This SOP outlines additional protections that WVU researchers and IRBs must provide to pregnant women, fetuses, or neonates involved in human subject research. The requirements described below apply to research involving pregnant women, fetuses, or neonates.
Federal regulations require additional protections for pregnant women, fetuses, or neonates involved in research. The requirements include that research involving more than minimal risk is conducted only when benefits are anticipated for the mother and/or fetus, preclinical and clinical research has been conducted (where scientifically appropriate) that provide data for assessing potential risks, and informed consent processes describe the reasonably foreseeable risks to the fetus or neonate.
3.1. To approve research involving pregnant women, fetuses, or neonates, the IRB must determine that the research provides the additional protections described in 45 CFR 46 Subpart B (see “Additional Protections” section below) in addition to meeting regulatory criteria for approval of research involving non-pregnant participants (See SOP 012: Informed Consent Requirements).
3.2. In general, the risk to the fetus from research procedures (e.g., ultrasound, changes in maternal diet, etc.) must not be greater than minimal (i.e., only minimal risk). When the risk is considered to be more than minimal, the risk must be justified
3.3. “Viable” neonates may be included in research that provides the additional protections for children involved as participants in the research described by federal regulations and SOP 014: Research Involving Children.
4.1. Pregnant women or fetuses may be involved in research only if all of the following conditions are met (the IRB must determine these specific findings):
Regarding the risk(s) of the research, any risk is the least possible for achieving the objectives of the research, and either of the following applies:
Consent of the pregnant woman is obtained and documented as described by SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process. Consent is obtained in any of the following circumstances:
The research offers the prospect of direct benefit to the pregnant woman
The research offers the prospect of direct benefit to both the pregnant woman and the fetus
The research does not offer the prospect of benefit for either the woman or the fetus, but the risk to the fetus is not greater than minimal (i.e., only minimal risk) and the purpose of the research is the development of important knowledge that cannot be obtained by any other means.
The consent of both parents must be obtained and documented as described by SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process for research that holds out the prospect of direct benefit solely to the fetus, with the following exceptions:
The father’s consent need not be obtained if the pregnancy resulted from rape or incest.
Each individual providing consent is fully informed regarding the reasonably foreseeable influence of the research on the fetus or the neonate
No inducements (monetary or otherwise) will be offered to terminate the 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
Individuals engaged in the research will have no part in determining the viability of a neonate.
Nonviable neonates and neonates of uncertain viability may be involved in research as described below:
Where scientifically appropriate, preclinical and clinical research has been conducted and provides data for assessing potential risks to neonates
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 knowledge that cannot be obtained by other means
The consent of both parents must be obtained and documented as described by SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process, with the following exceptions:
If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent is sufficient
The consent of a legally authorized representative (for either or both of the parents of a nonviable neonate) is not sufficient
Provisions for waiver or alteration of the consent process are not applicable
The father’s consent need not be obtained if the pregnancy resulted from rape or incest.
Each individual providing consent is fully informed regarding the reasonably foreseeable influence of the research on the neonate
Individuals engaged in the research will have no part in determining the viability of the neonate.
Neonates of uncertain viability may be involved in research (until a physician has determined whether or not the neonate is viable) only if all of the following conditions are met:
Where scientifically appropriate, preclinical and clinical research has been conducted and provides data for assessing potential risks to neonates
Regarding the risk(s) of the research, one of the following applies:
The research offers 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
If the research does not offer the prospect of enhancing the probability of survival, the purpose of the research is the development of important knowledge that cannot be obtained by other means, and there will be no added risk to the neonate resulting from the research.
The consent of either parent is obtained and documented as described by SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process, with the following exceptions:
If neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of either parent’s legally authorized representative is obtained
The consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
Each individual providing consent is fully informed regarding the reasonably foreseeable influence of the research on the neonate
Individuals engaged in the research will have no part in determining the viability of the neonate.
For research involving pregnant women, fetuses, or neonates that is subject to DHHS regulations, the below additional requirements apply:
6.1. Pregnant women and/or fetuses may be involved in more than minimal risk research without the prospect of direct benefit for the pregnant woman or the fetus if the applicable conditions described above (see “Additional Protections for Women and Fetuses”) are met, with the following additional requirement:
6.2. Nonviable neonates may be involved in research if the applicable conditions described above (see “Additional Protections for Certain Neonates”) are met, with the following additional requirement:
6.3. Neonates of uncertain viability may be involved in research that does not offer the prospect of enhancing the probability of the neonate’s survival (to the point of viability) when there is no added risk to the neonate resulting from the research if the applicable conditions described above (see “Additional Protections for Certain Neonates”) are met, with the following additional requirement:
6.4. Research involving pregnant women, fetuses, or neonates that does not meet the conditions for approval described by federal regulations and this policy may be conducted only if all of the following conditions are met:
For cases in which pregnancy is incidental to participant selection for research participation, the additional protections described by federal regulations and this policy do not specifically apply. However, researchers and the IRB will consider additional protections when an individual’s participation could pose any risk to a potential fetus. In some research, participants should be advised to avoid pregnancy during or following the research, and to notify the researcher(s) immediately if pregnancy occurs. Exclusion of all women who could become pregnant may be justified in research involving potential serious risk(s) to a fetus.
8.1. The IRB considers each of the specific findings related to additional protections required for research involving pregnant women, fetuses, or neonates. WVU OHRP staff document discussions of controverted issues at convened meetings in the meeting minutes.
8.2. Specific findings are either documented by WVU OHRP staff in the meeting minutes (i.e., for protocols reviewed by the convened board) or by expedited reviewers in determinations in accord with applicable SOPs. The IRB does not reapply categories during subsequent reviews unless changes to the protocol warrant such review.
WVU Policies:
SOP 012: Informed Consent Requirements
SOP 014: Research Involving Children
SOP 016: Documentation of the Informed Consent Process
Federal Regulations:
45 CFR 46.204
45 CFR 46.205
45 CFR 46.206
45 CFR 46.207
45 CFR 46.402
AAHRPP:
Standard II-4
