Any investigator proposing to use fetal tissue must complete an application form for full CPHS review and approval. The application must include a copy of the consent form used to obtain consent for donating the tissue. CPHS must be assured that the woman donating tissue has been given an opportunity to understand the procedures, any possible risks to her privacy or well-being, and to assure that she has an opportunity to give free and informed consent to the donation. Tissue may only be obtained from women over the age of 18.

The timing of the already agreed-upon surgical procedure must not be changed for research purposes; postponement is not permitted.

Regardless of the circumstances of donation, whether by spontaneous miscarriage and subsequent retrieval of any remaining tissue or by elective abortion, the tissue must be obtained from a dead fetus.

A two-step consent process is necessary. The woman should sign the appropriate surgical consent form for the underlying surgical procedure. Only after giving consent to the surgery, may the woman be approached for the research donation of fetal tissue. This should occur prior to the administration of any sedative, with adequate time to consider the request and ask any questions to ensure an informed decision.

A consent form for the research donation should include the following information:

• a statement that the fetal tissue will be used in research and a short description of the reasons for the research
• a statement that the decision to donate or not, will not affect the planned surgical procedure; that there will be no modification in the procedure; no additional risks or discomforts associated with the donation
• a statement that the tissue will not be identified and that the woman will not be identifiable
• a statement as to whether any special tests of the woman or fetus will be performed (blood tests for infection, HIV, etc.). If so, whether the information will be available to the woman donating the tissue
• a statement that there will be no additional costs to the woman as a result of the decision to donate
• a statement that there is no benefit to the woman for the donation
• a statement that if the woman chooses to withdraw consent for the research donation, she may do so
• a statement giving the name and telephone number of the investigator indicating a willingness to answer questions