Research involving fetal tissue increasingly could be affected by new state regulations. The changes come in the aftermath of the 2015 Planned Parenthood controversy in which an activist posed as a representative from a biomedical research company to secretly videotape discussions with Planned Parenthood officials about fetal tissue donation.
The videos that were edited to paint fetal tissue research in a negative light have resulted in Congressional investigations, reports, and subpoenas. Soon, the research world will see a final report with possible recommendations that could further affect how such research, which has included the development of Ebola and HIV vaccines, is conducted.
States recently have been passing legislation about fetal tissue research, undoing some of the research ground accomplished since 1993 when Congress passed the National Institutes of Health (NIH) Health Revitalization Act that allowed federal funding for fetal tissue transplantation research and regulated the transfer of human fetal tissues. The act also prohibited anyone from taking payments for human fetal tissue, other than to reimburse for transportation and other costs.
“Because we’re in an election year, this has brought some of these conversations of ethics and funding and logistics of fetal tissue research to the forefront,” says Heather H. Pierce, JD, MPH, senior director, science policy regulatory counsel, scientific affairs at the Association of American Medical Colleges in Washington, DC.
“With this as the political context of what’s happening right now, there have been a significant number of states that have moved to introduce or pass new laws that could have some impact on the ability of a researcher to conduct research with fetal tissue,” Pierce says.
According to the Guttmacher Institute, 38 states and the District of Columbia have Uniform Anatomical Gift Act regulations that treat fetal tissue the same way as other human tissue. Five states ban research using fetal tissue obtained from abortions.
“IRBs need to be thinking about this quickly moving process in certain states, ensuring that the institution’s research or collection of tissue is in line with current state law,” she adds.
For instance, some states have introduced laws that prohibit donation and research with fetal tissue. Some prohibit the sale of the tissue or making a profit. Other states have introduced legislation about the disposition of fetal remains and what must be done with the remains of a spontaneous or induced abortion, Pierce explains.
Such laws could make fetal tissue unavailable, making sure there is no fetal tissue available for such research, she says.
“Some states have a law requiring consent from a woman before the donation takes place, specific to fetal tissue research, and this is of interest to IRBs,” Pierce says.
Even though the women had already given consent for the abortion and donation, they might not have been asked to consent for the fetal tissue to be used in specific research, and now they are required to obtain that specific consent, she adds.
“Most state laws apply primarily to fetal tissue from miscarriage, stillbirth, or abortion,” Pierce says. “In some cases, the difference may well be in the definition of fetus versus embryo.”
No one can say what the long-term effect of the changes will be. What is known is that fetal tissue research has been recognized as an important direction for researchers involved in vaccine development, as well as in research involving Alzheimer’s disease, Parkinson’s disease, and other incurable conditions, Pierce says.
“Many researchers have pointed out the importance of studying developing fetuses in order to make advances,” she says.
“Most of the new laws and much of the discussions have really focused on the ethics of doing the research at all, and I’m not suggesting the IRBs debate that,” Pierce adds. “But most of the regulations and proposed state laws are really at the tissue acquisition and collection side of things and not about the research itself unless fetal tissue is banned as a whole in the state.”
But when researchers begin to acquire fetal tissue, they could be affected by new laws, and it’s important for the IRB to be aware of these sorts of questions, Pierce says.
Research involving fetal tissue increasingly could be affected by new state regulations.
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