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Topic: Research Ethics
July 2, 2013 | Posted By Bruce D. White, DO, JD

Recall the June 7, 2013 New York Times article by Andrew Pollock titled “An Experimental Drug’s Bitter End”? The author reminds us again about how difficult it is for patients and those involved in their care to understand that new drug clinical trials are experiments and not therapeutic interventions.

The goals of researchers in conducting new drug clinical trials – experiments – are clearly not the same as the goals of a physician who prescribes an approved drug as a therapeutic modality. How better can we help patients and their families understand this primary goal of medical research? In clinical trials, when the experiment ends, the patient may worsen clinically, or the patient may get better clinically, and the improving patient probably will no longer have access to the perceived beneficial drug as a therapy option. Regardless, after sufficient data is collected – whether good or bad – the experiment ends.

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 13, 2013 | Posted By Ricki Lewis, PhD

Earlier today, my “in” box began to fill with info from everyone I’ve ever met letting me know that the Supreme Court had ruled on the Myriad case about patenting the breast cancer genes BRCA1 and BRCA2. I also received a dozen pitches from PR people offering me all manner of instant interviews with lawyers, doctors, bioethicists, and health care analysts.

No one offered me an interview with a geneticist – a person who knows something about DNA. So being such a person myself, I decided to take a look at the decision. And I found errors – starting right smack in the opening paragraph.

“Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening exons.”

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 20, 2013 | Posted By Jane Jankowski, LMSW, MS

Helping individuals with mental retardation maximize their autonomy and enjoy fulfilling quality life experiences is often at the core of ethical arguments surrounding healthcare options for individuals with these disabilities. Having worked with adults with mental retardation I have known some who gave birth, some who got married, and many who were sexually active. There are ranges in function and comprehension in any population group, and the options ought to apply fairly with consideration for the patient’s preferences and best interests guiding decision making. I will argue that in some cases, sterilization promotes autonomy and ought to be considered an option for those with mental retardation as it is for those without any cognitive impairment.  The benefits are the same for person with mental retardation as for any individual – freedom to engage in sexual activity without the risk if unwanted pregnancy. Unlike the old sterilization policies which allowed procedures to be performed over the objections of patients and guardians, this elective procedure may be permissible if an appropriate consent process is in place and engages the patient and his or her support network in the conversation. 

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 18, 2013 | Posted By Ricki Lewis, PhD

You have your genome or exome (the protein-encoding part) sequenced to help diagnose a puzzling set of symptoms, and something totally unrelated, and unexpected, turns up – a so-called “incidental finding.”

Surprises, of course, aren’t new in medicine. The term “incidental finding” comes from “incidentaloma,” coined in 1995 to describe an adrenal tumor found on a scan looking for something else. I had one — a CT scan of my appendix revealed a polycystic liver. A friend had it much worse. She volunteered to be a control in an Alzheimer’s imaging trial, and her scan revealed two brain aneurysms!

Geneticists have long expected an avalanche of incidental findings from clinical (exome or genome) sequencing. Researchers from Baylor College of Medicine and NHGRI and elsewhere described several cases at the American Society of Human Genetics annual meeting last fall. My favorites:

- A boy had his genome sequenced as part of a project to better diagnose syndromes of developmental delay, intellectual disability, and seizures. Researchers found the aorta weakening of Marfan syndrome, gave the boy a repurposed drug in clinical trials, and he’s ok.

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 19, 2013 | Posted By Lisa Campo-Engelstein, PhD

The Dickey-Wicker Amendment (DWA) was passed in 1996 and prevents federal funding of research that destroys embryos. This congressional prohibition defines a human embryo as “any organism not protected as a human subject” that was “derived by fertilization, parthenogenesis, or any other means from one or more human gametes.” While there has been much debate in the bioethics and popular press media about the ethics of embryo research, what has been almost entirely overlooked is the ethics of parthenote research.

The DWA conflates embryos and parthenotes even though there are important scientific and ethical differences between them. Parthenotes are cells derived by parthenogenesis, the process in which eggs become activated to begin dividing without fertilization. Because there is no sperm involvement, parthenotes contain genetic material from only one source (i.e. the egg). In contrast, embryos are created through fertilization and contain genetic material from two genetically dissimilar cells (i.e. egg and sperm). Another important difference is that while embryos can result in a live birth baby, human parthenotes cannot. Human parthenotes, whether they come into existence naturally or in a lab, die in the early stages of development. Scientists can create human parthenotes in the lab by activating eggs through chemical stimuli that mimic fertilization, but studies in other mammals indicate that, without the required genetic imprinting, further development is ruled out.

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 8, 2013 | Posted By John Kaplan, PhD

Anonymity has always been an important component of protecting the privacy of human participants in research and other activities including biobanking. In his January 21, 2013 post to this blog, my colleague Zubin Master asked the question “could it be possible to identify people who have participated in biobanking projects?”  We did not have to wait very long for an answer. It turns out that the January 18, 2013 issue of Science was already on my desk.  In a study in that issue, Melissa Gyrmek and colleagues in a group led by Yaniv Ehlich describe how they used a published genetic sequence as well as accompanying metadata and freely accessible genealogy websites to identify the sequence’s owner. This was big enough news to merit a news article and a policy forum examining the ethical implications all in one issue.

A previous study (Science, September 5, 2008 p1278) had allowed donor identification from a blood sample through analysis of single nucleotide polymorphisms by sequencing a blood sample. This new study is the first to use simply a published sequence.

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 21, 2013 | Posted By Zubin Master, PhD

Biobanking involves the collection and long-term storage of biological material (e.g., cells, DNA, tissue, blood) and health information (medical history, age, weight, diet, lifestyle). Biobanking permits the examination of genetic and other biological markers on thousands of samples at a time in a given population. Thus, there has been a tremendous amount of interest by scientists, clinicians, and even bioethicists on biobanking. It has been touted as the next frontier expanding on the work done with genomics and proteomics. The value of biobanking research is that although the samples and health information are collected at some point and stored, they can be used for future research when new biomarkers are discovered. Many if not most bioethicists have explained that biobanking risks are pretty low. Risks surrounding privacy can be protected so long as proper measures are in place. As sample collection involves a blood draw or collecting tissue as part of routine care, there is also low risk of physical harm to participants. Because of the scientific and social value of biobanking and its potential minimal harms to participants, many scholars have explained that a broad or blanket informed consent procedure is suitable. According to biobanking advocates, broad consent (consent to certain broad categories of research i.e., cardiovascular or cancer research) or blanket consent (consent to all research or any medical research) is both ethically and legally permissible because re-consenting to each and every future study is resource intensive and burdensome, and there is little harms to participants and privacy risks can be protected. So what’s the problem?

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 5, 2012 | Posted By John Kaplan, PhD

It seems today that the popular press is replete with stories telling us that scientific findings which were widely believed based on earlier studies were untrue, that conclusions unsupported by previous studies are true, and in the extreme that most medical research is wrong. Why is this happening, how could this be, and most important are the studies indicating that things are not as was previously believed, in fact, correct? It turns out that much of the basis for these contradictions is the increasingly prevalent use of meta-analysis.

Meta-analysis is a technique which combines the results of multiple studies in order to provide more statistical power to the study. Statistical power is a concept that basically says that as the number of experimental observations increases, the variance (variation of data) decreases and the effect size (difference between control and experimental observations) increases, a study becomes more powerful. Therefore, by using the results of multiple studies statistical power increases, generally due to a greater number of experimental observations.

It is important to keep in mind that meta-analysis is not a single well established technique but rather a general approach with various techniques used to combine results. Most use weighted averages of outcomes with weighting of individual studies based on sample size or event rate. There is nothing wrong with this approach. 

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.

July 6, 2012 | Posted By John Kaplan, PhD

In an opinion piece by Thomas Stossel, the Harvard physician and researcher argues that financial conflicts of interest between academic research investigators and industry are “unequivocally beneficial” and that the concern that these may cause bias is a “mania”.  Dr. Stossel seems to be on a crusade in this regard having written numerous similar opinion pieces published in industry supported blogs, Forbes, and the Wall Street Journal and has even started an organization (Association of Clinical Research and Educators) for the purpose of advancing his viewpoint. Dr. Stossel is the brother of well known libertarian and Fox News commentator John Stossel and seems to be expressing a similar libertarian view on biomedical research. Especially interesting considering the apparent strength of his beliefs is his recent publication in Nature Biotechnology in which he claims to prove that those who hold an opposing point of view are biased.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

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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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