NHMRC guidelines recommend embryo access freeze

A freeze on access by researchers to any human embryo not in storage for at least one year is among proposed official guidelines on the use of embryonic stem cells released this week by the National Health and Medical Research Council (NHMRC).

Created in the aftermath of new legislation governing research involving human embryos, the guidelines will impact IVF clinics and medical researchers, including embryonic stem cell researchers.

Initial reaction to the draft rules appears to be favourable, although the guidelines have not yet been widely studied. They are open for public submissions and comment until March 28 and available on the NHMRC's website.

They state that "people must not be approached to donate their embryos to research until the embryo has been in storage for at least one year.

"After the embryo has been in storage for one year, and if the persons for whom the embryo is stored have made an independent decision that they no longer require the embryo for treatment, they may be approached to donate the embryo to research or other activities."

The one-year freeze is already effectively in place because the new legislation bars researchers from deriving stem cells from embryos frozen after April 5, 2002. By the time the new regulations are bedded down, around June 2003, any usable embryo will be more than a year old. However, the April 2002 deadline is due to be phased out by 2005 or sooner, at which point the year-long hiatus would be enforced only by the guidelines.

The guidelines will form part of the new legislative framework to regulate research involving excess assisted reproductive technology (ART) embryos under the Research Involving Human Embryos Act 2002.

Before applying for a licence to conduct research involving excess ART embryos, the research proposal must have been approved by a human research ethics committee in accordance with the guidelines.

In terms of record keeping, the guidelines require IVF clinics to keep records that enable staff to trace what happens to an individual embryo, egg or sperm sample from the date of collection and maintain them indefinitely.

The new proposals, if adopted, will rule out anonymous sperm donors in future. New donors must consent to release of identifying information about themselves to persons conceived as result of their donations.

The proposals set out the criteria under which research involving destruction of an embryo can be approved by an institutional ethics committee.

It also spells out the rules that researchers must follow when obtaining consent to use products from an embryo. These include giving donors a full explanation of:

• The proposed research or other activities (including the proposed method and its scientific aims) and why it would represent a significant advance in knowledge, or
• Improvement in technologies for treatment.

If results of research may have commercial potential, embryo donors must be told and agree that they will not receive financial or any other benefits from any such future commercial development.

The provision meets no opposition from companies with commercial stem cell interests, such as BresaGen.

Chris Juttner, BresaGen's executive director and vice-president of clinical development, said: "We would agree with that. The question of financial benefits needs to be dealt with up front and we wanted it to be brought in to any guidelines."