Overturning of Roe v. Wade Impacts Medical Research and Treatments
The US Supreme Court announced the Dobbs v. Jackson decision overturning Roe v. Wade and the constitutional right to abortion on June 24, 2022. The ruling turned the decision to protect or restrict abortion back to individual states, producing a patchwork of laws throughout the country—and creating an ethical bind for researchers.
States opposed to abortion moved quickly to pass legislation that would curtail reproductive rights. As of December 12, 2022, 13 states had fully banned abortions and Georgia outlawed abortions after six weeks. The decision to restrict abortion access will have substantial ramifications on biomedical research, impacting research institutions, healthcare providers, researchers, and individuals who can become pregnant.
Ethical Bind, Legal Complications for Researchers
Miscarriage/spontaneous abortion is prevalent and often indistinguishable from medically induced abortion. This raises compelling questions: If a research subject becomes pregnant while they are enrolled in a research study or clinical trial and subsequently has a miscarriage, will the research team be compelled to report this situation to the authorities, according to state law? Will researchers be required to share clinical data, including pregnancy status, with state officials? Could the research subject now be charged with a crime?
That is the ethical and legal bind that researchers could find themselves in going forward. If researchers don't want to be put in that position, they might be forced to exclude people who can get pregnant from participating in research—and in the process impede valuable research.
Creating a Blind Spot in Research
There is growing concern about the impact abortion restrictions will have on people who are or can become pregnant participating in research. Clinical trials that could improve health outcomes for pregnant people and their fetus are already impeded by fear of drug-related birth defects and miscarriage (despite recent progress around the inclusion of pregnant persons in research and advances in medical knowledge). The trials which led to the authorization of COVID-19 vaccinations, for example, excluded pregnant people despite the fact that this is a high-risk group that would directly benefit from inclusion.
Abortion bans further threaten progress regarding the inclusion of women and pregnant persons in research by introducing concerns about potential reporting and prosecution.
In light of the Dobbs ruling, researchers may be deterred from enrolling people who could become pregnant to ongoing research to avoid potential legal and ethical complications that could result if they learn a pregnancy has ended.
Likewise, individuals may decline to participate in clinical research based on concerns that any potential pregnancy status may be shared with state officials, potentially leading to criminal prosecution if an abortion is suspected. If people of child-bearing potential voluntary opt out of research, it could negatively impact diversity and representativeness of clinical trials, further exacerbate gaps in knowledge about the effectiveness of interventions in women and others who can become pregnant, and increase risks for such individuals when those interventions come to market.
Some of these concerns were highlighted by Aoife Brennan, CEO of Cambridge, Massachusetts-based Synlogic, in an essay in STAT last fall. “Balancing the need to have representative, diverse clinical trials with mitigating the risk of exposing a fetus to an experimental therapy requires thousands of pregnancy tests weekly in the U.S. Until recently, this was something I took for granted as established practice. The U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization changed that,” she said.
Limiting Research
Scientists have also expressed concern that state-level abortion bans could decrease the availability of fetal tissue, which is used to test drugs, develop vaccines, and study and treat diseases.
Additionally, embryonic stem cell (ESC) research is at risk of being curtailed. Some states may ban ESC research because the tissue being used comes from fertilized eggs, which would have been discarded during the IVF process. Loss of access to these important research tools could hinder the discovery of life-saving developments.
The Scientist spoke with several researchers who rely on the use of fetal tissue, ESCs, or related materials to conduct their work. Anita Bhattacharyya, PhD, a neurologist at University of Wisconsin-Madison, has been able to study how brain development is influenced by Down Syndrome and other neurodevelopmental disorders. She works primarily with human induced pluripotent stem cells (iPSCs) in culture, but uses fetal and adult tissue to validate the results of her work with stem cells.
Debomoy Lahiri, PhD, MS, an Indiana-based researcher, has made great strides in identifying the role of microRNAs (miRNAs) in the progression of Alzheimer’s disease. His research is contingent on the use of fetal tissue since target sequences are different in non-human animals. Timothy Kamp, MD, PhD, FACC, a stem cell biologist at the University of Wisconsin-Madison, has worked to create heart cells from pluripotent stem cells, including human ESCs, as a model for arrhythmias. These heart cells serve as a critical model for the effect of the disease at the different stages of development.
The overturning of Roe raises a number of ethical issues for medical and behavioral researchers in states with abortion bans. The effects could ripple nationwide.
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https://www.tandfonline.com/doi/full/10.1080/15265161.2022.2088894?cookieSet=1
States opposed to abortion moved quickly to pass legislation that would curtail reproductive rights. As of December 12, 2022, 13 states had fully banned abortions and Georgia outlawed abortions after six weeks. The decision to restrict abortion access will have substantial ramifications on biomedical research, impacting research institutions, healthcare providers, researchers, and individuals who can become pregnant.
Ethical Bind, Legal Complications for Researchers
Miscarriage/spontaneous abortion is prevalent and often indistinguishable from medically induced abortion. This raises compelling questions: If a research subject becomes pregnant while they are enrolled in a research study or clinical trial and subsequently has a miscarriage, will the research team be compelled to report this situation to the authorities, according to state law? Will researchers be required to share clinical data, including pregnancy status, with state officials? Could the research subject now be charged with a crime?
That is the ethical and legal bind that researchers could find themselves in going forward. If researchers don't want to be put in that position, they might be forced to exclude people who can get pregnant from participating in research—and in the process impede valuable research.
Creating a Blind Spot in Research
There is growing concern about the impact abortion restrictions will have on people who are or can become pregnant participating in research. Clinical trials that could improve health outcomes for pregnant people and their fetus are already impeded by fear of drug-related birth defects and miscarriage (despite recent progress around the inclusion of pregnant persons in research and advances in medical knowledge). The trials which led to the authorization of COVID-19 vaccinations, for example, excluded pregnant people despite the fact that this is a high-risk group that would directly benefit from inclusion.
Abortion bans further threaten progress regarding the inclusion of women and pregnant persons in research by introducing concerns about potential reporting and prosecution.
In light of the Dobbs ruling, researchers may be deterred from enrolling people who could become pregnant to ongoing research to avoid potential legal and ethical complications that could result if they learn a pregnancy has ended.
Likewise, individuals may decline to participate in clinical research based on concerns that any potential pregnancy status may be shared with state officials, potentially leading to criminal prosecution if an abortion is suspected. If people of child-bearing potential voluntary opt out of research, it could negatively impact diversity and representativeness of clinical trials, further exacerbate gaps in knowledge about the effectiveness of interventions in women and others who can become pregnant, and increase risks for such individuals when those interventions come to market.
Some of these concerns were highlighted by Aoife Brennan, CEO of Cambridge, Massachusetts-based Synlogic, in an essay in STAT last fall. “Balancing the need to have representative, diverse clinical trials with mitigating the risk of exposing a fetus to an experimental therapy requires thousands of pregnancy tests weekly in the U.S. Until recently, this was something I took for granted as established practice. The U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization changed that,” she said.
Limiting Research
Scientists have also expressed concern that state-level abortion bans could decrease the availability of fetal tissue, which is used to test drugs, develop vaccines, and study and treat diseases.
Additionally, embryonic stem cell (ESC) research is at risk of being curtailed. Some states may ban ESC research because the tissue being used comes from fertilized eggs, which would have been discarded during the IVF process. Loss of access to these important research tools could hinder the discovery of life-saving developments.
The Scientist spoke with several researchers who rely on the use of fetal tissue, ESCs, or related materials to conduct their work. Anita Bhattacharyya, PhD, a neurologist at University of Wisconsin-Madison, has been able to study how brain development is influenced by Down Syndrome and other neurodevelopmental disorders. She works primarily with human induced pluripotent stem cells (iPSCs) in culture, but uses fetal and adult tissue to validate the results of her work with stem cells.
Debomoy Lahiri, PhD, MS, an Indiana-based researcher, has made great strides in identifying the role of microRNAs (miRNAs) in the progression of Alzheimer’s disease. His research is contingent on the use of fetal tissue since target sequences are different in non-human animals. Timothy Kamp, MD, PhD, FACC, a stem cell biologist at the University of Wisconsin-Madison, has worked to create heart cells from pluripotent stem cells, including human ESCs, as a model for arrhythmias. These heart cells serve as a critical model for the effect of the disease at the different stages of development.
The overturning of Roe raises a number of ethical issues for medical and behavioral researchers in states with abortion bans. The effects could ripple nationwide.
##
https://www.tandfonline.com/doi/full/10.1080/15265161.2022.2088894?cookieSet=1