Against Consent Form Language Requiring Multiple or Specific Methods of Contraception

Strength through Structure: Defending a Structured Approach to Contraceptive Mandates in Clinical Research

“…I n “Against Consent Form Language Requiring Multiple or Specific Methods of Contraception,” in the May–June 2018 issue of this journal, Kuczewski and Anderson argue that, for clinical trials, requiring that female research participants use specific forms of contraception and/or that consent form language detail specific forms of acceptable contraception does not achieve any of three purported goals: it does not decrease a sponsor's legal liability for negative pregnancy outcomes, it fails to protect the health of children, and it is paternalistic toward women 1 . Instead, the authors advocate for general language that describes the potential reproductive risks of a study and the precautions that should be taken to prevent pregnancy, without detailing specific contraception.…”