Tag Archives: Research ethics

Attend the Third Annual Teaching Skills in International Research Ethics Workshop

TaSkR IIIThe IU Center for Bioethics and the IU-Moi University Academic Research Ethics Partnership will host its annual Teaching Skills in International Research Ethics (TaSkR) workshop April 12-14 in the Health Information and Translational Sciences (HITS) Building, room 1110.

This workshop will focus primarily on the ethics of research involving human subjects—both behavioral and biomedical—conducted in an international forum, as well as developing stronger pedagogical skills.

The workshop will be attended by over 40 participants plus faculty facilitators.  Participants include faculty who teach within the broad domain of international research ethics, whether this is in the classroom, through lectures, or mentoring students, fellows, and post-docs.  Attendees include faculty who teach in medicine, public health, behavioral science, and a number of liberal arts subjects.  Our guest speakers include: Henk ten Have (University of Duquesne) Peter Schwartz (Indiana University), Margaret Gaffney (Indiana University), Edwin Were (Moi University), Kenneth Goodman (University of Miami), Martin Were (Indiana University), Charles Rotimi (National Institutes of Health), and David Ayuku (Moi University).  We will be joined by Joseph Ali (Johns Hopkins University), Ross Upshur (University of Toronto), Henry Silverman (University of Maryland), and Solomon Benatar (University of Toronto, University of Cape Town). TaSkR will also include an African Fogarty Director’s Roundtable discussion.  We hope this discussion will lead to mutual problem solving strategies and enhance collaboration between the African Fogarty Directors.

There is no cost to attend.  For more information or to register, contact Kalli D. McBride, JD, at kdmcbrid@iupui.edu.

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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.

Brain Stimulation: Research Ethics in the News

With deep brain stimulation, experts want to tread carefully.  Andreas von Bubnoff. Los Angeles Times, June 1, 2009.

Deep brain stimulation research also raises ethical questions, such as how to make sure patients who may have diminished capacity to consent understand the risks and benefits of participating in the trials. In 2007, researchers met to discuss such issues. Recommendations will be published in an upcoming paper.

Research Ethics in the News: Stem Cells

New Rules on Stem Cells Threaten Current Research. Rob Stein, The Washington Post. 25 May 2009.

The concern focuses on strict new ethics criteria that the National Institutes of Health has proposed. Advocates of stem cell research say that most of the work currently underway passed close ethical scrutiny but that the procedures varied and usually did not match the details specified in the proposed new guidelines.

“It’s not that past practices were shoddy,” said Lawrence S. Goldstein, director of the stem cell program at the University of California at San Diego. “But they don’t necessarily meet every letter of the new guidelines moving forward. We’d have to throw everything out and start all over again.

Helsinki Discords

If you’re interested in the ethical issues of international research, be sure to read Helsinki discords: FDA, ethics, and international drug trials. This is a recent commentary co-authored by IUCB’s Eric M. Meslin. The full text is free (with registration) and a brief excerpt has been posted that this CiteULike account.

Full citation:

Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet. 2009 Jan 3;373(9657):13-4. PMID: 19121708

Electroshock Ethics on Sound Ethics

Although electroconvulsive therapy (ECT) is currently used successfully in a clinical setting, the therapy has a controversial past. In addition to the many negative portrayals of the ECT in film and fiction, including Ken Kesey’s novel One Flew Over the Cuckoo’s Nest, public perception may have been influenced the questionable experimental use of the therapy in medical research during the post-WWII era. These experiments included those which were partly funded by the CIA during the 1950s and the early 1960s as a part of the agency’s MK-ULTRA program. The MK-ULTRA program explored methods of mind-control by experimenting with LSD and ECT. Donald Ewen Cameron, as Director of the Allan Memorial Institute of McGill University, oversaw an academic research project partly funded by this CIA initiative. Cameron’s research (1957-1964) involved the use of high-powered ECT treatments with mentally ill, anxious, and depressed patients. Cameron experimented with ECT to “depattern” the brain and, thereafter, used other techniques, called “psychic driving”, in an attempt to re-pattern the brain.

In this episode of Sound Ethics (Sound Medicine), Eric Meslin talks with Dr. Steven Jay, a professor of public health at the IU School of Medicine. In 1965, while Dr. Jay was a medical student on a visiting fellowship at McGill, he witnessed the end of this use of ECT.

Visit the IUCB Website for a brief bibliography on this topic and other Sound Ethics’ topics.