23.3(a) Pregnant Women and Fetuses
Federal regulations (45 CFR 46, Subpart B) and University ethical standards require that principal investigators and the IRB shall be sensitive and apply special conceptual and regulatory protections to research involving pregnant women, human fetuses and neonates (newborn children). Key among these concepts is that investigators shall acknowledge and be sensitive to the vulnerability of subjects who are pregnant or newborn especially within the unique times of labor and delivery. Investigators shall also take into account that the health and wellbeing of the mother, the fetus and/or the newborn should take priority over the goals of any research study. Investigators shall ensure the highest possible standards in the conduct of research involving pregnant patients including cooperation from all involved in the labor and delivery processes.
Pursuant to special regulatory protections and in addition to the general requirements for IRB reviews (see earlier sections of these policies), the IRB shall require, in addition to all other requirements, that the following ten conditions be met and documented to approve the involvement of pregnant women or fetuses in research (c.f. 45 CFR 46.204). These required conditions are:
1) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant 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 the 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 consistent is obtained in accord with the informed consent provisions of these policies and procedures; 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 in these policies and procedures, 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 conditions (4) or (5) [above] is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; AND
7) For children [as defined in these policies and procedures] who are pregnant, assent and permission are obtained in accordance with the provisions in these policies and procedures involving children; 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.
In conducting an IRB-approved research study involving pregnant women and fetuses, investigators should carefully and sensitively consider the process for obtaining informed consent. Whenever practical and feasible, information about the study should be made available prior to labor. If the patient must be approached during labor, permission should be sought first from the patient's obstetric care provider and the patient's primary nurse should be involved in discussions regarding the appropriateness of such an approach. If the obstetric care provider and/or the primary nurse believe that the patient may not comprehend a research protocol, the patient should not be approached for research participation. Investigators should also delay approaching patients for research participation if the patient's capacity for informed consent is impaired by medications.
Coincidental Pregnancy: There are circumstances in which pregnancy is coincidental to participant selection within a research study. This may occur, for example, when potential participants are recruited from a population that includes women of child bearing potential. In these circumstances, the IRB shall determine such matters as whether:
1) Participants should be advised on the risks of participation in the study
2) Participants should be advised to avoid pregnancy or nursing during or following participation in the study
3) Participants should be advised to notify the principal investigator immediately should they become pregnant
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
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