Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 17

Pregnant Women as Research Participants

Pregnant women should be presumed to be eligible for participation in biomedical research. Investigators and ethical review committees should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to themselves, their pregnancies, the fetus and their subsequent offspring, and their fertility.

Research in this population should be performed only if it is relevant to the particular health needs of a pregnant woman or her fetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.

Commentary on Guideline 17

The justification of research involving pregnant women is complicated by the fact that it may present risks and potential benefits to two beings, the woman and the fetus, as well as to the person the fetus is destined to become. Though the decision about the acceptability of risk should be made by the mother as part of the informed consent process, it is desirable in research directed at the health of the fetus to obtain the father's opinion also, when possible. Even when evidence concerning risks is unknown or ambiguous, the decision about the acceptability of risk to the fetus should be made by the mother as part of the informed consent process.

Especially in communities or societies in which cultural beliefs accord more importance to the fetus than to the woman's life or health, women may feel constrained to participate, or not to participate, in research. Special safeguards should be established to prevent undue inducement to pregnant women to participate in research in which interventions hold out the prospect of direct benefit to the fetus.

Where fetal abnormality is not recognized as an indication for abortion, pregnant women should not be recruited for research in which there is a realistic basis for concern that fetal abnormality may occur as a consequence of participation as a subject in research. Investigators should include in protocols on research on pregnant women a plan for monitoring the outcome of the pregnancy with regard to both the health of the woman and the short-term and long-term health of the child.

The Islamic Point of View Concerning Guideline 17

Pregnant Women as Research Participants

1. Because of the need pregnant women and their fetuses have for the prospective benefits of biomedical research, there is no objection in Islamic Law to the participation of this group of women in such research, provided that the mother or fetus is likely to gain an absolute or outweighing benefit and that risks or prospects of fetus mutation, or similar things, resulting from the mother's involvement in the research, are nominal and unlikely.

2. A condition for that involvement is to obtain the voluntary, informed consent of the pregnant woman, after she receives specific information concerning the potential hazards and benefits, and after all the risks and consequences to her and her fetus are explained to her.

3. When there are potential risks for the fetus, even when they are minor or outweighed, the investigator should also obtain the consent of the father, who naturally has an interest in the fetus, based on his full knowledge and awareness of the consequences of his consent.

4. In case there are potential risks for a pregnant woman involved in biomedical research in which the benefit hoped for serves the interest of the fetus, without any direct benefit to the mother, the risks should be made clear to her, so that her consent would be given out of altruistic motives and with the awareness that she is making a sacrifice. She should not be under any illusion that the research will positively influence the success of her conception, which is an instinctive desire of every prospective mother, so that she may not be influenced by her emotions, rather than her reason, into giving her consent. Islamic Center of Southern California