Bioethics Journal Club: Religious Belief and Surrogate Decision Making

Please join us for the next meeting of the Bioethics Journal Club on Thursday, November 12th from 4:00-4:45pm at the IU Center for Bioethics, 410 W 10th Street, Suite 3100, Indianapolis, IN.

The Bioethics Journal Club meeting will be an informal discussion led by Meg Gaffney, MD.  Dr. Gaffney is a Faculty Investigator at the Indiana University Center for Bioethics and Clinical Associate Professor in the Department of Medicine.  In addition, she is the director of the Introduction to Clinical Medicine Course and of the Moral Reasoning and Ethical Judgment competency in the revised curriculum of the Indiana University School of Medicine. Dr. Gaffney also chairs the Wishard Ethics Committee, serves on the Clarian and Riley Hospital ethics committees, and collaborates on the Indiana University Conscience Project.  She will facilitate a discussion on an article entitled “Religious Belief and Surrogate Medical Decision Making.”

Light refreshments will also be provided. Contact Maureen Craney at mocraney@iupui.edu for more information.

Center News, October 2009

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. Visit Sound Medicine for more information.

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

- J.O.

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.

Other Research Ethics News

Ju-min Park. Disgraced cloning scientist Hwang Woo-suk guilty of embezzlement. Los Angeles Times. October 27, 2009.

Related:

Mark Henderson. Hwang Woo-suk’s cloning fraud has not set back stem cell research. Times Online. October 27, 2009.

David Cyranoski. Woo Suk Hwang convicted, but not of fraud. Nature News. October 26, 2009.

Stacy Battenberg. Group receives ethics research grant to protect human subjects. The Minnesota Daily. October 26, 2009.

Julie Steenhuysen. Risks to personalized medicine seen in U.S. reform. Reuters. October 26, 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.

Simon Baron-Cohen. Studying autism genetics responsibly. BioNews. October 5, 2009.

- J. O.

Virtue Ethics for CBPR? Research Ethics in the Academic Literature

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. In other words, which comes first, the ethics or the eggs?

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.

Other Recent Research Ethics Articles (October 2009)

- J.O.

OHRP, Columbia and Hetastarch: Research Ethics in the News

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). Assuming that Columbia will comply with this request, what will these patients do now?

Other Research Ethics News

John Schmid. UW calls proposal to change patent law ‘reckless’. Milwaukee Journal Sentinel. October 9, 2009.

Meg Tirrell. Doctors Fail to Report $12 Million in Industry Fees at Meeting. Bloomberg.com. October 7, 2009.

Chris Kaposy. The H1N1 Vaccine and Pregnant Women. Bioethics Forum. October 6, 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.

Michael Rugnetta. Collins Reports to Colbert. Science Progress. October 2, 2009.

Shelley Wood. New “principles” on authorship and COI from PhRMA get mixed response. TheHeart.org. October 2, 2009.

- J.O.

Comparative Effectiveness: Humanities Initiative Grant Awarded to the Center for Bioethics

The Indiana University Center for Bioethics (IUCB) has recently been awarded a $1,300 Humanities Initiative Grant for a new Comparative Effectiveness (CE) project. The official title of the project is, “Ethical and Social issues in Comparative Effectiveness Research: How the Humanities can Contribute to the Developing National Conversation about Research Reform.” It is Co-sponsored with IU School of Liberal Arts, Department of Philosophy and the IU-School of Law Indianapolis, Hall Center for Law and Health and works closely with the School of Public and Environmental Affairs, Center for Health Policy.

Current discussion of healthcare reform emphasizes the importance of determining what drugs, treatments, and procedures work best, in order to improve healthcare and control spending. However, carrying out CE research and healthcare raises crucial ethical, legal, and social issues. Measuring “effectiveness” requires quantifying and comparing diseases, disabilities, and suffering, which raises profound moral questions about how society should make these assessments and then utilize them. The technical aspect of CE assessment can be done by mathematicians, statisticians, and economists. However, the corresponding ethical, legal, and social issues can only be addressed through conversations amongst the humanities and social sciences.

The need to conduct comparative effectiveness research and use it as a cornerstone in healthcare reform stems from recognition that healthcare in the United States excessively adopts forms of testing and treatment that are expensive and ineffective. CE can involve complex questions and tradeoffs. In many cases the most effective treatment is also the most expensive, leading to questions about when an increase in effectiveness is worth an increase in cost. For instance, an extremely expensive drug for treating cancer may cost hundreds of thousands of dollars per patient but extend life by only a few months. When insurance companies cover such treatments the costs rise and more people go without health insurance. The uninsured and under-insured then forgo treatments that are most effective and inexpensive. Instead, they end up in the emergency room much sicker than they would have been and requiring much more expensive care. As health care costs keep rising there is a need to know what we have to show for it.

The IUCB collaborative project comprises of two substantial efforts. It will host at least two public lectures by prominent humanities experts focusing on the ethical, legal, and social issues raised by comparative effectiveness research. It will also convene a year-long Comparative Effectiveness Study Group (CESG) from September 2009 – May 2010. CESG will read the most important literature on the ethical, legal, and social issues raised by CE research. The goals of both projects are to produce academic publications. Contribute to informed policy development within the state, and provide the public with additional knowledge to aid in their own deliberations on these issues. Experts from different areas of the humanities will provide leadership including: Eric Meslin PhD (Philosophy, IUCB), Peter Schwartz MD, PhD (Philosophy, IUCB), Eleanor Kinney, JD (Law School), Ralph Hall JD (Law School), Jason Eberl PhD (Philosophy), and Eric Wright PhD, (Health Policy, SPEA).

Center News, September 2009

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.

Events

Be sure to attend ethics events hosted by our friends and partners.

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.]

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

J.O.

Peer Review: Research Ethics in the News

Earlier this month, The Sixth International Congress on Peer Review and Biomedical Publication (PRC) met in Vancouver. Sessions and posters addressed a number of research ethics issues, including: ghost writing, ethical and editorial standards, conflicts of interest, bias and “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–that’s “Case Study Publications for Peer Review” (the allusion to Casper the ghost is defended as a “whimsical” choice). The president of Chadds Ford, the involved writing company, also notes: “At that time, around 2000, there were no negative ethical implications associated with the term ghostwriter.” For additional reading, the topic of ghost writing was also covered in an earlier post at this blog; also see the ongoing attention to the issue by Stuart Laidlaw of the Toronto Star on his Medical Ethics blog: Ghostwriting.

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.

Other Research Ethics News

Jocelyn Kaiser. To help young scientists, NIH bends quality rules. ScienceInsider. September 22, 2009.

Nancy Walton. Moving Ethics Review Out of the institution: Are We Throwing Caution to the Wind? The Research Ethics Blog. September 22, 2009.

NIH Opens Website for Human Embryonic Stem Cell Lines for Approval and Announces Members of Working Group. NIH News. September 21, 2009.

Michael B. Blank, Patrick S. Sullivan and Paul A. Lombardo. When Less Paperwork Means No Science: The Paperwork Reduction Act and Unintended Consequences for Public Health Research. Science Progress. September 21, 2009.

New Program in International Research Ethics Commences at IUPUI. Indiana University School of Medicine. September 17, 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.

Kevin B. O’Reilly. Outsourcing clinical trials: Is it ethical to take drug studies abroad? AMNews. September 7, 2009.

- J.O.

Syphilis, Lead Paint and the IRB: Research Ethics in the Academic Literature

Many of the current human subject protections were formed with the disastrous consequences of the well-known Tuskegee Syphilis Study in mind. While we all hope that these rules have made the practice of human subjects research safer, they cannot prevent future disasters without the reliable performance of the individuals and organizations. The Kennedy Krieger Institute Lead-Based Paint Study (KKI), in which researchers measured the blood lead levels of children living in homes that received differing methods of lead abatement, for example, became a public scandal and legal disaster many years after Tuskegee, even though the study was reviewed by institutional review boards (IRBs). Will IRBs fail to stop similar studies in the future? What can institutions do to decrease the likelihood of seeing another Tuskegee or KKI debacle in the future?

To begin to answer these questions, 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 point to the KKI 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.”

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:

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

Other Recent Research Ethics Articles (September 2009)

– J. O.

NSF Requires Ethics Education: Research Ethics in the News

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 existing and recently NSF funded ethics education resources, including:

• Ethics Education in Science and Engineering (EESE)

• National Digital Library for Ethics in Science & Engineering

• Online Ethics Center

Also see a report detailing the results of an NSF workshop on ethics education is 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

Other Research Ethics News

Roger Collier. Prevalence of ghostwriting spurs calls for transparency. CMAJ. September 9, 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.

Katherine Harmon. Should Doctors Disclose Conflicts of Interest to Trial Patients? Scientific American. August 27, 2009.

- J.O.