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
Activities
The Center's Dr. Meg Gaffney and her husband and teaching partner, Dr. Matthew Galvin, recently began a 6 week seminar series on Understanding Conscience in Ethics and Faith Experience at Trinity Episcopal Church in Indianapolis. The short course is offered for all persons at Trinity Church who are interested in conscience development and functioning, and especially those who have the opportunity to shape the development of conscience in young people. During the course participants will engage in conscience sensitive tasks, explore the essential domains of conscience, learn about connections between psychology and values, appreciate change and diversity in the contours of conscience across a lifespan, recognize moral dilemmas and identify strategies for resolving them, and, with the help of clergy, discuss conscience in the context of faith.
Faculty Investigator, Dr. Peter Schwartz will contribute to a panel discussion entitled "The Policy Path for Comparative Effectiveness" at the Indiana Life Sciences Collaboration Conferences Series, Comparative Effectiveness: The Dollars and Sense (November 13, 2009).
Sound Ethics
Eric M. Meslin, Ph.D., director of the IU Center for Bioethics and Daniel Callahan, Ph.D., senior research scholar and President Emeritus of the Hastings Center, will discuss Callahan's new book, Taming the Beloved Beast: Why Medical Technology Costs are Destroying Our Health Care System. Learn more about Sound Medicine or listen to the show at: Sound Medicine, November 1, 2009.
Publication
The MIT Press has published a new book in its Basic Bioethics series which includes a chapter by Eric M. Meslin, "Can national bioethics commissions be progressive? should they?". See: Moreno JD, Berger S. Progress in bioethics: science, policy, and politics. Cambridge, MA, MIT Press, 2010.
New Items in the Bioethics Digital Library
Survey Research Center at IUPUI. Public attitudes regarding genetic research: survey methods and findings. Indianapolis: Indiana University-Purdue University, Indianapolis. April 2009. http://hdl.handle.net/1805/1959
Schwartz PH. The value of information and the ethics of personal-genomic screening. Am J Bioeth. 2009 Apr;9(4):26-7. http://hdl.handle.net/1805/1962
Gaffney MH. Strange bedfellows: torture and medical professionals. [Presentation]. May 28, 2008. http://hdl.handle.net/1805/1960
Upcoming Events
Melissa Cavaghan, MD; Alexia M. Torke, MD, MS,; Lucia D. Wocial, RN, PhD. Clinical & Ethical Aspects of Caring for Transgendered Persons. Fairbanks Ethics Lecture Series. November 4, 2009. 12:00-1:00 PM, Methodist Petticrew Auditorium.
Susan Lederer. The Politics of Pounds and Ounces: How Obesity Became a Public Health Issue. November 12, 2009, 12:00 - 1:00, Medical Science Building, Room 311 A/B.
Richard Gregory and William Schneider. "Temples of the Future: Laboratories of the 19th Century" A viewing and discussion of "Dr. Ehrlich's Magic Bullet" (1940), Spirit & Place Festival. November 13, 2009. 7:00-9:30 p.m., Indiana Medical History Museum Amphitheater, 3045 W. Vermont Street. Registration is required at www.imhm.org.
Peter Schwartz. "Using Numbers to Change Minds: Using 'Personalized' Risk and Benefit Data to Influence Decision Making in Medicine". November 16, 2009. 2:00-3:00, Indiana University Center for Bioethics.
Eleanor Kinney, "Professional Profiteering in Failed Health Care Services Markets". November 19, 2009. Health Care Ethics Seminars, Poynter Center for the Study of Ethics and American Institutions,618 East Third Street, Bloomington IN.
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
Purdue Bioethics Seminar Series, Schedule 2009 - 2010
Research Ethics in the News
Not Reporting Harm: CONSORT and Clinical Trials
In 2004 an extension to Consolidated Standards of Reporting Trials (CONSORT) to aid in the reporting of adverse events was published (see: Ioannidis JP. PubMed PMID: 15545678), but did it work? Are the studies published in leading medical journals doing a better job of reporting negative "side effects" in clinical trials? Not according to a new review published in the Archives of Internal Medicine.
In "Reporting of Safety Results in Published Reports of Randomized Controlled Trials," Isabelle Pitrou and her co-authors conclude "that despite the publication of a CONSORT statement extension for harm-related data, the reporting of harm remains inadequate." Not only did 18% of studies fail to provide numerical data about adverse events in each trial arm, but 27% did not include information about the severity of events while 47% failed to report adverse event related patient withdrawals from the trials.
In a related editorial, John P.A. Ioannidis laments the ongoing "plague" of poor reporting of adverse events in randomized trials. In addition to faulty study design and professional neglect, he also cautions against restricted reporting, intentional distortion of results (in the literature and the media), and even (in some conflicts of interest cases) the "orchestrated silencing of the evidence."
References:
Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169(19):1756-1761. PubMed PMID: 19858432
Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009;169(19):1737-1739. PubMed PMID: 19858427
Related:
The CONSORT Group - http://www.consort-statement.org/
John Gever. Spotty Reporting of Adverse Events Noted in Big-Name Journals. MedPage Today. October 26, 2009.
Karen Kaplan. What researchers don't want you to know about their clinical trials. Los Angeles Times. October 26, 2009.
OHRP, Columbia and Hetastarch
Jeanne Lenzer and Shannon Brownlee, in investigative coverage published by the Huffington Post, report that the Office of Human Research Protections have requested Columbia University to notify research subjects that they may "have suffered harms that were a function of the design and procedures of [a] study" conducted a decade ago. According to the Huffington Post, some of the patients in a study ("Effect of different intravenous fluids on thromboelastography during cardiac surgery") had adverse reactions to a blood-expanding solution (a potential substitute for blood transfusion) which contained hetastarch. Some patients, in the study partially funded by Abbott Laboratories, suffered from excess bleeding during surgery and at least two patients died.
Howard Brody at Hooked: Ethics, Medicine, and Pharma observes that this case has been "tossed around since 1999″ and that it "defies a quick summation." Lenzer and Brownlee, however, do a good job of digging up key documents and of telling a story obscured by past (and future?) lawsuits. Clearly the study was a nightmare for all involved: the PI (Elliott Bennett-Guerrero), the IRB at Columbia University College of Physicians and Surgeons, Abbott Laboratories, the surgeons, and (most importantly) the patients. One gets the impression from reading this story that no one wanted to harm patients and that, while all the parties involved were doing their jobs, they were trying to do too much-a member of the IRB lamented "[m]ost of us barely get to read the birthday cards from our kids . . ." and Bennett-Guerrero was "simultaneously running 25 clinical trials."
According to Lenzer and Brownlee, the OHRP's letter to Columbia (June 8, 2009) requires the institution to draft a letter explaining the study and the likelihood that patients who received hetastarch did worse than the others (including excess bleeding, decreased renal function, and an increased need for re-operation).
More Research Ethics News
Ju-min Park. Disgraced cloning scientist Hwang Woo-suk guilty of embezzlement. Los Angeles Times. October 27, 2009.
Duff Wilson. Research Uproar at a Cancer Clinic. The New York Times. October 22, 2009.
National Institutes of Health (NIH). Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data. NOT-HG-10-006. October 19, 2009.
David Armstrong. New Conflict Rules at Medical Journals. The Wall Street Journal. October 14, 2009.
A Clear Line on Stem Cells. The Washington Post. October 10, 2009.
John Schmid. UW calls proposal to change patent law 'reckless'. Milwaukee Journal Sentinel. October 9, 2009.
John Timmer. Anonymized genetic research data still carries privacy risks. Ars Technica. October 6, 2009.
IU Center receives NIH grant to improve privacy protection in medical research. IU News Room. October 5, 2009.
Ed Silverman. Out of sight. Portfolio.com. October 5, 2009.
Shelley Wood. New "principles" on authorship and COI from PhRMA get mixed response. TheHeart.org. October 2, 2009.
Research Ethics in the Academic Literature
Virtue Ethics for CBPR
Community-based participatory research (CBPR), by definition, includes communities as partners in the research process. Therefore, although individual research participants (also known as "human subjects") may be sufficiently protected, the barriers and risks of full community participation will also need to be addressed. Are the ethical principles of "autonomy," "nonmaleficence," "beneficence," and "justice" enough or do we need more than the principles-based approach of the Belmont Report to resolve the ethical issues in CBPR?
In "A virtue ethics guide to best practices for community-based participatory research", Marjorie A. Schaffer proposes the addition of a virtues approach to the ethics toolbox. A list of relevant virtues might vary depending on the context, but Schaffer chooses to focus on six: compassion, courage, honesty, humility, justice, and practical reasoning. For example, Schaffer observes: "The compassionate researcher will imagine what the research experience is like for community partners and participants." Likewise, the author advocates for humility because it can "guide the researcher to examine the inadequacies in their own understanding of community experiences and viewpoints as well as examine both knowledge and lack of knowledge in implementing the research process." Schaffer devotes the most attention to justice, which, among other things, "means including vulnerable and disadvantaged populations in one's research agenda, planning research that will benefit these groups (based on their input), and using research findings to contribute to improved social conditions."
In this paper, Schaffer provides a good overview (with plenty of references) of the value of the virtues to the practice of ethical research in the community. In addition, the table of "best practices" walks through the CBPR steps and marks the places in which the virtues can assist. It seems to me, however, that a few issues will need to be addressed before a virtue ethics approach can be widely recognized and explicitly employed in CBPR. First, how do we teach (Schaffer suggests mentoring) and systematize the virtues? Is it really possible? Second, which virtues do we chose and why? And finally, Schaffer notes that "virtue ethics supports a collaborative approach", but it might be more accurate to say that a collaborative approach requires or even instills the virtues in its practitioners.
Reference:
Schaffer MA. A virtue ethics guide to best practices for community-based participatory research. Progress in Community Health Partnerships: Research, Education, and Action. 2009 3(1), 83-90. DOI: 10.1353/cpr.0.0053
Related:
Frey WJ. Teaching virtue: pedagogical implications of moral psychology. Sci Eng Ethics. 2009 Sep 1. PMID: 19728163.
Holland S. The virtue ethics approach to bioethics. Bioethics. 2009 Aug 25. PMID: 19709078.
Shore N, Wong KA, Seifer SD, Grignon J, Gamble VN. Introduction to special issue: advancing the ethics of community-based participatory research. J Empir Res Hum Res Ethics. 2008 Jun;3(2):1-4. PMID: 19385741.
Research Ethics Bibliography, October 2009
Slomka J. Manufacturing Mistrust: Issues in the Controversy Regarding Foster Children in the Pediatric HIV/AIDS Clinical Trials. Sci Eng Ethics 2009 Oct 27. PMID: 19859829
Petrini C. "Broad" consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med 2009 Oct 21. PMID: 19853341
Kaiser K. Protecting respondent confidentiality in qualitative research. Qual Health Res 2009 Nov;19(11):1632-41. PMID: 19843971
Gillam L, Guillemin M, Bolitho A, Rosenthal D. Human research ethics in practice: deliberative strategies, processes and perceptions. Monash Bioeth Rev 2009 Mar;28(1):7 1-17. PMID: 19839277
Petersen A. The ethics of expectations: Biobanks and the promise of personalised medicine. Monash Bioeth Rev 2009 Mar;28(1):5 1-12. PMID: 19839276
Zeng W, Resnik D. Research integrity in China: problems and prospects. Dev World Bioeth 2009 Oct 14. PMID: 19832885
Vallely A, Shagi C, Lees S, et al. Microbicides development programme: engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania. BMC Med Ethics 2009;10:17. PMID: 19814830
Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009 Oct 8;361(15):1466-74. PMID: 19812403
Massimo LM, Calcagno A, Battaglia T, Pistorio A. A project for the evaluation of awareness of under-aged patients involved in clinical trials. Development of the IGG- Awareness Scale. Minerva Pediatr 2009 Oct;61(5):483-8. PMID: 19794374
Nakkash R, Makhoul J, Afifi R. Obtaining informed consent: observations from community research with refugee and impoverished youth. J Med Ethics 2009 Oct;35(10):638-43. PMID: 19793946
Schumm WR, Nazarinia RR, Bosch KR. Unanswered questions and ethical issues concerning US biodefence research. J Med Ethics 2009 Oct;35(10):594-8. PMID: 19793937
Wassenaar DR, Ramjee G. A developing country response to Lavery et al. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?". BMC Med Ethics 2009;10:16. PMID: 19788765
Bovenberg J, Meulenkamp T, Smets E, Gevers S. Biobank research: reporting results to individual participants. Eur J Health Law 2009 Sep;16(3):229-47. PMID: 19788002
Saginur R. Research ethics and infection control. Clin Infect Dis 2009 Oct 15;49(8):1254-8. PMID: 19757994
Printz C. National Institutes of Health releases new guidelines for stem cell research. Cancer 2009 Sep 15;115(18):4043-4. PMID: 19731340
Tangwa GB. Research with vulnerable human beings. Acta Trop 2009 Nov;112 Suppl 1:S16-20. PMID: 19699174
Noor RA. Health research oversight in Africa. Acta Trop 2009 Nov;112 Suppl 1:S63-70. PMID: 19698692
Tekola F, Bull S, Farsides B, et al. 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
Smoyer AB, Blankenship KM, Belt B. Compensation for incarcerated research participants: diverse state policies suggest a new research agenda. Am J Public Health 2009 Oct;99(10):1746-52. PMID: 19696389
Resnik DB. Environmental health research and the observer's dilemma. Environ Health Perspect 2009 Aug;117(8):1191-4. PMID: 19672396
Barrett JR. Double protection: reaching accord on the ethical conduct of child observational research. Environ Health Perspect 2009 Aug;117(8):A354-7. PMID: 19672389
Nyika A. Ethical and practical challenges surrounding genetic and genomic research in developing countries. Acta Trop 2009 Nov;112 Suppl 1:S21-31. PMID: 19665983
Chilengi R. An ethics perspective on responsibilities of investigators, sponsors and research participants. Acta Trop 2009 Nov;112 Suppl 1:S53-62. PMID: 19665980
Tangwa GB. Ethical principles in health research and review process. Acta Trop 2009 Nov;112 Suppl 1:S2-7. PMID: 19665441
Taljaard M, Weijer C, Grimshaw JM, et al. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 2009;10:61. PMID: 19638233
Goldenberg AJ, Hull SC, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr 2009 Oct;155(4):578-83. PMID: 19595370
Yearley S. The ethical landscape: identifying the right way to think about the ethical and societal aspects of synthetic biology research and products. J R Soc Interface 2009 Aug 6;6 Suppl 4:S559-64. PMID: 19447816
Oprea L, Braunack-Mayer A, Gericke CA. Ethical issues in funding research and development of drugs for neglected tropical diseases. J Med Ethics 2009 May;35(5):310-4. PMID: 19407037
Tereskerz PM, Hamric AB, Guterbock TM, Moreno JD. Prevalence of industry support and its relationship to research integrity. Account Res 2009 Apr-Jun;16(2):78-105. PMID: 19353387
Krimsky S. Attitudes and behavior of privately-funded biomedical scientists. Account Res 2009 Apr-Jun;16(2):75-7. PMID: 19353386
Holubkov R, Dean JM, Berger J, et al. Is "rescue" therapy ethical in randomized controlled trials? Pediatr Crit Care Med 2009 Jul;10(4):431-8. PMID: 19307815
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
