Appropriate Consent Form Language for Studies that Exclude Women

Once one has reached the conclusion that the exclusion is valid, the consent form approach should be to present the information rather than simply state a proscription.

The idea is to be informative and respectful, leaving the decision to the informed woman when possible, and ALWAYS leaving the decision to her if the risk/benefit balance is such that real justice issues are raised.

Appropriate examples:

• "This is a new drug, and we don’t yet know if it is safe to give to women who are pregnant. If you could be pregnant now, or could get pregnant during the study, we suggest that you not participate or that you use reliable contraception while you are in the study."
• "This is a new drug, and we don’t yet know if it is safe to give to women who are pregnant. Other drugs in the same family have caused birth defects in animals. For this reason, we don’t want anyone to be in the study who is pregnant, or who might get pregnant during the study. We will do a pregnancy test before you start the drug; if you are sexually active, we will ask you to use a reliable form of birth control during the study (we’ll give you our recommendations about the best choices)."
• "This drug is known to cause birth defects in animals, and we think it may cause birth defects in people. We do not intend to enroll any patients who are pregnant or who might become pregnant. We will do a pregnancy test before you start the drug; if you are sexually active, it is very important that you use a reliable form of birth control during the study (we’ll give you our recommendations about the best choices)."

It may also be appropriate to add some language about contingencies. One of the basic principles of IRB review, "respect for persons," necessitates a description about the exclusion telling them why and using polite language. Examples:

• "If your pregnancy test is positive, we will discuss with you whether you wish to proceed with the study. (appropriate if risk relatively low or unknown, and chance of benefit is real)"
• "If you think you may have gotten pregnant during the study, please let the study doctors know about it right away. We will discuss with you whether you wish to stay in the study; whether you stay in the study or not, we will want to know if you have any problems with the pregnancy."
• "If you think you may have gotten pregnant during the study, let the study doctors know right away. It will then be dangerous for you to stay in the study. We will discuss with you what other options might be available to you."

Adapted from "What is appropriate wording for the consent form for a study that
excludes women or a subset of women?"
Dale Hammerschmidt, M.D.
June, 2000