The fence over using human being fetal tissue in medical research came roaring dorsum on the national policy agenda last summer when a group of antiabortion activists began releasing deceptively edited videos almost Planned Parenthood's treatment of fetal tissue donations for this purpose. Fetal tissue inquiry dates back to the 1930s, and has led to major advances in human wellness, including the virtual elimination of such babyhood scourges as polio, measles and rubella in the United States.1,2 Today, fetal tissue is being used in the development of vaccines against Ebola and HIV, the report of human development, and efforts to care for and cure atmospheric condition and diseases that agonize millions of Americans.

To ensure it meets the highest upstanding standards, fetal tissue inquiry has been bailiwick to stringent laws and regulations for decades. Ballgame foes are now accusing wellness care providers and researchers of violating these laws and ethical standards, in hopes of undermining the right to ballgame and ending fetal tissue research. These attacks non just threaten sexual and reproductive health and rights, simply as well pose a threat to the large numbers of people who could benefit from fetal tissue inquiry, given the wide range of conditions that such inquiry might meliorate. Any impediment to ongoing scientific research in the field caused by the current controversy would accept substantial consequences.

Importance of Fetal Tissue Enquiry

Unlike embryonic stem jail cell enquiry, which uses cells from days-old embryos created through in vitro fertilization, fetal tissue research uses tissue derived from induced abortion of pregnancies at or after the ninth week.1,3 (Fetal tissue obtained from a miscarriage is often not suitable for research purposes because of concerns about potential chromosomal abnormalities that led to the miscarriage.3) Researchers near often acquire fetal tissue from a tissue banking company or, sometimes, directly from a infirmary or abortion clinic.4

Considering it is non equally developed every bit developed tissue and is able to adjust to new environments, fetal tissue is critical to the study of a wide diversity of diseases and medical conditions, according to the American Society for Cell Biology.1 Researchers apply fetal tissue—and cell cultures derived from such tissue, which tin can be maintained in a laboratory environment for decades—to written report fundamental biological processes and fetal development. Co-ordinate to the U.S. Section of Health and Human being Services, fetal tissue continues to exist an of import resource for researchers studying degenerative heart illness, human development disorders such as Down syndrome, and early on encephalon development (relevant to understanding the causes of autism and schizophrenia).2

Fetal tissue has also been used to develop vaccines that have saved and improved the lives of billions of people worldwide.1,two,v The 1954 Nobel Prize in Medicine was awarded for work using cell cultures originating from fetal tissue that led to the development of the polio vaccine. Vaccines for diseases such as measles, mumps, rubella, chickenpox, whooping cough, tetanus, hepatitis A and rabies were also created using fetal cell cultures, and researchers are now using fetal cells to develop vaccines against other diseases, including Ebola, HIV and dengue fever.

In add-on, researchers use fetal tissue in transplantation research. Fetal tissue has several unique properties that make it peculiarly suitable for transplantation. Not only do fetal cells grow at a much faster rate than developed cells, they too arm-twist less of an allowed response, which lowers the hazard of tissue rejection.6 Clinical trials transplanting fetal cells are currently underway for people with spinal cord injury, stroke and ALS (Lou Gehrig's disease), and may soon brainstorm for those with Alzheimer'due south illness, Parkinson'south affliction and multiple sclerosis.ane

The National Institutes of Health (NIH) has been supporting enquiry using fetal tissue since the 1950s, and in FY 2014, NIH provided roughly $76 1000000 for this work.iii According to an analysis of NIH enquiry grants published in Nature, NIH funded 164 projects using fetal tissue in 2014, most oft for research on infectious diseases, eye part and disease, and developmental biological science (see chart).vii,8

Many of the nation's leading academic medical centers are involved in fetal tissue research.vii,9,x Researchers at the University of Northward Carolina at Chapel Hill are using prison cell cultures derived from fetal tissue for their piece of work on hepatitis B and C—specifically, on how the viruses evade the man immune system and cause chronic liver diseases. At the University of Wisconsin-Madison, fetal cell cultures are used to report heart disease, including sudden cardiac arrest. At Stanford University, fetal tissue has been used to study Huntington'south disease, juvenile diabetes, autism and schizophrenia. And scientists at Colorado State University are conducting HIV inquiry using fetal tissue.


Federal Constabulary and Regulation

Soon after the U.Due south. Supreme Courtroom'southward Roe v. Wade decision in 1973 legalizing ballgame nationwide, antiabortion leaders in Congress seized on fetal tissue research equally a weapon in the war against abortion. Fetal tissue research was perhaps an inevitable target: It provided an aura of legitimacy to abortion itself and, at the same fourth dimension, could exist easily exploited to bear witness how abortion "dehumanizes" the fetus.11 Accordingly, antiabortion activists employed graphic visuals to shock members of Congress, try to personify the fetus, and demonize abortion providers and the procedure itself.

This beginning incarnation of the controversy coincided with public revelations near the infamous Tuskegee syphilis study—a study that enrolled blackness men living in Alabama to investigate the long-term effects of syphilis. In 1973, an ad hoc advisory panel convened by the Department of Wellness, Educational activity and Welfare (now the Department of Health and Man Services) ended that, in retrospect, the report was "scientifically unsound" and "ethically unjustified."12 In response to the Tuskegee revelations, Congress felt force per unit area to create protections for human research subjects, and by 1974, Congress passed the National Inquiry Human action. The law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines on the ethical principles that apply to enquiry on all human subjects, also as on particular principles that apply to research involving fetuses and using fetal tissue.

The committee'southward report on enquiry on the fetus, issued in 1975, led to the creation of regulations during the Ford administration that set out the rules of the road for federally funded fetal tissue research. The regulations—which are still in effect—specify that "no inducements, monetary or otherwise, will be offered to terminate a pregnancy." They likewise provide that "individuals engaged in the enquiry will accept no role in whatever decisions as to the timing, method, or procedures used to terminate a pregnancy."

Fetal tissue research receded as a political outcome until the late 1980s, when a group of NIH scientists sought approval from the Reagan administration for a proposed project involving the transplantation of fetal tissue. Afterwards deliberating on the request, the assistants appointed an advisory panel—which included a chair and several members who were well-known opponents of abortion rights—to examine the upstanding, legal and scientific questions raised past this blazon of inquiry. In 1988, the panel issued its report and, despite its mixed limerick, it concluded that "in light of the fact that abortion is legal and that the research in question is intended to accomplish significant medical goals…the use of such tissue [for research] is adequate public policy."13

Key recommendations of the panel were later codification into police force with the passage of the NIH Revitalization Human action of 1993. The legislation won broad bipartisan back up in Congress, including from several prominent senators with solid antiabortion records. Amidst them were Sens. Robert Dole (R-KS), a longtime advocate for people with disabilities, and Strom Thurmond (R-SC), who had a girl with juvenile diabetes.14,xv

The NIH Revitalization Deed of 1993 added several provisions to the existing regulations governing fetal tissue research. One such provision prohibits anyone from accepting payment for human fetal tissue other than "reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue." Thus, although individuals may be compensated for any costs they incur in the acquisition, receipt or transfer of fetal tissue, they are prohibited from making a turn a profit from these activities, regardless of whether the projection is federally funded or not.

The law likewise imposes additional requirements when the donated tissue is used in federally funded research involving the transplantation of fetal tissue for therapeutic purposes. Amongst these are provisions for informed consent and prohibiting physicians and researchers from altering the timing or method used to terminate the pregnancy solely for the purposes of obtaining the tissue. Although all of these requirements technically apply only to federally funded transplantation research, as a applied matter, they set the standard for all inquiry using fetal tissue. For instance, the policies and procedures for fetal tissue donation issued by Planned Parenthood Federation of America and past the National Ballgame Federation comprise the substance of these federal requirements.16,17

State Policies

At the state level, fetal tissue donation is regulated by the Compatible Anatomical Gift Act (UAGA), versions of which are in outcome in every state.13,18 Co-ordinate to an analysis past the Guttmacher Institute, 38 states and the District of Columbia take UAGA laws that explicitly care for fetal tissue the aforementioned fashion every bit other human tissue, permitting it to be donated by the adult female for enquiry, therapy or education. The remaining 12 states take laws that are silent, neither assuasive nor disallowing the donation of fetal tissue (see map). UAGA also prohibits profiting from the sale or buy of anatomical gifts for transplantation or therapy.

Fetal tissue donation and research are also regulated in some states by specific statutes. Often, these statutes incorporate many of the same standards set by federal law and regulations. For example, 12 states prohibit making a turn a profit from the donation or transfer of fetal tissue for enquiry purposes, and eight states require the woman's consent for inquiry.

Five states have laws that ban research using fetal tissue obtained from abortions throughout pregnancy. (Iv other states also ban enquiry using postabortion fetal tissue, but these laws accept been struck down past the courts.) I of these states with a ban in issue, Indiana, too has a law that requires the disposal of postabortion fetal tissue in an established cemetery or by cremation, presumably precluding whatsoever possibility of donation for inquiry.


Political Firestorm

The current furor over the use of fetal tissue in research ignited last summer, after the release of heavily edited videos purporting to capture surreptitious sting operations targeted at Planned Parenthood. The serial of videos—released in close cooperation with members of Congress who want to ban abortion19—show an antiabortion activist posing every bit a representative of what turned out to be a sham biomedical research company, in frank discussions with various Planned Parenthood officials about tissue donation policies and reimbursement.

The fallout from the videos has been swift, severe and wide-ranging. The stated targets are Planned Parenthood, abortion providers and the legitimacy of ballgame. The videos besides threaten to undermine fetal tissue research itself, however, by sowing confusion, and past using graphic descriptions and images to turn the public against this enquiry.

The master goal of this current campaign has been to portray Planned Parenthood as callous and its providers every bit possibly criminal. Antiabortion policymakers have accused Planned Parenthood of violating several provisions of the NIH Revitalization Act of 1993, such every bit profiting from the auction of fetal tissue and altering the abortion procedure solely for the purpose of obtaining tissue. Opponents of abortion have also accused providers of using a procedure that violates the so-chosen "partial nativity" abortion ban. As an instigator of the videos, David Daleiden explained in an interview with Politico, "For me, the goal was to document and illustrate for the public really, really clearly how Planned Parenthood harvests and sells the body parts of the babies that they abort."20

Antiabortion elected officials ran with this narrative and immediately chosen for investigations of the organization. In Oct 2015, congressional leaders formed a special committee to carry out an official research into Planned Parenthood—bringing the full number of investigations into Planned Parenthood in the Business firm and Senate to 5 since the kickoff video was released. In Jan 2016, the Firm's first substantive slice of business organisation was however another endeavor to cut off funding for Planned Parenthood, one of several such efforts recently to scale back abortion rights and women's wellness care. As well, officials in xi states have ended investigations into claims that Planned Parenthood profited from fetal tissue donation, and each i of these investigations has cleared the organization of wrongdoing.21

Yet, the grandstanding has continued unabated. Antiabortion leaders, lawmakers and all the Republican presidential candidates accept used the opportunity to demonize abortion and paint a ghoulish picture of organ harvesting, all in an effort to gin upwards public disgust and attract public support for themselves and against ballgame and Planned Parenthood. Indeed, the videos and the hype effectually them appear to have provoked at least four arson attacks on Planned Parenthood clinics since July 2015 and gear up the phase for yet some other extreme act of violence in Colorado Springs over Thanksgiving weekend.ten It was there that Robert Lewis Dear Jr. allegedly killed three people and injured 9 others at a Planned Parenthood health centre. During his arrest, Honey shouted "no more baby parts," suggesting that the abiding barrage of inflammatory rhetoric effectually the fetal tissue consequence over the prior months played a function in triggering his actions.22

High Stakes

Beyond the attacks on Planned Parenthood, withal, the use of fetal tissue in inquiry also is under direct attack. Since July, bills accept been introduced in Congress and in several states that would brand it more difficult to donate tissue or use fetal tissue in inquiry. Other bills would ban fetal tissue research outright. This tendency is nearly certain to proceed through 2016 every bit the issue is sure to be exploited in land and federal elections.

Meanwhile, the videos appear to have had a spooky upshot on scientific discipline. According to Theresa Naluai-Cecchini, a scientist at the Birth Defects Research Laboratory at the University of Washington (a federally funded entity that has served every bit a source of donated fetal tissue to researchers nationwide for more than 50 years), tissue donations have dropped dramatically since July 2015.10 Naluai-Cecchini told Mother Jones that if this trend continues, research that may salvage lives would take considerably longer.

Some scientists involved in fetal tissue research have been afraid to speak out.seven They take seen how ballgame providers have been targeted, and now they too fear for their personal safety. Others have spoken out strongly to defend the importance of their work, pointing out that tissue that would otherwise be discarded has played a vital role in lifesaving medical advances and holds groovy promise for new breakthroughs. In an October 2015 open letter to Congress, 41 scientists called for the end to political interference with scientific discipline and research: "Fetal tissue research has already saved and improved the lives of countless people. [Nosotros] cannot permit political agendas to undermine our nation's legacy of leadership in medical and scientific innovation."23 In some other action, the Association of American Medical Colleges released a statement on January 6, 2016 signed by 59 academic medical centers, scientific societies and allied groups—from the University of Alabama School of Medicine to Duke Academy School of Medicine, from the University of Wisconsin-Madison to Tulane Academy School of Medicine.24 The statement expresses "grave concerns" virtually the numerous legislative proposals now in play in Congress and in many states, and it calls on lawmakers to reject any proposals that restrict admission to fetal tissue for inquiry.

Ironically, in the wake of all the heightened focus on fetal tissue donation, Planned Parenthood officials report they take seen an uptick in the number of women obtaining abortion who request that the fetal tissue be donated to research. The role that Planned Parenthood plays in providing postabortion tissue to researchers, however, is pocket-size: Just 1% of the approximately 700 health centers that are function of the Planned Parenthood network are equipped for fetal tissue donation. And in another response to the disinformation campaign and to endeavor to quell some of the controversy, Planned Parenthood appear in Oct 2015 that its clinics will no longer seek reimbursement for their costs related to fetal tissue donation, even though the do is perfectly legal and commonplace.

Bioethicist R. Alta Charo has argued that enabling the utilize of fetal tissue to accelerate scientific inquiry for the benefit of humankind must be seen equally something of a moral imperative. "Almost every person in this country has benefited from enquiry using fetal tissue," she wrote in the New England Journal of Medicine. "Every child who's been spared the risks and misery of chickenpox, rubella, or polio can thank the Nobel Prize recipients and other scientists who used such tissue in research yielding the vaccines that protect the states….Any discussion of the ethics of fetal tissue inquiry must begin with its unimpeachable merits to take saved the lives and wellness of millions of people."25

As the full impact of the current firestorm surrounding fetal tissue research is still unfolding, it remains to be seen how much this research will continue be used every bit a weapon against abortion or become a serious target itself—or both. To be sure, the electric current controversy threatens non just admission to safe and legal abortion and the providers who care for the women who seek this essential health service. It also threatens the millions of people globally who could benefit from fetal tissue inquiry—and that includes nearly all of us, whatever our views on abortion rights may be.

REFERENCES

1. American Society for Prison cell Biological science, FAQs on fetal tissue research, 2015, http://www.ascb.org/wp-content/uploads/2015/ten/fetal-tissue.pdf.

2. Letter from Jim Esquea to Sens. Joni Ernst and Roy Edgeless, Aug. 14, 2015, http://www.plannedparenthood.org/files/3514/4709/3497/HHS_Letter_2015_08_14_-_FT_Research.pdf.

3. Congressional Inquiry Service, Fetal tissue research: oft asked questions, 2015, http://fas.org/sgp/crs/misc/R44129.pdf.

4. U.S. Government Accountability Office (GAO), Human Fetal Tissue: Conquering for Federally Funded Biomedical Research, Washington, DC: GAO, 2000, http://www.gao.gov/products/164170.

5. U.S. Department of Wellness and Human Services, The effectiveness of immunizations, no date, http://archive.hhs.gov/nvpo/concepts/intro6.htm.

6. Ishii T and Eto K, Fetal stem cell transplantation: past, nowadays, and time to come, Globe Journal of Stem Cells, 2014, 6(4):404–420.

7. Wadman M, The truth nigh fetal tissue enquiry, Nature, December. 7, 2015, http://www.nature.com/news/the-truth-well-nigh-fetal-tissue-research-1.18960.

8. Wadman M, New America Foundation, Washington, DC, personal communication, Jan. 6, 2016.

nine. Binkley C and Johnson CK, Scientists say fetal tissue essential for medical research, Associated Press, Aug. 11, 2015, http://news.yahoo.com/medical-researchers-fetal-tissue-remains-essential-053139330--politics.html.

ten. Andrews B, How the attack on Planned Parenthood is hindering cures for deadly diseases, Mother Jones, Oct. 26, 2015, http://www.motherjones.com/politics/2015/10/planned-parenthood-attack-videos-pain-fetal-tissue-enquiry.

11. Gold RB and Lehrman D, Fetal inquiry under fire: the influence of ballgame politics, Family unit Planning Perspectives, 1989, 21(ane):6–11 & 38.

12. Public Wellness Service, U.S. Department of Health, Education and Welfare, Final Report of the Tuskegee Syphilis Sudy Advertizement Hoc Advisory Panel, Washington, DC: U.S. Department of Health, Education, and Welfare, 1973.

13. Advisory Committee to the Director, National Institutes of Wellness, Human Fetal Tissue Transplantation Research, Bethesda, Doctor: National Institutes of Health, 1988.

14. Golden RB, Embryonic stem cell research—old controversy; new debate, The Guttmacher Study on Public Policy, 2004, 7(4):4–6, http://world wide web.guttmacher.org/pubs/tgr/07/4/gr070404.html.

15. Charo RA, Yes, Republicans are outraged about Planned Parenthood. But they used to support fetal tissue research, Washington Post, Aug. 4, 2015, https://www.washingtonpost.com/posteverything/wp/2015/08/04/despite-their-planned-parenthood-outrage-many-republicans-in-congress-once-supported-fetal-tissue-research/.

16. Committee on Energy and Commerce, U.S. House of Representatives, Update on the Commission'south ongoing investigation of Planned Parenthood Federation of America, Sept. 9, 2015, https://democrats-energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/Memorandum%20from%20Energy%20and%20Commerce%20Committee%20Democratic%20Staff%2C%2009.09.2015.pdf.

17. National Ballgame Federation, National Abortion Federation guidelines relating to fetal tissue donation, no date, http://prochoice.org/wp-content/uploads/NAF-Tissue-Donation-Guidelines.pdf.

18. Uniform Law Commission, Anatomical Gift Act (2006), no date, http://world wide web.uniformlaws.org/Act.aspx?championship=Anatomical%20Gift%20Act%twenty(2006).

19. Khurshid South, Lawmakers knew near Planned Parenthood video weeks agone, Roll Call, Jul. 16, 2015, http://blogs.rollcall.com/218/interview-didnt-happen/?SD.

xx. Haberkorn J, Run across the 26-year-old activist who could close the authorities, Political leader, Sept. 21, 2015, http://www.politico.com/story/2015/09/planned-parenthood-government-shutdown-david-daleiden-ballgame-213866#ixzz3wfkgFJTK.

21. Planned Parenthood Federation of America (PPFA), Planned Parenthood files federal lawsuit confronting people behind fraudulent smear entrada, news release, New York, NY: PPFA, Jan. 14, 2016.

22. Lowery West, Paquette D and Markon J, 'No more baby parts,' doubtable in attack at Colo. Planned Parenthood clinic told official, Washington Post, November. 28, 2015, http://www.washingtonpost.com/politics/no-more-baby-parts-suspect-in-attack-at-colo-planned-parenthood-clinic-told-official/2015/xi/28/e842b2cc-961e-11e5-8aa0-5d0946560a97_story.html.

23. ACLU, Open up alphabetic character to Congress: stop interfering with science and research, 2015, http://world wide web.aclu.org/letter of the alphabet/open-letter-congress-stop-interfering-science-and-research.

24. Association of American Medical Colleges, Argument in support of fetal tissue inquiry, 2016, http://www.aamc.org/download/444248/data/statementinsupportoffetaltissueresearch.pdf.

25. Charo RA, Fetal tissue fallout, New England Journal of Medicine, 2015, 373(3):890–891.