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Topic: Research Ethics
November 26, 2014 | Posted By John Kaplan, PhD

When I was a young scientist (quite some time ago) there was a joke that seemed to be circulating about how our older established colleagues conducted science. This was a somewhat cynical exercise motivated, at least in part, by professional jealousy. The joke went on to say that one could establish a fact by writing two papers. In the first paper the author speculates that something might be true. In the second paper the author says that the previously speculated thing is true, and references the paper containing the original speculation. In fact I have rarely seen this actually done. But as I write blog I have an example sitting in front of me on my desk. It is especially intriguing that this paper was written by an individual who maintains that “most published research findings are false”.

The paper in question was published just last month with the rather presumptuous title: “How to make more published research true”.  This, of course, is a statement predicated on the presumption that much published research is false. Indeed the author says in the first paragraph, referring to scientific research, that “Many new proposed associations and/or effects are false or grossly exaggerated” and refers to two previously published papers both single author papers by him.

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 3, 2014 | Posted By Luke Gelinas, PhD

Recently prominent bioethicists have voiced disagreement over whether it could be ethical to test experimental Ebola vaccines in placebo-controlled randomized trials.  Such trials would involve taking a group of people currently infected with Ebola and randomizing half of them to an arm that receives the experimental vaccine (plus, let us assume, the best current standard of care for Ebola), and the other half of them to an arm that receives a placebo instead of the vaccine (plus the same standard of care).  

The main worry with these trials is that it is unethical to give Ebola-sufferers a placebo when an experimental vaccine is available that holds the prospect of benefit. (The prospect of benefit is typically inferred from success in trials with animals; at least one experimental vaccine, ZMapp, has showed notable efficacy at preventing deadly disease in macaque monkeys inoculated with a virulent strain of Ebola.)  As a prominent group of bioethicists recently pointed out, conventional care for Ebola “does not much affect clinical outcomes,” resulting in a mortality rate as high as 70%.  “When conventional care means such a high probability of death,” they continue, “it is problematic to insist on randomizing patients to [a placebo arm] when the intervention arm holds out at least the possibility of benefit.”  Moreover, they insist, “none of us would consent to be randomized in such circumstances.” 

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.

August 8, 2014 | Posted By John Kaplan, PhD

Questions regarding the availability and utilization of experimental drugs for treatment of disease have moved to the forefront following the apparently successful use of an experimental treatment used for two American health workers treating the Ebola outbreak in West Africa. 

The questions that have been raised include both who such drugs should be made available to and under what circumstances they should be made available. An additional consideration is what processes should be put into place to assure that these decisions are made properly to allow patients with valid cases to obtain access while protecting ill people from inappropriate risks and suffering. An additional question which I will not delve into here is who pays for them. Health insurance does not pay for experimental treatments so someone else must. First I should clarify exactly what I mean by an experimental drug. I am referring to drugs that have a scientific rationale for their use and some scientific basis for believing they might work. I do not include cockamamie ideas with no reasonable basis simply because somebody thinks they should be used. I have previously written about physicians who chose to use unreasonable treatments.

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. 

June 19, 2014 | Posted By Zubin Master, PhD

By sharing a recent experience in which I delivered a lecture and case at a responsible conduct of research (RCR) workshop for biomedical science trainees, I will comment on why I believe that pedagogy on the RCR, specifically for biomedical scientists, needs two essential ingredients: delivering knowledge/information and providing case-based learning. The art is to determine how much of each element is needed and how to most effectively deliver information on an RCR topic and ensure trainees get the most from the ethical analysis of cases.

Ethics Workshop: Responsible Research Conduct & Misconduct in Stem Cell Research

As part of Canada’s Stem Cell Network at http://www.stemcellnetwork.ca, I had the unique opportunity to organize and present an Ethics Workshop as part of the Network’s annual Till & McCulloch Meetings in October 2013. The workshop was a lecture followed by an interactive ethical case using “The Lab: Avoiding Research Misconduct” video hosted by the Office of Research Integrity (ORI) athttps://ori.hhs.gov/thelab. The 50 to 60 workshop attendees were primarily master’s, doctoral, and post-doctoral trainees, and almost all were biomedical researchers working with stem cells. Most attendees had never heard of RCR. Thus, the goals of the workshop were modest and involved introducing attendees to the following: RCR, research misconduct (fabrication, falsification, and plagiarism), the RCR link to scientific retractions, issues of authorship and publication ethics, and Canada’s RCR framework.

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.

June 3, 2014 | Posted By John Kaplan, PhD

The essence of responsible conduct of research is to assure that science concerns itself with the identification and clarification of objective truth.  I have spent some time this past week trying to read a recent study by Fanelli and Ioannidis entitled “US studies may overestimate effect sizes in softer research” published in the Proceedings of the National Academy of Science

 This is a statistical paper, written densely, but still mostly understandable even to a mere scientist such as myself. Many of you have probably heard of John Ioannidis. He has gained prominence by doing theoretical analysis of the studies of others and using his results to conclude that most biomedical research is wrong or at least biased. I may be wrong, or at least biased, but I have come to believe upon reading this work that Dr. Ioannidis is wrong and maybe biased as well.

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

April 3, 2014 | Posted By John Kaplan, PhD

The scientific and medical potential of stem cells hold so much promise that progress in this area is widely followed with intense interest. Since pluripotent stem cells are able to differentiate into any cell type they hold the promise of leading to therapies for a wide variety of diseases and disabilities which cause human suffering and end lives prematurely. This field of research and development has attracted the efforts of large numbers of the most brilliant and talented biomedical researchers in the entire world. This raises the vexing question of why some of these brilliant and talented researchers are doing some very stupid things.

It seems like only yesterday (it was actually in 2004 and 2005) that Hwang Woo-Suk a renowned Korean veterinarian and researcher published the first reports in Science Magazine of the derivation of pluripotent stem cells from human embryos and subsequently the successful cloning of human embryonic stem cells. Hwang was a national hero. However these studies were recognized in 2006 as being the result of fraud.  I remember wondering then, just as I am wondering now, how someone could risk all that they had earned by committing such blatant fraud. How could they not realize that misconduct in such important work would be discovered and punished. I do not get it.

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.

March 17, 2014 | Posted By John Kaplan, PhD

Three eminent bioethicists have proposed, in an article published in the New England Journal of Medicine last month, that some comparative effectiveness research should not require informed consent from patients. I do not agree, at least not yet. Drs. Faden, Beauchamp, and Kass have provided a thoughtful justification for their position. However the circumstances in which this new scenario would work does not yet exist.

Let’s be more specific. These authors have been among those advocating what they term a learning healthcare system which blurs the line between clinical care and research but predicates both on a common set of research and clinical ethics principles.  Research and medical practice allows the system to learn and implement improvements. They lay down seven ethical principles to guide such a health care system. The first of these principles is to “respect the rights and dignity of patients.” It does not seem to me that you can meaningfully respect the rights and dignity of people and use them in clinical trials, even comparative effectiveness trials, without their permission. The seventh principle, “contribute to the common purpose of improving the quality and value of clinical care and health care systems” seems in some ways laudable but is dubious in the context of respect for rights. The first six principles define obligations of the participants in the health care system. This seventh principle describes an obligation on the patients to “participate in certain types of learning activities that will be integrated with their clinical care.” 

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.

February 27, 2014 | Posted By Aidan B. Ferguson, LCSW and Zubin Master, PhD

Before research involving humans can commence, the ethical aspects of the research study are reviewed by local ethics boards in the United States known as Institutional Review Boards (IRBs). IRBs review many factors surrounding the ethics of research involving humans, including whether the science is valid, there is a favorable benefit-to-risk ratio, participants are recruited fairly and have retained the right to withdraw from research, privacy is protected, and the informed consent process will be performed such that participants are fully informed and understand the nature of the study. IRBs are located within institutions that perform human research such as universities and colleges, research centers, government agencies, and others. IRBs consist of individuals with a diversity of scientific, clinical, ethics, and legal expertise. The advantage of performing ethics review at the local level is that IRB members know their community, including the prevalence of health issues and the average educational level allowing them to be able to effectively communicate with community members and ensure they can access beneficial research. As trust is an essential element to voluntary community participation, an absence of it might lead to decreased enrolment in clinical trials. Knowing that a body of experts has reviewed the ethical aspects of research is likely to promote trust between participants and the research institution.

While local review certainly has its advantages, more research is being performed at multiple institutions, such as large phase 3 and 4 clinical trials that can be performed at dozens of research sites across the country. Currently, this means that researchers will have to submit their protocol to every individual IRB for approval. Several studies surrounding multisite ethics review have been performed and many question whether a more efficient system cannot be developed. Below we discuss some of the issues with multisite ethics review and outline a few reform strategies.

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.

October 8, 2013 | Posted By John Kaplan, PhD

My last blog, written just a few weeks ago, discussed the case of two neurosurgeons who had purposely introduced bowel bacteria into the brains of patients with glioblastoma, a process they termed “probiotic intracranial therapy”. In that blog I expressed the opinion that the physicians had inappropriately exposed their patients to excessive risk and compared the incident to assault. In the brief time since then high risk research has been covered in both the biomedical literature and the popular press. We have also seen more news regarding treatments with bowel bacteria indicating that fecal bacteria may well have their place in medical treatment. Their place, however, is in the gut not the brain.

In the journal Lancet, David Shaw argues that Institutional Review Boards “should never reject a study because it poses too high a risk to participants.” Institutional Review Boards are the mechanisms that review research protocols designed to be conducted with human subjects. Among the charges to Institutional Review Boards is to evaluate the balance between the potential benefits and potential risks of a proposed research project. When assessing protocols of prospective therapies they need to identify that there is adequate reason, both theoretical and experimental, to think the therapy might work. They should also assure that the risks of the proposed study do not endanger the participants out of proportion to the potential benefits. These dangers were excessive in the well known Tuskegee syphilis studies and similar studies in Guatemala as well as the supposed research in the Nazi atrocities. This horrendous history drove many of the protections we now use to safeguard human research participants.

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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ABOUT BIOETHICS TODAY
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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