Basic Consent Form Template Language Regarding Pregnancy Risks

Basic Consent Form Template language regarding pregnancy risks:

Is there any way being in this study could be bad for me? [Include for research that involves pregnant women or women of child-bearing potential and procedures that involve risks to an embryo or fetus or whose risk profile in pregnancy is not well known. Otherwise delete.] The procedures in this research are known to hurt a pregnancy or fetus in the following ways: ______. [Omit the previous sentence if there are no known risks.] The research may also hurt a pregnancy or fetus in ways that are unknown. These may be a minor inconvenience or may be so severe as to cause death. [Omit the previous two sentences for research whose risk profile in pregnancy is well known.] You should not be or become pregnant [include as applicable “or father a baby”] while on this research study.

Additional language for different types of pregnancy risks (recommended as necessary):

Is there any way being in this study could be bad for me? For female participants who have the potential to become pregnant: There are/may be risks to a fetus if you become pregnant while participating in this study. The potential risks to a fetus or a nursing child are not known. If you are pregnant or nursing a child you cannot participate in this trial. You will be tested to see if you are pregnant and you must confirm that you do not intend to become pregnant during the trial. If you become pregnant or suspect being pregnant during study treatment or within [include the timeframe] after completing study treatment, you must inform the Study Doctor immediately, and you will need to stop taking the study drug immediately. You will not continue study treatment; however, your study doctor will want to follow your pregnancy. You may be asked to sign another consent form so information can be collected about the outcome of your pregnancy. Premenopausal females who can become pregnant must agree to either practice total abstinence or use effective contraception before participating in this study. The rhythm method, “natural family planning”, and withdrawal are not acceptable methods of contraception for this trial. Effective contraception for this study includes: [include the acceptable method(s) of birth control for participating in this study, deleting those not allowed] male condom, female condom, contraceptive sponge, contraceptive diaphragm, combined oral contraceptive pill, contraceptive patch, contraceptive vaginal ring, progestin-only pill, injectable, hormonal intrauterine device, non-hormonal intrauterine device, contraceptive implant, male sterilization, female sterilization (including hysterectomy). You must use contraception, at least [include the timeframe] before starting study treatment unless you abstain from sexual intercourse. You must use contraception during study treatment and for at least [include the timeframe] after stopping study treatment.

For male participants with female partners who have the potential to become pregnant:

There may be risks to the fetus if your partner is pregnant or becomes pregnant while you are in this study. You and your partner must either practice total abstinence or use effective contraception before participating in this study. The rhythm method, “natural family planning”, and withdrawal are not acceptable methods of contraception for this trial. Effective contraception for this study includes: [include the acceptable method(s) of birth control for participating in this study, deleting those not allowed] male condom, female condom, contraceptive sponge, contraceptive diaphragm, combined oral contraceptive pill, contraceptive patch, contraceptive vaginal ring, progestin-only pill, injectable, hormonal intrauterine device, non-hormonal intrauterine device, contraceptive implant, male sterilization, female sterilization (including hysterectomy)

You should also refrain from donating semen during therapy and for [include the timeframe] after stopping the therapy.

There is theoretical concern that study treatment can result in sperm abnormalities and/or can transmit harmful substances in their semen during sex. Therefore, if you are a male, you must remain abstinent or to use a condom, even if you have undergone vasectomy, and to advise your female partners of childbearing potential to use highly effective contraception while you are receiving study treatment and for [include the timeframe] after you stop study treatment. You must tell your study doctor or study personnel immediately if your partner becomes pregnant during this time.

If your partner becomes pregnant or suspects becoming pregnant during study treatment or within [include the timeframe] after completing study treatment, you must inform the Study Doctor immediately. Your Study Doctor may want to follow the pregnancy and may ask your partner to sign a consent form so he/she can collect information about the outcome of the pregnancy.