Professional Ethics Report

Publication of the American Association for the Advancement of (AAAS), Scientific Freedom, Responsibility & Law Program, in collaboration with the AAAS Committee on Scientific Freedom & Responsibility

VOLUME XXIII NUMBER 2 SPRING 2010 THE COMING REVOLUTION IN shares with the woman carrying it. to a previously untapped source of fetal PRENATAL Obtaining DNA from this protected DNA. source has required invasive methods. Henry T. Greely and Jaime S. King Scientists have known for many years Amniocentesis, the most common that fetal DNA leaks into the maternal Greely is the Deane F. and Kate Edelman method, pokes a needle through the blood stream through the placenta, Johnson Professor of Law and a pregnant woman’s abdomen at 16 to 20 usually in the form of whole fetal cells. Professor, by courtesy, of Genetics at weeks of pregnancy to withdraw Detecting such cells is difficult, but Stanford University. King is an amniotic fluid containing fetal cells. possible. Testing them for fetal DNA, Associate Professor at the Hastings Another method, chorionic villus however, is complicated by the fact that College of Law. Correspondence should sampling (CVS), is performed at 10 to 12 many women still have some cells in be addressed to Greely at weeks, usually by snaking a catheter their blood derived from earlier [email protected]. through the vagina and the cervix to pregnancies. Finding the fetal retrieve a bit of placenta. Both methods At least since the 1932 publication of needles in the haystack of a pregnant are expensive and uncomfortable; both Brave New World, our society has woman’s blood will not be helpful if they increase the risks of miscarriage for the worried about the possibility of someone are not from the current pregnancy. fetus by about one-half to one percentage selecting the next generation based on its point. Improvements in non-invasive But blood also contains a great deal of genes. Prospective parents have had the ways to screen for Down syndrome and cell-free DNA (“cfDNA”), DNA that has opportunity to do prenatal genetic testing neural tube defects have led to the decline been released by the death of cells and for over forty years, and yet the Brave in the number of women seeking invasive then chopped up by blood-borne enzymes New World has not appeared. prenatal genetic testing. into fragments about 100 base pairs long. Of the roughly 5.2 million American We all have large quantities of cfDNA Another way to get a potential child’s women who were pregnant in 2009, only circulating in our own blood. Pregnant DNA is through preimplantation genetic about 60,000 – just over 1 percent – women, though, have cfDNA not only diagnosis (PGD), which allows obtained some form of prenatal genetic from their own cells but from fetal cells. prospective parents to select embryos for diagnosis. The mystery of why so few Within the first few weeks of a transfer to the uterus based on genetic women get this testing is not hard to pregnancy, five to ten percent of the characteristics. This method can be done solve – the testing is expensive, cfDNA in a pregnant woman’s blood only with in vitro fertilization, where the uncomfortable, and carries risks. That serum is from the current fetus. After embryo is easily accessible rather than may soon change. If it changes as we delivery or termination, cfDNA from the hidden somewhere in the Fallopian tubes expect, millions of women will receive fetus disappears from the woman’s or uterus. A few thousand babies are this kind of testing every year, a system within 24 hours, eliminating any born in the United States each year after quantitative change that will force our question regarding the origin of any non- PGD. But, of course, in vitro fertilization societies to face questions that we have maternal DNA. with PGD is even more expensive, been able until now to ignore. uncomfortable, and risky to the mother Several academic researchers (and Prenatal Testing, Today and than amniocentesis or CVS – and its several companies) are trying to develop Tomorrow chances of producing a baby are limited. useful genetic tests from fetal cfDNA. Professor Steve Quake at Stanford is Current reproductive genetic testing So we can test the genetic make-up of the exploiting the sharply reduced cost of methods can be divided into two next generation, but, for reasons of cost, DNA sequencing to examine by shotgun categories – prenatal and preimplantation. discomfort, and risk, we rarely do it. sequencing all the cfDNA in 7 to 15 Prenatal genetic diagnosis requires DNA This is about to change – and with it may milliliters of pregnant woman’s blood from the fetus, but the fetus is carefully change the future of human reproduction. serum. Roughly 90 percent of the DNA insulated from the outside world, floating Change is coming because of a will be from the woman, but the other 10 aloof and apart in its amniotic sac, its technological advance that permits access percent or so will be from the fetus. By only connection through the placenta it counting matching sequences, he expects Spring 2010 Professional Ethics Report 1 to be able to determine reliably which trisomies already demonstrated, but • How widely would the technique be bits of sequence are from the pregnant variations in the sex chromosomes. used? woman alone and which are from the Determining fetal sex is almost trivially • Who is going to talk to patients fetus. In a 2008 study, Quake easy. about it and how? demonstrated the effectiveness of his Whether and how well the method can • Who will pay for it? approach in ascertaining aneuploid work beyond counting chromosomes • What will the effects be? fetuses (those not bearing the usual 46 remains to be seen. Quake believes that • What will, and can, the law do? chromosomes), by accurately he can detect several megabases of • What should we, as a society, do? distinguishing between nine fetuses with genomic sequence, picking out those that trisomy 21 (Down syndrome), two with In general, the social and ethical may be of particular interest to potential trisomy 18 (Edward syndrome), one with challenges raised by fetal cfDNA testing parents, such as the common pathogenic trisomy 13 (Patau syndrome), and six differ in degree rather than in kind from alleles in Mendelian diseases – or, with the normal number of chromosomes those raised by current reproductive perhaps, the whole sequence for the [1]. genetic testing techniques. exons and other sensitive regions of the The Conference genes involved in those diseases. No The first three areas were all linked to obvious barrier exists, but the accuracy of each other and to the effectiveness and On May 7, 2010, the Stanford Center for such a method (and, perhaps, its accuracy cost of the testing. Uptake of testing Law and the Biosciences and the when repeated a second time for critical would likely vary by socioeconomic, Stanford Center for Integrating Research regions) is likely to determine whether religious, education, cultural, and other in Genetics and Ethics sponsored a day- the technique is useful as a diagnostic test characteristics of pregnant women, in long conference at Stanford Law School or as just another screening procedure. ways that might be socially important. to discuss this technology [2]. Variations in who uses genetic testing for Fundamentally, we were interested in two The answer will make a huge difference reproductive selection can further stratify questions. First, does this seem likely to in the technique’s use. Another blood- socioeconomic groups across not just work (and, if so, how well)? Second, based screen for aneuploidies will spark wealth lines, but also in their what would be the social and ethical only limited interest; a non-invasive predisposition to disease and undesirable implications if it did? diagnostic test for aneuplodies would genetic traits. Less obviously, but ignite more. For Mendelian diseases and As to the first question, the conference equally importantly, uptake would also traits, a non-invasive screening would did not bring to light any reasons to vary by the of the communication likely find substantial interest, but a non- believe some version of this method and consent process. If women just invasive diagnostic test would probably would not work. The reduced cost of receive one more form to sign, be revolutionary. DNA sequencing makes it possible to authorizing more tests on yet another sequence as many tags as necessary to The bulk of the conference considered blood draw, many may be shocked later illuminate the relevant sections of the this last possibility. We assumed that to find that they had authorized genetic fetus’s . Aneuploidies are clearly non-invasive cfDNA testing could testing of the fetus. The conference discoverable, including not only the three provide diagnostic information about reached a consensus around the need to aneuploidies and roughly 100 Mendelian educate both pregnant women and the Editor: Mark S. Frankel diseases or traits without needing follow- general population about the implications Deputy Editor: Nicole Carlozo up by amniocentesis or CVS needed. of all forms of genetic testing. Providing Contributing Authors: Nicole Carlozo, This hypothetical test would require 10 good counseling for millions of women a Rebecca Carlson, Erin Heath, Anna Ing, milliliters of blood from the pregnant year will be extremely challenging. Jordan Johnson, Emil Kiner, Lindsay Pascal woman, could be performed as early as Who will pay will also be important. At

the fifth week after the last menstrual the stipulated $1,000 per test, some The Professional Ethics Report is period, and would cost about $1,000. If published quarterly by the Scientific people might choose to pay for it so, we asked, “What happens?” Freedom, Responsibility and Law Program themselves, but far more, no doubt,

in collaboration with the Committee on The Implications would opt for the test if it were covered Scientific Freedom and Responsibility. by their health plans. Whether health A few writers have discussed some social plans would cover this kind of testing is American Association for the Advancement and ethical issues raised by non-invasive of Science, 1200 New York Avenue, NW, unclear. They might find it in their Washington, DC 20005 (202) 326-6217; prenatal diagnosed [3-5]. We examined financial self-interest, both as less Fax(202)289-4950; Email [email protected] this particular technology and asked six expensive than other testing methods and http://www.aaas.org/spp/sfrl/per/newper specific questions raised by the limited as a result of the termination of Back issues of Professional Ethics Report are literature on its likely social and ethical pregnancies – and eventual children – on-line at implications: involving expensive diseases or http://www.aaas.org/spp/sfrl/per/archives1.s conditions. More broadly, it is unclear html Letters to the Editor: The editors welcome comments from our readers. We whether a health plan not motivated by This newsletter may be reproduced reserve the right to edit and abridge the profit would or should find the benefits without permission as long as proper letter as space permits. Please address all of widespread testing worth the costs. acknowledgement is given. correspondence to the deputy editor. ISSN: 1045-8808 (Greely & King continued on page 3) Spring 2010 Professional Ethics Report 2

(Greely & King continued from page 2) of tests is likely to force us finally to face Noninvasive Prenatal Diagnosis, J. Am. Med. challenging questions we have been Ass’n, 301:2154-56 (2009) One fascinating question is the position avoiding - whether a woman should be [5] Peter A. Benn and Audrey R. Chapman, Ethical of Medicaid. Medicaid pays for about 40 able to abort a fetus for any reason, no Challenges in Providing Noninvasive Prenatal percent of the births in the United States. Diagnosis, Curr. Opin. Ob. & Gyn. 22:128-134 matter how trivial, or whether there are It is a joint federal/state program. States (2010) some genetic characteristics (sex, might well differ in whether they wanted cosmetic traits, predispositions to certain This work was supported in part by a grant to pay for testing that could lead to more from the National Research conditions, etc.) for which no embryo abortions. For all health plans, coverage Institute to the Stanford University Center for should be terminated. A handful of states might also be affected by whether the Integration of Research in Genetics and Ethics have already prohibited abortions technique had been reviewed and (#2P50HG003389). performed on the basis of the fetus’s sex; approved by the Food and Drug others might attempt to restrict access to Administration. tests they consider inappropriate. The In the News The social effects, of course, depend on federal Constitution may limit such how many women choose to be tested, interventions – or it may not. And, of AT THE BLEEDING EDGE OF SYNTHETIC what genetic conditions will be tested, course, in a world of easy travel and the test’s accuracy, and how the test “reproductive tourism,” we would need In an article in Science published online affects abortion decisions. Because it to think about what the law should or can on May 20, 2010, researchers reported might be available as early as five weeks do across national borders? “the synthesis, assembly, cloning, and gestation, cfDNA testing could change Finally, what should we do . . . we successful transplantation of the 1.08Mbp the calculus for many women in deciding scientists, physicians, lawyers, ethicists, [million base pair] … genome, to create a whether to have an abortion. At five citizens, prospective parents, and moral new cell controlled by this synthetic weeks, the woman has only known she beings? What if the parents choose to genome” [1]. was pregnant for a short time, she has not terminate a fetus based on its sex, on its experienced fetal movement, she is not “I actually thought it was going to be a cosmetic characteristics, on its having – showing, and a chemical, rather than whole lot faster. We feel bad it’s taken us or not having – a particular disability? surgical abortion, remains an option. By so long,” replied J. Craig Venter to the We might ignore testing that affects one eliminating many of the inherent House Committee on Energy and percent of pregnancies; should we– can personal, physical, financial and moral Commerce, upon being asked how long we – ignore it if affects two-thirds of barriers associated with current he thought it would take when he and his pregnancies? reproductive genetic testing, cfDNA team at the J. Craig Venter Institute (JCVI) first undertook the endeavor [2]. testing has the potential to increase The conference shed a great deal of light dramatically the number of people on some of these questions, but produced The process involved designing the engaging in reproductive selection and very few clear answers. What is clear, genome on a computer, chemically thereby its social ramifications. For though, is that within the next two or synthesizing it in 1,000bp segments, and instance, the number of children born three years, ready or not, our society will a series of steps to progressively “stitch” with certain genetic diseases (or other have to start answering these and other the segments together into the final genetic traits) could decline significantly. questions. Some new world, brave or product. Since the synthetic genome was This could have negative implications for otherwise, seems likely to be born. We mostly a copy of a naturally occurring people already living with those must begin preparing for it. genome, the JCVI team added four conditions or those who would continue References “watermarks” into inactive portions of to be born with them. They could see the genome to differentiate it from the less research into their conditions, less [1] H.C. Fan, Y.J. Yair, U. Chitkara, L. Hudgins, S. naturally occurring variety. A secret code understanding of their conditions, and R. Quake, Noninvasive Diagnosis of Fetal Aneuploidy by DNA from within the watermark contains the names diminished political power to fight for Maternal Blood, Proc. Nat’l Acad. Sci. 105:16,266- of the 46 JCVI team members, quotations their rights and interests. 16,271 (Oct. 21, 2008). from famed scientists and philosophers,

If the technology becomes common, the [2] The Coming Revolution in Prenatal Genetic as well as a web site to which successful Testing? Scientific, Ethical, Social, and Policy code-breakers can report. law is likely to become involved, but Responses to Maternal Serum Cell-Free Fetal DNA how? Obstetricians could be affected by Testing. Speakers included Wade Aubry, Audrey To be sure, the synthetic genome does potential liability in “wrongful birth” Chapman, Alan Fleischman, Jeremy Goldhaber- not contain anything that does not suits brought by parents complaining Fiebert, Henry T. Greely, Louanne Hudgins, Jaime King, Jessica Lehman, Mary Norton, Kelly currently exist in nature. Venter, calling about a failure to offer the test, which Ormond, Steven R. Quake, John Robertson, DNA the software of life, says that the would probably increase use of the test. Michael Snyder, and Sharon Terry. already living recipient cell was “booted- Whether the FDA will regulate the safety http://www.law.stanford.edu/calendar/details/3908/ up” with new software. According to #related_media and efficacy of such tests is not at all Venter, the new approach, itself a proof clear. Neither is the possible role of the [3] Carolyn Jacobs Chachkin, What Potent Blood: of concept, “should be applicable to the state or federal governments in restricting Non-Invasive Prenatal Genetic Diagnosis and the Transformation of Modern Prenatal Care, Am. J. synthesis and transplantation of more or promoting the availability or use of a Law Med. 33:9- (2007). novel as genome design test so closely tied to parental decisions [4] Peter A. Benn and Audrey R. Chapman, (News continued on page 4) about their children. The sheer volume Practical and Ethical Considerations of Spring 2010 Professional Ethics Report 3

(News continued from page 3) caution lest the discovery “turn against been a significant increase in research the dignity of and respect for human life” financing by the industrial sector [1]. progresses.” [5]. At the congressional hearing, In a press release on May 20, NIH Asked about the implications of his concerns were expressed about the Director Francis S. Collins stressed the achievement, Venter explained the only implications for security and importance of the relationships between limit is one’s imagination. Synthetic bioterrorism, but the committee researchers and industry, noting, Genomics, a for-profit company founded members’ fears were assuaged when the however, the often complex financial by Venter, funded the current study and invited panel assured them that this arrangements between the two [2]. The retained ownership of the intellectual development didn’t add any new new proposal raises the standards of property rights. The company has a capabilities to a nefarious actor’s tool kit. financial accountability for both $600mm contract with ExxonMobil to The committee also seemed satisfied with participating institutions and develop algae that will consume carbon the statement by the Director of the investigators. It explicitly defines dioxide and secrete fuel [2]. Venter National Institute of Allergy and financial conflict as “a significant testified before Congress that within the Infectious Disease, Dr. , financial interest that could directly and next year, and possibly for the next flu that the current regulatory framework in significantly affect the design, conduct, season, he expects this technology to place at the NIH is equipped to deal with or reporting of PHS-funded research” [3]. eliminate the 3-month turnaround time this new development. Congressman The basic intent of the policy is the for flu vaccine development. Instead, a Burton (R-TX) jokingly expressed hope reduction of or removal of bias, vaccine candidate can be ready for testing for the development of a synthetic gene especially that which may be tied to within 24 hours of its design [2]. that would predispose people to vote external funding, from scientific research. republican [2]. A week after the JCVI study, Nature The current policies, which were instated published an article giving the opinions [1] Gibson, D.G. et al., Creation of a Bacterial Cell in 1995, entrust research institutions with and impressions of leading , Controlled by a Chemically Synthesized Genome. Science. (May 20, 2010). the primary responsibility for identifying bioethicists, and philosophers [3]. The http://www.sciencemag.org/cgi/rapidpdf/science.11 and regulating financial conflicts. They scientists were congratulatory, expressing 90719v1.pdf require that research institutions maintain hope for the future implications of the [2] Hearing on Developments in Synthetic and enforce policy aimed at the lessening technology, but also urged caution and Genomics and Implications for Health and Energy. of financial conflicts of interest. All put a realistic spin on the media’s initial 05/27/2010. conflicts must be reported to the PHS claims that scientists have created life. http://energycommerce.house.gov/index.php?option =com_content&view=article&id=2012:hearing-on- Awarding Component, and direct action Arthur Caplan, professor of bioethics at developments-in-synthetic-genomics-and- must be taken to remove or to reduce the the University of Pennsylvania, said the implications-for-health-and-energy&catid=128:full- problem. Additionally, investigators must achievement “is likely to prove as committee&Itemid=84 disclose any Significant Financial momentous to our view of ourselves and [3] Life after the synthetic cell. Nature. 465, 422- Interests (SFIs), those that are greater our place in the Universe as the 424 (05/27/2010). than $10,000. discoveries of Galileo, Copernicus, http://www.nature.com/nature/journal/v465/n7297/f ull/465422a.html Darwin and Einstein.” Mark Bedau, In response to the increasing visibility of professor of philosophy and humanities [4] President’s letter to Dr. Amy Gutmann. biomedical and behavioral research, and (05/20/2010). at Reed College, unsure about the http://www.whitehouse.gov/sites/default/files/micro in conjunction with the growing demand consequences of making new forms of sites/ostp/Gutmann-Letter.pdf for alternative funding from non- life, called for “fundamental innovations [5] Risso, A. (May 21, 2010). Church warns cell governmental sources, NIH sought policy in precautionary thinking and risk scientists not to play God. The Associated Press. recommendations to ensure research analysis.” Meanwhile, George Church, http://www.google.com/hostednews/ap/article/ALeq integrity and monitoring of FCOIs. The geneticist at Harvard Medical School, M5ha2hIikQvHx347p3JzHAAdXUIIjAD9FRB948 proposal reads, “Investigator 0 reminded us that, “[p]rinting out a copy collaborations have become more of an ancient text isn’t the same as *EK complex and public scrutiny has understanding the language.” NIH PROPOSES INCREASED increased significantly creating an environment that would benefit from a Outside of the academic community, OVERSIGHT FOR FINANCIAL regulation with more effective means for reactions toward the scientific CONFLICTS OF INTEREST management and oversight” [4]. The achievement have mostly ranged from On May 21, 2010 the National Institutes series of modifications proposed by NIH reservedly inquisitive to outright of Health (NIH) released its proposal for include, in summary: supportive. The day the study was amending current regulations of financial published, President Obama asked the conflicts of interest (FCOI) in behavioral Definitional clarifications Presidential Commission for the Study of and biomedical research at institutions Included is a revision of “Significant Bioethical Issues to consider the potential • that receive Public Health Service (PHS) Financial Interests,” reducing the medical, environmental, and security funding. The PHS receives funding required reported value from benefits as well as the possible risks applications from approximately 5,000 $10,000 to $5,000 of any type of associated with this “scientific milestone” research institutions annually. Over the payment not constituting salary or [4]. The Vatican expressed optimism for past fifteen years, however, there has the medicinal implications but urged (News continued on page 5) Spring 2010 Professional Ethics Report 4

(News continued from page 4) [4] http://www.gpo.gov/fdsys/pkg/FR-2010-05- votes that are not at risk of being 21/pdf/2010-11885.pdf p. 28702 influenced by other votes. In addition, job related expense. *RC device reviewers will no longer present a Revision of institutional responsibilities unified consensus analysis of supporting FDA AIMS FOR TRANSPARENCY data but rather the range of scientific • All institutional FCOI policies must IN ADVISORY COMMITTEES opinions in the group. be publicized on the web On April 21, the Food and Drug The draft guidelines are posted at: • Required training of all participating Administration issued draft guidelines for investigators with respect to the http://www.fda.gov/downloads/RegulatoryInfor enhancing transparency in its 49 advisory mation/Guidances/UCM209201.pdf institution’s FCOI policy committees, panels that advise the agency • Increased guidelines for the For more on changes in the work of expert on a variety of scientific, technical and panels on medical device matters, see: participation of subrecipients in policy matters. These matters can include http://www.fda.gov/NewsEvents/Newsroom/Pre PHS-funded research product approvals as well as regulations ssAnnouncements/ucm209791.htm • Refined disclosure obligations for and guidance. *EH investigators Members of FDA advisory committees Regulations for the reporting of FCOIs REFORM LEGISLATION SEEKS can seek waivers to participate in TO INCREASE TRANSPARENCY IN • New requirement for the meetings if they have financial conflicts HEALTH CARE SECTOR implementation of a management of interest. The waiver system allows the In a widely supported initiative, the plan when a financial conflict is agency to maintain flexibility and to seek identified out broad expertise. In deciding on a health care reform bill includes a provision that will require drug/medical Institutional review and assessment waiver, the FDA must consider the nature • device companies to publicize their of whether an FCOI exists within of the conflict, the function of the payments to physicians and hospitals. sixty days of SFI disclosure by either advisory committee, and the justification Commonly-known as the Physician a new or current investigator, after for including an expert with a conflict. Payments Sunshine Act of 2009, the PHS funded research has begun There is an annual cap on how many legislation states that manufacturers will Any incidents of investigator FCOI, waivers the agency may grant. • soon be required to submit annual reports or pre-existing SFIs, must be Said FDA Commissioner Margaret to the Secretary of Health and Human accessible to the public online. These Hamburg: “FDA staff should search far Services (HHS). must also be reported to the PHS and wide for experts who have the Awarding Component before any requisite knowledge without conflicts of The Physician Payments Sunshine Act funds are used. interest. At the same time, however, I (H.R. 3590, Section 6002) was signed

recognize the fact that many of the top into law by President Barack Obama on The policy changes are intended to authorities in specific areas may have March 23, 2010 as part of the Patient increase the visibility of the financial conflicts of interest.” Protection and Affordable Care Act of practices of research institutions, and the 2009. The Act requires that annual accountability of both investigators and Current advisory panel members must reports must include all “payments or institutions. The disclosure regulations disclose to the agency if they work with a other transfers of value” between the will ensure that the PHS is informed of sponsor or competitor of a drug or device company and the covered recipients (i.e., any conflicts. Although under the NIH under FDA review. Under the new physicians and teaching hospitals). proposal, much of the financial guidelines, they would have to go further, Information excluded from annual reports regulatory responsibility will remain in revealing publicly the names of the include: educational materials, the hands of the institutions, increased relevant companies along with the range drug/medical device samples, and monitoring of research practices will be of how much money is involved. FDA transfers valued less than $10 (unless the more directly accessible to both the plans to post the information on its web yearly aggregate exceeds $100). public and the government. The NIH site. Manufacturers need only publicize proposal will be open for comment until Public comment on the draft guidelines is payments related to a new drug or July 20, 2010. open until June 21. medical technology after approval from To view the NIH proposal, go to: the Food and Drug Administration or http://www.gpo.gov/fdsys/pkg/FR-2010-05- The agency subsequently announced four calendar years after the initial 21/pdf/2010-11885.pdf changes to the way its expert panels payment, whichever occurs earlier. In To learn more about FCOIs, go to: review and discuss data during hearings addition to requiring the submission of http://grants.nih.gov/grants/policy/coi/tutorial/fc on medical devices under review for pre- transparency reports, the law requires oi.htm market approval, effective on May 1. manufacturers and group purchasing [1] http://www.gpo.gov/fdsys/pkg/FR-2010-05- Instead of voting on the approvability of organizations to disclose information 21/pdf/2010-11885.pdf applications, panels will now vote on regarding physicians who have [2] http://www.nih.gov/news/health/may2010/od- device safety and effectiveness and its ownership or investment interests. 19.htm risks versus benefits. Panel members will The law also grants HHS the regulatory [3] http://www.gpo.gov/fdsys/pkg/FR-2010-05- vote by ballot instead of a show of hands; 21/pdf/2010-11885.pdf p. 28690 although the results of the vote will still power to penalize manufacturers or group

be public, the change is intended to allow (News continued on page 6) Spring 2010 Professional Ethics Report 5

(News continued from page 5) Singh spent two years fighting against the The Court of Appeal ruling adds to libel suit. In May of 2009, High Court present political concerns over England’s purchasing organizations that do not judge Justice Eady ruled in favor of the libel laws. Justice Secretary Jack Straw’s comply with its provisions. Failure to BCA by labeling Singh’s comments as libel working group released a Libel submit yearly reports before the 90th day “fact” and requiring him to procure Working Group Report in March of 2010. of each year is subject to civil money evidence to prove his claims against the The report was to determine if “the law penalties up to $10,000 for each violation association. April’s Court of Appeal of libel, including the law relating to of the Act, and may not exceed $150,000 ruling, however, overturned that decision. 'libel tourism', in England and Wales was annually. In a more severe scenario, The judges determined that Singh’s in need of reform and, if so, to make group purchasing organizations and comments were “honest opinion” and recommendations as to solutions,” and manufactures that knowingly fail to allowed his appeal, as well as his use of addressed concerns such as libel tourism; report may be fined at least $10,000, but the “fair comment” defense. In response the role of public interest considerations may not exceed $100,000. Annually, to this decision, the BCA dropped its in establishing defense to libel action; these fines may not total more than libel case against Singh on April 15, just rules about multiple publications; and $1,000,000. The funds collected from two weeks after the appeal was granted. procedural and case management issues these enforcement actions will be used to relating to the conduct of libel litigation. fund continued surveillance and This ruling follows a libel reform The working group’s proposals and regulation. campaign from charitable trust Sense conclusions will serve, along with other About Science and free speech groups Ultimately, the yearly reports submitted considerations, as a basis for libel law English PEN and Index on Censorship. to HHS are to be made available on an reform, which will be considered in the Supporters of the campaign include Internet website so that consumers can next Parliament session [2]. groups such as the British Science easily access and search for information. Association and the National Union of For further background on this issue, see PER The Secretary is also responsible for Journalists. The campaign stems from Volume 23(1), Winter 2010 presenting an annual report to Congress concerns about the restriction of To view the Court of appeal judgment, visit: that summarizes the aggregate academic debate and open discussion http://www.senseaboutscience.org.uk/PDF/Judge information of each manufacturer/group among scientists, journalists, and ment.pdf purchasing organization as well as the publishers due to England’s libel laws. To view the Libel Working Group Report, visit: enforcement actions taken during the http://www.justice.gov.uk/publications/docs/libel previous year. In addition, the Secretary The Royal Courts of Justice addressed -working-group-report.pdf must submit a report to each state. The concerns over England’s libel laws in the [1] “Science writer Simon Singh wins libel appeal,” reports only contain the summaries that April 1 judgment, stating that scientific BBC News: http://news.bbc.co.uk/2/hi/uk_news/ pertain to covered recipients in a controversies should not be settled in the 8598472.stm particular state. courtroom, but by other means. The [2] “Reform of libel laws will protect freedom of judgment also noted the “chilling effect” These provisions of the Act are scheduled expression,” Ministry of Justice News Release: that current libel laws have had on public http://www.justice.gov.uk/news/ to go in effect on January 1, 2012, which debate. While Singh’s case has come to a newsrelease230310b.htm is the date that manufacturers must begin close, other libel cases remain in limbo. recording all payments and transfers of *NC For example, consultant cardiologist Dr. value. On March 31, 2013, each Peter Wilmshurst is currently being sued EU NANOTECHNOLOGY CODE OF manufacturer must file its first by NMT Medical for questioning a heart CONDUCT TO BE REVISED transparency report with the Secretary of implant device. Further debate might Health and Human Services. On March 24, 2010, the European assist patients when deciding whether or Commission released results from a To view H.R. 3590, Section 6002, visit: not to follow suit or seek other treatment public consultation of its Code of http://www.prescriptionproject.org/tools/sunshin options, but the current legal situation has Conduct for Responsible Nanosciences e_docs/files/Sunshine_Leg_Language.pdf limited such discussions. and Nanotechnologies. The Commission

*JJ has been involved with the responsible The Singh ruling is viewed as a triumph BRITISH CHIROPRACTIC by the scientific community, as well as use of nanotechnology in Europe since ASSOCIATION HALTS LIBEL for journalists and publishers alike. In a 2004, when it began targeting policy CASE AGAINST SCIENCE WRITER statement on the Libel Reform Campaign makers, industry members, and media website, Singh argues “fear of libel and civil society organizations involved On April 1, 2010, England’s Court of means that good research is not always or interested in nanosciences and Appeal ruled in favor of UK author and published because those with vested nanotechnologies (N&N) research. journalist Simon Singh in a libel case interests might sue, and bad research that Subsequent dialogues led to a 2007 report between Singh and the British should be withdrawn is not pulled on the implementation of Europe’s Chiropractic Association (BCA). The because the authors might sue the Nanotechnologies Action Plan and the BCA sued Singh in 2008 following journal.” If the appeal had been rejected, eventual adoption of the February 2008 publication of an opinion piece in The then scientists, journalists and other Code of Conduct. Guardian, in which he questioned the professionals would have faced greater effectiveness of the BCA’s chiropractic The Code of Conduct was intended to risks of libel action [1]. treatments for children. (News continued on page 7)

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(News continued from page 6) Industry members made conflicting Roman Catholic Church has long contributions to the N&N consultation. opposed. “promote integrated, safe and responsible Companies such as EuCheMs and CEFIC nanosciences and nanotechnologies Adult stem cells are thought to be less submitted positive comments on the code research in Europe for the benefit of versatile than embryonic cells and and its effectiveness in promoting a society as a whole,” by providing scientists have had more trouble growing global dialogue, but many national Member States, employers, funders, adult stem cells than embryonic cells. organizations voiced negative opinions, researchers and other organizations with Yet, adult stem cells may be easier to use labeling it “unnecessary” due to the “guidelines favoring a responsible and because they could be harvested from the national guidelines and regulations open approach to N&N research in the patients themselves and may therefore already in place. All comments from the Community.” The Commission based its have less risk of rejection or reaction to a public consultation will be considered in guidelines on the general principles of transplant. the revision process. sustainability, precaution, inclusiveness, However, little is known about adult excellence, innovation and To view the 2008 Commission Recommendation intestinal stem cells, and clinical research accountability. The Commission also on a Code of Conduct for Responsible is not currently feasible. The consortium supported comprehensive research Nanosciences and Nanotechnologies Research, visit: http://ec.europa.eu/research/science- will work initially to answer two essential activities performed in the best interest of society/document_library/pdf_06/nanocode- questions about intestinal stem cells. The the public. recommendation-pe0894c08424_en.pdf researchers must first determine how to On September 26, 2008, the European To view the 2008 Council Conclusions on coax the intestinal cells to survive and Commission released the Council Responsible Nanosciences and replicate in the laboratory, and once Conclusions on Responsible Nanotechnologies, visit: flourishing, the researchers must then http://register.consilium.europa.eu/pdf/en/08/st1 Nanosciences and Nanotechnologies. The 3/st13672.en08.pdf determine how to induce the cells to Council acknowledged the pivotal role of transform into different types of cells. nanotechnology in Europe’s economy To view the 2009-2010 public consultation analysis, visit: In 2006, Pope Benedict XVI said the and society at large and recognized the http://ec.europa.eu/research/consultations/nano- Roman Catholic Church approves and need for “safe and responsible code/results_en.pdf encourages the use of adult stem cells development of nanotechnologies,” because this research respects human life especially with respect to researchers, *NC at every stage of existence [1]. The workers, health care professionals, and VATICAN SUPPORTS STEM CELL church has funded non-embryonic stem patients exposed to nanoparticles. PARTNERSHIP cell research in the past, providing grant Ultimately, the Commission agreed to money for adult stem cell research in monitor EU and international N&N On April 23, 2010, the Vatican and the Istituto Superiore di Sanita, the Italian South Korea and Australia. developments while advancing efforts to support N&N research and continuing equivalent to the U.S. National Institutes To read the University of Maryland press dialogues with Member States, of Health, announced a stem cell research release, visit: stakeholders, and the general public. The partnership with the University of http://www.umm.edu/news/releases/stem_cell_v atican.htm Commission planned to revise the Code Maryland School of Medicine. This of Conduct regularly, beginning in International Intestinal Stem Cell [1] Pope Benedict XVI. Address of His Holiness Consortium will lead a research coalition Benedict XVI to the Participants in the Symposium February 2010. Accordingly, public on the Theme: “Stem Cells: What Future for comments were accepted for consultation to study adult intestinal stem cells in hopes of discovering treatments for Therapy?” http://www.vatican.va/holy_father/ from October 20, 2009 to January 3, benedict_xvi/speeches/2006/september/documents/ 2010. diseases without the use of controversial hf_ben-xvi_spe_20060916_pav_en.html embryonic stem cells. *LP Respondents to the Commission’s public consultation included researchers, Though the exact amount of the grant is being negotiated, the Vatican has agreed CHILDREN’S STEM CELL BOOK members of industry, and policy makers. RECEIVES MIXED RESPONSE Overall, 88% of respondents believe that to provide around $2.7 million for the research efforts. The funding will go On April 8, 2010, Jef Akst of The Code of Conduct revisions are necessary, Scientist posted a review of a children’s and about 75% agree that the code should directly to the University of Salerno’s Medical School Foundation in Italy, and book called Super Stemmys: Doris and not be limited to research. All policy the Super Cells, authored by David makers who commented fall into these will then be distributed to the project partners. Granovsky, with illustrations by Greg categories. While a majority of the Boone. Granovsky is the director of researchers who commented want Intestinal stem cells are highly active communications for the Repair Stem Cell revisions to the Code, few elaborated on cells that support the shedding and Institute (RSCI), which provides patients what those revisions might entail. Over replacing of all the cells lining the with the contact information of stem cell 60% of all respondents suggested intestine once every four to seven days. treatment centers located around the alterations to the Code’s principles, and The cells are multipotent and can be world. The story follows a bone marrow about 53% want more appropriate programmed to generate a variety of cell stem cell, named Doris, through her research regulations. types. Importantly, adult intestinal stem journey to repair a damaged heart. cell research does not require the destruction of an embryo, a practice the (News continued on page 8) Spring 2010 Professional Ethics Report 7

(News continued from page 7) publications directly relating to the Call for Applications – The OpenSeminar in research project. Research Ethics will hold a two-day workshop on The book was published by RSCI in July teaching ethics on July 12-13, 2010 at North 2009 in an effort to increase awareness of Under the new regulations, researchers Carolina State University. Visit: http://openseminar.org/ethics/. stem cell treatments. Granovsky wrote are allowed to cite a maximum of five the book at a sixth-grade level, although publications on their curriculum vitas. Call for Case Studies – The Center for the Study of Ethics at Valley University invites there are some who consider its use of Reports of proposed or finished projects submissions of case studies on environmental ethics rhyming and illustrations more juvenile. are restricted to two publications per year for its archive. Accepted studies will be used as There is also controversy on the subject of funding. An individual researcher classroom discussion and research resources. For matter, itself. Some scientists are applying for three years of grant funding more information, see: http://environmentalethics.info. Send submissions concerned that children will be may, therefore, list up to six publications. to: [email protected] and [email protected] misguided about the true nature and Proposals involving multiple applicants Call for Papers – The Center for Applied Ethics function of stem cells because of the may include up to three publications per and Philosophy at Hokkaido University invites book’s narrow focus. The author does year. In addition, citations are limited to papers for the Fifth International Conference on not explain that there are different types published work only. Applied Ethics from November 5-7, 2010 in of stem cells, nor does he define Sapporo, Japan. Paper topics may include The president of DFG, Matthias Kleiner, scientific terms so that readers could bio/medical ethics, engineering ethics, ethics of claims that conventional mechanisms to science and technology, information ethics, understand the scientific procedure evaluate proposal quality rely heavily on environmental ethics, and business ethics, among underlying the storyline. However, others. Abstract submissions of 300-500 words are numerical indicators like the Hirsch Xiangru Xu, a molecular at due by August 7. Visit: index and impact factor—this approach http://ethics.let.hokudai.ac.jp. Yale University, called the story a deemphasizes proposal content and puts “scientific-based fairytale” that provides Call for Papers – The American Journal of pressure on researchers to publish as readers with an introduction to stem cells Bioethics-Neuroscience is accepting articles on much as possible. Limiting citations may neuroethics-related topics such as imaging, mental in an exciting way. also prevent cases of scientific illness, neuromarketing, lie detection, human enhancement and animal models, among others. To To read the Jef Akst’s article, visit: misconduct, in which false statements submit articles for peer review, visit: http://www.the- concerning the status of a publication are http://mc.manuscriptcentral.com/neuroscience scientist.com/blog/display/57276/ provided. For instance, to bolster their Call for Papers – Articles, case studies, To learn more about Super Stemmys: Doris and curriculum vitae, some past applicants commentaries, and other submissions are invited for the Super Cells, visit: have fallaciously claimed that certain the Cambridge Quarterly of Healthcare Ethics’ new https://www.createspace.com/3391680 articles had been submitted for Professionalism Department. Topics of interest include conscience-based refusals to provide health *AI publication even when they had not [1]. related services; strikes; prescribing for physical and/or cognitive enhancement; GERMAN FUNDER LIMITS Similar publication restrictions exist in professional obligations during pandemics, PUBLICATION CITATIONS IN other countries. For example, in the U.S., bioterrorist attacks, and natural disasters; and RESEARCH PROPOSALS research proposals submitted to the cosmetic surgery, among others. Send manuscripts National Science Foundation are and abstracts to co-editors Mark Wicclair, On February 23, 2010, the Deutsche [email protected]; and David Barnard, permitted to cite five publications related Forschungsgemeinschaft (DFG), [email protected]. For submission guidelines, visit: to the proposal project and up to five Germany’s leading research foundation, http://assets.cambridge.org/CQH/CQH_ifc.pdf. additional publications, while the announced new regulations to counter the Centers – The Regional Documentation and National Institutes of Health allow a total flood of publications in scientific Information Centre for Bioethics and Ethics of of 15 publications. Science and Technology was opened on March 29, research. Beginning July 1, 2010, the 2010 at the Academy of Scientific Research and new policy will limit the number of To read the press release, visit: Technology with support from the UN Educational, publications that researchers can list in www.dfg.de/en/service/press/press_releases/201 Scientific and Cultural Organization (UNESCO). their funding proposals and final reports. 0/pressemitteilung_nr_07/index.html This regional center, based in Cairo, Egypt, will organize seminars and workshops on ethics issues, [1] Kleiner, M. (2010). Quality Over Quantity. The ruling aims to reduce the importance develop teaching curricula, establish ethics German Research, 32(1), 2-3. committees and databases, and disseminate http://www.dfg.de/download/pdf/dfg_magazin/wiss of publication lists and numerical indices information on bioethics and ethics education. enschaft_oeffentlichkeit/forschung_magazin/germa in proposal reviews and seeks to place UNESCO Contacts: Ms Orio Ikebe; n_research_1_10_en.pdf more emphasis on the description of the [email protected]; Ms Rania Anis, [email protected]. research project. By restricting the *LP number of publication citations, the main Conference – The University of Pennsylvania content of a proposal—an applicant’s Center for Neuroscience and Society is hosting the Penn Conference on Clinical Neuroscience and research objectives and preliminary Announcements Society from July 23-25, 2010. This Conference work—is highlighted. Until now, will review the latest developments in brain researchers could list an unlimited Award – The Health Improvement Institute invites imagery, psychopharmacology, and medicolegal number of publications. applications for the 2010 Award for Excellence in practices while exploring ethical, legal, and social Human Research Protection. Individuals and issues for healthcare practitioners. For more The regulations apply to two key sections institutions conducting research involving human information, see: within all proposals and final reports: the beings or contributing to human research protection http://neuroethics.upenn.edu/index.php/events/clinic are eligible. Applications may be submitted for one al-conference. Contact: publication lists cited on an applicant’s or more of the award categories: best practice, [email protected] curriculum vitae, and the references to innovation, life-time achievement. Contact: [email protected]. Visit: http://www.hii.org/ Spring 2010 Professional Ethics Report 8