EthxWeb Search Results Document 1 Document 2€¦ · Scientific American 2011 Nov; ... (SCI) is a major focus for stem cell therapy (SCT). However, the science of SCT has not been

EthxWeb Search Results

Search Detail: Result=((("18.7".CL.) OR (STEM ADJ (CELL.TI.))) OR (("18.5.4".CL.) SAME "15.1")) AND (@YD > "20041231") 2=1 : " Documents: 1 325 of 2547

Document 1 Wells, Robert J The American Academy of Pediatrics policy statementchildren as hematopoietic stem cell donors. Pediatric blood & cancer 2011 Dec 1; 57(6): 10867; author reply 10889

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Document 2 Blendon, Robert J; Kim, Minah Kang; Benson, John M The public, political parties, and stemcell research. The New England journal of medicine 2011 Nov 17; 365(20): 18536


Document 3 Holmes, David Sound and fury after stem cell ruling. Lancet 2011 Nov 5; 378(9803): 1617


Document 4 Galef, Julia You say embryo, I say parthenote. Scientific American 2011 Nov; 305(5): 30


Document 5 Vogel, Gretchen Europe. Dismay, confusion greet human stem cell patent ban. Science (New York, N.Y.) 2011 Oct 28; 334(6055): 4412


http://bioethics.georgetown.edu/databases/https://bioethics.georgetown.edu/databases/EthxWeb/ethxbool.htmhttp://kie.georgetown.edu/netacgi/nph-brs?co1=AND&co2=AND&co3=AND&co4=AND&d=EWEB&Sect2=THESOFF&u=https%3A%2F%2Fbioethics.georgetown.edu%2Fdatabases%2FEthxWeb%2Fethxbool.htm&r=0&p=2&f=S&l=50&s4=((STEM+ADJ+(CELL+.TI.))+OR+((%2218.5.4%22.CL.)+SAME+%2215.1%22)+or+18.7.cl.)+AND+(%40YD+%3E++%2220041231%22)&s2=&co5=AND&pg1=SUBJ&op1=AND&s1=&co6=AND&op6=AND&s6=&Sect3=PLURON&Sect5=HITOFF&l=0http://kie.georgetown.edu/netacgi/nph-brs?co1=AND&co2=AND&co3=AND&co4=AND&d=EWEB&Sect2=THESOFF&u=https%3A%2F%2Fbioethics.georgetown.edu%2Fdatabases%2FEthxWeb%2Fethxbool.htm&r=0&p=1&f=1&l=50&s4=((STEM+ADJ+(CELL+.TI.))+OR+((%2218.5.4%22.CL.)+SAME+%2215.1%22)+or+18.7.cl.)+AND+(%40YD+%3E++%2220041231%22)&s2=&co5=AND&pg1=SUBJ&op1=AND&s1=&co6=AND&op6=AND&s6=&Sect3=PLURON&Sect5=HITOFF&l=0http://ethicslab.org/openurl/wc/0000341173/http://ethicslab.org/openurl/gt/0000341173/http://ethicslab.org/openurl/wc/0000341130/http://ethicslab.org/openurl/gt/0000341130/http://ethicslab.org/openurl/wc/0000341108/http://ethicslab.org/openurl/gt/0000341108/http://ethicslab.org/openurl/wc/0000341037/http://ethicslab.org/openurl/gt/0000341037/http://ethicslab.org/openurl/wc/0000341012/http://ethicslab.org/openurl/gt/0000341012/

Document 6 Vogel, Gretchen Stem cells. Where do human eggs come from? Science (New York, N.Y.) 2011 Oct 7; 334(6052): 27


Document 7 SleeboomFaulkner, Margaret; Patra, Prasanna Kumar Experimental stem cell therapy: biohierarchies and bionetworking in Japan and India. Social studies of science 2011 Oct; 41(5): 64566 Abstract: This article concerns new developments in autologous adult stem cell research in Japan and India throughthe notions of biohierarchy and bionetworking. It conceptualizes how human subject research in one country may beturned into experimental stem cell therapies in another through bionetworks. We analyse the processes that enableresearchers in Japan to discard a therapy as being of reputational risk, while researchers in India employ it so that itbecomes reputation enhancing. At the same time, scientists from both countries collaborate in and potentially benefitfrom the same bionetwork. Explaining how the recruitment of patients and scientists is organized throughbionetworking, this article analyses how experimental research in India thrives using Japanese technologies. Theconcept of biohierarchy illustrates how inequalities in health and standards of living in India and in Japan underpinthe methods by which researchers, medical professionals, managers and patients collaborate in bionetworks. Theconcept of 'boundary object' here captures the ways in which the meaning of experimental therapy is defined bysubjective categories projected onto it by patients and scientists alike. The article is based on fieldwork conductedby both authors during 3 months between September and December 2008 at various locations in India and Japan.Data for this article were collected from a wide range of interviews with stem cell researchers, medical doctors,coordinators, managers and patients, primary and secondary sources gathered at these centres, and through weband archival research.


Document 8 International stem cell tourism in Russia and India: clinical research, innovative treatment, or unprovenhype? Kennedy Institute of Ethics journal 2011 Sep; 21(3): viiviii


Document 9 Parke, Sara; Illes, Judy In delicate balance: stem cells and spinal cord injury advocacy. Stem cell reviews 2011 Sep; 7(3): 65763 Abstract: Spinal cord injury (SCI) is a major focus for stem cell therapy (SCT). However, the science of SCT has notbeen well matched with an understanding of perspectives of persons with SCI. The online advocacy community is akey source of health information for primary stakeholders and their caregivers. In this study, we sought tocharacterize the content of SCI advocacy websites with respect to their discussion of SCT and stem cell tourism.We performed a comprehensive analysis of SCI advocacy websites identified through a web search and verified byexpert opinion. Two independent researchers coded the information for major themes (e.g., scientific & clinical facts,research & funding, policy, ethics) and valence (positive, negative, balanced, neutral). Of the 40 SCI advocacywebsites that met inclusion criteria, 50% (N=20) contained information about SCT. Less than 18% (N=7) containedinformation on stem cell tourism. There were more than ten times as many statements about SCT with a positivevalence (N=67) as with a negative valence (N=6). Ethicsrelated SCT information comprised 20% (N=37) of the totalcontent; the largest proportion of ethicsrelated content was devoted to stem cell tourism (80%, N=30 statements).

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Of those, the majority focused on the risks of stem cell tourism (N=16). Given the stilldeveloping science behindSCT, the presence of cautionary information about stem cell tourism at advocacy sites is ethically appropriate. Theabsence of stem cell tourism information at the majority of advocacy sites represents a lost educational opportunity.


Document 10 Knoppers, Bartha M; Isasi, Rosario; Benvenisty, Nissim; Kim, OckJoo; Lomax, Geoffrey; Morris, Clive; Murray,Thomas H; Lee, Eng Hin; Perry, Margery; Richardson, Genevra; Sipp, Douglas; Tanner, Klaus; Wahlström, Jan; deWert, Guido; Zeng, Fanyi Publishing SNP genotypes of human embryonic stem cell lines: policy statement of the International StemCell Forum Ethics Working Party. Stem cell reviews 2011 Sep; 7(3): 4824 Abstract: Novel methods and associated tools permitting individual identification in publicly accessible SNPdatabases have become a debatable issue. There is growing concern that current technical and ethical safeguards toprotect the identities of donors could be insufficient. In the context of human embryonic stem cell research, there areno studies focusing on the probability that an hESC line donor could be identified by analyzing published SNPprofiles and associated genotypic and phenotypic information. We present the International Stem Cell Forum (ISCF)Ethics Working Party's Policy Statement on "Publishing SNP Genotypes of Human Embryonic Stem Cell Lines(hESC)". The Statement prospectively addresses issues surrounding the publication of genotypic data andassociated annotations of hESC lines in open access databases. It proposes a balanced approach between thegoals of open science and data sharing with the respect for fundamental bioethical principles (autonomy, privacy,beneficence, justice and research merit and integrity).


Document 11 Ellison, Brooke; Meliker, Jaymie Assessing the risk of ovarian hyperstimulation syndrome in egg donation: implications for humanembryonic stem cell research. The American journal of bioethics : AJOB 2011 Sep; 11(9): 2230 Abstract: Stem cell research has important implications for medicine. The source of stem cells influences theirtherapeutic potential, with stem cells derived from earlystage embryos remaining the most versatile. Somatic cellnuclear transfer (SCNT), a source of embryonic stem cells, allows for understandings about disease developmentand, more importantly, the ability to yield embryonic stem cell lines that are genetically matched to the somatic celldonor. However, SCNT requires women to donate eggs, which involves injection of ovulationinducing hormones andegg retrieval through laparoscopy or transvaginal needle aspiration. Risks from this procedure are fiercely debated,most notably risk of ovarian hyperstimulation syndrome (OHSS). This review examines risk of OHSS resulting fromoocyte donation. We conclude that risk posed by OHSS in egg donation is not significant enough to warrant undueconcern, and much of this can be eliminated when proper precautions are taken. This bears relevance to the futureof stem cell research policymaking.


Document 12 Kalfoglou, Andrea L; Sauer, Mark V A precautionary approach to oocyte donation for stem cell nuclear transplantation. The American journal of bioethics : AJOB 2011 Sep; 11(9): 313


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Document 13 Mertes, Heidi; Pennings, Guido Ethical concerns eliminated: safer stimulation protocols and egg banking. The American journal of bioethics : AJOB 2011 Sep; 11(9): 335


Document 14 Stein, Andrea L The conundrum of oocyte donation, human research, OHSS, and ethics. The American journal of bioethics : AJOB 2011 Sep; 11(9): 357


Document 15 Bamford, Rebecca Reconsidering risk to women: oocyte donation for human embryonic stem cell research. The American journal of bioethics : AJOB 2011 Sep; 11(9): 379


Document 16 Batzer, Frances; Daar, Judith Harmony and compensation for oocyte providers. The American journal of bioethics : AJOB 2011 Sep; 11(9): 3941


Document 17 Fiore, Robin N; Hinsch, Kathryn M Oocytes for research: reevaluating risks and compensation. The American journal of bioethics : AJOB 2011 Sep; 11(9): 423


Document 18 Sanal, Madhusudana Girija Future of liver transplantation: nonhuman primates for patientspecific organs from induced pluripotentstem cells. World journal of gastroenterology : WJG 2011 Aug 28; 17(32): 368490 Abstract: Strategies to fill the huge gap in supply versus demand of human organs include bioartificial organs,growing humanized organs in animals, cell therapy, and implantable bioengineered constructs. Reproducing thecomplex relations between different cell types, generation of adequate vasculature, and immunological complicationsare road blocks in generation of bioengineered organs, while immunological complications limit the use of humanizedorgans produced in animals. Recent developments in induced pluripotent stem cell (iPSC) biology offer a possibilityof generating human, patientspecific organs in nonhuman primates (NHP) using patientderived iPSC and NHP

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derived iPSC lacking the critical developmental genes for the organ of interest complementing a NHP tetraploidembryo. The organ derived in this way will have the same human leukocyte antigen (HLA) profile as the patient. Thisapproach can be curative in genetic disorders as this offers the possibility of gene manipulation and correction of thepatient's genome at the iPSC stage before tetraploid complementation. The process of generation of patientspecificorgans such as the liver in this way has the great advantage of making use of the natural signaling cascades in thenatural milieu probably resulting in organs of great quality for transplantation. However, the inexorable scientificdevelopments in this direction involve several social issues and hence we need to educate and prepare society inadvance to accept the revolutionary consequences, good, bad and ugly.


Document 19 Kaiser, Jocelyn Embryonic stem cells. NIH wins suit challenging legality of research. Science (New York, N.Y.) 2011 Aug 5; 333(6043): 683


Document 20 Annas, George J Assisted reproductionCanada's Supreme Court and the "global baby". The New England journal of medicine 2011 Aug 4; 365(5): 45963


Document 21 Safe, not secure. Nature 2011 August 3; 476(7358): 5


Document 22 Wadman, Meredith Court quashes stemcell lawsuit. Nature 2011 August 2; 476(7358): 145


Document 23 Jenks, Susan Embryonic stem cell research moves slowly through appeals courts, cancer trials. Journal of the National Cancer Institute 2011 Jul 20; 103(14): 10789


Document 24

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Power, Carl; Rasko, John E J Will cell reprogramming resolve the embryonic stem cell controversy? A narrative review. Annals of internal medicine 2011 Jul 19; 155(2): 11421 Abstract: In the past few years, relatively straightforward laboratory techniques have been developed to reprogramnormal body cells to enter an embryonic stem celllike state. Not only do these induced pluripotent stem cells holdgreat medical promiseperhaps greater than that of embryonic stem cellsbut they also have escaped the ethicalcontroversy in which the latter is mired. This article examines how cell reprogramming is likely to transformregenerative and reproductive medicine and highlights some of the medical, moral, and political hurdles that it faces.It also argues that induced pluripotent stem cells are more ethically problematic than most people believe and thatcell reprogramming will not solve the stem cell controversy but complicate it further.


Document 25 Claiborn, Kathryn Federal funding for stem cell research: 15 years of indecision. The Journal of clinical investigation 2011 Jul 1; 121(7): 2531


Document 26 Seitz, R; Schneider, C K; Hengel, H [Advanced therapy medicinal products : Scientific, medical, economic, and ethical aspects]. = Arzneimittelfür neuartige Therapien. Wissenschaftliche, medizinische,ökonomische und ethische Aspekte. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jul; 54(7): 78990


Document 27 VoltzGirolt, C; Celis, P; Boucaumont, M; D'Apote, L; Pinheiro, MH; PapalucaAmati, M The advanced therapy classification procedure. Overview of experience gained so far. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jul; 54(7): 8115 Abstract: The classification procedure, introduced by the European Regulation on advanced therapy medicinalproducts (ATMPs), has received a tremendous interest from companies, academic and public sponsors developingATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developingcan be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the EuropeanUnion for these types of medicinal products. This procedure is optional, free of charge and may take place at anystage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefingmeetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMPclassification and are a starting point for the interactions between the Agency and the developers of ATMPs. Thisarticle reviews the advantages of the classification procedure for both the developers of ATMPs and the Europeanregulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee forAdvanced Therapies (CAT) has finalised 38 applications for classification.


Document 28 Berger, A; Schüle, S; Flory, E [The certification of advanced therapy medicinal products. A quality label for product development in smalland mediumsized enterprises]. = Die Zertifizierung neuartiger Therapien. Ein Gütesiegel für dieProduktentwicklung in kleinen und mittelständischen Unternehmen.


Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jul; 54(7): 81621 Abstract: Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineeredproducts. To gain access to the market within the European Union, ATMPs must be authorized by the EuropeanCommission (EC). Especially for small and mediumsized enterprises (SMEs), the European centralized procedureof marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a majorchallenge, because SMEs often have little experience with regulatory procedures and many have limited financialpossibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMPdevelopment was introduced by the EC. Independently from a marketing authorization application, developmentand/or production processes can be certified. An issued certificate demonstrates that the respective process meetsthe current regulatory and scientific requirements of the EMA, representing a valuable milestone for putativeinvestors and licensees. This article highlights the background, the detailed procedure, the minimum requirements,as well as the costs of certification, while giving further noteworthy guidance for interested parties.


Document 29 Reiss, M; Büttel, I C; Schneider, C K [Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medicaltreatment with advanced therapy medicinal products]. = Erfahrungsbericht aus dem Ausschuss für neuartigeTherapien (CAT). Fallstricke auf dem Weg vom Konzept zur medizinischen Anwendung neuartiger Therapien.Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jul; 54(7): 82230 Abstract: Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. Theycomprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissueengineered products(TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory frameworkwas created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays acentral role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of variousprocedures. Often ATMPs are developed by small and mediumsized enterprises (SME) which also facenonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its20102015 work program.


Document 30 Thanner, M; Nagel, E [A comprehensive assessment of ATMP. Difficulties and approaches]. = Arzneimittel für neuartige Therapienumfassend bewerten. Problemfelder und Lösungsansätze in der Übersicht. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jul; 54(7): 8438 Abstract: Advanced therapy medicinal products (ATMP) are associated with high expectations because they offernew opportunities for the treatment of diseases, e.g., the possibility of regenerating damaged or lost tissue. What theproducts (gene therapy, somatic cell therapy, and tissue engineered products) have in common is an innovative andcomplex development process that combines science and engineering. At the same time, this field of research isbecoming increasingly interdisciplinary and requires international cooperation. A comprehensive assessment ofATMP has to take these issues into account. The application of Beauchamp and Childress' Four Principles(PrincipleBased Ethics) as well as Discourse Ethics as a framework may lead to a broader consideration of medicalethics issues.


Document 31 Krahn, Timothy M; Wallwork, Thomas E Who cares about consent requirements for sourcing human embryonic stem cells? Are errors in the pastreally errors of the past? Accountability in research 2011 JulAug; 18(4): 25088


Abstract: Through an Access to Information Act request, we have obtained the consent forms used by the providersof every human embryonic stem cell (hESC) line approved for use by the Canadian Institutes of Health Research(CIHR), and examined them to verify whether or not they meet the consent requirements established by Canadianlaw and regulations. Our findings show that at least seven out of ten consent forms studied did not satisfy theseminimum requirements. We then outline various options for responding to this situation in terms of: (i) remedialmeasures for dealing with executive problems with regulatory oversight procedures; and (ii) remedial measures fordealing with the impugned lines.


Document 32 Terzic, Andre; Folmes, Clifford D; MartinezFernandez, Almudena; Behfar, Atta Regenerative medicine: on the vanguard of health care. Mayo Clinic proceedings. Mayo Clinic 2011 Jul; 86(7): 6002


Document 33 Zacharias, David G; Nelson, Timothy J; Mueller, Paul S; Hook, C Christopher The science and ethics of induced pluripotency: what will become of embryonic stem cells? Mayo Clinic proceedings. Mayo Clinic 2011 Jul; 86(7): 63440 Abstract: For over a decade, the field of stem cell research has advanced tremendously and gained new attention inlight of novel insights and emerging developments for regenerative medicine. Invariably, multiple considerationscome into play, and clinicians and researchers must weigh the benefits of certain stem cell platforms against thecosts they incur. Notably, human embryonic stem (hES) cell research has been a source of continued debate,leading to differing policies and regulations worldwide. This article briefly reviews current stem cell platforms, lookingspecifically at the two existing pluripotent lines available for potential therapeutic applications: hES cells and inducedpluripotent stem (iPS) cells. We submit iPS technology as a viable and possibly superior alternative for futuremedical and research endeavors as it obviates many ethical and resourcerelated concerns posed by hES cells whileprospectively matching their potential for scientific use. However, while the clinical realities of iPS cells appearpromising, we must recognize the current limitations of this technology, avoid hype, and articulate ethicallyacceptable medical and scientific goals.


Document 34 Haimes, Erica; Taylor, Ken The contributions of empirical evidence to socioethical debates on fresh embryo donation for humanembryonic stem cell research. Bioethics 2011 Jul; 25(6): 33441 Abstract: This article is a response to McLeod and Baylis (2007) who speculate on the dangers of requesting fresh'spare' embryos from IVF patients for human embryonic stem cell (hESC) research, particularly when those embryosare good enough to be transferred back to the woman. They argue that these embryos should be frozen instead. Weexplore what is meant by 'spare' embryos. We then provide empirical evidence, from a study of embryo donation andof embryo donors' views, to substantiate some of their speculations about the problems associated with requestingfresh embryos. However, we also question whether such problems are resolved by embryo freezing, since furtherempirical evidence suggests that this raises other social and ethical problems for patients. There is little evidencethat the request for embryos for research, in itself, causes patients distress. We suggest, however, that no requestsfor fresh embryos should be made in the first cycle of IVF treatment. Deferring the request to a later cycle ensuresthat potential donors are better informed (by experience and reflection) about the possible destinations of theirembryos and about the definition of 'spare embryos'. Both this article, and that by McLeod and Baylis, emphasizethe need to consider the views and experiences of embryo donors when evaluating the ethics of embryo donation forhESC research.



Document 35 Jones, David Albert More at stake in stemcell patents. Nature 2011 June 29; 474(7353): 579


Document 36 Ledford, Heidi Stemcell scientists grapple with clinics. Nature 2011 June 28; 474(7353): 550


Document 37 Scott, Christopher Thomas; McCormick, Jennifer B; DeRouen, Mindy C; OwenSmith, Jason Democracy derived? New trajectories in pluripotent stem cell research. Cell 2011 Jun 10; 145(6): 8206 Abstract: How has the development of human induced pluripotent stem cells (hiPSCs) modified the trajectory ofstem cell research? Here, coauthorship networks of stem cell research articles and analysis of cell lines used instem cell research indicate that hiPSCs are not replacing human embryonic stem cells, but instead, the two celltypes are complementary, interdependent research tools. Thus, we conclude that a ban on funding for embryonicstem cell research could have unexpected negative ramifications on the nascent field of hiPSCs.


Document 38 Evans, M D R; Kelley, Jonathan US attitudes toward human embryonic stem cell research. Nature biotechnology 2011 June 7; 29(6): 4848


Document 39 Annas, George J Sudden death for a challenge to federal funding of stemcell research. The New England journal of medicine 2011 Jun 2; 364(22): e47


Document 40 Cohen, I Glenn; Adashi, Eli Y Human embryonic stemcell research under siegebattle won but not the war.


The New England journal of medicine 2011 Jun 2; 364(22): e48


Document 41 [Report of the Central Ethics Committee for Stem Cell Research (ZES) : eighth report after the enactment ofthe Stem Cell Act (StZG), Reporting Period: 1 December 2009 to 31 December 2010]. = Tätigkeitsbericht derZentralen EthikKommission für Stammzellenforschung (ZES) : Achter Bericht nach Inkrafttreten desStammzellgesetzes (StZG) für den Zeitraum vom 01.12.2009 bis 31.12.2010. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 2011 Jun; 54(6): 7605


Document 42 Andersson, AnnaKarin M Embryonic stem cells and property rights. The Journal of medicine and philosophy 2011 Jun; 36(3): 22142 Abstract: This article contributes to the current debate on human embryonic stem cell researchers' possiblecomplicity in the destruction of human embryos and the relevance of such complicity for the issue ofcommodification of human embryos. I will discuss if, and to what extent, researchers who destroy human embryos,and researchers who merely use human embryos destroyed by others, have moral use rights, and/or moral propertyrights, in these embryos. I argue that the moral status of the human embryo, however justified, places fewrestrictions on the latter researchers' use of it, and property rights in it, once it is destroyed. I argue that the formerresearchers have no property rights in the destroyed embryo but use rights in it to the extent allowed by thelegitimate owners of the destroyed embryo. I discuss the implications of this account for previous and current USfederal law regulating human embryonic stem cell research.


Document 43 Hinkley, Aaron E Introduction: embryonic stem cell research, abortion, euthanasia, and the plurality of moralities in bioethics.The Journal of medicine and philosophy 2011 Jun; 36(3): 21720


Document 44 Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane Italian ethical committee intervention in a case of embryofetal medicine. Medicine and law 2011 Jun; 30(2): 20114 Abstract: Embryofetal experimentation is intuitively associated with a therapeutic intent, according to aconsolidated line of thought on the international and national levels. We report on a researcher's request for EthicsCommittee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed withdystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The EthicsCommittee rejected the request because of deontological issues and clinical judgments about the potential good tobe derived from the procedure. In particular, in this case there was no preclinical or animal research on theprocedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance withItalian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.



Document 45 Ehrich, Kathryn; Farsides, Bobbie; Williams, Clare; Scott, Rosamund Constructing an ethical framework for embryo donation to research: is it time for a restricted consent policy?Human fertility (Cambridge, England) 2011 Jun; 14(2): 11521 Abstract: An Ethics & Policy Workshop was held with 20 invited UK stakeholders to consider whether embryodonors should be able to restrict the future use of human embryonic stem cells (hESCs) created from their embryos.Participants cited tensions between pure altruism and a more reciprocal basis for donation; and between basicresearch (in which genetic material would never form part of another living being) and treatment applications. Tworestriction models were suggested to acknowledge specific ethical issues raised by hESCs' use in research andtreatments: (1) a two tier system: hESCs with unrestricted consent could go to the UK Stem Cell Bank; those withrestricted consent could be used in individual labs which could guarantee to honour the restrictions, and Bankdeposit would not be required. (2) a three category system: restrictions could include (i) basic hESC research; (ii)hESC research and treatment; no gamete derivation (iii) 'unrestricted' hESC research and treatment.


Document 46 Neri, Demetrio The race toward 'ethically universally acceptable' human pluripotent (embryoniclike) stem cells: only aproblem of sources? Bioethics 2011 Jun; 25(5): 2606 Abstract: Over the past few years, several proposals aimed at procuring human pluripotent (embryoniclike) stemcells without involving the destruction of a human embryo have been proposed and widely discussed. This articlefocuses on a basic aspect of the debate, namely the plausibility of one or more of these new proposals being able tomeet the ethical requirements that those who regard the human embryo as sacred have tried to impose on stemcells research in the last ten years. The thesis of the article is that focusing the discussion only on the sources ofstem cells has prevented a full understanding of the foundation, meaning and scope of these ethical requirements.To substantiate this thesis, the article takes into consideration two issues: the first has to do with the potential of thecells obtained through some of the new approaches (iPS included), the second (and decisive) with the argument ofthe 'indirect complicity', applied to the use of 'contaminated' knowledge.


Document 47 Niemelä, Jussi What puts the 'yuck' in the yuck factor? Bioethics 2011 Jun; 25(5): 26779 Abstract: The advances in biotechnology have given rise to a discussion concerning the strong emotional reactionexpressed by the public towards biotechnological innovations. This reaction has been named the 'Yuckfactor' byseveral theorists of bioethics. Leon Kass, the former chairman of the President's council on bioethics, has appraisedthis public reaction as 'an emotional expression of deep wisdom, beyond reason's power fully to articulate it.'(1)Similar arguments have been forwarded by the Catholic Church, several Protestant denominations and the ProLifemovement. Several bioethicists have, however, opposed the idea of a disgustbased morality.(2) Recent findings incognitive science support the view that the strong negative emotions people often experience when faced withbiotechnological ideas are not expressions of inner wisdom. The negative emotions may rather be the result of acognitive violation the biotechnological innovations easily cause. Due to their evolutionary background, people havecertain automatic and quick cognitive tendencies routinely used for categorizing and reasoning about nature, usuallytermed 'folk biology'. Biotechnological processes like hybridisation and cloning clearly violate several of the cognitiverules people naturally apply for the explanation and categorization of their natural environment. As the cognitivetendencies routinely applied to the explanation of biological world are violated, an emotional response of fear, disgustand of something unnatural being underway is easily provoked. It is suggested in this paper that the reason behindthe Yuckfactor is not a deep inner wisdom, but a violation of natural human cognitive tendencies concerning thebiological world.

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Document 48 RamalhoSantos, João Human procreation in unchartered territory: new twists in ethical discussions. Human reproduction (Oxford, England) 2011 Jun; 26(6): 12847 Abstract: Since their validation in mammals, there have been profound ethical discussions on the possibleapplications of somatic cell nuclear transfer, human embryonic stem cells and induced pluripotent stem cells toreproductive medicine. This has been the case whether these technologies were considered as direct (i.e. whenprocreation is the ultimate goal) or indirect applications. In most countries, the majority of these approaches havebeen either stringently regulated, or regulation has been strongly and consensually suggested. However, this is notnecessarily the case for possibilities such as samesex chimaeras or the direct differentiation of gametes fromsomatic cells, skipping a pluripotent cell intermediate. The author suggests that the field of reproductive medicineshould be more proactive in discussing both current and emerging developments with possible implications forhuman reproduction, even those reaching beyond current paradigms.


Document 49 Feldman, Robin Whose body is it anyway? Human cells and the strange effects of property and intellectual property law. Stanford law review 2011 Jun; 63(6): 1377402 Abstract: Whatever else I might own in this world, it would seem intuitively obvious that I own the cells of my body.Where else could the notion of ownership begin, other than with the components of the tangible corpus that all wouldrecognize as "me"? The law, however, does not view the issue so neatly and clearly, particularly when cells are nolonger in my body. As so often happens in law, we have reached this point, not by design, but by the piecemealdevelopment of disparate notions that, when gathered together, form a strange and disconcerting picture. This Articleexamines both property and intellectual property doctrines in relation to human cells that are no longer within thebody. In particular, the Article discusses the Bilski decision, in the context of life science process patents, and theMolecular Pathology case, in the context of gene patents. For patent law, the Article concludes that the problem liesnot with the fact that genes constitute patentable subject matter, but rather with the extent of the rights that aregranted. For both property and intellectual property law, the Article concludes that a more careful application of basiclegal principles would better reflect the interests of society as a whole and the interests of individual human subjects,as well as the interests of those who innovate.


Document 50 Joyce, James J Issue calls for reasoned discussion, not politics. Minnesota medicine 2011 Jun; 94(6): 5


Document 51 Taylor, Patrick L Responsibility rewarded: ethics, engagement, and scientific autonomy in the labyrinth of the minotaur. Neuron 2011 May 26; 70(4): 57781 Abstract: Dramatic changes in the stem cell ethical and research ecosystem in the last 10 years depended onactive engagement among scientists, ethicists, government, and public. Tracing that story demonstrates the value


of such engagement, and forecasts a successful method for meeting future challenges.


Document 52 Bretzner, Frédéric; Gilbert, Frédéric; Baylis, Françoise; Brownstone, Robert M Target populations for firstinhuman embryonic stem cell research in spinal cord injury. Cell stem cell 2011 May 6; 8(5): 46875 Abstract: Geron recently announced that it had begun enrolling patients in the world's firstinhuman clinical trialinvolving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding thefuture of hESCbased therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacyconcerns with this research, as well as the ethics of fair subject selection. We consider other populations that mightbe better for this research: chronic complete SCI patients for a safety trial, subacute incomplete SCI patients for anefficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacytrial.


Document 53 Wirth, Edward 3rd.; Lebkowski, Jane S; Lebacqz, Karen Response to Frederic Bretzner et al. "Target populations for firstinhuman embryonic stem cell research inspinal cord injury". Cell stem cell 2011 May 6; 8(5): 4768 Abstract: We address concerns raised in this issue by Bretzner et al. (2011) by explaining the rationale for includingsubjects with subacute, neurologically complete spinal cord injuries in the Phase 1 trial of GRNOPC1. We alsopresent elements of the informed consent process that minimize the likelihood of therapeutic misconception.


Document 54 Solbakk, Jan Helge; Zoloth, Laurie The tragedy of translation: the case of "first use" in human embryonic stem cell research. Cell stem cell 2011 May 6; 8(5): 47981 Abstract: Who should go first in phaseI human trials when neither risks nor benefits can be estimated? Byassessing concerns raised by Bretzner et al. (2011), we highlight a tragic dimension underlying all such trials. Wediscuss strategies to avoid the pitfalls of ethical hubris by promoting fidelity and trust.


Document 55 Kaiser, Jocelyn Stem cells. NIH wins in appeals court, but legal battle continues. Science (New York, N.Y.) 2011 May 6; 332(6030): 651


Document 56 Hoppe, Nils; Denoon, Alexander


An ethical framework for expanded access to cellbased therapies. Regenerative medicine 2011 May; 6(3): 2735


Document 57 Aurelio, M T; Aniasi, A; Haworth, S E; Colombo, M B; Dimonopoli, T; Mocellin, M C; Poli, F; Torelli, R; Crespiatico,L; Serafini, M; Scalamogna, M Analysis of the motivation for hematopoietic stem cell donation. Transplantation proceedings 2011 May; 43(4): 9814 Abstract: The Italian Bone Marrow Donor Register is the institutional organization for management of unrelatedhematopoietic stem cell donors. The law requires only a donor's clinical history, but not a psychosocial profile forregistration. We have studied the donor's motivation for enlistment on the donor registry and the medical staff's needfor this information to interact correctly with the donor. For this purpose we distributed a questionnaire to new donorsat the 20 centers in the Lombardy Region over a period of 1 year. The analysis of the responses revealed aprevalence of extrinsic motivations that would not ensure continued registration for donation. Therefore, it isnecessary that the donor be well informed and better educated about all aspects of donation, in order to produce ashift to an intrinsic motivation. This objective can be facilitated via professional training of health workers incommunication.


Document 58 Firpo, Meri; Wagner, John Stem cell research in Minnesota: here today, gone tomorrow? Minnesota medicine 2011 May; 94(5): 345


Document 59 Hyun, I The bioethics of iPS cellbased drug discovery. Clinical pharmacology and therapeutics 2011 May; 89(5): 6467 Abstract: The ability to generate human induced pluripotent stem (iPS) cells presents exciting prospects for drugdiscovery and the development of safer, more effective drugs. Given the enormous potential for iPS cellbased drugdevelopment, what ethical issues could possibly cloud this new biomedical horizon?


Document 60 Hayden, Erika Check California ponders cellbanking venture. Nature 2011 Apr 28; 472(7344): 403


Document 61 Smith, Austin


'No' to ban on stemcell patents. Nature 2011 Apr 28; 472(7344): 418


Document 62 Droste, Sigrid; HerrmannFrank, Annegret; Scheibler, Fueloep; Krones, Tanja Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematicliterature review. BMC medical ethics 2011 April 15; 12: 6 Abstract: An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identifiedserious ethical issues associated with this intervention. Our objective was to systematically review these aspects bymeans of a literature analysis.


Document 63 Kalista, Tasha; Freeman, H Austinn; Behr, Barry; Pera, Renee Reijo; Scott, Christopher Thomas Donation of embryos for human development and stem cell research. Cell stem cell 2011 Apr 8; 8(4): 3602 Abstract: Using donated human embryos for scientific research raises ethical questions about the donation process.We describe a twostage consent process designed to help couples make informed decisions about embryodisposition. This consent methodology minimizes conflict of interest, respects patient choice, and provides a muchneeded resource to patients and the research community.


Document 64 Cesarino, Letícia; Luna, Naara The embryo research debate in Brazil: from the National Congress to the Federal Supreme Court. Social studies of science 2011 Apr; 41(2): 22750 Abstract: New forms of life produced by biomedical research, such as human embryonic stem cells (hESC), havebeen the object of public debate beyond the scientific fields involved. This article brings to light the case of Brazil,where recently passed federal legislation has authorized research with in vitro human embryos. It focuses on thelegislative debate in the Brazilian National Congress between 2003 and 2005 on the Biosafety Bill of Law, whichcleared for hESC research a certain share of supernumerary and unviable human embryos frozen in the country'sassisted reproduction clinics. The passing of this Bill triggered other public reactions, chiefly a Direct Action ofUnconstitutionality in Brazil's Federal Supreme Court. This study adopts an anthropological perspective fordescribing and analyzing the chief arguments in both debates, in terms of how the notion of 'life' was deployed andnegotiated by contending parties. If, on the one hand, the definition of life appeared firmly attached to a conceptionof both the in vitro embryo and the fetus as a human person, on the other a movement towards breaking down lifealong utilitarian lines was found when the potential beneficiaries of stem cell therapy came into the equation. In allcases, however, notions of life were negotiated from a hybrid continuum of (biological) facts and (religious, moral andjuridical) values, and resonated in different ways with the idea of the individual as privileged mode of constructingpersonhood in the context of modern nation states.


Document 65 Baylis, Françoise Supreme Court of Canada decision on the Assisted Human Reproduction Act creates urgent need for action.


Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC2011 Apr; 33(4): 3179


Document 66 McTeer, Maureen A Assisted human reproduction: Canada needs a uniform code of practice. Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC2011 Apr; 33(4): 3235


Document 67 Klopsch, C; Donndorf, P; Kaminski, A; Ma, N; Steinhoff, G [Cell sources for cardiovascular tissue engineering]. = Zellquellen für kardiovaskuläres Tissue Engineering. Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen 2011 Apr; 82(4): 295302 Abstract: Numerous studies have confirmed that stem cell therapy has significant potential for the regeneration ofcongenital and acquired heart diseases. The utilization of embryonic stem cells and induced pluripotent stem cellspromises a possible generation and regeneration of all cardiovascular structures. On the one hand fetal and adultstem cells, e.g. endothelial progenitors, mesenchymal, hematopoietic, cardiac stem cells and myoblasts, possesslimited potential for multilinear differentiation. On the other hand these cells have high paracrin activity and supportwith wellconfirmed safety the reconstruction and formation of cardiovascular structures. On the visionary tracktowards an autonomously functioning autologous heart generated by tissue engineering, vascular, valvular andmyocardial tissues have already been successfully created. This manuscript describes the possible stem cellsources for cardiovascular tissue engineering and evaluates their potency and safety from a medical and ethicalpoint of view employing the data from systematic reviews (Medline database) and own investigations.


Document 68 Robertson, John A Contractual duties in research, surrogacy, and stem cell donation. The American journal of bioethics : AJOB 2011 Apr; 11(4): 134


Document 69 Forraz, N; McGuckin, C P The umbilical cord: a rich and ethical stem cell source to advance regenerative medicine. Cell proliferation 2011 Apr; 44 Suppl 1: 609 Abstract: Science and medicine place a lot of hope in the development of stem cell research and regenerativemedicine. This review will define the concept of regenerative medicine and focus on an abundant stem cell source neonatal tissues such as the umbilical cord. Umbilical cord blood has been used clinically for over 20 years as a cellsource for haematopoietic stem cell transplantation. Beyond this, cord blood and umbilical cordderived stem cellshave demonstrated potential for pluripotent lineage differentiation (liver, pancreatic, neural tissues and more) in vitroand in vivo. This promising research has opened up a new era for utilization of neonatal stem cells, now usedbeyond haematology in clinical trials for autoimmune disorders, cerebral palsy or type I diabetes.



Document 70 Suaudeau, J From embryonic stem cells to iPS an ethical perspective. Cell proliferation 2011 Apr; 44 Suppl 1: 7084


Document 71 Address of His Excellency the most Reverend Mgr Bernard Barsi, Archbishop of Monaco to participants ofthe second international congress on responsible stem cell research. Cell proliferation 2011 Apr; 44 Suppl 1: 856


Document 72 Sharma, Harsha; Johnstone, Erica B; Gates, Elena; Sohn, Sae H; Huddleston, Heather G; Fujimoto, Victor Y Asian immigrants to the United States are less likely to donate cryopreserved embryos for research use. Fertility and sterility 2011 Apr; 95(5): 16726 Abstract: To determine whether there are ethnic differences in the proportion of IVF patients donating excesscryopreserved embryos for use in research.


Document 73 Revera, Greg H; Frangoul, Haydar A parent's point of view on the American Academy of Pediatrics policy statement: Children as hematopoieticstem cell donors. Pediatric blood & cancer 2011 Apr; 56(4): 5156


Document 74 Joffe, Steven; Kodish, Eric Protecting the rights and interests of pediatric stem cell donors. Pediatric blood & cancer 2011 Apr; 56(4): 5179


Document 75 Ross, Lainie Friedman In defense of the American Academy of Pediatrics policy statementchildren as hematopoietic stem celldonors. Pediatric blood & cancer 2011 Apr; 56(4): 5203



Document 76 Ledford, Heidi Hidden toll of embryo ethics war. Nature 2011 Mar 17; 471(7338): 279


Document 77 Abbott, Alison Europe rules against stemcell patents. Nature 2011 Mar 17; 471(7338): 280


Document 78 Caocci, Giovanni; La Nasa, Giorgio; d'Aloja, Ernesto; Vacca, Adriana; Piras, Eugenia; Pintor, Michela; Demontis,Roberto; Pisu, Salvatore Ethical issues of unrelated hematopoietic stem cell transplantation in adult thalassemia patients. BMC medical ethics 2011 March 8; 12: 4 Abstract: Beta thalassemia major is a severe inherited form of hemolytic anemia that results from ineffectiveerythropoiesis. Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curativetherapy. Unfortunately, the subgroup of adult thalassemia patients with hepatomegaly, portal fibrosis and a history ofirregular iron chelation have an elevated risk for transplantationrelated mortality that is currently estimated to beabout 29 percent.


Document 79 Oakley, Justin Editorial. Regulation of therapeutic and reproductive cloning. Monash bioethics review 2011 Mar; 29(3): 01.1


Document 80 Brassington, Iain; Oultram, Stuart The topsyturvy cloning law. Monash bioethics review 2011 Mar; 29(3): 04.118 Abstract: In debates about human cloning, a distinction is frequently drawn between therapeutic and reproductiveuses of the technology. Naturally enough, this distinction influences the way that the law is framed. The generalconsensus is that therapeutic cloning is less morally problematic than reproductive cloningone can hold thisposition while holding that both are morally unacceptableand the law frequently leaves the way open for somecloning for the sake of research into new therapeutic techniques while banning it for reproductive purposes. We claimthat the position adopted by the law has things the wrong way around: if we accept a moral distinction betweentherapeutic and reproductive cloning, there are actually more reasons to be morally worried about therapeutic cloningthan about reproductive cloning. If cloning is the proper object of legal scrutiny, then, we ought to make sure that weare scrutinising the right kind of clone.



Document 81 Sullivan, Stephen Stem cell research in the Emerald Isle. Bioengineered bugs 2011 MarApr; 2(2): 6970 Abstract: Fiscal policy, governance, education and a more internationally integrative strategic policy significantlyassists Ireland's competitiveness in stem cell R&D sector.


Document 82 Ho, Anthony D Law, ethics, religion, and clinical translation in the 21st centurya conversation with Anthony D. Ho.Interview by Majlinda Lako, Alan O. Trounson, and Susan Daher. Stem cells (Dayton, Ohio) 2011 Mar; 29(3): 3878


Document 83 Mummery, Christine; Westgren, Magnus; Sermon, Karen Current controversies in prenatal diagnosis 1: is stem cell therapy ready for human fetuses? Prenatal diagnosis 2011 Mar; 31(3): 22830


Document 84 Holm, Søren The concise argument. Journal of medical ethics 2011 Mar; 37(3): 129


Document 85 Master, Zubin; Crozier, G K D Symbolism and sacredness of human parthenotes. The American journal of bioethics : AJOB 2011 Mar; 11(3): 379


Document 86 Mosteller, Tim Teleology, embryonic personhood, and stem cell research Ethics & Medicine 2011 Spring; 27(1): 4350



Document 87 Borjesson, Dori L; Peroni, John F The regenerative medicine laboratory: facilitating stem cell therapy for equine disease. Clinics in laboratory medicine 2011 Mar; 31(1): 10923 Abstract: This article focuses on the emerging field of equine regenerative medicine with an emphasis on the use ofmesenchymal stem cells (MSCs) for orthopedic diseases. We detail laboratory procedures and protocols for tissuehandling and MSC isolation, characterization, expansion, and cryopreservation from bone marrow, fat, and placentaltissues. We provide an overview of current clinical uses for equine MSCs and how MSCs function to heal tissues.Current laboratory practices in equine regenerative medicine mirror those in the human field. However, thetranslational use of autologous and allogeneic MSCs for patient therapy far exceeds what is currently permitted inhuman medicine.


Document 88 Mathews, Debra J H; Graff, Gregory D; Saha, Krishanu; Winickoff, David E Access to stem cells and data: persons, property rights, and scientific progress. Science (New York, N.Y.) 2011 Feb 11; 331(6018): 7257 Abstract: Many fields have struggled to develop strategies, policies, or structures to optimally manage data,materials, and intellectual property rights (IPRs). There is growing recognition that the field of stem cell science, inpart because of its complex IPRs landscape and the importance of cell line collections, may require collective actionto facilitate basic and translational research. Access to pluripotent stem cell lines and the information associatedwith them is critical to the progress of stem cell science, but simple notions of access are substantially complicatedby shifting boundaries between what is considered information versus material, person versus artifact, and privateproperty versus the public domain.


Document 89 Wadman, Meredith Stem cells: the crusader. Nature 2011 Feb 10; 470(7333): 1569


Document 90 Saha, Krishanu; Hurlbut, J Benjamin Disease modeling using pluripotent stem cells: making sense of disease from bench to bedside. Swiss medical weekly 2011 February 9; 141: w13144 Abstract: New advances in human stem cell biology now permit the derivation of diseasespecific inducedpluripotent (iPS) stem cell lines, socalled "diseaseinadish" (DIAD) models. This is a promising approach for thestudy of disease phenotypes at the cellular and molecular level, both because such human cell lines may producemore faithful experimental models of disease than can be produced using nonhuman organisms, and becausereprogrammed cell lines can provide a virtually infinite supply of cells without requiring additional tissue donation.However, expectations placed on this emerging technology privilege the laboratory over the clinic as the site formaking sense of disease, thereby distracting from the socially embedded meanings of disease and reorienting howthe goals of medicine are imagined. Here we identify and review the implications of this area of research for clinicalapproaches to disease. We argue that there is a central place for the larger medical community and patients in thevery construction of experimental research programs and the expectations placed thereon. By attending to theconstellation of social factors that inform understanding, treatments and experiences of disease, DIAD projects canbe more effectively placed in the service of clinical goals, in both their research design and in the forms of innovation


they claim to anticipate.


Document 91 Courtney, Aidan; de Sousa, Paul; George, Carol; Laurie, Graeme; Tait, Joyce Balancing open source stem cell science with commercialization. Nature biotechnology 2011 Feb; 29(2): 1156


Document 92 Kazi, Javed Iqbal; Mubarak, Muhammed Stem cells in kidney disease: opportunities and challenges. JPMA. The Journal of the Pakistan Medical Association 2011 Feb; 61(2): 1123


Document 93 Bredenoord, A L; Dondorp, W; Pennings, G; De Wert, G Ethics of modifying the mitochondrial genome. Journal of medical ethics 2011 Feb; 37(2): 97100 Abstract: Recent preclinical studies have shown the feasibility of specific variants of nuclear transfer to preventmitochondrial DNA disorders. Nuclear transfer could be a valuable reproductive option for carriers of mitochondrialmutations. A clinical application of nuclear transfer, however, would entail germline modification, more specifically agermline modification of the mitochondrial genome. One of the most prominent objections against germlinemodification is the fear that it would become possible to alter 'essential characteristics' of a future person, therebypossibly violating the child's right to an open future. As only the nuclear DNA would contain the ingredients forindividual characteristics, modification of the mtDNA is often considered less controversial than modification of thenuclear DNA. This paper discusses the tenability of this dichotomy. After having clarified the concept of germlinemodification, it argues that modification of the mtDNA is not substantively different from modification of the nuclearDNA in terms of its effects on the identity of the future person. Subsequently the paper assesses how thisconclusion affects the moral evaluation of nuclear transfer to prevent mtDNA disorders. It concludes that the moralacceptability of germline modification does not depend on whether it alters the identity of the future childall germline modifications dobut on whether it safeguards the child's right to an open future. If nuclear transfer to preventmtDNA disorders becomes safe and effective, then dismissing it because it involves germline modification isunjustified.


Document 94 Butler, Declan France mulls embryo research reform. Nature 2011 Jan 20; 469(7330): 277


Document 95


Lodi, Daniele; Iannitti, Tommaso; Palmieri, Beniamino Stem cells in clinical practice: applications and warnings. Journal of experimental & clinical cancer research : CR 2011 January 17; 30: 9 Abstract: Stem cells are a relevant source of information about cellular differentiation, molecular processes andtissue homeostasis, but also one of the most putative biological tools to treat degenerative diseases. This reviewfocuses on human stem cells clinical and experimental applications. Our aim is to take a correct view of theavailable stem cell subtypes and their rational use in the medical area, with a specific focus on their therapeuticbenefits and side effects. We have reviewed the main clinical trials dividing them basing on their clinicalapplications, and taking into account the ethical issue associated with the stem cell therapy. METHODS: We havesearched Pubmed/Medline for clinical trials, involving the use of human stem cells, using the key words "stem cells"combined with the key words "transplantation", "pathology", "guidelines", "properties" and "risks". All the relevantclinical trials have been included. The results have been divided into different categories, basing on the way stemcells have been employed in different pathological conditions.


Document 96 Boo, Michael; van Walraven, Suzanna M; Chapman, Jeremy; Lindberg, Brian; Schmidt, Alexander H; Shaw,Bronwen E; Switzer, Galen E; Yang, Edward; Egeland, Torstein; World Marrow Donor Association Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow DonorAssociation. Blood 2011 Jan 6; 117(1): 215 Abstract: Hematopoietic stem cell transplantation is a curative procedure for lifethreatening hematologic diseases.Donation of hematopoietic stem cells (HSCs) from an unrelated donor, frequently residing in another country, may bethe only option for 70% of those in need of unrelated hematopoietic stem cell transplantation. To maximize theopportunity to find the best available donor, individual donor registries collaborate internationally. To providehomogeneity of practice among registries, the World Marrow Donor Association (WMDA) sets standards againstwhich registries are accredited and provides guidance and regulations about unrelated donor safety and care. A basictenet of the donor registries is that unrelated HSC donation is an altruistic act; nonpayment of donors is entrenchedin the WMDA standards and in international practice. In the United States, the prohibition against remuneration ofdonors has recently been challenged. Here, we describe the reasons that the WMDA continues to believe that HSCdonors should not be paid because of ethical concerns raised by remuneration, potential to damage the public will toact altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to localtransplantation programs and international stem cell exchange, and the possibility of benefiting some patients whiledisadvantaging others.


Document 97 Matthews, Kirstin R W; Rowland, Maude L Stem cell policy in the Obama age: UK and US perspectives. Regenerative medicine 2011 Jan; 6(1): 12532 Abstract: In this article, we compare two different approaches to establishing stem cell policy: a defined policy (theUK) and a changing policy (the US). The UK has a clear and precise policy, agreed upon and supported bylawmakers, scientists and the public. By contrast, US federal policy is continuously being updated based onbalancing political ideologies and advances in science, and it only regulates federal funding. By investigating thesecontrasting policy approaches, we hope to demonstrate the impact of policy on stem cell research and publicopinion.


Document 98


Rota, Cinzia Law, ethics, religion, and clinical translation in the 21st centurya conversation with Cinzia Rota. Interviewby Majlinda Lako, Alan O. Trounson, and Susan Daher. Stem cells (Dayton, Ohio) 2011 Jan; 29(1): 12


Document 99 King, R J; Confer, D L; Greinix, H T; Halter, J; Horowitz, M; Schmidt, A H; Costeas, P; Shaw, B; Egeland, T; Ethics and Clinical Working Groups of World Marrow Donor Association Unrelated hematopoietic stem cell donors as research subjects. Bone marrow transplantation 2011 Jan; 46(1): 103 Abstract: Requests for participation of unrelated stem cell donors in research transplant protocols are becomingmore frequent. World Marrow Donor Association calls on donor registries to participate in research activities. Here,we discuss various implications of research participation and make some recommendations as how to make thispossible.


Document 100 Appelbaum, F R Unrelated hematopoietic stem cell donors as research subjects. Bone marrow transplantation 2011 Jan; 46(1): 14


Document 101 Apperley, J F Regulation of donor participation in research studies: is there another way? Bone marrow transplantation 2011 Jan; 46(1): 156


Document 102 de MeloMartín, Inmaculada Human dignity in international policy documents: a useful criterion for public policy? Bioethics 2011 Jan; 25(1): 3745 Abstract: Current developments in biomedicine are presenting us with difficult ethical decisions and raising complexpolicy questions about how to regulate these new developments. Particularly vexing for governments have beenissues related to human embryo experimentation. Because some of the most promising biomedical developments,such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodieshave drafted documents aimed to provide guidance to governments when developing biomedical science policy.Here I focus on two such documents: the Council of Europe's Convention for the Protection of Human Rights andDignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights andDignity of the Human Being. I argue that by using human dignity as a criterion to determine the permissibility ofparticular human embryo research practices, these documents cannot aid in identifying research that would becontrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of humandignity as a criterion makes their task of offering guidance unfeasible because the concept as used in thesedocuments is too vague and is applied in contradictory ways. I discuss the main goals of these documents and theirclaims in relation to human embryo research. I then discuss how they have influenced public policy in severalcountries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in

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