo/fetus. Fertile women may be screened for pregnancy before exposure to ionizing radiation by interview, general examination, or pregnancy test. Use of the sensitive serum pregnancy test has become common because it offers concrete evidence that the woman is not pregnant (more specifically, that an embryo is not implanted). Evidence suggests that risk to the embryo from radiation exposure before organogenesis is extremely low or nonexistent. Further, demonstrated effects on organogenesis are rare or inconclusive at fetal doses below 50 mSv (5 rem). Therefore, there may be some level of radiation exposure below which risk to the fetus may be considered essentially zero, and a serum pregnancy test is unnecessary. This paper reviews the fetal risks and suggests that consideration be given to establishing a limit to the fetus of 0.5 mSv (50 mrem), below which pregnancy screening need not include the use of a serum pregnancy test.