Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 16

Women as Research Subjects

Investigators, sponsors, or ethical review committees should not exclude women of reproductive age from biomedical research. The potential for becoming pregnant during a study should not, in itself, be used as a reason for precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman's ability to make a rational decision to enroll in a clinical study. In this discussion, if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant, the sponsors/investigators should guarantee the prospective subject a pregnancy test and access to effective contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research women who might become pregnant.

Commentary on Guideline 16

Women in most societies have been discriminated against with regard to their involvement in research. Women who are biologically capable of becoming pregnant have been customarily excluded from formal clinical trials of drugs, vaccines and medical devices owing to concern about undetermined risks to the fetus. Consequently, relatively little is known about the safety and efficacy of most drugs, vaccines, or devices for such women, and this lack of knowledge can be dangerous.

A general policy of excluding from such clinical trials women biologically capable of becoming pregnant is unjust in that it deprives women as a class of persons of the benefits of the new knowledge derived from the trials. Further, it is an affront to their right of self-determination. Nevertheless, although women of childbearing age should be given the opportunity to participate in research, they should be helped to understand that the research could include risks to the fetus if they become pregnant during the research.

Although this general presumption favors the inclusion of women in research, it must be acknowledged that in some parts of the world women are vulnerable to neglect or harm in research because of their social conditioning to submit to authority, to ask no questions, and to tolerate pain and suffering. When women in such situations are potential subjects in research, investigators need to exercise special care in the informed consent process to ensure that they have adequate time and a proper environment in which to take decisions on the basis of clearly given information.

Individual Consent of Women. In research involving women of reproductive age, whether pregnant or non-pregnant, only the informed consent of the woman herself is required for her participation. In no case should the permission of a spouse or partner replace the requirement of individual informed consent. If women wish to consult with their husbands or partners or seek voluntarily to obtain their permission before deciding to enroll in research, that is not only ethically permissible but in some contexts highly desirable. A strict requirement of authorization of spouse or partner, however, violates the substantive principle of respect for persons.

A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman's ability to make a rational decision to enroll in a clinical study. For women who are not pregnant at the outset of a study but who might become pregnant while they are still subjects, the consent discussion should include information about the alternative of voluntarily withdrawing from the study and, where legally permissible, terminating the pregnancy. Also, if the pregnancy is not terminated, they should be guaranteed a medical follow-up.

The Islamic Point of View Concerning Guideline 16

Women as Research Subjects

It is not right to exclude women of reproductive age from biomedical research, for the mere possibility of their becoming pregnant during a study, which may involve risks to the pregnant woman and to her fetus. This social segment has a pressing need to benefit from the outcome of formal trials of drugs, vaccines , and medical devices used in tests. Sufficient precautions should be taken to spare a woman, if she becomes pregnant, and her fetus any hazards. It is an instance of injustice and inequity to exclude women, as a social group, from the benefits gained through the new information learned through such trials.

However, the participation of a woman in research is, the same as in the case of a man, contingent on her voluntary, informed consent, given after she receives adequate information and proper understanding based on specific data of what she is consenting to, and after she is told all potential hazards and consequences that she needs to know. (See the Islamic Point of View in regards to Guideline 5.)

Therefore, an investigator must obtain the personal, voluntary consent of an adult female to participate in research. In Islamic Law, it is unacceptable for the permission of a husband to replace that of his wife, because that would be an affront to her human rights, as members of both sex enjoy full competence. An individual's independence, whether male or female, should be respected, and he/she should be allowed to make his/her personal choice and make the decision suitable for him/her in regards to involvement in research. This should be done, however, without any coercion, undue influence, deception, or exploitation, and after the person concerned receives the necessary information and comprehends it fully.

Still, out of consideration, to maintain a better and stronger marital relationship, and to avoid family problems, it is preferable to obtain the husband's consent. Islamic Center of Southern California