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Anonymous ID: a75c38 Feb. 11, 2019, 10:54 a.m. No.5124101   🗄️.is 🔗kun   >>4115 >>4290 >>4599 >>4797

Statute on Fetal Tissue Transplantation Research (1993)

 

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/public-law-103-43/index.html

 

(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.

 

(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;

 

(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–

 

(A) use such material or information only for the purposes of verifying compliance with the requirements of this section;

 

(B) not disclose or publish such material or information, except where required by Federal law, in which case such material or information shall be coded in a manner such that the identities of such individuals and entities are protected; and

 

(C) not maintain such material or information after completion of such audit, except where necessary for the purposes of such audit.

 

PROHIBITIONS REGARDING HUMAN FETAL TISSUE SEC. 498B.

 

(a) PURCHASE OF TISSUE- It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

Anonymous ID: a75c38 Feb. 11, 2019, 10:54 a.m. No.5124115   🗄️.is 🔗kun   >>4130 >>4200 >>4290 >>4599 >>4797

>>5124101

 

Grassley Refers Planned Parenthood, Fetal Tissue Procurement Organizations to FBI, Justice Dept. for Investigation

 

WASHINGTON – Following an investigation into the practice of fetal tissue transfers and the federal laws governing the practice, Senate Judiciary Committee Chairman Chuck Grassley is referring several Planned Parenthood affiliates and companies involved in fetal tissue transfers, as well as the Planned Parenthood Federation of America, to the FBI and the Department of Justice for investigation and possible prosecution.

 

“I don’t take lightly making a criminal referral. But, the seeming disregard for the law by these entities has been fueled by decades of utter failure by the Justice Department to enforce it,” Grassley said. “And, unless there is a renewed commitment by everyone involved against commercializing the trade in aborted fetal body parts for profit, then the problem is likely to continue.”

 

Grassley’s referral follows the completion of a Senate Judiciary Committee majority staff analysis of more than 20,000 pages of documents provided voluntarily by the organizations and companies involved. While the impetus for the investigation was the release of a series of videos regarding transfers of fetal tissue by the Center for Medical Progress, the committee’s analysis and findings are based strictly on the documents obtained independently from tissue procurement companies and Planned Parenthood.

 

 

The Majority Staff Report concludes:

 

• Despite the clear legislative history of the 1993 NIH Revitalization Act, the executive branch across multiple administrations has failed to enforce the law’s safeguards.

 

• Since 2010, three companies - Advanced Bioscience Resources, Inc.; StemExpress, LLC; and Novogenix Laboratories, LLC (Novogenix has since gone out of business) - have paid affiliates of Planned Parenthood Federation of America to acquire aborted fetuses, and then sold the fetal tissue to their respective customers at substantially higher prices than their documented costs.

 

• The Planned Parenthood Federation of America (PPFA) initially had a policy in place to ensure its affiliates were complying with the law, but the affiliates failed to follow its fetal tissue reimbursement policy. When PPFA learned in 2011 of this situation, PPFA cancelled the policy rather than exercise oversight to bring the affiliates back into compliance. Thus, PPFA not only turned a blind eye to the affiliates’ violations of its fetal tissue policy, but also altered its own oversight procedures enabling those affiliates’ practices to continue unimpeded.

 

• The cost analyses provided by affiliates of Planned Parenthood Federation of America lack sufficient documentation and rely on unreasonably broad and vague claims of costs for “the transportation, implantation, processing, preservation, quality control or storage of” fetal tissue. Planned Parenthood attorneys acknowledge that the affiliates had failed to follow procedures put in place to ensure compliance with the law. In addition, the cost analyses were only performed long after the fact and at the insistence of the committee.

 

The full report details the long history of the controversy surrounding human fetal tissue research and the bipartisan legislative approach taken to resolve the issue at the time, as well as the subsequent lack of enforcement. As the report explains, “Support for the 1993 NIH Revitalization Act was premised on the idea that the ban on buying or selling fetal tissue would be a safeguard against the development for a market for human fetuses. Tragically, the executive branch has either failed or simply refused to enforce that safeguard. As a result, contrary to the intent of the law, companies have charged thousands of dollars for specimens removed from a single aborted fetus; they have claimed the fees they charged only recovered acceptable costs when they had not, in fact, conducted any analysis of their costs when setting the fees; and their post hoc accounting rationalizations invoked indirect and tenuously-related costs in an attempt to justify their fees.”

 

https://www.grassley.senate.gov/news/news-releases/grassley-refers-planned-parenthood-fetal-tissue-procurement-organizations-fbi

 

The report can be found here.

 

https://www.grassley.senate.gov/sites/default/files/judiciary/upload/22920%20-%20FTR.pdf

 

The referral can be found here.

 

https://www.grassley.senate.gov/sites/default/files/judiciary/upload/Life%2C%2012-12-16%2C%20Referral%20letter%20to%20DoJ%20Fetal%20Tissue%20oversight.pdf