Topic: Consent
November 20, 2015 | Posted By Benita Zahn, DPS

I like watching a doctor drama as much as the next person. But I don’t watch it like my friends. That’s because I’m always on alert to the bioethical issues playing out on the small screen. Often the show writers get the issues right and the program, along with its entertainment value, serves as an educational tool for the community. But when they get it wrong my forehead wrinkles and I grit my teeth. And that’s just what happened while watching a recent episode of the long running ‘Grey’s Anatomy’.

The show centered around a female patient who was diagnosed with a pituitary tumor that was causing her to add inches to her height but more importantly, threaten her life. She was given two options: surgery or probable death. The chief of surgery, the persuasive and powerful Dr. Miranda Bailey ( played by Chandra Wilson) made a clear case for surgery. But the patient wasn’t buying it and wanted to be released from the hospital. Here’s where my brow began knitting. The good Dr. Bailey wouldn’t let her go.

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 11, 2015 | Posted By Paul Burcher, MD, PhD

A couple of weeks ago I was I was the faculty attending on Labor and Delivery. We were inducing a woman with severe pre-eclampsia and an IUGR fetus. Things went well until she was five centimeters dilated, at which point the fetal tracing went rapidly from category one to category three (reassuring to really bad). I quickly explained the situation to the patient with a resident and a nurse in the room. She heard the reasons I was recommending a cesarean section, a brief discussion of its risks, and an even briefer discussion of the alternatives (continue labor placing the fetus at risk of permanent injury or death). She had no questions, and since she had already signed a cesarean consent at the beginning of the induction, we proceeded to the operating room to perform a cesarean.  She needed general anesthesia because her platelets were low, so it was too risky to give her a spinal anesthetic. During the induction but before intubation, the circulating nurse announced that she couldn’t find the “informed consent” and that we could not proceed. My response involved a reference to male cattle manure, and the comment that informed consent had just happened and that she had witnessed it herself. The anesthesiologist agreed, and the cesarean section occurred without delay.

This case exemplifies the ambiguity around “informed consent.”  The nurse was referring to a document, a signed piece of paper; I was referencing a conversation, a process involving sharing information and answering questions. From a legal perspective, informed consent would seem to represent the document, whereas from an ethical perspective it is the process, not the paper that embodies informed consent.  Of course, ultimately, both have a role to play, and in the case of a significant procedure it is best to have both sides of this informed consent coin documented.  But what I would like to suggest is that the signed document represents an artifact—a physical symbol that two parties agree that the real nature of informed consent has been fulfilled.  The piece of paper is derivative, and a signed document that lacks the ethical underpinning of a complete and valid consent discussion is meaningless. A lawyer would probably give a slightly different answer, but this is an ethics blog, not a discussion of medical malpractice.  

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 23, 2015 | Posted By Wayne Shelton, PhD

The issue of truth telling in medicine was a lively concern in the early days of modern medical ethics during the 1970’s. A new moral awareness had emerge that provided a clear moral rejection of the paternalistic approach taken in the physician-patient relationship that prioritized the traditional values of beneficence and non-maleficence over truth telling. Of course the key development that fueled this new moral perspective as well as the growing passion for medical ethics was the newfound sense that arose beginning in the 1960’s that patients with capacity have a fundamental right both to refuse unwanted treatment and give voluntary informed consent to treatments they were considering. It became obvious to students of medical ethics that if patients are to be able to exercise their right to give voluntary informed consent they must receive a full and accurate disclosure of the relevant information necessary for them to make a decision.

Up to the early 1960’s, patients coming into the health care system very well may not have had an opportunity to give voluntary informed consent. Giving patients this opportunity just wasn’t part of the medical culture. In the early 1960’s it was common for oncologists to not disclose a diagnosis of cancer; by the late 1970’s there was almost universal agreement that full disclosure was the expectation. The full moral force of the principle of respect for patient autonomy happened relatively quickly, especially after the Belmont Report of 1978, which articulated the basic principles of medical ethics (though non-maleficence was subsumed under beneficence). There is no question that the physician-patient relationship has been evolving ever since with new levels of expectations and involvement of patients and their surrogates. There is now universal agreement that physicians are expected to be truthful to patients and accurately disclose their medical condition, including diagnosis and prognosis. Without this first basic step of truth telling in disclosing the medical facts to the patient about their condition, patients cannot exercise their right to express their preferences and wishes about medical treatment and care goals, and specially give voluntary informed consent to medical interventions to treat their condition.

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.

September 18, 2015 | Posted By Jane Jankowski, DPS, LMSW

Frankenstein might want to weigh in on the release of a plan to provide a new body to a Russian man suffering from the rare muscle wasting disease, Werdnig-Hoffmann disease.  Commentators speculate that the proposed fusion of “Mr. Valery Spiridonov, a 30-year-old computer scientist from Vladimir, Russia” to a donor body is unlikely to ever actually be performed due to the seeming unlikely odds that the technical challenges could be overcome. Nonetheless, this extreme experimental undertaking raises important ethical questions about how far to press the boundaries of surgery. At one time, hemicorporectomy surgery was proposed as theoretically feasible, and though the suggestion was laughed at initially, this procedure has now been done successfully multiple times, albeit with significant risk of mortality. If we are indeed embarking on a new path where the head of one living being can be transplanted onto another, we must attend to the underlying values that we ascribe to mind, body, and personhood.

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 14, 2015 | Posted By Jane Jankowski, DPS, LMSW

Articles about improving organ donation registration rates by targeted social media campaigns have indicated that such efforts can successfully increase the numbers of individuals who elect to become organ donors (Pena, 2014) (Cameron AM, 2013). While it is acknowledged that social medial is a useful medium for generating widespread recognition of the need for organ donation, concerns about whether or not donor registration actually increases donation rates is left unknown. Additional concerns about such registrations meet the standards for informed consent. These are productive conversations, and social media holds tremendous potential for conveying information and generating levels of interest in topics at a ‘viral’ level.

Discussions up to this point seem to focus on donation after death, or in the context of imminent death. What has not been robustly discussed is the role of social media in the role of live organ donation. How should transplant programs view the relationship of acquaintances that begin on social media in the context of seeking information or support related to organ donation? Decisions to donate a solid organ, such as a kidney, ought not to be undertaken lightly, and perhaps the screening process will weed out donors with ambivalent intent or poor understanding of what they have offered a recipient. Given that concerns about informed consent have been noted in prior studies, it seems prudent to exercise added caution when approving donation transactions initiated via social media outlets.

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 26, 2015 | Posted By Zubin Master, PhD

In the past State of the Union address, Obama announced his precision medicine initiative involving the creation of a new, national level biobank.

Biobanks collect biological samples (e.g., DNA, cells, tissues, blood) and health and lifestyle information (e.g., disease information, smoking habits). By collecting it once, biobanks store biosamples and information such that they can be used as new biomarkers are discovered. As the samples are shared with others, biobanking research offers a novel research platform to perform large-scale, epidemiological studies in order to associate genotypic or biological information with healthand disease. Many nations have made significant investments into biobanking research creating national level biobanks such as the U.K. Biobank, which has half a million samples, and the Icelandic biobank called deCode Genetics.

Obama’s goal is to have at least 1 million American volunteers enroll in the biobank which will aim to conduct longitudinal studies examining genes, health and the environment. Collecting these many samples may not be so straightforward concluded a panel of experts at a recent workshop at the National Institutes of Health. Several scientific and logistical issues were discussed. What types of diseases will be studied? Who will have access to the data? Who will be recruited? Will samples from other biobanks be incorporated into the precision medicine initiative? Yet with the many scientific and logistical issues, there are numerous ethical issues including informed consent, commercialization, and the return of results that must be given due consideration.

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.

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.

SEARCH BIOETHICS TODAY
SUBSCRIBE TO BIOETHICS TODAY
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.
TOPICS