Cal. Code Regs. tit. 17 § 100085

Current through Register 2024 Notice Reg. No. 43, October 25, 2024

Section 100085 - Use of Fetal Tissue

Fetal tissue shall be procured in accordance with 17 Cal. Code of Regs. section 100080, subdivision (a)(2). In addition, research involving human fetal tissue will adhere to the following provisions:

(a) The woman who donates the fetal tissue must sign a statement declaring:

(1) That the donation is being made for research purposes, and

(2) The donation is made without any restriction regarding who may be the recipient(s) of materials derived from the tissue; and

(b) The attending physician must:

(1) Sign a statement that he or she has obtained the tissue in accordance with the donor's signed statement. In the case of tissue obtained pursuant to an induced abortion, the physician must sign a statement stating that he or she:

(A) Obtained the woman's consent for the abortion before requesting or obtaining consent for the tissue to be used for research;

(B) Did not alter the timing, method, or procedures used to terminate the pregnancy solely for the purpose of obtaining the tissue for research; and

(C) Performed the abortion in accordance with applicable law.

(2) Disclose to the donor any financial interest that the attending physician has in the research to be conducted with the tissue.

(3) Disclose any known medical risks to the donor or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman's medical care.

(c) The principal investigator of the research project must sign a statement certifying that he or she:

(1) Is aware that the tissue is human fetal tissue obtained in a spontaneous or induced abortion or pursuant to a stillbirth;

(2) Is aware that the tissue was donated for research purposes;

(3) Had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy; and

(4) Is not the donor's attending physician.

Cal. Code Regs. Tit. 17, § 100085

1. New section filed 7-24-2007; operative 8-23-2007 (Register 2007, No. 30).
2. Amendment of first paragraph filed 5-30-2008; operative 6-29-2008 (Register 2008, No. 22).

Note: Authority cited: California Constitution, article XXXV; and Section 125290.40(j), Health and Safety Code. Reference: Sections 125290.35, 125290.40, 125290.55 and 125300, Health and Safety Code.