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Pregnant Women, Fetuses and Neonates: Regulations

IRB MEMBER FACT SHEET

Summary

Federal regulations require that IRBs give special consideration to protecting the welfare of vulnerable subjects. Title 45 CFR Part 46, Subpart B provides for "Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research."

IRB Member's Role

When reviewing protocols that propose to enroll pregnant women, fetuses, or neonates, IRB members must pay particular attention to the additional regulatory requirements outlined in Subpart B. In order to approve the enrollment of pregnant women, fetuses, or neonates, each IRB member must assess the proposed project to determine whether it fits into one of the categories described below. Enrollment of pregnant women, fetuses, or neonates cannot be approved if the proposed project does not fit into one of the allowable categories.

46.204

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

  • Where 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;
  • 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;
  • Any risk is the least possible for achieving the objectives of the research;
  • 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 of subpart A of this part;
  • 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 of the Common Rule, 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.
  • Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
  • For children who are pregnant, assent and parental permission are obtained in accord with the provisions of subpart D;
  • No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
  • 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
  • Individuals engaged in the research will have no part in determining the viability of a neonate.

46.205:

  • Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
    • Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.
    • Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
    • Individuals engaged in the research will have no part in determining the viability of a neonate.
    • The requirements for risks to the fetus as described above have been met as applicable.
  • Neonates of uncertain viability: Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:
    • The IRB determines that:
      • 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; and
    • The 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 in accord with the Common Rule, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
  • Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this subpart unless all of the following additional 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;
    • The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
    • The legally effective informed consent of both parents of the neonate is obtained in accord with the Common Rule, except that the waiver and alteration provisions for obtaining informed consent 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.

Definitions

Dead fetus:

A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery:

Complete separation of the fetus from the woman by expulsion or extraction or any other means.

Fetus:

The product of conception from implantation until delivery.

Neonate:

A newborn.

Nonviable neonate:

A neonate after delivery that, although living, is not viable.

Pregnancy:

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.

Secretary:

The Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

Viable:

As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.

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