Institutional Review Board
Information and Forms
Pregnancy Exclusion Language for Consent Forms
The Institutional Review Board has adopted policies and language for consent forms related to pregnancy exclusion in clinical trials, which are below. It is believed reasonable uniformity will protect subjects, fetuses, and investigators and the institution.
This language should be adopted in consent forms submitted with new protocols, and in consent forms submitted for renewal.
- Subjects are males only, or females not of childbearing potential:
No pregnancy exclusion language needed.
- Subjects include females of childbearing potential and drug NOT fetotoxic/fetocidal:
No pregnancy exclusion language needed.
- Subjects include females of childbearing potential and drug fetotoxic/fetocidal (or unknown) and terminal disease fatal regardless of treatment or immediately life-threatening:
No pregnancy exclusion language needed.
- Subjects include women of childbearing age, and drug fetotoxic/fetocidal (or unknown), and illness non-terminal, and immediate treatment required (less than 15 days from diagnosis):
"Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are considered to be: abstinence (not having sex), oral contraceptives (the "pill"), intrauterine device (IUD), DepoProvera, Norplant, tubal ligation ("tubes tied"), or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and a spermicidal foam or gel and/or a cervical cap or sponge. We encourage you to discuss this issue further with your physicians if you have any questions."
"Pregnant women are excluded from participation in this study. Because some methods of birth control are not 100% reliable, a pregnancy test is required at least 10 days after your last normal menstrual period if you are a sexually active woman of childbearing potential."
- Subjects include women of childbearing potential, and drug fetotoxic/fetocidal (or unknown), and illness non-terminal, and immediate treatment NOT required:
"Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are considered to be: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, Norplant, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and a spermicidal foam or gel and/or a cervical cap or sponge. We encourage you to discuss this issue further with your physicians if you have any questions."
"Pregnant women are excluded from participation in this study. If you are a sexually active woman of childbearing potential and have not been using an accepted method of birth control, two negative pregnancy tests performed 15 days apart are required to check for possible early pregnancy prior to starting treatment."