FDA to enhance oversight regulations on 'human subject' research amid calls from pro-life advocates

FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located in Silver Spring, Maryland.
FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located in Silver Spring, Maryland. | Official FDA photo

A pro-life think tank has voiced its support for a proposed U.S. Food and Drug Administration rule seeking to increase regulatory safeguards for research on "human subjects," claiming that the current system fails to address issues with informed consent, patient privacy and commercialization of donated fetal tissue.

Dr. David Prentice, vice president, and research director at the Charlotte Lozier Institute, the education and research arm of Susan B. Anthony Pro-Life America, told The Christian Post that the FDA is in the process of revising regulations surrounding fetal tissue research. 

CLI submitted a letter on Nov. 28 to the agency supporting the proposed rule published in September that seeks to enhance its oversight of "human subject research." A copy of the letter, which was submitted on the last day of the public comment period, was provided to CP.

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In addition to its support for the proposed rule, CLI urges the Department of Health and Human Services to "amend both FDA regulations and the Common Rule to explicitly require all of the regulations' informed consent protections when researchers are soliciting donations from ... women undergoing abortion; parents undergoing in vitro fertilization (IVF); and parents whose fetuses or newborns may undergo whole genome sequencing (WGS)."

Among the FDA's proposed revisions is a recommendation to change the information included on informed consent forms patients fill out when agreeing to participate in human subject research. 

Under the proposed revisions, the informed consent document must be in an "organized and understandable manner" and include relevant information that will help patients understand whether they want to participate in the process. The provisions include a "new basic element of informed consent and three new additional elements of informed consent."

According to Prentice, the goal of the FDA's proposal was to "normalize" the organization's regulations with those from the HHS and National Institutes of Health in the "Common Rule," a 1981 rule of ethics pertaining to research involving human subjects. 

"Of course, we are opposed to research with aborted fetal tissue or destroyed human embryos," Prentice told CP. 

"So if we can at least make a statement, maybe make some effect on current regulations under current law, it gives us an opportunity to at least point out where they need to improve their protections for human life." 

One of the issues CLI noted with the current process surrounding is that it implies patients are donating fetal tissue to help develop cures for diseases.

In 2016, the Select Investigative Panel of the U.S. House Energy and Commerce Committee found a consent form widely used by abortion facilities informed patients fetal tissue research has been used to develop cures for diabetes, Parkinson's disease, Alzheimer's disease, cancer and AIDS.

Prentice argued that there aren't any cures derived from fetal tissue, noting that these diseases are still considered incurable despite decades of fetal tissue research. He also asserted that telling women their aborted children's remains will be used to develop cures for life-threatening diseases is a form of coercion. 

"This is, quite frankly, antiquated science," he said, stating that arguments for the alleged medical benefits derived from fetal tissue research are based on ideology instead of science. 

The researcher contends that ethical alternatives to fetal tissue research, such as adult stem cells, are available.

In a November 2017 report, CLI analyzed adult stem cell research, stating that over 1 million patients worldwide have already benefited from adult stem cell research, according to data gathered in December 2012. 

In June 2019, CLI addressed common questions about fetal tissue research, including whether it has proven useful in curing diseases. The document asserted that it is not the only resource for developing cures and testing therapies for certain ailments. 

CLI has requested that regulations protect patient privacy, an issue that received heightened focus in 2013.

Descendents of Henrietta Lacks complained after information about the HeLa genome, a cell line obtained from a biopsy performed on Lacks in 1951, was published without the family's consent. 

The pro-life organization claimed that considering the "scope of personal information" acquired through whole genome sequencing (WGS), FDA regulations should allow donors to withdraw consent for the use of any "donated tissue or biospecimen" at any time. 

CLI also voiced concern about the commercialization of donated fetal body parts. According to Prentice, without the use of ethical alternatives, there is a "supply and demand" for parts from scientists interested in continuing this form of research. 

The pro-life researcher emphasized the need for transparency regarding how fetal tissue is obtained, how scientists plan to use it in experiments and whether there are any profit motives in the donation of the tissue. 

Under federal law, it is "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce." However, the law permits "reasonable payments" for the "transportation, processing, preservation, quality control, and storage of human fetal tissue." 

CLI noted in its letter to the FDA that the U.S. House of Representatives and the U.S. Senate investigated human fetal tissue trafficking. Reports from the House Committee on Energy and Commerce Select Investigative Panel and the Senate Judiciary Committee documented multiple instances of researchers paying tissue procurement companies for fetal eyes, livers, and other body parts. 

A 2016 report published by the Select Investigative Panel of the Energy and Commerce Committee examined allegations of fetal tissue sales. It made several criminal referrals to the U.S. Department of Justice. StemExpress, a fetal tissue procurement company, reportedly paid a total of $152,640 to three Planned Parenthood affiliates and five independent abortion clinics for fetal tissue. 

Prentice hopes CLI's letter will force the regulatory body and the public to think about the issue, highlighting the need for education about the flaws with the current system. 

"There are better ways to do science now," he argued. "There are modern ways that don't rely on trafficking aborted baby body parts." 

Samantha Kamman is a reporter for The Christian Post. She can be reached at:

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