Pregnant Women, Fetuses and Neonates
Pregnant women or fetuses may be involved in the research if the risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means.
The following definitions may help in determining selections:
- Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
- Embryo broadly refers to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy).
- Fetus means the product of conception from implantation until delivery.
- Neonate means a newborn. Nonviable neonate is an expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance.
In addition to the requirements of subpart A, subpart B of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46 identifies more requirements for research involving prisoners.
References and Additional Guidance
U.S. Office of Human Research Protections (OHRP), section 45 CFR 46, subpart B.