(Legal opinion is requested from Nhan Nguyen, MD, JD) 

Uncertain status of human embryos

The uncertainty that arises with the position of an Embryology practitioner originates from the uncertain status of the human embryo.

The status of an Embryo before implantation is a highly debated issue with opponents taking equally radical positions: preimplantation embryo is a human being vs preimplantation embryo is a clump of cells (like any other cells).

In the absence of the consensus on what is a human embryo, the federal government (FDA) cannot create clear guidelines for embryology practice, even though it recently started applying FDA standards to embryology laboratory supplies.

Consequently, if an embryo is considered a human people, who work with the preimplantation embryos would be need to be medical practitioners, while if the embryo is considered a "clump of cells" (specimen) the people working with the embryos would only be preforming a technical job (perhaps diagnostic testing).

ACE's consensus position on human embryos is that they should not be defined as humans or cells, but instead as an appropriate set of regulation, addressing unique properties of this stage of human development should be developed.  

At this stage, the ambiguity of the status of an embryo creates many practical problems for embryology practitioners, one of them being the patient’s consultation.

Since embryology is without any doubts an area of highly specialized expertise, a qualified embryology practitioner is in the best position to speak with the patients about their embryos, which in most cases is what they do.

ACE is therefore seeking legal guidance on the scope of the embryologist consultation and for the ability of clinics or embryologist to receive monetary compensation for such consultations.

Considerations:

1. Unless embryos are “officially” recognized as humans – working with embryos or discussing embryo development and any other embryo qualities with patients does not constitute a practice of medicine
2. Since it is legal for non-physician to charge money for providing non-medical advice, it is legal to get paid for such advice, provided a respective disclosure has been made to the patient.
3. In order to not-overstep the boundaries of medical advice, the scope of embryology practice has to be defined.

Scope of embryology practice:

If qualified, an embryology practitioner can:

1. Determine whether an embryo is viable (i.e. has a reasonable chance to become a baby, once transferred into the uterus)
2. Decide which embryos are the most viable and assign them to the transfer or freezing
3. Select the optimal laboratory treatment modality (culture system choice, duration of culture etc) for the particular embryo or a cohort of embryos.
4. Extrapolate embryo development on possible reasons affecting embryo quality of the particular patient 
5. Perform embryo biopsy to obtain a specimen for testing embryo chromosomal competency and alike.
6. Perform embryo freezing and thawing
7. Perform any other manipulations with the embryo that an embryology practitioner feels would improve  
8. Discuss all the above with the patient, including for a fee