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Topic: Research Ethics
June 4, 2015 | Posted By Bruce White, DO, JD

On May 7, 2015, The New York Times reported that Johnson & Johnson (New Brunswick, New Jersey) had asked Arthur Caplan, PhD, Professor of Bioethics at New York University School of Medicine to create a new panel “that will make decisions about patients’ requests for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved [by the FDA].” 

Compassionate use” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.” Of late, several states have enacted “Right to Try” statutes in an attempt to craft a legally-recognized right to early access to drugs still in clinical trials.

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.

May 8, 2015 | Posted By John Kaplan, PhD

I recently read a paper written by my colleagues at Alden March Bioethics Institute entitled “In Particular Circumstances Attempting Unproven Interventions and Circumstances is Permissible and even Obligatory”. 

I do not entirely agree with my colleagues. I do not disagree that there are some very limited circumstances in which unproven interventions are warranted nearly all of which are in the research or compassionate use context. The recent Ebola crisis is an example of that where the use of monoclonal antibodies against the Ebola virus was consistent with theory and prior scientific precedent. However we must balance that against the harm done. The consumption of available ZMapp antibody in compassionate use likely precluded the opportunity to conduct clinical trials in a timely manner to determine if it actually did provide any benefit. Had it been used to prove efficacy it could have justified the investment necessary to prepare it large quantity and let future physicians and patients make informed decisions on its use. Moreover the manner in which the compassionate use was implemented, nearly exclusively available to US and European health care workers and barely any availability to Africans could hardly be considered just. During the next Ebola outbreak we may be faced with the same circumstances because we still do not really know its efficacy. There is now enough ZMaap available to conduct trials and these have been initiated but there may not be enough patients available to conduct them.

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 12, 2015 | Posted By John Kaplan, PhD

Late in 2013 I posted an entry to this blog which described PubPeer, the newly implemented system for post publication peer review. In that blog I raised the question whether this is a good idea compared to other opportunities for post publication commentary such as letters to the editor or even new publications which would either support or challenge previously published research. The system has been going for a bit over a year now and I thought it would be appropriate to revisit the question of promise or chaos.

One of my principal concerns related to the ability of anyone who met the qualifications to comment to jump in and comment. The necessary qualifications are quite easy to meet and quite arbitrary. Anyone who has been funded to do research by the National Institutes of Health (US) or the Wellcome Trust (UK) is considered qualified. I have no idea why someone funded by the National Science Foundation (US) or the National Research Council (Canada) is not qualified.  

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 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.

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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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