(Note that viable neonates are considered minors, and are therefore
covered under section 10, in compliance with 45CFR46 Subpart D)

A. Definitions

• fetus: the product of conception from implantation until delivery
• neonate: a newborn
• nonviable neonate: a newborn that, although living after delivery, is not viable
• viable: being able to survive to the point of independently maintaining heartbeat and respiration (if the neonate is viable, it is covered by subpart D - minors)

Those involved in the research must have NO PART in any decisions as to the timing, method or procedures used to terminate a pregnancy (and must provide NO inducement to do so), OR in determining the viability of the neonate.

B. For Research involving Pregnant Women or Fetuses, CORIHS must determine:

• Where scientifically appropriate, preclinical (animal) studies, and clinical studies have been done on nonpregnant women to assess potential risks to women and fetuses
• Risk to fetus must be either:


• caused by procedures holding out the prospect of direct benefit for the woman or fetus;
OR
• if no direct benefit, risk to fetus must be 'minimal', and purpose of research is to yield important biomedical knowledge which cannot be obtained by any other means.

ONLY THE PREGNANT WOMAN'S CONSENT IS NEEDED IF there is possibility of direct benefit to the pregnant woman OR both the pregnant woman and the fetus, OR no direct benefit to the woman or fetus but the risk to fetus is minimal (as above).

BOTH THE PREGNANT WOMAN'S AND FATHER'S (OF THE FETUS) CONSENT IS NEEDED IF the only potential benefit is to the fetus. Father requirement is waived if he is unavailable, he is incompetent, he is temporarily incapacitated, or the pregnancy is a result of rape or incest.

C. For Research Involving Neonates (non- or questionably-viable)

CORIHS must determine that where scientifically appropriate, preclinical and clinical studies have been done for assessing potential risks to neonates.

1. Neonates of Uncertain Viability:

Until it has been determined whether or not a neonate is viable, the neonate must not be included in research unless:

• the research holds out the prospect of enhancing the probability of the neonate's survival to the point of viability, and the neonate is subject to the least possible amount of risk;

OR

• the purpose of the research is the development of important biomedical knowledge which can't be obtained by any other means, and there will be no added risk to the neonate resulting from the research;

AND

• consent from EITHER parent is obtained (or if neither is available, competent, etc. either parent's legally authorized representative can do so).

2. Nonviable Neonates:

After delivery, such neonates may not be involved in research unless all of the following conditions are met:

• Vital functions of the neonate will not be artificially maintained.
• The research will not terminate the heartbeat or respiration of the neonate.
• There will be no added risk to the neonate resulting from the research.
• Purpose of the research is the development of important biomedical knowledge which can't be obtained by any other means.

AND

• Consent of both parents of the neonate is obtained. Waiver and alteration possibilities allowed by 45CFR46.116 (c and d, see handbook section 12.A) can't be applied. If either parent is unable to consent, as outlined in the sections above, the informed consent of the other parent will suffice. The consent of the father is not needed if the pregnancy resulted from rape or incest. Consent of legally authorized reps of either or both parents of a nonviable neonate will NOT SUFFICE to meet the requirements of this section.

Return to Human Subjects Research at SBU

Last Updated: 2006-01-31