Pregnant Women, Human Fetuses, and Neonates

 

General Limitations on Research Involving Pregnant Women or Fetuses

Pregnant women or fetuses may be involved in research if all of the following conditions are met: (45 CFR 46.204(a-j)):

1. Scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
2. 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;
3. Any risk is the least possible for achieving the objectives of the research;
4. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions outlined earlier;
5. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions outlined earlier, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;
6. Each individual providing consent will be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
7. For children as defined in this Handbook (45 CFR 46.402(a)) who are pregnant, assent and permission are obtained in accord with the provisions of 45 CFR 46.401-409;
8. No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
9. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
10. Individuals engaged in the research will have no part in determining the viability of a neonate.

 

Research Involving Neonates

Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met (45 CFR 46.205):

1. Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates;
2. Individuals engaged in research will have no part in determining the viability of the neonate;
3. The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective; or the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research;
4. Legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained as outlined earlier, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest; and
5. Each individual providing consent will be fully informed regarding the reasonably foreseeable impact of the research on the neonate.

After delivery a nonviable neonate may not be involved in research unless all of the following additional conditions are met:

1. Vital functions of the neonate will not be artificially maintained;
2. The research will not terminate the heartbeat or respiration of the neonate;
3. There will be no added risk to the neonate resulting from the research;
4. Purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means; and
5. Legally effective informed consent of both parents of the neonate is obtained as outlined earlier, except that the waiver and alteration provisions do not apply. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice, except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph.

A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of 45 CFR 46 subparts A and D.

 

Research Involving, After Delivery, The Placenta, The Dead Fetus or Fetal Material

Whether consent is required for research involving, after delivery, the placenta, the dead fetus, macerated fetal material, or cells, tissue, or organs excised from a dead fetus shall be determined by the IRB after review.

 

Research Not Otherwise Approvable Which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of Pregnant Women, Fetuses, or Neonates

If the IRB does not believe the research meets the requirements as outlined in the sections entitled "Research Involving Pregnant Women or Fetuses" or "Research Involving Neonates", the research may be conducted only if:

1. The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates; and
2. The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either: (a) that the research in fact satisfies the conditions of "Research Involving Pregnant Women or Fetuses"; or (b) the following: (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates; (ii) the research will be conducted in accord with sound ethical principles; and (iii) informed consent will be obtained in accord with the informed consent provisions outlined earlier.