SPECIAL PRECAUTIONS FOR PREGANT WOMEN

FETUSES, PREGNANT WOMEN, AND HUMAN IN VITRO FERTILIZATION

To assure that research involving fetuses, pregnant women, and human in vitro fertilization conforms to appropriate ethical standards and relates to important society needs, DHHS created additional responsibilities for DRP and other Institutional Review Boards (IRBs). first on the list is an evaluation of the manner of selecting potential subjects and the adequacy of provisions for monitoring the actual informed consent process. Among the mechanisms that CRP might impose is the presence of a Committee member, a cornet auditor, or a subject advocate during consent proceedings or the verification of the procedures through sampling. If an investigator proposes to make contact with potential subjects who are pregnant women through a health care institution, he or she should be aware of normal hospital desires to reserve the anonymity of patient identities with respect to non therapeutic research contacts and to maintain normal physician-patient relations. Therefore, researchers should follow carefully the institutions’s procedures for arranging referrals through the patient’s normal health care team. In no case should the investigator expect medical records or other administrative personnel to provide the names of potential subjects. Nor should the investigator bypass regular procedures.

To assure high standards of research conduct for this sensitive population CRP may also arrange for monitoring the research itself through site visits and other means of continuing evaluation. Essentially, these provisions apply to research that presents greater than minimal risk to this group pf subjects. Survey instrument, interview, and observational research in forms normally eligible for exemption from review through submission of Form A ordinarily require no special precautions when the subjects are pregnant women. Nevertheless, the provisions demonstrate the profound concern for these subjects that DHHS has embedded within the regulations. Regardless of the level of risk inherent in any proposed research activity, CRP will examine carefully the approach taken to pregnant subjects of the research.

At the the core of the detailed regulations lies the ideal of presenting the fetus and the mother with minimal risk.  The regulations themselves embody language most appropriate to biomedical research, but concerns over risks must also include the potential for psychological and social injury that may affect the fetus or the mother. Where apt, studies on animals and non pregnant individuals must be complete before proposing research on pregnant women. The research must not itself determine the time for terminating the pregnancy. Nor may individuals engaged the research play a role in deciding the timing, methods, or procedures used to terminate the pregnancy or determine the viability of the fetus at that time. Finally, researchers may not offer monetary or other inducements to terminate pregnancy for the sake of the research. 

If any pregnant woman qualifies as a potential subject of research, either the activity must meet the health needs of the mother (while placing the fetus at risk only to the degree necessary to meet those needs) OR the activate its reset the fetus with minimal risk.  Informed consent procedures must include a statement regarding the possible impact of the research upon the fetus, as well as all the other elements of informed consent. Unless the pregnancy results from rape, the activity is to meet the mother’s health needs, or the father is not identifiable or not reasonably available, both parents must sign any consent to participate in the research. Provisions of other parts of the regulations also apply to pregnant women, for example, the rules governing research with children. These rules would generally require consent of the parents or guardians of a pregnant woman under 18 years of age for participation in research.

In some instances, state laws or legal precedents may conflict with human subjects regulations. For example, laws may establish the emancipation or some pregnant teenagers under certain conditions. In such cases, the researcher should request a waiver of normal consent procedures on Form B. The request should clearly explain the rationale for the waiver, citing specific leal provisions wherever relevant. The request should also provide details of the proposed informed consent procedures to permit CRP to evaluate the adequacy of safeguards for the potential subjects. 

The regulations contain additional provisions governing research directed toward fetuses in utero as subjects, fetus ex utero and nonviable fetuses as subjects, and the use of dead fetuses, fetal material, and the placenta. Researchers who plan research in these subject areas should consult the applicable provisions of the regulations or consult with the Chair or members of CRP.