The chairwoman of a special House committee investigating links between abortion clinics and medical researchers is accusing a firm that transfers fetal tissue between the two of violating federal privacy laws and ethics regulations.
Rep. Marsha Blackburn (R-Tenn.), who leads the select investigative panel established last year, alleges that California-based StemExpress engaged in “systematic violations” of federal health privacy laws and accuses it of “fraudulently using invalid consent forms” in its dealings with Planned Parenthood abortion clinics.
The charges are the most detailed accusations of wrongdoing made by the select panel, which was formed last year after antiabortion activists released undercover videos of people involved in procuring fetal tissue and using it for research. Previous investigations by law enforcement and congressional committees have found no legal violations.
The allegations are laid out in two letters sent Wednesday to officials at the Department of Health and Human Services, which investigates possible violations of the Health Insurance Portability and Accountability Act (HIPAA), as well as the regulations surrounding the ethical review of medical research.
Blackburn, in a statement, said the allegations are rooted in a “business contract between StemExpress and the abortion clinics under which both sides make a profit from the baby body parts inside the young woman’s womb.”
“The contract changes the way both entities view the young woman: her baby is now a profit center,” she said. “This betrayal of a young woman’s trust should disgust us all. It takes financial advantage, obtains consent through coercion and deceives the woman, all in violation of federal privacy laws.”
StemExpress, whose role in the procurement of fetal tissue for researchers has made it an emerging target for antiabortion activists, released this statement:
Stem Express is confident there has been no violation of law and appropriate consents were made for every fetal tissue donation. We welcome the opportunity to answer any questions from the U.S. Department of Health and Human Services or any other agency related to Representative Blackburn’s continued unfounded accusations. Stem Express will continue to support life-saving research.
StemExpress chief executive Cate Dyer recently defended the firm’s work in an interview with The Washington Post. “We lose money doing this,” she said about working with fetal tissue. “We don’t have to do this, and we won’t stop doing this.” Most of the firm’s business, she said, pertains to the procurement of adult human cells and tissue for research.
A spokeswoman for the Democrats on the select panel, who have repeatedly called for a shutdown of the investigation, said the letters “cite unverified ‘documents and testimony’ from so called ‘informants’ to allege wrongdoing by StemExpress.”
“StemExpress offered to appear and answer the panel’s questions months ago, but Republicans have refused to take them up on that offer lest they lose their last excuse for continuing this unjustified witch hunt,” said the spokeswoman, Karen Lightfoot.
The Republicans’ charges center on how StemExpress works in tandem with abortion clinics to procure fetal tissue for researchers. It was in the process of identifying potential donors and securing their consent, they say, that privacy and ethics laws may have been broken.
According to the letters and supporting documents released by Blackburn, contracts between StemExpress and clinics specified that StemExpress employees would not privy to names or other identifying information “except as necessary to obtain patients’ consent.”
That language, a letter to one HHS official claims, cannot override the provisions of HIPAA, which requires specific advance consent from the clinic’s patients giving StemExpress access to their private health records. And StemExpress, the Republicans say, does not qualify for exceptions to HIPAA for entities involved in human transplantation or research. Nor, they say, does it qualify as an exempted “business associate” of a health provider, such as an accountant or billing processor.
“No evidence suggests the abortion clinics’ patients provided authorization for StemExpress staff to view their [private health information] prior to seeking their consent to donate tissue,” one letter reads. “Therefore, regardless of whether a patient ultimately consented to tissue donation and authorized disclosure … her privacy was violated.”
Both letters claim that the forms that patients later signed, giving their consent for the tissue donation, did not meet the HIPAA requirements and that the procurement process raises ethical concerns.
The second letter, to a separate HHS official, describes email correspondence between a StemExpress employee and one of the firm’s customers who inquired “if there are any cases within our gestation range for today?”
“There is one case currently in the room,” the employee responds, referring to an abortion underway. Later, the customer agrees.
“The fact that StemExpress was attempting to interest a customer in fetal body parts before an abortion had taken place raises serious concerns that there may have been coercion or undue influence upon the patient to consent to procurement,” the letter states.
The letter also focuses on whether the consent forms and process were properly reviewed by an “institutional review board” — an outside entity charged with approving and overseeing medical research to make sure it complies with ethical standards and federal regulations.
Republicans charge that StemExpress relied on the services of BioMed IRB, a California-based organization that was temporarily sanctioned in 2012 by the Food and Drug Administration and recently told the panel it had no documents pertaining to its oversight of StemExpress — a violation of federal regulations, they charge.