Potentially Childbearing/Pregnant Women & Fetuses

Basic Ethical Principles & Concerns

1. Inclusion of women in studies should be the norm, not the exception.
2. The fetus is considered a vulnerable research subject and deserves special protection from harm.
3. The decision-making authority for fetal risk is ordinarily with the pregnant or potentially-pregnant woman; this authority should not be displaced elsewhere for research participation.
4. Under-representation of women in research has led to a systematic lack of data about drugs and treatments with them, displacing the "experiment" to the uncontrolled setting of clinical use; this creates scientific and justice concerns.
5. In the case of studies of new therapies - especially for diseases with poor standard therapy options - the systematic exclusion of women may be unjustly denying them access to benefits of research participation.

Additional Resources

Appropriate Consent Form Language for Studies that Exclude Women

IRB Stance on Pregnancy Testing

Allowable Exclusions

Exclusion of women and subgroups of women can be approved by the IRB when they meet criteria set out by federal regulations (see 45 CFR 46 subpart B).

To determine if the exclusion of women in a research study could be allowable, see Making an Exclusion Decision. Also see the conditions below that could make this decision irrelevant.

There are some studies that simply aren’t relevant to women of childbearing potential, and thus a decision about exclusion isn't necessary. Examples:

• The study could be of a disease that doesn’t occur in women of childbearing potential (prostate cancer, post-menopausal osteoporosis);
• The study could be of a disease that is normally not treated until after delivery if it occurs in a pregnant woman;
• The study could be one for which childbearing potential would be a legitimate scientific exclusion (anorexia nervosa, in which menstruation may identify subjects who are less severe than those the study is intended to address)

What to do in these cases

• In the IRB application, specifically explain that this is the basis on which a claim for allowability of the exclusion is based; and
• explain any non-obvious basis for the belief that the study is not a direct benefit;
• Provide a respectful consent form (see Consent form language) and process that explain the exclusion rather than just demanding it.