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Topic: Consent
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.

January 13, 2014 | Posted By Marleen Eijkholt, PhD

Understanding death is difficult. And this issue is an everyday occurrence for clinical ethicists. In questions around withdrawal of life support, or a shift towards comfort care if a patient’s death is imminent, such misunderstanding is a recurring problem. The case of Jahi McMath, which I will deal with later illustrates this. Death is not necessarily a flat line on a screen. Especially when machines interfere, the blibs and curves on the screen keep going. Also death might not mean a total absence of reflexes, such as reflexes to stimuli might not necessarily mean that something is alive or has consciousness.

In the clinic, I cannot necessarily rely on analogies from nature to explain that someone is no longer ‘alive’, for fear of being insensitive about loved ones. But in this blog I can draw on such analogies to illustrate my case. If you behead a chicken (for compassionate or consumerist reasons), it will continue to jump around for a couple of minutes until it bleeds out. This does not mean that the chicken is still alive after you beheaded it. The jumps are a response of the autonomic nervous system and come from a jolt of adrenaline. Similarly, a ‘sensitive-plant’ or the ‘mimosa pudica’ will retract its leaves after you touch it. It moves. See here. I don’t think that this means the plant is alive like a human being or that it ‘understands’ your touch. The retraction of the leaves is a natural reaction. Its movement does not imply consciousness. Finally, during winter time, the breaks of my bike contract and they push on the wheel. This makes it harder for me to cycle. During summer time the breaks expand and cycling is not a problem. The breaks of my bike respond to the weather, but I would not call them ‘alive’.  

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, 2013 | Posted By Benita Zahn, MS

Like everyone else, I don't want dangerous criminals roaming the streets. So on the face of things the recent US Supreme Court ruling allowing states could take DNA samples from persons accused of serious crimes without need of a warrant, sounds like a good thing. 

But, like everything in life, the devil's in the details. 

If it's okay to get that swap from a suspect's mouth for DNA when the crime is 'serious' what about when it's less serious? Who will be the judge of what constitutes a 'serious' crime? That has not been determined. 

What if the police get 'the wrong guy' .. not the guilty one. What happens to that DNA evidence and all the information contained within? 

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 5, 2013 | Posted By Marleen Eijkholt, PhD

Early November 2013: TB, a 32 year old deer hunter from Indiana, falls 16 feet from a tree while on a hunting trip and crushes his spinal cord. He injures his C3,4 and 5 vertebrae, but does not suffer any brain damage. TB’s prognosis includes paralysis from the shoulders down and potentially life-long dependence on a ventilator. His family asks the physicians if they can get him out of sedation and remove his ventilator, so that he can decide about how to proceed with his treatment. Once awake, TB hears his prognosis and asks to stop treatment. He dies one day after incurring his injury.

Several factors seem to have sparked the headlines and stir controversy, and I would like to focus on one of these. I question whether TB’s decision was and could be informed. Using this case, I propose that TB’s decision was perhaps a shot in the dark. I raise some of the pressing questions about informed consent in the clinical ethics context. I ask how we should ensure informed decision making, what we should do to enlighten patient’s perspectives and what we should do if patients refuse information that we consider material in the decision making process? 

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 13, 2013 | Posted By Jane Jankowski, LMSW, MS

This past week brought the announcement of an agreement between the living relatives of Henrietta Lacks and the U.S. National Institute of Health (NIH) regarding use of genetic information derived from HeLa cells, NY Times. Henrietta Lacks was a patient at Johns Hopkins Hospital in Baltimore, Maryland in 1951 where she was treated for and ultimately died from, cervical cancer. During her hospitalization, cells were retrieved from her tumor without her knowledge or permission. It is these cells, named HeLa cells, which proved to have an unprecedented ability to grow in laboratory cultures and were the source of many important scientific advances in the 20th centuryWall Street Journal . Neither she nor her family ever received any financial compensation for the vast contribution HeLa cells have made to science and society and restitution is not part of the story this week. Privacy of genetic information derived from Henrietta’s cells is the family’s concern, and rightly so. Of note, the story of Henrietta Lacks, her family, and HeLa cells is now widely known with the publication of Rebecca Skloot’s book, “The Immortal Life of Henrietta Lacks” in 2010 – a recommended read for anyone regardless of prior interest or knowledge in biomedical ethics www.rebeccaskloot.com

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 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.

May 22, 2013 | Posted By Benita Zahn, MS

In their 2012 article "Preserving the Right to Future Children: An ethical Case Analysis" the authors apply a principalist approach to the ethical analysis of a mother’s decision to allow her 2 year old daughter, Daisy, to undergo OTC to preserve her fertility following stem cell transplant to treat her severe Sickle Cell disease.

While this approach gives one clear parameters to make ethical decisions by identifying issues of autonomy, non-maleficence, beneficence and justice, it does not adequately provide for the contextual issues surrounding such an emotionally charged decision and thus may miss crucial points.  A narrative ethics approach would better identify the contextual issues and create an environment for those issues to be factored into the decision. 

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 30, 2012 | Posted By Michael Brannigan, PhD

Here is cardiac surgeon Christiaan Barnard's account of his conversation with Louis Washkansky just before he performed on him the first human heart transplant, in 1967:

"'We know you have a heart disease for which we can do nothing more. You have had all possible treatment, and you are getting no better. We can put a normal heart into you, after taking out your heart that's no longer any good, and there's a chance you can get back to normal life again.'

"'So they told me. So I'm ready to go ahead.'

"Washkansky said no more. His eyes remained on me but with no indication he wanted to know anything more.

"'Well, then ... goodbye,' I said.

"'Goodbye.'"

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 ourwebsite.

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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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