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Topic: Publication Ethics
January 27, 2014 | Posted By Michael McNichol and Zubin Master, PhD

Since the discovery of human embryonic stem cells in 1998, many promises have been made by individuals and groups about the potential of stem cell research to revolutionize the practice of regenerative medicine. Yet to date, very little has been seen in terms of novel therapies in the clinic. Because of the substantive economic investments made in stem cell research in order to realize the promise they can offer, greater efforts to translate stem cell research into medicines has ensued. However, many factors might impede the clinical translation of stem cell research. In this blog, we briefly highlight the ethical and scientific issues surrounding the successful translation and commercialization of stem cell research.

The process of clinical translation begins with preclinical research using in vitro systems and animal models to show proof-of-principle and demonstrate safety and efficacy of a potential therapeutic. For example, if a stem cell is to be transplanted into a patient to treat a degenerative disease, then the type of stem cell that is being used must show that it can successfully treat a similar disease in animals prior to testing the product in humans. There are many reasons for using appropriate animal models that mimic human diseases: low cost, reproductive cycle, number of offspring, genetic similarity, similarity in the manifestation of the disease in humans, and ease of handling. However, there are many limitations to animal models that do not result in direct translation in humans, meaning what may work in animals may not at the end of the day be effective in people. While we choose animals as models to mimic human disease, the biology of animals is still significantly different than humans and thus may simply not translate 100%. This issue is difficult to get around. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

January 2, 2014 | Posted By John Kaplan, PhD

In the good old days when I spent most of my time as a practicing biomedical research scientist it was pretty clear to me what qualified as a scholarly communication. Such communications consisted of submissions of presentations to meetings of scholarly academic societies; submissions and presentations of original research to journals; presenting seminars; and writing the occasional review articles, book chapters, or even books. Now that I spend much of my time as a bioethicist it is no longer so clear to me. It is probably important to note that the uncertainty I feel about this is probably only partly attributable to the difference in discipline and may indeed be primarily due to the emergence of our modern-day online communications including the blogging and social media culture.

The communication you are reading now is a blog, only a blog, not a scholarly communication. Al least I am pretty sure that is the case. I cite no evidence. I reference lightly if at all. I write what I want. I am merely expressing my opinions. I am not really accountable to anyone for what I say here. I can write it in minutes or hours, not weeks or months. This all sounds to me that this is not a scholarly publication. Yet I have read in both blogs and on social media such as facebook and twitter people raising questions about the distinction. (Please note that I did not reference my statement, further evidence that this is not a scholarly publication.) I have seen questions which ask how are blogs and scholarly writings different if indeed they are different. I have seen writers ask if blogs should be included in one’s Curriculum Vita as a publication. Please note that this will not be posted in my Curriculum Vita because it is, again, only a blog.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 16, 2013 | Posted By John Kaplan, PhD

Open post-publication scientific peer review is here. Almost. Now we need to ask whether or not that is a good thing. Some are trumpeting this as a game-changing innovation which will improve the quality of scientific publication. Others are concerned that scientific publication will become more like Twitter and Facebook.

The site Pubmed Commons allows one to comment on any Pubmed indexed publication. Although the system now permits access in a limited way for testing, it will be open to essentially all who have Pubmed indexed papers in the relatively near future. Just as there are sites to review movies, restaurants, and contractors one will soon be able to include their insights and feelings about scientific papers. The advocates of this system believe that post-publication will open the peer review system to all qualified and can allow science to be communicated in a more transparent and less biased manner.

Advocates of post-publication peer review have been very critical of conventional pre-publication peer review

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 3, 2013 | Posted By Zubin Master, PhD

This is part 2 of a blog written last month. In Part 1, I explained how open access (OA) journals work and some of the shortcomings of peer review. This was done to provide a background on a recently published study by staff at the leading journal Science. In this part, I will cover the specific experiment reported by Science and explain some of the limits of its design followed by an interesting and novel model of the non-profit OA journal BioéthiqueOnline.

Part 2: Open Access Journals, Peer Review, and Conflicts of Interest

Do OA Journals Perform Rigorous Peer Review?

Recently, John Bohannon of the Science group conducted an investigation where he submitted scientifically flawed papers using fake names and provided the names of research or academic institutions that didn’t exist to 304 OA journals (Science 342: 60-65, 2013). The idea was to create a scientific paper with major errors, so that “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s shortcomings immediately.” Bohannon created a database of molecules, lichens and cancer cell lines and ran them through a computer program to generate unique papers, but with a standard structure: “molecule X from lichen species Y inhibits the growth of cancer cell Z.” He also created fake authors from fictitious African institutions with the hope that using developing world authors would lessen suspicion by journal editors. The main flawed graph showed a dose-dependent decrease in cell growth yet despite rising concentrations, the effects on cells were modest. In addition, the anti-proliferative molecule was dissolved in a large amount of ethanol and because the control group was not treated with the same solution buffer, the anti-proliferative effects seen could simply be due to the cytotoxic effects of ethanol. In a second experiment, Bohannon attempted to show an “interactive effect” by adding the molecule with radiation, but the control cells were not exposed to any radiation. As the experiments had a tragically flawed design, the idea was that any peer reviewer should pick them up and the article should be rejected.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 4, 2013 | Posted By Zubin Master, PhD

This blog will be written in two parts. It discusses some interesting results produced by the publisher Science in regards to the quality of peer review of open access (OA) journals. In this first part, I will provide a brief explanation of OA journals and how peer review works and cover some of the shortcomings of peer review. In the second part of this blog post, I will discuss the specific experiment reported by Science and explain some of the limits of its design and end off with an interesting and novel model of the OA journal BioéthiqueOnline.

Part 1: The Open Access Movement and Limits of Traditional Peer Review

There has been a rise in OA journals, which are scholarly journals that are available online and are free to access or can be heavily subsidized. There is variation in how OA journals function e.g., authors may self-archive and upload a copy of the paper to an institutional or central repository (e.g., PubMed Central), journals may provide free access after an embargo period typically 6-12 months, or all journal articles may be made available online but authors pay a fee to publish. This last model is one we will pay attention to for the purposes of this blog.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 20, 2012 | Posted By Zubin Master, PhD

Last month, I discussed a research integrity case making international headlines of an iPS cell study conducted by a researcher Hisashi Moriguchi who had allegedly falsified or fabricated data, provided false institutional affiliation, plagiarized work, and had questionable publication practices. In this post, I want to outline a few of the lessons we can learn from this case.

I think Péter Kakuk said it best when he wrote that the Hwang cloning scandal “might shed light on the often neglected benefits of the 'social control of science'".  As a trained scientist, I can say that I used to believe that many of the safeguards felt more like impediments to research progress. As a bioethics researcher, I still feel there are kinks in the system of ethical oversight and there is evidence to support this view. However, I also believe that the ethical safeguards are in place to promote the responsible conduct of research and ensure that research is performed by upholding the utmost standards of integrity. In every issue of Nature or Science there is some report of research misconduct or misbehavior. There have been studies done in the US and many other nations about the frequency of misconduct. Yet despite such reports, I feel many scientists still believe there are too many research hurdles only to catch a few bad apples. This view needs to shift.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 16, 2012 | Posted By Zubin Master, PhD

This blog will have two parts. In this first entry, I present will discuss a recent case of stem cell fraud and the subsequent blog entry will discuss possible lessons to learn appearing next month.

The tale begins when Woo-Suk Hwang, a once celebrated hero of South Korea, claimed to have made the first, patient-specific human embryonic stem cell (hES) line through a technique called somatic cell nuclear transfer (commonly referred to as research or therapeutic cloning). This study was soon after proven to be fraudulent. Not to get into too many details, but this technique requires obtaining ova from women providers, enucleating its genetic material, and placing the nucleus from a somatic cell and parthenogenically activating the egg. This initiates embryonic development and at about day 3-4 of development (where the embryo is at the blastocyst stage), hES cells can be isolated from the inner cell mass of blastocysts. This incredible feat in stem cell research was published in Science in 2004 and another study in 2005. In 2006, Hwang was discredited for fabricating results and after an investigation, he was convicted for embezzlement and bioethical allegations. He embezzled approximately 830 million won (US $700,000) of government funds and apparently used 2,200 eggs obtained from his female postgraduate students and junior researchers. All wasted!

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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