Subject: Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review research involving pregnant women, human fetuses, and neonates and approve only research which satisfies the requirements of 45 CFR 46 Subpart B ^[1] and other applicable Federal, State, and Local laws. ^[2], ^[3]

1. Research involving pregnant women or fetuses.

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

   1. 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; and
   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 that purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means; and
   3. Any risk is the least possible for achieving the objectives of the research; and
   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 of IRB Policy IV.A.; ^[4] and
   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 of IRB Policy IV.A, ⁴ 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; and
   6. Each individual providing consent under (D) or (E) above, is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; and
   7. For children who are pregnant, assent and permission are obtained in accord with the provisions of IRB Policy IV.D; ^[5] and
   8. No inducements, monetary or otherwise, will be offered to terminate a pregnancy; and
   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. ^[6]
2. Research Involving Neonates.
   1. Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
   2. 1. Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates; and
      2. Each individual providing consent under paragraph B.2 or C.5 of this section is fully informed regarding the reasonably foreseeable impact of the research on the neonate; and
      3. Individuals engaged in the research will have no part in determining the viability of the neonate; and
      4. The requirements of paragraph B or C of this section have been met as applicable.
   3. 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 policy unless the following additional conditions have been met:
   4. 1. The IRB determines that:
      2. 1. 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
         2. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.
      3. 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 IRB Policy IV.A ³ except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
   5. Nonviable neonates. After delivery a nonviable neonate may not be involved in research covered by this policy unless all of the following additional conditions are met:
   6. 1. Vital functions of the neonate will not be artificially maintained; and
      2. The research will not terminate the heartbeat or respiration of the neonate; and
      3. There will be no added risk to the neonate resulting from the research; and
      4. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
      5. The legally effective informed consent of both parents of the neonate is obtained in accord with IRB Policy IV.A., ³ except that the waiver and alteration provisions of IRB Policy IV.C ^[7] 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 to meet the requirements of this paragraph, 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.
   7. Viable neonates. 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 ^[8] and D. ^[9], ^[10]
3. Research involving, after delivery, the placenta, the dead fetus, or fetal material.
   1. Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or Local laws and regulations regarding such activities.
   2. If information associated with material described in paragraph A of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all IRB policies are applicable. ^[11]
4. 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. Research that the IRB does not believe meets the requirements of this policy:
   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 of DHHS, 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:
   3. 1. That the research, in fact, satisfies the conditions of 45 CFR 46.204 ⁶ as applicable; or
      2. The following:
      3. 1. 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 research will be conducted in accord with sound ethical principles; and
         3. Informed consent will be obtained in accord with the informed consent provisions of 45 CFR 46 Subpart A ⁸ and other applicable subparts of 45 CFR 46. ^[12]
5. Exemption from Review. The exemptions from IRB review listed at IRB Policy III.C ^[13] may be applied to research involving pregnant women, human fetuses, and neonates. ^[14], ^[15]

^[1] 45 CFR 46 Subpart B

^[2] 45 CFR 46.203

^[3] 21 CFR 56.111 (b)

^[4] IRB Policy IV.A

^[5] IRB Policy IV.D

^[6] 45 CFR 46.204

^[7] IRB Policy IV.C

^[8] 45 CFR 46 Subpart A

^[9] 45 CFR 46.205

^[10] 45 CFR 46 Subpart D

^[11] 45 CFR 46.206

^[12] 45 CFR 46.207

^[13] IRB Policy III.C

^[14] 45 CFR 46.101(b)

^[15] 45 CFR 46.201 (b)