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IRB SOP 902
Research Involving Pregnant Women, Fetuses and Neonates
Purpose
This Standard Operating Procedure (SOP) describes the additional responsibilities and procedures involved when reviewing research that involves pregnant women, human fetuses and neonates or women who become pregnant while on a study.
Scope
This SOP applies to all research involving pregnant women, human fetuses, and neonates, regardless of funding source and IRB members. The term “pregnant women” is used in this document to refer to pregnant women and/or their fetuses.
Applicability
This policy applies to all research conducted under the auspices of University of South Alabama.
Definitions
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. Presumptive signs of pregnancy are signs and symptoms suggestive of pregnancy that may also indicate another condition. They occur early and are more subjective than other signs. The presumptive signs are missed menses, nausea and vomiting, frequent urination, and fatigue.
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.
Viability of a neonate: Being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Policy
IRBs must consider that research involving women of childbearing potential might involve pregnant women (and viable fetuses), and should evaluate research protocols and risks, inclusion and exclusion criteria, and informed consent procedures, with this in mind.
For research involving pregnant women as participants, the USA IRB follows federal regulations at 45 CFR 46 Subpart B in addition to those imposed under other USA IRB policies and procedures, ethical considerations and other applicable federal, state and local laws for review and approval.
The USA IRB approves research involving pregnant women by following the “ Investigator Checklist for Research Involving Pregnant Women ”.
Conditions required for pregnant women or fetuses to be involved in research:
(a) 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; (45 CFR 46.204(a))
(b) 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; (45 CFR 46.204(b))
(c) Any risk is the least possible for achieving the objectives of the research; (45 CFR 46.204(c))
(d) If the research holds out the prospect of direct benefit to the pregnant woman, the
Consent Decision Chart for Pregnant Women and Fetuses
Direct benefit to mother only
Direct benefit to mother and fetus
Direct benefit to fetus only
No direct benefit or societal benefits only
Risk is more than minimal
Mother's consent
Mother's consent Mother and father's consent
NOT APPROVABLE BY
IRB
Risk is no more than minimal
Mother's consent
Mother's consent Mother and father's consent
Mother's consent
1.0 Neonates
Conditions required for neonates of uncertain viability and nonviable neonates to be involved in research:
A neonate is defined as a newborn child. The following HHS regulations apply to research involving neonates:
(a) 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 (45 CFR 46.205(a)(1)).
- 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 (45 CFR 46.205(a)(2))
- Individuals engaged in the research will have no part in determining the viability of a neonate (45 CFR 46.205(a)(3))
- The requirements of paragraph (b) or (c) of this section have been met as applicable (45 CFR 46.205(a)(4)).
(b) 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 are met:
- The IRB determines that:
i. 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
ii. 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 subpart A of this part, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
(c) Nonviable neonates. After delivery, a 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 subpart A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) 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 (c)(5), 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
in accord with 28.0: Informed Consent, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest. (45 CFR 46.205(b)(2))
4.0 Nonviable Neonates
After delivery a nonviable neonate may not be involved in research covered by this subpart unless all the following additional conditions are met:
- Vital functions of the neonate will not be artificially maintained; (45 CFR 46.205(c)(1))
- The research will not terminate the heartbeat or respiration of the neonate; (45 CFR 46.205(c)(2))
- There will be no added risk to the neonate resulting from the research; ( CFR 46.205(c)(3))
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and (45 CFR 46.205(c)(4))
- The legally effective informed consent of both parents of the neonate is obtained in accord with 28.0: Informed Consent, except that the waiver and alteration provisions of 45 CFR 46.116(c) and (d) 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. (45 CFR 46.205(c)(5))
5.0 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 subparts A and D of 45 CFR 46.
Procedures
1.0 Investigator Responsibilities
1.1 Provide accurate information in the IRB application about the inclusion of pregnant women, fetuses or neonates.
1.2 Provide justification for the use of pregnant women, fetuses, or neonates as the targeted population in the proposed research 1.3 Respond in a timely fashion to any requests for changes or clarification needed prior to review or approval. 1.4 Plan for appropriate consent procedures as described below in section 6.0 as determined by protocol.
2.0 IRB Responsibilities
2.1 Review the research study to ensure it has addressed all regulatory requirements for inclusion of pregnant women, fetuses, and neonates.
2.2 Request necessary changes or clarification about any component of the research study prior to granting approval.
3.0 Coincidental Pregnancy
There are circumstances in which pregnancy is coincidental to participant selection and safeguards may need to be in place if a subject becomes pregnant. In these circumstances, the IRB shall determine such matters as to whether or not:
3.1 Participants should be advised on the risks of participation in the study 3.2 Participants should be advised to avoid pregnancy or nursing during or following participation in the study 3.3 Participants should be advised to notify the principal investigator immediately should they become pregnant 3.4 Participants should avoid causing a pregnancy during or following participation in the study and whether the participant should notify the principal investigator should the participant cause a pregnancy 3.5 Pregnant women should specifically be excluded from the study or whether specified methods of contraception should be required during or following participation in the research
Regulated Documents
45 CFR 46 Subpart B
Related Forms
Investigator Checklist for Research Involving Pregnant Women (located in IRBNet forms/templates)
