If you plan to include pregnant participants and/or neonates in your study, additional regulatory requirements may apply. For details on requirements for studies involving pregnant participants and/or neonates, refer to HRP 412-CHECKLIST-Pregnant Participants, HRP 413-CHECKLIST-Non-Viable Neonates, and HRP 414-CHECKLIST-Neonates of Uncertain Viability.

In Wisconsin, the reporting of pregnant participants who habitually abuse drugs or alcohol to a severe degree is permissive but NOT mandatory. Pregnant participants seeking help for drug or alcohol abuse generally do not meet reporting criteria. For studies conducted in Wisconsin that include participants who are or could become pregnant and involve asking questions about illicit drug use or alcohol abuse, or performing toxicology tests to obtain this information, add the language provided here ONLY if the study does NOT have a Certificate of Confidentiality (CoC) AND there is any possibility that a member of the research team may report a participant to state authorities. If the study team will not report a pregnant participant found to be abusing drugs or alcohol, the language does not need to be added.

For studies with a CoC, the CoC protects information about drug or alcohol use from disclosure. In this case, reporting may not occur without explicit consent of the participant. It is advised that researchers not combine the consent to report with the research consent form, especially for potentially therapeutic studies. Rather, if it is determined in a specific case that a report should be made, it is recommended that consent is obtained through a separate form obtained at the time of a proposed report. No reporting may occur if the pregnant participant refuses consent. Contact UW legal counsel for assistance.