Ensuring the right steps are taken to prevent pregnancy can be an important part of research subject safety, particularly for drug studies, as the effects of a research intervention on an embryo or fetus are often unknown. But what’s the best way to describe the requirement to avoid pregnancy in a consent form? Quorum Review IRB, in its recent e-publication “How to Simplify Your Consent Form,” points out that often the consent form language about contraception/abstinence is written very broadly, rather than being tailored to the study population, or to an individual potential subject. Also, effective contraceptive methods may change during the course of a study, so a list of specific methods may become outdated as the study proceeds.
Any particular contraceptive methods medically contraindicated during a study need to be spelled out in a consent form. However, Quorum Review suggests that many consent forms’ description of a general requirement to avoid pregnancy can be shortened to something like: If you can become pregnant or can father a child, you will be required to use contraception (birth control) during the study and for 30 days after your last dose of study drug. Your study doctor will discuss appropriate methods of birth control with you. It is important that you tell the study doctor immediately if you become pregnant during the study.
The above language allows the study team to weigh in on what the best contraceptive method is for a particular subject’s circumstances. It is also much shorter than the typical language we see, which often spells out the sponsor’s definition of who must use contraception, and includes a list of acceptable methods.
We know that many of these consent forms come from industry sponsors of investigational drug studies, and by the time the IRB sees them, it may be too late to request changes to this language. But what do you think? Would industry sponsors be amenable to simplifying this language if sites were to ask them to do so earlier in the process?