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This report is part of a series examining the ethical, policy and scientific issues that arise in the controversial field of human embryo research. A list of acronyms used is available here.
“It is not birth, marriage or death, but gastrulation, which is truly the most
important time in your life.”
— Lewis Wolpert (2015)
The Nuremberg Code describes ethical principles that should govern human research (Nuremberg Code 1949). Developed in response to significant human rights violations related to Nazi research on concentration camp prisoners, the code’s basic elements shaped future human subject codes and regulations. However, it was not until 1972, when the public learned of the U.S. Public Health Service study at Tuskegee University of untreated syphilis—where subjects were not given access to drug treatments so researchers could observe the disease’s natural course of development—that the idea of federal oversight of human research gained widespread support in the United States.
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR), whose reports and recommendations would be highly influential in shaping the federal regulations governing much of the human research in the United States today (National Research Act of 1974; NCPHSBBR 1979). The U.S. Department of Health and Human Services (DHHS) would also eventually publish the Federal Policy for the Protection of Human Subjects in 1991 (45 C.F.R. §46.202(c)), with a new version in January 2017 (Federal Policy for the Protection of Human Subjects 2017). These regulations—also known as the “Common Rule”—are followed by 18 federal agencies; they include rules for approving and overseeing human research and limit what investigators may do to human research participants (U.S. DHHS 2016). Although some provisions are widely debated, there is widespread acceptance of the research permitted and restricted by the Common Rule. However, there is much less agreement on where to draw the line between permissible and impermissible research on human embryos, which are not fully encapsulated by the Common Rule.
The term “embryo” is widely accepted as the mass of cells in the earliest stages of development into a new organism. Scientists define the human embryo as the time from fertilization to the eighth week of gestation (56 days after conception), when it becomes known as a fetus and starts to develop more advanced physical and neurosensory features (Sadler 2015). U.S. federal law does not define the term “embryo”; instead, it defines a fetus as the entity from the implantation stage (which scientists define as 7–14 days after conception) to delivery. For this paper, we will use the term “embryo” to describe the time of development from conception to 56 days post-conception.
Human embryo research has been controversial, as it sets the pursuit of knowledge through biomedical research and the commitment to advance knowledge against the moral commitment to protect early human life. It forces us to consider who counts as a person, what it means to be a human being, what rights and interests are accorded to human beings at various stages of development, and what may be done to humans at various stages of life under different circumstances. The research has also been linked to public debates and disagreements, in the U.S. especially, related to abortion and right-to-life and pro-choice discussions. Finally, this area of research requires us to determine the limits we should place on scientific research and knowledge. Is any human embryo research that advances knowledge acceptable? If not, what limits should be imposed, and who should set them?
