Contraception Requirements and What They Ask of Participants

Part of Consent and Vulnerable Populations: Pregnancy, Breastfeeding and the Evidence Gap.

About 5 minutes. Free, in your language, no account needed.

Why this matters

Most trials of investigational products require participants of childbearing potential to use contraception, often specified in detail and often for a period extending beyond the trial.

These requirements are usually written by people who will not have to follow them, applied to populations whose circumstances were not considered, and presented in the consent form as a condition rather than as a subject of discussion.

They are also, for some participants, the most personally consequential thing the trial asks of them, and they deserve the attention that implies.

What the requirements actually ask

A specific method, or a combination. Protocols frequently specify "highly effective" methods and sometimes require two methods used together.

For a defined period, typically from before the first dose until some interval after the last, which may be months.

Of a partner in some cases, where the participant is male and the concern is exposure through seminal fluid.

With verification, through pregnancy testing at defined intervals.

Each of these lands differently depending on the participant's circumstances, and the protocol usually treats them uniformly.

Where the requirements collide with reality

Availability. A method specified as required may not be available, affordable, or legal in a participant's country. A protocol specifying a method available in one setting and not another has made the trial inaccessible in the second, usually without anyone noticing.

Religion and personal conviction. A participant whose beliefs preclude a specified method is being asked to choose between their convictions and participation, which is a real exclusion rather than a neutral condition.

Partner cooperation. A requirement depending on a partner's agreement puts the participant in a position they may not control, and for some participants raises safety issues at home.

Privacy. A requirement that a participant discuss contraception with a partner, or that their contraceptive use be recorded and monitored, is an intrusion that some will decline and others will comply with uncomfortably.

Applicability. Blanket requirements applied to participants for whom pregnancy is not possible, because of age, surgery or other reasons, are common, and they signal that the criteria were not thought about.

What good practice looks like

Specify by effectiveness rather than by method wherever the science permits, so that participants and sites can select an available and acceptable option.

Check availability per country at protocol design, rather than discovering at site initiation that a required method is not obtainable.

Make it a conversation, not a clause. The consent discussion should establish what the participant will actually use, whether it is available to them, and whether they have any difficulty with the requirement.

Allow abstinence where genuinely appropriate, assessed honestly rather than accepted as a box to tick, since a declared abstinence that is not real produces the outcome the requirement exists to prevent.

Explain the reason. A participant told that a requirement exists because the product's effects on a developing pregnancy are unknown will engage with it differently from one told it is a study requirement.

In practice

A trial specifies two highly effective contraceptive methods used simultaneously, for the duration and for six months afterward.

At a site in a country where one of the specified methods is not routinely available, the coordinator raises it during study start-up rather than at the first screening failure.

The protocol is amended to specify a required effectiveness level with a list of acceptable methods per region, developed with the sites.

Screening at that site proceeds. Under the original criteria, a substantial proportion of otherwise eligible women would have been excluded for a reason that had nothing to do with the science and everything to do with a protocol written elsewhere.

What this looks like when it goes wrong

A trial requires participants of childbearing potential to use a specified method and to confirm at each visit that they are doing so.

A participant is not using it. Her circumstances at home make it impossible for her to do so without a conversation she is not able to have.

She confirms at each visit that she is complying, because the alternative is being withdrawn from a trial she wants to remain in, and because the question is asked as a yes or no by a coordinator with a form.

She becomes pregnant in month nine and is withdrawn.

The requirement did not prevent the pregnancy. It produced a participant giving an untrue answer at nine consecutive visits, and it removed any possibility of the site knowing her actual situation and helping with it.

The failure is not hers. A requirement that makes honesty costly will reliably produce dishonest answers, and the trial learned nothing about her real circumstances at any point.

Key takeaways