Fetal Tissue From Abortions for Research Is Traded in a Gray Zone
By Denise Grady and Nicholas St. Fleur
July 27, 2015
Videos released by an anti-abortion group during the last two weeks have drawn attention to a little-known practice: the buying, selling and research use of fetal tissue acquired from abortion clinics.
The group behind the tapes accuses Planned Parenthood of selling fetal tissue for profit — which is illegal and which Planned Parenthood denies doing. House Republicans plan to investigate. This may be just one more battle in the nation’s long war over abortion, but the dispute has raised questions about who the buyers and sellers are, what fetal tissue is used for and what the law allows.
Scientists at major universities and government labs have quietly been using fetal tissue for decades. They say it is an invaluable tool for certain types of research, including the study of eye diseases, diabetes and muscular dystrophy. Nevertheless, some agree to talk about it only if their names and their universities’ names are withheld, because they have received threats of violence from abortion opponents. Companies that obtain the tissue from clinics and sell it to laboratories exist in a gray zone, legally. Federal law says they cannot profit from the tissue itself, but the law does not specify how much they can charge for processing and shipping.
The National Institutes of Health spent $76 million on research using fetal tissue in 2014 with grants to more than 50 universities, including Columbia, Harvard, the Massachusetts Institute of Technology, Stanford, Yale and the University of California in Berkeley, Irvine, Los Angeles, San Diego and San Francisco. It expects to spend the same amount in 2015 and 2016.
Researchers say fetal tissue is a uniquely rich source of the stem cells that give rise to tissues and organs, and that studying how they develop can provide clues about how to grow replacements for parts of the body that have failed.
“Think of fetal tissue as a kind of instruction booklet,” said Sheldon Miller, the scientific director of the intramural research program at the National Eye Institute.
Stem cells derived from adult tissue may eventually replace fetal ones, researchers say, but the science is not there yet.
Eye tissue from fetuses has played a crucial role in studies aimed at finding treatments for degenerative diseases of the retina that are a major cause of vision loss in people as they age, according to Dr. Miller.
“We couldn’t get this information any other way,” Dr. Miller said. He said the eye institute bought fetal tissue from a company, created specialized cultures of retinal tissue from it and sent them to other researchers.
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A university researcher who asked not to be identified because he had received threats that led his institution to post a guard outside his laboratory, said fetal tissue was extraordinarily useful because “if you want to understand how a tissue or a disease develops, you should go back to the beginning.”
Another researcher, also concerned about threats, said fetal tissue was essential in research to develop treatments for degenerative diseases of muscle, because “to regenerate tissues in a human, you need to understand how human cells work.” Animal tissue can take researchers only so far, they say, because there are critical differences in development.
Fetal tissue can be used only with the consent of the woman having an abortion. Some researchers receive the tissue from abortion clinics at their own institutions, or from tissue banks maintained by some universities. Many buy the tissue from companies that act as middlemen. Those companies pay small fees, usually $100 or less a specimen, to abortion providers like Planned Parenthood, who say they charge only what they need to cover their expenses. The companies then process the tissue and sell it to researchers for higher prices that reflect the processing.
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https://www.nytimes.com/2015/07/28/health/fetal-tissue-from-abortions-for-research-is-traded-in-a-gray-zone.html
Statute on Fetal Tissue Transplantation Research (1993)
PUBLIC LAW 103-43; JUNE 10, 1993
NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1993
TITLE I - GENERAL PROVISIONS REGARDING TITLE IV
of PUBLIC HEALTH SERVICE ACT
Subtitle A - Research Freedom
PART II - RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
SEC. 111. ESTABLISHMENT OF AUTHORITIES.
Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.)
is amended by inserting after section 498 the following section:
RESEARCH ON TRANSPLANTATION OF FETAL TISSUE SEC. 498A.
(a) ESTABLISHMENT OF PROGRAM-
(1) IN GENERAL - The Secretary may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes.
(2) SOURCE OF TISSUE - Human fetal tissue may be used in research carried out under paragraph (1) regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.
(b) INFORMED CONSENT OF DONOR-
(1) IN GENERAL - In research carried out under subsection (a), human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that–
(A) the woman donates the fetal tissue for use in research described in subsection (a);
(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and
(C) the woman has not been informed of the identity of any such individuals.
(2) ADDITIONAL STATEMENT - In research carried out under subsection (a), human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that–
(A) in the case of tissue obtained pursuant to an induced abortion–
(i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in such research;
(ii) no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
(iii) the abortion was performed in accordance with applicable State law;
(B) the tissue has been donated by the woman in accordance with paragraph (1); and
(C) full disclosure has been provided to the woman with regard to–
(i) such physician's interest, if any, in the research to be conducted with the tissue; and
(ii) any known medical risks to the woman 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) INFORMED CONSENT OF RESEARCHER AND DONEE - In research carried out under subsection (a), human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual–
(1) is aware that
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and
(C) the tissue was donated for research purposes;
(2) has provided such information to other individuals with responsibilities regarding the research;
(3) will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and
(4) has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.
(d) AVAILABILITY OF STATEMENTS FOR AUDIT-
(1) IN GENERAL - In research carried out under subsection (a), human fetal tissue may be used only if the head of the agency or other entity conducting the research involved certifies to the Secretary that the statements required under subsections (b)(2) and (c) will be available for audit by the Secretary.
(2) CONFIDENTIALITY OF AUDIT - Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a confidential manner to protect the privacy rights of the individuals and entities involved in such research, including such individuals and entities involved in the donation, transfer, receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall–
….
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/public-law-103-43/index.html