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Against Consent Form Language Requiring Multiple or Specific Methods of Contraception

Abstract: Institutional review boards (IRBs) are tasked with reviewing language concerning reproductive risks in consent forms for clinical trials. Generally, pregnant women are excluded from clinical trials, and consent forms emphasize that female participants should not become pregnant during the study. Language varies widely, but sometimes specific forms of contraception that should be used are mentioned. The requirement that women of childbearing age use multiple or specific forms of contraception, rather than simply being told to avoid becoming pregnant, does not have any regulatory underpinning. However, it is regularly accepted without much scrutiny by IRBs. We argue against the use of overly specific consent language regarding contraception. We recommend instead using consent form language about the need to avoid pregnancy that respects the decision-making capacity of both female and male research participants and engages them in developing plans that adequately protect against the risk of becoming pregnant during their research participation.

Keywords: human subjects research, clinical trials, contraception, informed consent, respect for persons