PREGNANCY
Note: The following paragraphs should be included in all consent forms if there is a risk to either the mother or fetus sufficient to exclude pregnant women from participation and avoid fathering a child during the course on the study.
General Pregnancy Caution.
Pregnancy and this study are not compatible because this treatment may be harmful to an unborn child, adequate birth control measures (oral or barrier methods) must be used by all participants and their sexual partners while participants are enrolled in this study.
Pregnancy Caution
Some research medications or procedures may cause severe birth defects, and/or mental retardation to a fetus (unborn baby). It is not known yet if Note: (Insert Study Drug) causes any adverse effects in pregnant or nursing women, the unborn baby, or in the sperm of the male
BIRTH CONTROL AND PREGNANCY
Both men and women can join this study. All participants during the study and for six months after should use effective birth control (double barrier preferred) (i.e. surgically sterilized by tubal-ligation, hysterectomy or post menopausal or use an effective birth control method such as condoms, cervical caps, IUD, diaphragm, spermicidal cream with condom, oral, injectable, or implant contraceptives, or abstinence).
WOMEN ONLY:
Women who are able to have children should not take the study medications unless they are using birth control all the time. The safety of Note: (Insert study drug) during pregnancy is not known. Women who are able to have children must have a negative pregnancy test within 7 days before starting the study drugs. A repeat pregnancy test must be done if you miss a period or your menstrual cycle becomes very irregular.
If you do become pregnant while in this study or within 6 months after stopping treatment, you must contact your doctor, study nurse or principal investigator immediately. Your doctor will advise you of the possible risks to your unborn child and options available to you. Because of the possible risks to your unborn child, all study drugs would be stopped permanently. You would receive medical supervision during your pregnancy and for the child after birth. Upon consent, the investigator will request, collect and report information about your pregnancy and your child, to the Sponsor. Your identity and the identity of your baby would be kept confidential.
MEN ONLY:
Men should not father a child while on study treatments. If your partner is capable of becoming pregnant while you are participating in the study, it is important that you realize that it is your responsibility to inform your partner immediately, that the risks to her or any unborn child are not known.If your partner does become pregnant while you are taking part in this study, or within 90 days after you stop the treatments, it is very important that the study doctor should be informed; either you or your partner may do this.If your partner chooses to report her pregnancy directly to the study doctor, any information she provides to the study doctor will remain confidential. Your partner may contact the study doctor if she wishes further information about the study.
The Sponsor may require request that the outcome of the pregnancy be monitored
Note: (Insert Sponsor’s Name) to organize this medical supervision. If she agrees to participate in such supervision, she will be asked to sign a consent form to allow relevant data to be collected about her and the baby. If she is unwilling to participate in medical supervision or refuses to sign the consent form, your participation in the study will not be affected. Please ask your doctor if you wish to see a copy of this form.
Note: If applicable if a pregnancy occurs there is a consent form for the partner.
Version Date: June 17, 2009November 5, 2015