Statement
from the Department of Health and Human Services
In September 2018, the Department of Health and Human
Services (HHS) terminated a contract between Advanced Bioscience
Resources, Inc. and the Food and Drug Administration that provided
human fetal tissue from elective abortions to develop testing
protocols. The Department was not sufficiently assured that
contract included the appropriate protections applicable to fetal
tissue research or met all other procurement requirements. As a
result, HHS also initiated
a comprehensive review of all HHS research involving human
fetal tissue from elective abortions 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.
When the audit and review began, 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
90-day extensions while conducting its audit and review. 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 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. Intramural
research that requires new acquisition of fetal tissue from
elective abortions will not be conducted.
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. 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 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.
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. In December
2018, NIH announced
a $20 million funding opportunity for research to develop,
demonstrate, and validate experimental models that do not rely on
human fetal tissue from elective abortions. HHS is committed to
providing additional funding to support the development and
validation of alternative models.
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