Bioethics and Subject Advocacy Program, Indiana CTSI
Indiana University Center for Bioethics
410 W 10th Street, Suite 3100
Indianapolis, IN 46202
Tel: 317-278-4034 | Fax: 317-278-4050
Contents
Local News and Announcements
This month Indiana University Center for Bioethics worked with its collaborators to launch two new initiatives: an International Research Ethics concentration (a new track in the Masters degree offered by the Department of Philosophy) and the Comparative Effectiveness Study Group. The International Research Ethics (IRE) concentration offers students and professionals the opportunity to study the ethical and policy issues of research involving multinational populations and partners. Read the press release or learn more about this new educational opportunity on our website at bioethics.iu.edu/irema.
The Comparative Effectiveness Study Group (CESG) was recently funded by the Indiana Humanities Council to provide two public lectures. The CESG is comprised of experts from The Center for Health Policy, The Hall Center for Law and Health, the Center for Bioethics, and other friends of the Consortium for Health Policy, Law and Bioethics. The Group will examine the ethical, legal and policy issues of comparative effectiveness research.
IUCB in the News
Quoted in the The Salt Lake Tribune, IUCB faculty investigator, Katherine Drabiak-Syed commented on a gene-patenting lawsuit against Myriad Genetics.
Upcoming Events
Lucia D. Wocial, RN, PhD. Checking the Vital Signs of Clarian Nurses: Where are we with Moral Distress? Fairbanks Ethics Lecture Series. October 7, 2009. 12:00-1:00 PM. Riley Out-Patient Center Auditorium. [View the entire 2009-2010 Schedule.]
Jason Eberl, PhD. Discussing: Buchanan A. Human nature and enhancement. Bioethics. 2009 Mar;23(3):141-50. Bioethics Journal Club. October 8, 2009. 4:00-4:45 PM. IUCB, HITS 3139.
Rob Kunzman. Write These Laws On Your Children. Poynter Center Roundtable. October 8, 2009. 4:00-5:30 PM. Poynter Center for the Study of Ethics and American Institutions, 618 East Third Street, Bloomington IN 47405-3862. [Poynter Center Roundtables, Fall 2009]
Guo Liping, Associate Director, Medical Humanities Institute, Peking University Health Science Center . Medical Humanities in China. October 19, 2009, 12:00 – 1:00 PM. CA Room 438. [View the entire 2009-2010 schedule – PDF 38 KB.]
Robert Crouch. Medical Interventions on Children for Nonmedical Reasons: How Far May Parents Go? Health Care Ethics Seminars. October 22, 2009. 4:00-5:15 PM. Poynter Center for the Study of Ethics and American Institutions, 618 East Third Street, Bloomington IN 47405-3862. [View the Health Care Ethics Seminars, Fall 2009 schedule.]
Robert Katz. The Tissue Transplantation Industry: A Case Study in How Market Actors Can Reduce Transaction Costs by Economizing on Moral Externalities. October 26, 2009. 3:00-4:00 PM; IUCB, HITS 3139. [View PredictER's Fall 2009 Schedule; PDF - 59 KB.]
Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010
PredictER Meetings, Fall Schedule 2009
Poynter Center for the Study of Ethics and American Institutions, Fall 2009 Events
New Items in the Bioethics Digital Library
Schwartz PH. Decision and discovery in defining ‘disease’. In: Kincaid H, McKitrick J, editors. Establishing medical reality: essays in the metaphysics and epistemology of biomedical science. Dordrecht: Springer; 2007. p. 47-63. http://hdl.handle.net/1805/1944
Schwartz PH. Defining dysfunction: natural selection, design, and drawing a line. Philosophy of Science. July 2007;74(3):364-385. http://hdl.handle.net/1805/1943
Schwartz PH, Meslin EM. The ethics of information: absolute risk reduction and patient understanding of screening. J Gen Intern Med. 2008 Jun;23(6):867-70. http://hdl.handle.net/1805/1942
Schwartz PH. Disclosure and rationality: comparative risk information and decision-making about prevention. Theor Med Bioeth. 2009;30(3):199-213. http://hdl.handle.net/1805/1935
Research Ethics in the News
Peer Review
The Sixth International Congress on Peer Review and Biomedical Publication (PRC) met in Vancouver, September 10-12, 2009. Sessions and posters addressed a number of research ethics issues, including: ghost writing, ethical and editorial standards, conflicts of interest, bias or “spin”, clinical trials registration, and quality reporting. Of these, the topic of ghost writing in medicine, continues to make headlines. The New York Times reports the results of a study published in JAMA (this research was also presented at PRC; see MedPage Today). The Guardian reports that a British doctor faces disciplinary action for his role in “writing”. The Chronicle of Higher Education pursues a different angle and covers the cost (to journals) of fighting industry support. The Philadelphia Inquirer covers a Paxil suit and the GlaxoSmithKline (GSK) project CASPPER (Case Study Publications for Peer Review).
Other PRC related topics were also widely reported this month, including: registering clinical trials in The New York Times, Nature News [subscription required], and Science Progress; conflicts of interest in AMNews; ScienceNews reports that reviewers do not get better with practice; and Chris Lee at Ars Technica reflects on the results of a new survey from the Publishing Research Consortium.
- Ghostwriting and the Pharmaceutical Industry. Research Ethics News Digest. Indiana University Center for Bioethics. August 2009.
- Stuart Laidlaw. Ghostwriting. Medical Ethics blog, The Toronto Star. http://thestar.blogs.com/ethics/ghostwriting/
Related:
NSF Requires Ethics Education
The National Science Foundation (NSF) will require all institutions applying for funding to provide ethics education for grantees. The new requirement, reported in the Federal Register [August 20, 2009 (Volume 74, Number 160), 42126-42128], will go into effect on January 4, 2010. At that time, grant proposals to NSF must describe “a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.”
Bob Grant at The Scientist acquired comments from John Galland and John Dahlberg (from the Office of Research Integrity) on the news. Galland pointed to the difference between the NSF and the NIH approach to encouraging the responsible conduct of research. Both Galland and Dahlberg see research ethics education as a wise investment, but Dahlberg cautions, “There are still going to be bad actors.”
During the public comment period the new guidelines received 188 comments, many of these included concerns about training guidance and access to online resources. In response, the NSF points to its funded ethics education resources, including:
Also see a report detailing the results of an NSF workshop on ethics education available from the National Academy of Engineering:
National Academy of Engineering (NAE). Ethics Education and Scientific and Engineering Research: What’s Been Learned? What Should Be Done? Summary of a Workshop at the National Academies Keck Center, August 25–26, 2008. Available from: http://www.nae.edu/?ID=14646
More Research Ethics News
Drug trials outsourcing: clinical concerns. The Guardian. September 28, 2009.
Ben Harder. Should You Join a Research Study? 9 Tips for Volunteers in Clinical Trials. U.S. News & World Report. September 23, 2009.
NIH Opens Website for Human Embryonic Stem Cell Lines for Approval and Announces Members of Working Group. NIH News. September 21, 2009.
Sean Teehan. Monkeys suffered in lab, suit says. The Boston Globe. September 17, 2009.
Bob Grant. More regulatory science: FDA chief. The Scientist. September 17, 2009.
Gardiner Harris. Where cancer progress is rare, one man says no. The New York Times. September 15, 2009.
Laura Donnelly. Human tissue can be taken for human-animal embryo experiments without consent. Telegraph.co.uk. September 12, 2009.
Karen J. Maschke. Disputes over Research with Residual Newborn Screening Blood Specimens. Bioethics Forum. September 8, 2009.
Andrew Pollack. First Stem Cell Drug Fails 2 Late-Stage Clinical Trials. The New York Times. September 8, 2009.
Public Health Association (NZ). Maori team produce new ethical research guidelines. Scoop. September 3, 2009.
PredictER: Predictive Health Ethics Research
Data Sharing and Privacy
Roughly one year after the NIH and The Wellcome Trust restricted access to genome-wide association studies [see: Modifications to Genome-Wide Association Studies (GWAS) Data Access (NIH, August 28, 2008 - PDF)], data sharing is back in the news. ... Read more from PredictER Blog, September 22, 2009.
Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal
On August 21, 2009 the Department of Health and Human Services (HHS) issued “Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening” relating to storage and use of newborn blood spots (NBS). ... Read more from PredictER Blog, September 4, 2009.
Research Ethics in the Academic Literature
Syphilis, Lead Paint and the Instituional Review Board [IRB]
Barry Bozeman, Catherine Slade and Paul Hirsch in “Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board” propose studying the organizational behavior of IRBs. The authors assert that IRBs as organizational systems are functioning well with a large number of low-risk, routine decisions, but are more likely to fail when confronting idiosyncratic and novel decisions. The authors recall the history of the the well-known Tuskegee Syphilis Study and point to the more recent Kennedy Krieger Institute Lead-Based Paint Study (KKI) [PDF - 46.8 KB] case as an example and note: “There is no evidence that IRB procedures differed significantly in this case from hundreds of other instances, ones that drew less attention and escaped the wrath of the press and the public.” In other words, the day the KKI study was approved, the IRB was just doing its job, but (we know now) that clearly was not enough.
Before addressing these potential vulnerabilities in IRB decision making, the authors propose that IRBs themselves become the subject of future behavioral research studies. They propose three well-used methods: case studies, survey research, and experiments or simulations. While IRB members and the institutions they serve might resist studies of their decision making behavior, the authors remind us: “There is no reason to assume that IRB processes should prove a more intractable learning environment than, say, corporate board rooms, air control towers, space centers, or war rooms.”
- Bozeman B, Hirsch P. Science ethics as a bureaucratic problem: IRBs, rules, and failures of control. Policy Sci. 2006; 38:269–291. doi:10.1007/s11077-006-9010-y
- Buchanan DR, Miller FG. Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions. Am J Public Health. 2006 May;96(5):781-7. PMID: 16571697
- Candilis PJ, Lidz CW, Arnold RM. The need to understand IRB deliberations. IRB. 2006 Jan-Feb;28(1):1-5. PMID: 16680872
Reference:
Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health. 2009 Sep;99(9):1549-56. PMID: 19608947
Related:
Research Ethics Bibliography, September 2009
Hoglund AT, Helgesson G, Eriksson S. Ethical Dilemmas and Ethical Competence in the Daily Work of Research Nurses. Health Care Anal 2009 Sep 25. PMID: 19779975
Knowles RL, Bull C, Wren C, Dezateux C. Ethics, governance and consent in the UK: implications for research into the longer-term outcomes of congenital heart defects. Arch Dis Child 2009 Sep 21. PMID: 19773220
Bueno M, Brevidelli MM, Cocarelli T, dos Santos GM, Ferraz MA, Mion D, Jr. Reasons for resubmission of research projects to the research ethics committee of a university hospital in Sao Paulo, Brazil. Clinics (Sao Paulo) 2009;64(9):831-6. PMID: 19759875
Saginur R. Research ethics and infection control. Clin Infect Dis 2009 Oct 15;49(8):1254-8. PMID: 19757994
Schmaling KB, Blume AW. Ethics instruction increases graduate students' responsible conduct of research knowledge but not moral reasoning. Account Res 2009;16(5):268-83. PMID: 19757232
Miller VA, Reynolds WW, Ittenbach RF, Luce MF, Beauchamp TL, Nelson RM. Challenges in measuring a new construct: perception of voluntariness for research and treatment decision making. J Empir Res Hum Res Ethics 2009 Sep;4(3):21-31. PMID: 19754231
Jones DA, MacKellar C. Consent for biobank tissue in somatic-cell nuclear transfer. Lancet 2009 Sep 12;374(9693):861-3. PMID: 19748385
Johnson CA, Toms AP. The impact of European research ethics legislation on UK radiology research activity: a bibliometric analysis. Clin Radiol 2009 Oct;64(10):983-7. PMID: 19748003
Kidd TJ, Marks GB, Bye PT, Wainwright CE, Robinson PJ, Rose BR, Harbour C, Bell SC, INVESTIGATORS AC. Multi-centre research in Australia: analysis of a recent National Health and Medical Research Council-funded project. Respirology 2009 Sep;14(7):1051-5. PMID: 19740265
Rabins P, Appleby BS, Brandt J, DeLong MR, Dunn LB, Gabriels L, Greenberg BD, Haber SN, Holtzheimer PE, 3rd, Mari Z, Mayberg HS, McCann E, Mink SP, Rasmussen S, Schlaepfer TE, Vawter DE, Vitek JL, Walkup J, Mathews DJ. Scientific and ethical issues related to deep brain stimulation for disorders of mood, behavior, and thought. Arch Gen Psychiatry 2009 Sep;66(9):931-7. PMID: 19736349
Angell E, Tarrant C, Dixon-Woods M. Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees? J Clin Pathol 2009 Sep;62(9):825-9. PMID: 19734481
Fassassi S, Bianchi Y, Stiefel F, Waeber G. Assessment of the capacity to consent to treatment in patients admitted to acute medical wards. BMC Med Ethics 2009;10:15. PMID: 19725954
Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009 Sep 2;302(9):977-84. PMID: 19724045
Rothstein MA. Currents in contemporary ethics. J Law Med Ethics 2009 Fall;37(3):507-12. PMID: 19723261
Kowalski CJ, Hewett JL. Data and safety monitoring boards: some enduring questions. J Law Med Ethics 2009 Fall;37(3):496-506. PMID: 19723260
Fry-Revere S, Malmstrom DB. More regulation of industry-supported biomedical research: are we asking the right questions? J Law Med Ethics 2009 Fall;37(3):420-30. PMID: 19723253
Wynia M, Boren D. Better regulation of industry-sponsored clinical trials is long overdue. J Law Med Ethics 2009 Fall;37(3):410-9. PMID: 19723252
Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals. Mayo Clin Proc 2009 Sep;84(9):811-21. PMID: 19720779
Maedler-Kron C. Dispatch from the medical front: Miss Scarlett, in the laboratory, with the microscope. CMAJ 2009 Sep 1;181(5):E79. PMID: 19720696
Ashton CM, Wray NP, Jarman AF, Kolman JM, Wenner DM, Brody BA. Ethics and methods in surgical trials. J Med Ethics 2009 Sep;35(9):579-83. PMID: 19717699
Knapp P, Raynor DK, Silcock J, Parkinson B. Performance-based readability testing of participant materials for a phase I trial: TGN1412. J Med Ethics 2009 Sep;35(9):573-8. PMID: 19717698
Jayasinghe S. Contracts to devolve health services in fragile states and developing countries: do ethics matter? J Med Ethics 2009 Sep;35(9):552-7. PMID: 19717694
Kachuck NJ. Reframing the conflicts of interest debacle: academic medicine, the healing alliance and the physician's moral imperative. J Med Ethics 2009 Sep;35(9):526-7. PMID: 19717688
Weinfurt KP, Hall MA, King NM, Friedman JY, Schulman KA, Sugarman J. Disclosure of financial relationships to participants in clinical research. N Engl J Med 2009 Aug 27;361(9):916-21. PMID: 19710491
McNutt LA, Gordon EJ, Uuskula A. Informed recruitment in partner studies of HIV transmission: an ethical issue in couples research. BMC Med Ethics 2009;10:14. PMID: 19709442
Lema VM, Mbondo M, Kamau EM. Informed consent for clinical trials: a review. East Afr Med J 2009 Mar;86(3):133-42. PMID: 19702101
Tekola F, Bull S, Farsides B, Newport MJ, Adeyemo A, Rotimi CN, Davey G. Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. BMC Med Ethics 2009;10:13. PMID: 19698115
Meyers K. Financial conflicts and clinical research. IRB 2009 Jul-Aug;31(4):17. PMID: 19697540
Research and ethics in China. Lancet 2009 Aug 15;374(9689):502. PMID: 19683624
Rapoport A. Addressing ethical concerns regarding pediatric palliative care research. Arch Pediatr Adolesc Med 2009 Aug;163(8):688-91. PMID: 19652098
Treish IM. Clinical research law in Jordan. Dev World Bioeth 2009 Aug;9(2):97. PMID: 19645717
Robinson P. Evidence pyramids, rigour and ethics review of public health research. Aust N Z J Public Health 2009 Jun;33(3):203-4. PMID: 19630836
Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health 2009 Sep;99(9):1549-56. PMID: 19608947
Weston R, Brooks R, Gladman J, Senior K, Denley L, Silove D, Whyman N, Kickett M, Bryant R, Files J, Aboriginal Community Advisory C. Ethical research in partnership with an Indigenous community. Australas Psychiatry 2009 Aug;17 Suppl 1:S51-3. PMID: 19579107
Puri KS, Suresh KR, Gogtay NJ, Thatte UM. Declaration of Helsinki, 2008: implications for stakeholders in research. J Postgrad Med 2009 Apr-Jun;55(2):131-4. PMID: 19550060
Vasconcelos S, Leta J, Costa L, Pinto A, Sorenson MM. Discussing plagiarism in Latin American science. Brazilian researchers begin to address an ethical issue. EMBO Rep 2009 Jul;10(7):677-82. PMID: 19525923
Blasko G, Kardos G. Clinical research in Hungary. Infrastructure, organisation, legislation and framework. The situation in 2008. Therapie 2009 Jan-Feb;64(1):33-45. PMID: 19463251
Taylor PL. Retroactive ethics in rapidly developing scientific fields. Cell Stem Cell 2009 Jun 5;4(6):479-82. PMID: 19446517
Mertes H, Pennings G. Cross-border research on human embryonic stem cells: legal and ethical considerations. Stem Cell Rev Rep 2009 Mar;5(1):10-7. PMID: 19052926
Whetstine LM. Conducting research on the critically ill: an ethical perspective. Minerva Anestesiol 2009 Jul-Aug;75(7-8):443-6. PMID: 18987570
Cohen ER, O'Neill JM, Joffres M, Upshur RE, Mills E. Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials. Dev World Bioeth 2009 Aug;9(2):74-80. PMID: 18445072
Perrey C, Wassenaar D, Gilchrist S, Ivanoff B. Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Merieux. Dev World Bioeth 2009 Aug;9(2):88-96. PMID: 18312433
Paez R, Garcia De Alba JE. International research and just sharing of benefits in Mexico. Dev World Bioeth 2009 Aug;9(2):65-73. PMID: 18302542
This news digest is supported by NIH/NCRR Grant Number RR025761. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
To follow the news in "real time", to leave comments on stories, or to subscribe to RSS feeds, visit Indiana Bioethics. Many of the items in this news digest were previously published on the Indiana Bioethics blog, category REND.
Readers interested in the ethics of genetic research, genetic testing, and personalized medicine will want to visit PredictER Blog, a publication of the Indiana University Center for Bioethics Predictive Health Ethics Research (PredictER) program.
Editor: Jere Odell
