The 14-Day Rule: Historical and Ethical Underpinnings

Insoo Hyun, PhD Case Western Reserve University

School of Medicine Dept. of Bioethics

Harvard Symposium 2016

Advance online publications: May 4, 2016.

Advance online publication: Nature, May 4, 2016.

Also, ongoing research on self-organizing embryo-like structures (SOELS).

What is the 14-day rule, and why is it important?

“No embryos will be sustained in vitro beyond the stage normally associated with the completion of implantation (14 days after fertilization).” U.S. Ethics Advisory Board,1979.

“No live human embryo derived from IVF may be kept alive, if not transferred to a woman, beyond 14 days after fertilization.” Warnock Committee, UK, 1984.

“All approved research must be restricted to the first 14 days of development of the human zygote.” Royal Commission on New Reproductive Technologies, Canada, 1993.

“No research involving embryos [should] be permitted after 14 days, with the exception of research to determine whether the appearance of the primitive streak can be reliably identified, which may occur later than 14 days in vitro, and research involving the development of cell lines from donated spare embryos, which would not involve an embryo that is continuing to develop as an organized, integrated whole.” NIH Embryo Panel, 1994.

The 14-day rule in stem cell research.

Impermissible research in stem cell guidelines:

“Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.” National Academy of Sciences, USA, 2005.

International Society for Stem Cell Research (ISSCR)

Guidelines for Stem Cell Science and Clinical Translation, 2016.

What type of rule is the 14-day rule? What are the rules for changing this rule?

Religious and secular ethical justifications and their difficulties:

Single criterion views of full moral status (e.g. conception ensoulment; sentience; viability; consciousness; self-consciousness).

Why should should a single (biological) property be determinative?

“Pluralistic properties” views of full moral status (i.e. moral status is based on a variety of distinct but intersecting factors).

This view is consistent with a “gradualist” approach to moral status, but at what point does something have “enough” moral status such that its instrumental use for research must be prohibited?

What type of rule is the 14-day rule? What are the rules for changing this rule?

The 14-day rule should be looked at as a public policy tool, not as a strict moral distinction, per se.

Perhaps the history of the 14-day rule reveals its ethical underpinnings.

As a product of public policy, the rules for changing this rule -- or for discussing even the option of changing it – should accord with normative standards for public policy formation in a pluralistic society.

Caveat: However, the rules for changing this rule may differ depending on whether the 14-day rule is a law, a guideline, or an institutional policy.

Final thought: Shifting lines in science

Yes to human-animal chimera research – but not at the embryo stage.

Yes to genetic engineering of human cells– but not the germ line.

Yes to human cloning for in vitro research – but not for reproduction.

Yes to payments for research egg donors’ direct expenses – but not for their non-financial burdens.

Is it time to get rid of such lines in the sand and rely solely on clear ethical principles for the review of specific protocols?

Thank you

insoo.hyun@case.edu