No reference to contraception may be used in the informed consent form or any other materials shared with research participants. If reproductive risks have been identified in a proposed study, the following language is required in the informed consent form.
Avoidance of Pregnancy: The medicines and procedures used in this study may be unsafe for an unborn baby, an infant, sperm, and eggs. If you, a woman of child bearing potential, are a study/trial participant, you must agree to avoid pregnancy during your participation in this study and for ____________ months after the completion of the study (include protocol time frame as appropriate); if you, as a participant are a man, you must agree to not conceive a child during your participation in this study and for ____________ months after the completion of the study (include protocol timeframe as appropriate). If you do become pregnant during the study or if you father a child during the study, you should immediately notify Dr. ____________ (name of contact) at _____________ (contact information). In addition, if you are already pregnant or are breast feeding, you cannot participate in this study.