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(CNSNews.com) – The Department of Health and Human Services, which has been conducting an audit of all HHS-funded fetal-tissue acquisitions along with a comprehensive review of HHS-funded fetal-tissue research, announced today that it is ending a multimillion-dollar contract it had maintained with the University of California at San Francisco that required UCSF to make “humanized mice” using organs taken from aborted babies.

“When the audit and review began,” HHS said in a statement today, “HHS had an existing contract with the University of California, San Francisco (UCSF) regarding research involving human fetal tissue from elective abortions.

“HHS has been extending the UCSF contract by means of a 90-day extension while conducting its audit and review,” the statement said. “The current extension expires on June 5, 2019, and there will be no further extensions.”

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” the statement said.

The statement also said that the National Institutes of Health, which is a division of HHS, will no longer be engaging in “intramural research” (within the NIH itself) that uses fetal tissue from abortions.

“Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted,” the statement said.

CNSNews.com first reported on Oct. 17, 2018 about the contract the National Institutes of Health had with UCSF that required UCSF to make at least two types of “humanized mice” using body parts taken from aborted babies. The contract was called “Humanized Mouse Models for HIV Therapeutics Development.”

From Dec. 6, 2006 through Dec. 5, 2013, the NIH had maintained a previous contract with UCSF that also required UCSF to make humanized mice using human fetal tissue. That contract was called “Tissue Based Small Animal Model for HIV Drug Discovery.”

The existing contract that HHS announced it was ending today began an initial one-year term on Dec. 6, 2013 with the NIH retaining an option to renew it for up to six additional one-year terms running through Dec. 5, 2020.

 

‘Obtain human fetal tissue.’

The “Statement of Work” included in the NIH solicitation for this contract included a list of its “major functions.” One of these was: “Obtain human fetal tissue.”

The “Statement of Work” also stated that the contractor was expected to make two different types of “humanized mice” both of which would be constructed with human fetal tissue.

“The current contract was awarded in 2006 to the University of California, San Francisco (contract number HHSN266200700002C) and will expire in December, 2013,” said the Statement of Work. “The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (severe combined immunodeficiency (SCID)-hu Thy/Liv) and infected with well-characterized isolates of HIV-1.”

“This solicitation is seeking proposals for the SCID-hu Thy/Liv model and for a second humanized mouse model,” the Statement of Work said. “The second mouse model will consist of immunodeficient mice engrafted with human fetal thymus and liver tissue and other cells and/or tissues, such that the model (or mice) has the following characteristics: can be infected by the systemic or mucosal routes, reconstitutes gut-associated and other lymphoid tissues, and develops viremia and disseminated infection in engrafted human tissue.”

When CNSNews.com reported about this contract in October, it sent a set of 16 questions to the NIH and UCSF. The University of California responded with a statement.

“The University of California conducts research using fetal tissue that is vital to finding treatments and cures for a wide variety of adult and childhood diseases and medical conditions,” said the statement from the University of California.

“This research is conducted in full compliance with federal and state law and is in keeping with the university’s education, research and public service missions,” said the statement.

“Since the 1930s, fetal tissue has been a critical component of biomedical science and breakthroughs that fundamentally changed the practice of medicine,” said the University of California. “Its importance to researchers today has not diminished, and it is still essential to ensuring that cells and tissues created from stem cells are correct. Fetal tissue is used for a broad range of research, from cell biology to the development of vaccines, including the polio vaccine that saved hundreds of thousands of lives and merited the 1954 Nobel Prize for Medicine.”

The NIH initially gave the UCSF humanized mouse contract a 90-day extension on Dec. 4, 2018. It subsequently gave the contract a second 90-day extension that ran through today.

In October, the NIH told CNSNews.com: “The actual total amount of this contract, including all options, is $13,799,501 for a full performance period through December 5, 2020. We have obligated $9,554,796 to date.”

On Aug. 7, 2018, CNSNews.com reported that the Food and Drug Administration had signed a $15,900 contract to acquire “human fetal tissue” from Advanced Bioscience Resources, a non-profit organization. “The objective is to acquire Tissue for Humanized Mice,” the FDA’s presolicitation notice for that contract said. In September, HHS announced that it was cancelling that contract.

HHS said in a statement at that time that it was “conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations.”

“In addition,” the statement said, “HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

In the statement it released today announcing the end of the humanized mouse contract with UCSF, HHS said the audit and review had aided in that decision.

“The audit and review helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research–research conducted within the National Institutes of Health (NIH)–involving the use of human fetal tissue from elective abortion,” today’s HHS statement said. “Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

The HHS also indicated that ongoing NIH projects involving fetal tissue research will not be impacted during their current funding period, but that new projects or existing projects seeking renewal will be reviewed by an ethics advisory board.

“No current extramural research projects (research conducted outside NIH, e.g., at universities, that are funded by NIH grants) will be affected during their currently approved project period,” HHS said.

“For new extramural research grant applications or current research projects in the competitive renewal process (generally every five years) that propose to use fetal tissue from elective abortions and that are recommended for potential funding through NIH’s two-level external scientific review process, an ethics advisory board will be convened to review the research proposal and recommend whether, in light of the ethical considerations, NIH should fund the research project—pursuant to a law passed by Congress,” HHS said.

“HHS will also undertake changes to its regulations and NIH grants policy to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue,” said HHS.

“Finally, HHS is continuing to review whether adequate alternatives exist to the use of human fetal tissue from elective abortions in HHS-funded research and will ensure that efforts to develop such alternatives are funded and accelerated,” it said.

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