Tag Archives: news

Eric M. Meslin Appointed to IOM Committee

Eric M. Meslin, Ph.D., Director of the IU Center for Bioethics and Associate Dean for Bioethics IUSM, has been appointed to the Institute of Medicine’s Committee on Drug Safety and Post-Marketing Requirements by IOM President Harvey Feinberg. The Committee has been asked by the FDA to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs. Questions to be explored by the committee include:

1. What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?
2. What are the strengths and weaknesses of various approaches, including observational studies, including patient registries, meta-analyses, including patient-level data meta-analyses, and randomized controlled trials, to generate evidence about safety questions?
3. Considering the speed, cost, and value of studies, what types of follow-up studies are appropriate to investigate different kinds of signals (detected pre-approval or post-marketing) and in what temporal order?
4. Under what circumstances should head-to-head randomized clinical trials for safety be required?
5. How should FDA factor in different kinds of safety evidence in considering different kinds of regulatory actions?

The Committee is charged with reporting its findings in March 2011. Complete information including the IOM Committee roster is available at: http://www.iom.edu/Activities/Quality/DrugSafetyPostMarket.aspx

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Obama Fills The Presidential Commision for the Study of Bioethical Issues: Research Ethics in the News

The White House announced the remaining members of the The Presidential Commission for the Study of Bioethical Issues on April 7, 2010 [press release – PDF]. The new members are:

Lonnie Ali, M.B.A
Anita L. Allen, J.D., Ph.D.
Barbara F. Atkinson, M.D.
Nita A. Farahany, J.D., Ph.D.
Alexander G. Garza, M.D.
Christine Grady, R.N., Ph.D.
Stephen L. Hauser, M.D.
Raju S. Kucherlapati, Ph.D.
Nelson Lee Michael, M.D., Ph.D.
Daniel Sulmasy, M.D., Ph.D.

President Obama appointed the Commission’s Chair (Amy Gutmann, Ph.D.) and Vice Chair (James W. Wagner, Ph.D.) in November 2009 (press release). According to Executive Order 13521 [PDF], the Commission’s members serve two year terms without compensation. The new Commission “works with the goal of identifying and promoting policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner.” Prior Presidents convened similar commissions. In 2001, President Bush created the President’s Council on Bioethics which replaced President Clinton’s National Bioethics Advisory Commission, created in 1996. A list of former commissions and their publications is provided on the Bioethics.gov website.

Related

Andrew Plemmons Pratt. Practical Science. Science Progress. April 8, 2010.
Jere Odell. Obama stops The President’s Council on Bioethics: Research Ethics in the News. Indiana Bioethics. June 24, 2009.

Other Research Ethics News

Robin Erb. In blood debate, new consent effort aims to open research doors. Detroit Free Press. April 8, 2010.

Lisbeth Fog. Tensions remain over biological access protocol. SciDevNet. April 2, 2010.

Ann E. Mills and Patti M. Tereskerz. The Uncertain Future of Gene Patents. Bioethics Forum. April 1, 2010.

Duff Wilson. Pfizer gives details on payments to doctors. The New York Times. March 31, 2010.

Donna Dickenson. Bioethics à la Française: the new French bioethics laws. BioNews. March 29, 2010.

Steve E. Nissen. Setting the RECORD Straight. JAMA. 2010;303(12):1194-1195.

Carla K. Johnson. Top US psychiatrist calls for ethics cleanup. [AP] Google News. March 23, 2010.

Gerd Antes. The new CONSORT statement. BMJ 2010;340:c1432. | doi:10.1136/bmj.c1432

Jocelyn Kaiser. Should NIH-Funded Researchers Be Required to Publicly Reveal Conflicts? ScienceInsider. March 16, 2010.

Jonathan D. Moreno. Red Tape Around Stem Cells? Science Progress. March 16, 2010.

— J.O.

Center News – Spring 2010

Teaching Skills in International Research Ethics (TaSkR) Workshop II
The Second TaSkR Workshop was successfully held February 3rd – 5th, 2010 in Nakuru, Kenya. This workshop was attended by 25 participants and faculty facilitators from both Moi University and Indiana University. The faculty facilitators were from various disciplines; medicine, reproductive health, public health, behavioral science, religious studies, medical education, anthropology, health services research, sociology, bioethics, and linguistics. TaSkR is a feature of the IU-Moi Academic Research Ethics Partnership (funded by grant from the NIH Fogarty International Center). Learn more about TaSkR on our website, at: http://www.bioethics.iu.edu/TaSkR.

International Research Ethics master’s program, Moi University Eldoret Kenya
In February 2010, the Senate of Moi University in Eldoret, Kenya approved a new master’s program in international research ethics. By design, the new program collaborates with a similar graduate level opportunity at IUPUI, the International Research Ethics, MA offered in the Philosophy department. The two programs are a feature of the IU-Moi Academic Research Ethics Partnership (funded by grant from the NIH Fogarty International Center). To learn more about this program, visit our website at: http://www.bioethics.iu.edu/arep.

Biobanks, Bioethics and Sophia University (Japan)
February 23, 2010, the Center for Bioethics hosted a delegation of 8 faculty from Japanese Universities led by Prof. Satoko Tatsui (Faculty of Law Meijigakuin University, Tokyo). The visit had three goals: to discuss ethics and governance on human biobanks and genetic databases in the US and Japan; the policy-making process in various circumstances; and the activities of the IUCB. The visit is a part of the preparatory work that this team is undertaking to establish a center for bioethics at Sophia University. We look forward to the future collaborations that will result from this successful, day-long visit.

Medical Ethics and Professionalism Elective
Indiana University School of Medicine students in their 3rd and 4th years have the option to enroll in a four week ethics elective. IUCB faculty investigator, Meg Gaffney leads this elective with participation from several of the Center’s investigators and affiliates. The most recent course (February 2010) included contributions from Eric M. Meslin, Peter Schwartz, and Kimberly Quaid. The Medical Ethics and Professionalism elective is offered annually in February. Enrollment is limited.

Students may also propose and develop an independent ethics elective or project at any time during the course of their medical studies.

IUCB in the News

Kristen Gerencher. Health reform a hot topic in bioethics circles. MarketWatch. March 19, 2010.
Office of External Affairs. Leadership forum reminds leaders of the power of diversity. Kelley School of Business [News], IUPUI. March 2, 2010.
Marilynn Marchione. AP IMPACT: Testing curbs some genetic diseases. 13 WTHR News. February 21, 2010.
Sound Ethics: How Biobanks Work. Sound Medicine. February 14, 2010.
Molecular Medicine Program Offers Hands-On Research for High School Students. IUPUI News Center. February 12, 2010.
Sound Ethics: Biobanks & Pediatric Research. Sound Medicine. February 7, 2010.

Recent Publications

Jere Odell. Peer-Driven Recruitment: Research Ethics in the Academic Literature. Indiana Bioethics. March 31, 2010.
Jere Odell. Comparative Effectiveness: Research Ethics in the News. Indiana Bioethics. March 15, 2010.
Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update. Indiana University Center for Bioethics. March 12, 2010.
Katherine Drabiak-Syed. Transparency of Texas’ NBS Transfer and Reassessing Evasive Statutory Interpretation. PredictER News. March 9, 2010.
Jere Odell. Newborn Blood Spots, Biobanks & the Law: Research Ethics in the News. Indiana Bioethics. February 26, 2010.
Eric M. Meslin. Bank On It. Science Progress. February 25, 2010.
Katherine Drabiak-Syed. Direct-to-Consumer Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection. PredictER News. February 2, 2010.
Research Ethics News Digest – January 2010. Indiana University Center for Bioethics. February 2, 2010.
Peter H. Schwartz. 2009 Walter C. Randall Lecture in Bioethics. Autonomy and consent in biobanks. Physiologist. 2010 Feb;53(1):1, 3-7.
Jere Odell. Autism, MMR, Wakefield and the GMC: Research Ethics in the News. Indiana Bioethics. January 29, 2010.

Recent Presentations

Kimberly A. Quaid. Diagnosis and Disclosure. 2010 Spring Symposium of the Indiana Alzheimer Center, Herron School of Art and Design, Indianapolis, IN. March 20, 2010.
Eric M. Meslin. The Evolution of Bioethics. Darwin Day Science Conference, Center for Inquiry Indiana and IUPUI Freethinkers. March 20, 2010.
Peter H. Schwartz. Mammograms, Decision-Making, and Values. Session: “Evidence in Breast Cancer Screening Decisions: Politics, Policy, and Patient Care,” Bioethics for Breakfast seminar series, Hall, Render, Killian, Heath & Lyman, P.C. and IU Center for Bioethics, Indianapolis, IN, March 5, 2010.
Eric M. Meslin. Science Policy Leadership in a (somewhat) Flat World: Why Bioethics Matters. Fifth Multi-Sector Forum of the Randall L. Tobias Center for Leadership Excellence, Indianapolis, Indiana. February 26, 2010.
Eric M. Meslin. The Underdeveloped Role of Science Policy in Meeting Our Ethical Obligations in Global Health. IU School of Medicine, February 17, 2010.
Katherine Drabiak-Syed. Panelist. Non-Traditional Health Law Careers. Indiana University School of Law- Indianapolis, Indianapolis, Indiana. February 16, 2010.
Kimberly A. Quaid. Ethical Issues in Genetic Testing. The Amelia Project: Giving Wings to Research, University Place Conference Center, Indianapolis, IN. February 13, 2010.
Katherine Drabiak-Syed. Baby Gender Mentor: Class Action Litigation Calls Attention to a Deficient Federal Regulatory Framework for DTC Genetic Tests, Politicized State Statutory Construction, and a Lack of Informed Consent. Predictive Health Ethics Research (PredictER) meeting, Indianapolis, Indiana. January 25, 2010.

Ethics Events

Peter H. Schwartz. Medicine unleashed: eliminating risk and stopping aging. Ethics at Lunch. IU School of Medicine. MS B26. 12:00 – 1:00 PM. April 6, 2010.
Physician Assisted Suicide? End-of-Life Care and Choices: A Discussion on Proposed Legal Changes. Presenters: Barbara Coombs Lee, PA, FNP, JD, and Katherine Drabiak-Syed, JD. Health Law Society. Indiana University School of Law – Indianapolis, Inlow Hall, RM 385. 4:15 PM. April 6, 2010.
Fairbanks Ethics Lecture Series: Ethical Treatment of the Defiant and Disruptive Patient. Michael Webber, MD. Riley Outpatient Center Auditorium, Indiana University School of Medicine, Indianapolis. 12:00-1:00 PM. April 7, 2010.
Seminar in Medical Humanities: The History of Rh Sensitization Disease and Its ‘Cure’. Dr. Peter Marcus, Ob/Gyn. Indiana University School of Medicine, Indianapolis. MS 311A/B.  12:00 – 1:00 PM. April 8, 2010.
Indiana CTSI 2nd Annual Meeting: A Case for Good Governance: Consent, Public trust, Commercialization and other issues for Biobanks. Timothy Caulfield, LL.M. Indiana University School of Medicine, Indianapolis. Health Information and Translational Sciences (HITS) Building. 1:00 – 1:30 PM. April 19, 2010.
Seminar in Medical Humanities: Modeling Life Through Death: Population Histories and the Evidence for Demographic and Epidemiological Change in the Late Prehistoric Midwest. Jeremy Wilson. IUPUI. Room TBA. 12:00 – 1:00 PM. April 19, 2010.
PredictER Meeting: Tailored Therapeutics. Mitchell Klopfenstien and colleagues from Eli Lilly. IU Center for Bioethics, Indianapolis. 3:00 – 4:00 PM. April 26, 2010.
Peter H. Schwartz. Panel discussion of breast cancer screening guidelines. The 2010 Doris H. Merritt, MD Lectureship in Women’s Health, IU National Center of Excellence in Women’s Health. Joseph Walter Hall (R3) Room 203. Indianapolis. 8:15 – 10:30 AM. April 28, 2010.
Fairbanks Ethics Lecture Series: Cultural Diversity/Cultural Sensitivity. Rita Bair, MD, MPH . Indiana University School of Medicine. Riley Outpatient Center Auditorium. Indianapolis. 12:00-1:00 PM. May 5, 2010.

Other Events

Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010 [PDF]
Poynter Center for the Study of Ethics and American Institutions, Spring 2010
PredictER Meetings, Spring Schedule 2010 [PDF]
Purdue Bioethics Seminar Series, Schedule 2009 – 2010

Center News, January 2010

Norman Daniels: Comparative Effectiveness Research
Norman Daniels, the Mary B. Saltonstall Professor and Professor of Ethics and Population Health at Harvard School of Public Health, will lecture on the ethical issues of comparative effectiveness research in health care. The lecture will be held on February 10, 2010 from 12:00 pm to 1:00 pm [CANCELED, BAD WEATHER] in room 1110 of the HITS Building. Read more at: http://bioethics.iu.edu/body.cfm?id=14#daniels

Teaching Skills in International Research Ethics
The second, annual workshop, Teaching Skills in International Research Ethics (TaSkR) will be held in Nakuru, Kenya, February 3-5, 2010. TaSkR is a feature to the Indiana University-Moi University Academic Research Ethics Partnership. To learn more about this program, visit our website at: http://bioethics.iu.edu/arep

Pandemic Influenza Ethics Toolkit
The Indiana State Department of Health (ISDH) and the Indiana University Center for Bioethics have collaborated on an ethics toolkit to support the ethical practice of health care during an influenza pandemic. The publication, Ethics Toolkit for Health Care Practitioners Working under Conditions of an Influenza Pandemic, includes: an “Ethics Guide” (a large version and a pocket version), a one-page patient guide, and a DVD, all contained in a plastic clamshell case. Read more and download copies of the Toolkit at: http://bioethics.iu.edu/PandemicToolkit

PredictER Meetings
On January 25, 2010 Katherine Drabiak-Syed will present “Baby gender mentor: class action litigation calls attention to a deficient federal regulatory framework for DTC genetic tests, politicized state statutory construction, and a lack of informed consent”. For more information and future PredictER meetings, download a copy of the schedule: http://bioethics.iu.edu/documents/PredictERSpring2010.pdf

David Haas and Becky Ross presented “Building Blocks of Pregnancy Biobank and Neonatal Biobank: Update”, December 7, 2009.

Peter H. Schwartz presented “Using Numbers to Change Minds: Using ‘Personalized’ Risk and Benefit Data to Influence Decision Making in Medicine”, November 16, 2009.

Journal Club
On January 14, 2010, Katherine Drabiak-Syed presented “Revisiting the USPTO’s examination guidelines for gene patents: congressional inaction, USPTO restraint, and judicial remedy”. For information about future Bioethics Journal Club events (Spring 2010), please contact Maureen Craney at: mocraney@iupui.edu

Margaret Gaffney, November 12, 2009, facilitated a discussion on an article entitled “Religious Belief and Surrogate Medical Decision Making”.

Recent Publications

Katherine Drabiak-Syed. Revisiting the USPTO’s examination guidelines for gene patents: congressional inaction, USPTO restraint, and judicial remedy. Journal of International Biotechnology Law. 2009 Sep;6(5):204–5. DOI: 10.1515/JIBL.2009.27
Katherine Drabiak-Syed. Commercialization and gene patenting. PredictER Law and Policy Update. Indiana University Center for Bioethics. December 11, 2009.
Katherine Drabiak-Syed. Direct-to-consumer genetic testing. PredictER Law and Policy Update. Indiana University Center for Bioethics. December 11, 2009.
Katherine Drabiak-Syed. Minnesota judge’s dismissal of newborn blood spot case misses the mark. Predictive Health Ethics Research News. December 14, 2009.
Katherine Drabiak-Syed. Lawsuit challenging Myriad’s BRCA1 and BRCA2 patents will go forward: judge rejects defendants’ attempts to preclude plaintiffs’ day in court. Predictive Health Ethics Research News. November 25, 2009.
Katherine Drabiak-Syed. Newborn blood spot litigation continues in Minnesota and Texas. Predictive Health Ethics Research News. November 20, 2009.
Eric M. Meslin. The areas of our expertise: why we can’t separate science and ethics. Science Progress. 2009 Dec 18.
Eric M. Meslin. Can national bioethics commissions be progressive? Should they? In Moreno JD, Berger S, Editors. Progress in bioethics: science, policy and politics. Cambridge, MA: MIT Press; 2010. p. 143.
Jere Odell. Conflicts of Interest: Research Ethics in the News. Indiana Bioethics. January 15, 2010.
Jere Odell. In the Literature: Altruism, the Self and Genetic Research. PredictER Blog. January 13, 2010.
Jere Odell. Another Look at Stateville Penitentiary: Research Ethics in the Academic Literature. Indiana Bioethics. January 6, 2010.
Jere Odell. Forty Human Embryonic Stem Cell Lines in 2009. Indiana Bioethics. December 31, 2009.
Kimberly A. Quaid. Presymptomatic genetic testing in children. In Miller G, editor. Pediatric bioethics. New York: Cambridge University Press; 2009. p. 125-40.
Peter H. Schwartz. Autonomy and consent in biobanks. The Physiologist. 2010 Feb;53(1):1-7.

Recent Presentations

Katherine Drabiak-Syed. Baby gender mentor: class action litigation calls attention to a deficient federal regulatory framework for DTC genetic tests, politicized state statutory construction, and a lack of informed consent. Presented at The Poynter Center for the Study of Ethics and American Institutions; 2009 Dec 10; Bloomington, IN.
Eric M. Meslin. What’s ethics got to do with genetics? [The secret teacher version]. Presented at: Molecular Medicine in Action for Teaching Professionals. Indiana University School of Medicine; 2009 Oct 10; Indianapolis, IN.
Eric M. Meslin. Grappling with financial conflicts of interest in biomedical research, education and practice [panel member]. McDonald-Merrill-Ketchum Lecture. Indiana University School of Law; 2009 Nov 5; Indianapolis, IN.
Eric M. Meslin. Conflated magisteria: what can bioethics learn from the evolution debates. Darwin’s living legacy: an international conference on evolution and society. Bibliotheca Alexandrina; 2009 Nov 16; Alexandria, Egypt.
Eric M. Meslin. The invaluable role of science policy in meeting our ethical obligations in global health. Ivey Global Health Innovation and Leadership Conference; 2009 Nov 24; Toronto, Canada.
Kimberly A. Quaid. Long term outcomes of genetic testing. 7th Leonard Berg Symposium; 2009 Oct 1; Washington University, St. Louis, MO.
Peter H. Schwartz. A three minute decision. Presented at: The policy path for comparative effectiveness. Comparative Effectiveness: The Dollars and Sense. Indiana Life Sciences Collaboration Conference Series; 2009 Nov 13; Bloomington, IN.
Peter H. Schwartz. Healthcare reform [panel]. The Economy … What’s Next? Exploring the Impact of the Recession, Stimulus Package and Healthcare Reform. Ivy Tech Community College – Central Indiana Excellence in Leadership Institute; 2009 Nov 18; Indianapolis, IN.
Peter H. Schwartz. QALYs: ethical and theoretical issues. Presented at Comparative Effectiveness Core Team meeting. Eli Lilly and Company; 2009 Dec 1; Indianapolis, IN.

Sound Ethics

Why Darwin Still Matters, January 3, 2010.
Eric M. Meslin discusses On the Origin of Species and a conference in Cairo marking the 200th birthday of Charles Darwin.

Predictive Testing for Genetic Disease, December 6, 2009.
IUCB’s Kimberly Quaid and Eric M. Meslin discuss genetic testing for a predisposition to Alzheimer’s disease.

Book: Taming The Beloved Beast, November 1, 2009.
Eric M. Meslin and Daniel Callahan, a senior researcher at the Hastings Center, discuss Callahan’s new book: Taming The Beloved Beast: How Medical Technology Costs Are Destroying our Health Care System.

Other Events

Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010 [PDF]
Poynter Center for the Study of Ethics and American Institutions, Spring 2010
Purdue Bioethics Seminar Series, Schedule 2009 – 2010

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.

Center News, August 2009

This month at the Indiana University Center for Bioethics (IUCB) wraps up a busy summer break and begins a new academic year.

Health Care Reform

Eric M. Meslin (IUCB director) and Aaron Carroll contributed to the nation’s focus on health care reform. Meslin participated in a public debate hosted by Smaller Indiana and also contributed to the Association of Bioethics Program Directors statement, “Three Myths about the Ethics of Health Care Reform.”

Among other media appearances, Carroll discussed health reform and the results of a new survey about government involvement in health insurance on Sound Medicine.  On a related topic, IUCB also released a new survey report co-authored with Indiana University Center for Health Policy and Professionalism Research (CHPPR): Do Americans believe the “myths” about health care reform? Yes, they do.

Recent Papers and Presentations

Faculty Investigator, Katherine Drabiak-Syed presented “Revisiting the USPTO’s Examination Guidelines for Gene Patents: Congressional Inaction, USPTO Restraint, and Judicial Remedy” at the August 17, 2009 PredictER meeting.

As the research ethics community waits for President Obama to name a new national bioethics commission, Eric M. Meslin reflects on the history and role of the commissions in “Should bioethics commissions have more authority?” for Bioethics Forum (August 4, 2009).

Other new publications from the Center and its faculty investigators include:

Sly PD, Eskenazi B, Pronczuk J, Srám R, Diaz-Barriga F, Machin DG, Carpenter DO, Surdu S, Meslin EM. Ethical issues in measuring biomarkers in children’s environmental health. Environ Health Perspect. 2009 Aug;117(8):1185-90.

Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer’s disease. N Engl J Med. 2009 Jul 16;361(3):245-54. PMID: 19605829

New Research Assistant

IUCB welcomes Kalli McBride as our new graduate, research assistant. Kalli is pursuing a dual degree (J.D., M.A.) in Law and Bioethics and will be working closely with our faculty on several programs.

Upcoming Events

Richard Gunderman, MD. Can We Do Well By Doing Good? IUSM Ethics at Lunch. August 27, 2009. Noon. VanNuys Medical Science Building, Room B13.

Jennifer Girod and Andy Klein. Predictive Health and Toxic Torts. PredictER Meeting. August 31, 2009. 3:00 pm, Indiana University Center for Bioethics.

Richard Gunderman, MD, PhD. Healing as calling. Fairbanks Ethics Lecture Series. Noon. Methodist Petticrew Auditorium. September 2, 2009.

George Sledge and Pamela Perry. Physician and Patient Experience of Recurrent Cancer Treatment; Pharmacogenomics and Personalized Medicine. PredictER Meeting, September 21, 2009. 3:30 pm, Indiana University Center for Bioethics.

Fairbanks Ethics Lecture Series 2009-2010

History of Medicine Speaker Series, 2009-2010

PredictER Meetings, Fall Schedule 2009

– J.O.

Industry; Transgenic Monkeys; Offshore Trials: Research Ethics in the News

Industry

Industry Funding of Research: Assessing the Harms. Susan Gilbert, Bioethics Forum. 29 May 2009.
No one argues about the importance of industry funding to medical research. Most clinical trials could not take place without it. The questions are about the effects of this relationship–does it bias researchers and degrade scientific integrity and, if so, in what ways? … A new study goes deeper than previous studies in answering these questions.

Transgenic Monkeys

Monkeying Around With Genetic ‘Enhancement’. Henry I. Miller, Forbes. 29 May 2009.
New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

Related:

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

Offshore Trials

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.
[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.

Related:

Outsourcing clinical trials: further thoughts. Nancy Walton, The Research Ethics Blog. 5 June 2009.

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Monkeying Around With Genetic ‘Enhancement’. Henry I. Miller, Forbes. 29 May 2009.

New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

Related:

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

http://www.timesonline.co.uk/tol/news/uk/science/article6375145.ece

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

http://pubmed.gov/19478777

http://www.forbes.com/2009/05/28/monkeys-genetic-enhancement-opinions-contributors-ethics.html

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.

[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.