The Potential Childbearing Population

The probability of potential early embryonic exposure occurring in a drug development program must be expected and confronted because, despite careful pregnancy testing and adequate contraceptive precautions being undertaken, it happens. Levine (1975) in his book suggested that, in the consent form, there should be 'a statement that the particular treatment or procedure may involve risks to the subject—(or to the embryo or fetus if the subject is or may become pregnant) which are currently unforeseeable'.

When a woman of childbearing age participates in a research procedure in which there is a risk to the fetus, the nature of the risk being either known or unknown, she should be advised that, if she wishes to be a subject, she should avoid becoming pregnant. Her plans for avoiding conception should be reviewed during consent negotiations. At times, if her plans seem inadequate and she does not consent to the investigator's suggestions, it will be necessary to exclude her from the research. She should be further advised that if she deviates from the plans discussed at the outset, she should advise the investigators immediately.

Halbreich and Carson (1989) made the point that not to include women of child-bearing age could even increase liability:

The general policy of an academic institution should be to favor the conduct of research involving women and children in testing of new drugs with potential for major therapeutic value to those populations. Such research may expose the institution to risk of liability for damage to subjects; however, that is inherent in research involving human subjects anyway, and there are many ways of minimizing such risks. Not to do such research, while it may serve to protect the interests of the institution as narrowly conceived, would involve a failure to serve the public interest in a much more serious manner by exposing classes of persons to knowable but unknown risks, through the practice of clinical medicines using drugs not thoroughly tested and understood, and withholding drugs that may be of benefit.

It has been suggested that members of female religious orders, women who have had tubal liga-tion or lesbians could provide a 'no-risk pregnancy' pool of volunteers. While possible, this is not generally a widely applicable solution, because geographic, environmental and volunteer numbers now become added variables.

Should women on oral contraceptives (OC) enter studies, could the high level of artificial hormones could confound the results? Female oral contraceptive users make up 28% of the potential child-bearing population (Ortho, 1991), and these hormone concentrations (10-20 times higher than the natural hormone levels) may cause drug interactions which cannot occur during ordinary menstrual cycling. Intra-uterine devices are currently regaining popularity, subdermalimplantshavehadlittleinfluenceon contraceptive practice at the epidemiological level.

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