Clinics Using Embryos for Target Practice
The number of procedures required for a trainee to reach proficiency in embryo-transfer is unknown. A new study* attempted to determine the learning curve of embryo-transfer by monitoring the pregnancy rates (PR) per transfer, carried out by five trainees. A PR of 40% was chosen to define adequate performance, whilst a PR of 20% was considered inadequate.
This study raises concerns about the principle of using both embryos and patients in human trials. Whilst all patients gave informed consent to the procedures, the result of the study indicated that up to 99 embryo transfers were being performed before trainees reached an adequate level of performance.
This research demonstrates an increasingly cavalier attitude towards the treatment and use of human embryos, with in this instance the training of embryologists clearly overriding the rights of the embryo.
*How soon can I be proficient in embryo transfer? Lessons from the cumulative summation test for learning curve (LC-CUSUM)
Human Reproduction, Vol. 25, No. 2 pp. 380 – 386, 2010
L Dessolle1, T Fréour1, P Barrière1, M Jean, C Ravel, Emile Daraï and David J. Biau
Breakthrough in Ethical Stem Cell Research
Human term placenta-derived cells continue to demonstrate promise in the field of regenerative medicine. The authors of this article* maintain that ongoing comparisons about the potentiality and characteristics of cells are essential to promote constant improvement in cell therapies. A better understanding of basic disease mechanisms is also crucial to tailoring stem cell therapy.
In March 2009 a workshop entitled ‘Placenta-derived stem cells for treatment of inflammatory diseases: moving toward clinical application’ was hosted in Brescia, Italy. The aim of the event was to update findings on basic inflammatory mechanisms with particular focus on the potential for placenta-derived cells to treat inflammatory diseases. Scientists are now assessing the regulation required to prepare these proposed treatments for clinical application.
Successful advances in regenerative medicine are consistently favouring ethical stem cell treatments. The latest developments utilising placenta-derived cells demonstrate that individually tailored cells are the best option for addressing disease-specific clinical needs. CORE commends the establishment of an International Placenta Stem Cell Society (IPLASS) in September 2009, which will support research in this auspicious field.
* Toward Cell Therapy Using Placenta-Derived Cells: Disease Mechanisms, Cell Biology, Preclinical Studies, and Regulatory Aspects at the Round Table
Stem Cells and Development. February 2010, 19(2): 143-154.
O Parolini, F Alviano, I Bergwerf, D Boraschi, C De Bari, P De Waele, M Dominici, M Evangelista, W Falk, S Hennerbichler, D C. Hess, G Lanzoni, B Liu, F Marongiu, C McGuckin, S Mohr, M Luisa Nolli, R Ofir, P Ponsaerts, L Romagnoli, A Solomon, M Soncini, S Strom, D Surbek, S Venkatachalam, S Wolbank, S Zeisberger, A Zeitlin, A Zisch, C V. Borlongan.
Controversy over new NIH Guidelines: Do Gamete Donors Realise What They’re Consenting to?
New guidelines issued by the National Institutes of Health (NIH) in the United States*, in relation to human embryonic stem cell (hESC) lines, present a controversial policy decision on the issue of informed consent for gamete donors. The regulations are expected to substantially increase the remit of hESC lines eligible for federal funding. Guidelines stipulate that whilst informed consent is required from embryo donors for derivation of hESC lines, third party gamete donors used to create the embryos are not subject to such consent.
We are extremely worried by the ethical issues raised in this article. IVF gamete donors will sign forms giving legal authority to patients to determine the destiny of any embryos created using their gametes, without having any real idea of what the future usage might entail. This may include options that were not specifically mentioned to the donor. For example the donor may personally object to hESC research but is not told, and therefore does not appreciate, the options available to the IVF patient.
Likewise using embryos for research without permission of third-party oocyte donors could fail to respect donors as persons, breaching a fundamental principle of bioethics. The terms of the NIH guidelines clearly need immediate revision to accommodate the complex issues of informed consent.
*NIH Guidelines for Stem Cell Research and Gamete Donors
Science 19 February 2010:
Vol. 327. no. 5968, pp. 962 – 963
B Lo, L Parham, M Cedars, S Fisher, E Gates, L Giudice, D Gould Halme, W Hershon, A Kriegstein, R Rao, C Roberts, R Wagner