NAS guidelines revised; more turmoil at AHRC

by Ubaka Ogbogu

NAS revises stem cell guidelines: The US National Academy of Sciences recently released amendments to its influential and widely adopted voluntary Guidelines for Human Embryonic Stem Cell Research. This is the third set of amendments since the guidelines were first issued in 2005 (previous amendments were issued in 2007 and 2008). Key revisions include:

• The guidelines now apply to derivation or research use of hESC lines from morulae, parthenogenesis, or androgenesis. Prior to the amendments, the guidelines applied only to hESC lines derived from blastocysts and SCNT into oocytes.
• Research involving the introduction of hESCs into nonhuman primates at the fetal or postnatal stage of development is now permissible following ESCRO review and approval (in addition to conventional reviews by institutional IRBs, Animal Care and Use Committees, and Biosafety Committees.
• Written evidence that a gamete donor agreed at the time of donation to allow future use of blastocysts and/or morulae resulting from their donation for embryo research is now sufficient proof of consent. 

Other provisions of the Guidelines remain unchanged, including the ban on compensation for oocyte or embryo donation, ESCRO review, and obtaining consent from all gamete donors prior to research. 

Further resignations at AHRC: Following my earlier post on the implications of the resignation of two members of the Board of Assisted Human Reproduction Canada for stem cell research oversight in Canada, Irene Ryll, the consumer representative on the Board, also resigned. The Board is now left with seven members with no direct and relevant expertise in key areas within the agency’s mandate, and who do not represent the interests of those most directly affected by their activities. Clearly, this raises very serious questions about the legitimacy of the Board. Although the Assisted Human Reproduction Act – the legislation that governs the existence of the Board – only specifies maximum membership (13), it does require that Board membership “reflect a range of backgrounds and disciplines relevant to the Agency’s objectives.” In my opinion, the constitution of current board does not meet this requirement. Also, given that the Act forbids those who hold or apply for licenses to conduct activities regulated by the Act, or their affiliates, from serving as Board members, it is doubtful that replacement appointees will be chosen on the basis of relevant background and expertise.