New Rules for Stem Cell Research: Research Ethics in the News

On Monday, July 6, 2009 Dr. Raynard S. Kington, acting director of the NIH, announced that the Obama administration had released the new rules on federal funding for stem cell research (Guidelines, 2009). The rules implement Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The new guidelines expand the number of potential cell lines available for use in federally funded research. The Washington Post estimates that 700 embryonic stem cell lines are currently in existence. Researchers may seek approval to use these cell lines, if the cells were acquired from embryos created for reproductive purposes and contributed by properly informed, consenting donors.

The New York Times quotes ethicist, R. Alta Charo, applauding the new rules as “a huge step forward”. Jonathon Moreno at Science Progress, also supports the change, declaring that the new rules are “a welcome reprieve for scientists, advocates, and patients who saw research opportunities contract under the eight years of the Bush administration’s distorted policy”. Moreno also notes: “the new guidelines are similar to those proposed in the Center for American Progress/Science Progress report, ‘A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically,’ published in January”. Among the critics of stem cell research, Richard Doerflinger of the U.S. Conference of Catholic Bishops lamented in The Washington Post: “For the first time in history, the federal government will encourage the destruction of human life at a very early stage for federally funded research”. For a wider range of reactions, one might wish to browse the 49,000 comments a version of guidelines received when an earlier draft was posted for public comment on April 23, 2009.

References

National Institutes of Health (NIH). National Institutes of Health Guidelines for Human Stem Cell Research. NIH, 2009.

Executive Order 13505, Removing barriers to responsible scientific research involving human stem cells. The White House, March 9, 2009.

Vedantam S. Rules on stem cell research are eased. The Washington Post. July 7, 2009.

Harris G. Rules will allow financing for old stem cell lines. The New York Times. July 6, 2009.

Moreno J. Back to the future: final stem cell rules support ethics and innovation. Science Progress, July 6, 2009.

National Institutes of Health (NIH). Listing of comments on Draft NIH Human Stem Cell Guidelines. NIH, 2009.

Other Stories on the New Stem Cell Guidelines

Shapiro J. New funding rules issued on stem cell research. NPR Morning Edition, July 7, 2009.

SNAP Analysis: Stem cell rules mean big change up to Congress. Reuters, July 6, 2009.

Related:

The Human Stem Cell Study Group, Indiana University Center for Bioethics. 2001-2002.

Research Ethics and Stem Cells. Stem Cell Information: The National Institutes of Health.

Insoo Hyun, “Stem Cells,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 159-162. Online at: http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2248

Siegel A. Ethics of stem cell research. The Stanford Encyclopedia of Philosophy (Fall 2008 Edition), Edward N. Zalta (ed.). Online at: http://plato.stanford.edu/archives/fall2008/entries/stem-cells/

Other Research Ethics News:

JAMA Conflicts Policy: now you see it, now you don’t. David Armstrong, WSJ Health Blog. July 10, 2009.

Helping science, making money. [Review of O'Meara A. Chasing Medical Miracles. Walker, 2009.] Scott Gottlieb, The Wall Street Journal. July 10, 2009.

Pick to lead health agency draws praise and some concern. Gardiner Harris, The New York Times. July 8, 2009.

International Research Standards: Xenotransplantation. Chris MacDonald, The Research Ethics Blog. July 6, 2009.

Paying egg donors for research: in defense of New York’s landmark decision. Bonnie Steinbock, Bioethics Forum. July 1, 2009.

Better ethics, cheaper drugs. The Boston Globe. July 1, 2009.

Grant system leads cancer researchers to play it safe. Gina Kolata, The New York Times. June 27, 2009.

State stem cell board needs overhaul, group says. Sandy Kleffman, San Jose Mercury News. June 26, 2009.

Obama’s Bioethics Commission: Providing Practical Policy Options. John H. Evans, Bioethics Forum. June 26, 2009.

Obama stops The President’s Council on Bioethics: Research Ethics in the News

Last week, Nicholas Wade reported in The New York Times that the President had pulled the plug on the most-recent version of the President’s Council on Bioethics. According to White House press officer, Reid Cherlin, President Obama disbanded the Council because it was “a philosophically leaning advisory group.” Wade also reports that Obama plans to create a new, more practical, bioethics commission in the future–Cherlin did not offer a timeframe.

James W. Fossett and Michelle N. Meyer respond in today’s Bioethics Forum with a (tongue-in-cheek) “who cares”–a comment in support of a federal commission focused on empirical research on bioethical issues. Similarly, Michael Cook, yesterday at BioEdge, speculated (but less happily) that this direction would mean “no more seminars; lots more Facebook.” Other reactions to this news include “Less Philosophy, More Policy” from Andrew Plemmons Pratt at Science Progress and a good-bye letter from Peter Augustine Lawler in the conservative publication The Weekly Standard.

Related:

President’s bioethics council disbanded. Alex Witze, The Great Beyond. June 19, 2009.

Gilbert Meilaender, Paul McHugh, Benjamin Carson, Nicholas Eberstadt, Jean Bethke Elshtain, Alfonso Gómez-Lobo, William Hurlbut, Donald Landry, Peter Lawler, and Diana Schaub. Federal Funding of Embryonic Stem Cell Research Science and Society. Bioethics Forum, March 25, 2009.

Other Research Ethics News:

EU legislation increases clinical-trial workloads. Nature News. June 24, 2009.

Drug ‘reports’ found to be faked. Stuart Laidlaw, Toronto Star. June 22, 2009.

Commentary: A Costly and Wasteful FDA. Henry I. Miller, Forbes. June 20, 2009.

NY to pay for eggs for research. Elie Dolgin, The Scientist. June 17, 2009.

Clinical Trials in India: Research Ethics in the News

The Times of India reports that the Drugs Controller of India has stipulated that all clinical trials (new and ongoing) in India must be registered with The Clinical Trials Registry- India (CTRI). The Indian Council of Medical Research (ICMR) expects that this will increase transparency and assist in the ethical conduct of research while adding to public trust. Read the full story:

Now, all human clinical trials to be registered. The Times of India. June 15, 2009.

Related Links:

Bio-Medical Ethics | ICMR
ICMR. Ethical guidelines for biomedical research on human participants. New Delhi, 2006. [PDF - 3.14 MB]

Other Research Ethics News:

Vaccine Plan Aims to Spur Drug Development for Poor Nations. Michael M. Phillips, The Wall Street Journal. June 12, 2009.

Comment: Human subjects have human rights. Daniel Everett, New Scientist. June 9, 2009.
Biologist Jared Diamond is being sued by people he studied.

Benefits of the stem cell ban. John D. Loike and Ruth L. Fischbach, The Scientist. June 8, 2009.
Federal aversion to embryonic stem cell research had a silver lining: it galvanized the development of new biotechnologies in stem cell science, two bioethicists argue.

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation: Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. GAO-09-448T. United States Government Accountability Office, March 26, 2009.

Ether and the Moral History of Pain: Research Ethics in the News

What can the history of medicine teach us about the barriers to translation? What are some of the obstacles between the bench and the bedside?

In a recent edition of The Boston Globe (7 June 2009), Mike Jay recounts an

Source: http://en.wikipedia.org/wiki/Anesthesia

interesting moment in the history of medicine and medical research, one in which “culture had finally caught up with chemistry”. As Jay observes, ether has a long history in science (with its effects on chickens recorded as early as 1525 by Paracelsus), but medicine waited for roughly 300 years to see this knowledge translated into improved medical care. What was in the way? Prior to October 16, 1846 (the date of the first operations conducted under anesthesia) our view of the person seemed inseparable from the concept of pain: “the vast majority of religious and medical opinion held that pain was inseparable from sensation in general, and thus from life itself”. Thus, while the technology was available, the doctors and the patients were not ready for medicine: less painful medical care “required not simply new science, but a radical change in how we saw ourselves”.

Read the full story:
Mike Jay. The day pain died: what really happened during the most famous moment in Boston medicine. The Boston Globe, June 7, 2009.

Other research ethics stories in the news:

Gene Patents on the Radio. PredictER Blog, 10 June 2009.
Rebecca Roberts discusses Patenting Genes with Joshua D. Sarnoff, Hans Sauer, and Shobita Parthasarathy on The Kojo Nnamdi Show.

Conflicts of interest bedevil psychiatric drug research. Marilyn Elias, USA Today. 2 June 2009.
Does it matter if most of the experts who are creating definitions of mental disorders, and standards for the best way to treat them, receive money from pharmaceutical companies?

Stem-cell clarity. [Editorial]. Nature. 2009 Jun 4;459(7247):615-6.
The draft NIH guidelines on stem-cell research are a good first step, but some revision is needed.

• Related: Stem Cell Research: Hope or Hype. FasterCures Blog, 5 May 2009.

Ethical and Policy Issues in International Research, Fall 2009

Please see the attached detailed summary for PHL 555 “Ethical and Policy Issues in International Research,” which will be taught this fall by Dr. Eric Meslin, Director of the Indiana University Center for Bioethics. The class will be held once a week in the IU Center for Bioethics conference room, 3rd floor of the HITS building, Friday mornings from 9am-11:40am. Class begins August 28th and is limited to 15 students.

In addition to counting as a specialized elective for the MA or Graduate Certificate in Bioethics, PHL 555 serves as one of the foundational courses for the MA program’s new concentration in International Research Ethics that will be launched this fall. This new concentration has been developed in cooperation with Moi University in Eldoret, Kenya and is supported by a grant from the Fogarty International Center at the National Institutes of Health. Further details will be forthcoming later in the summer.

Jason T. Eberl, Ph.D
http://liberalarts.iupui.edu/directory/bio/jeberl

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.

REBs and Inclusion: Research Ethics in the Academic Literature (REAL)

In a recent paper, Holly A. Taylor reports the results of a study on the role of the NIH inclusion guidelines and the attitudes of IRB administrators. Administrators of Research Ethics Boards (REBs) agree that the topic of including women, minorities, and children in research is “often discussed by their Boards”. While most REB administrators believe the NIH inclusion guidelines were “in part responsible” for IRB attention to inclusion/exclusion issues for special populations (nearly 60%), these administrators do not think that the guidelines are responsible for an increase in the number of women, children, and minorities in research. So, are the guidelines doing their job? Maybe. Graduates of ethics courses are more likely to think the NIH guidelines are adequate, but (more importantly, perhaps) administrators who had NOT taken an ethics course, were more likely to attribute attention to issues of inclusion to the guidelines. Given the somewhat mixed review, Taylor observes that small increases on the local level may not seem adequate to administrators, but these could contribute to improvements at the national level.

Reference:

Taylor HA. Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators. J Empir Res Hum Res Ethics. 2009 Jun;4(2):65-73. PMID: 19480593.

Related:

National Institutes of Health. (1998). NIH policy and guidelines on the inclusion of children as participants in research involving human subjects.  http://grants.nih.gov/grants/guide/notice-files/not98-024.html

National Institutes of Health. (2001). Amendment: NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html

National Institutes of Health. (2003). Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research. NIH Publication NO. 03-7036. http://orwh.od.nih.gov/inclusion/outreach.pdf

Other Recent Research Ethics Articles

Note: This post is the first in a series (category REAL – “Research Ethics in the Academic Literature”) sharing research ethics articles with the readers the newsletter Research Ethics News Digest, a service of Bioethics and Subject Advocacy Program, Indiana CTSI. To learn more about this new service, see Research Ethics News Digest from the Indiana University Center for Bioethics or browse the posts in the category REND.

Ethics Exchange: Western Australia

Indiana University Center for Bioethics director Eric Meslin recently

Those pictured from left are Dr. Eric Meslin, Dr. Fiona Stanley, U.S. Consul General Dr. Ken Chern, and Dr. Lyn Beazley. Source: Reception in Honor of Dr. Eric Meslin, Perth — 12 May 2009. 2009 Public Affairs Programs, Consulate General of the United States - Perth, Australia.

returned from his trip to Australia. While adding to our growing collaborations with researchers and ethicists in Australia, Eric served as Visiting Professor-at-Large at the University of Western Australia. Recently, the IU Center for Bioethics, the Indiana CTSI, and the Indiana University School of Medicine, were pleased to welcome Lynette Fernandes from the UWA School of Medicine and Pharmacology, Pharmacology and Anaesthesiology Unit. During her visit, Dr. Fernandes exchanged ideas and compared notes on our institutions’ responsible conduct of research training programs.

Related:

Beating swine flu. Karen Dearne, Australian IT. May 26, 2009
e-Health ‘could take fight to swine flu’. Sky News, May 31, 2009.
Visiting professor brings bioethical discussion to Perth. Laura Glitsos, ScienceNetwork Western Australia. 2 June 2009.

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.