Tag: informed consent

Bioethics Blogs

Webinar Follow-up: Common Rule Informed Consent, Part I

In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule. This is Part I of a two-part series.

The post Webinar Follow-up: Common Rule Informed Consent, Part I appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Organ donation for transplantation in children with cardiac arrest and dying person dignity

Premortem interventions before donation in circulatory arrest in children could have objective ethical problems 

(See our special reports about criterion of death and organs transplantation HERE)

Up until a few years ago, performing medical interventions in end-of-life situations had been proposed as actions centered on the best interests of the dying patient.

The growing demand for organs for transplantation has created a need to increase the number of organ donors (see HERE).

Since the number of brain-dead donors is currently insufficient to meet the needs of patients on the transplant waiting list, medical procedures have been developed in the last decade aimed at ensuring that the organs from donors in cardiac arrest are also suitable for successful solid organ transplantation (see HERE our article about the relation between excellent figures of organ donation and organ donors with cardiac arrest in Spain).

Nevertheless, in order to achieve sufficient organ viability in donors with cardiac arrest, a series of medical procedures need to be performed that have the main aim of reducing the warm ischaemia time to which these organs are subjected, in order to increase the chances of post-transplant success.

An article has recently been published in the Journal of Medical Ethics (1“Premortem interventions in dying children to optimise organ donation: an ethical analysis”, whose authors Joe Brierley and David Shaw analyze the ethical and legal aspects of premortem interventions performed in dying children, aimed at optimizing organ donation for transplantation following cardiac arrest.

Premortem interventions in pediatric patients for organ donation from an ethical perspective

This article examines the legislative aspects (specific to the United Kingdom), and also gives a description and analysis of the elements that, from an ethical perspective, might support – or contradict – the performance of premortem interventions in pediatric patients for organ donation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

End-of-Life Healthcare Sessions at ASBH 2017

The 2017 ASBH
conference
 in October 2017 includes over 400 workshops, panels, and
papers in bioethics and the health humanities.  Here are ones that pertain
to end-of-life issues.


THURSDAY, OCTOBER 19


THU 1:30 pm:  End-of-Life Care and Decision-Making in the ICU – Limited
English Proficiency as a Predictor of Disparities (Amelia Barwise)


Importance: Navigating choices in predominantly English-speaking care settings
can present practical and ethical challenges for patients with limited English
proficiency (LEP). Decision-making in the ICU is especially difficult and may
be associated with disparities in health care utilization and outcomes in critical
care. 


Objective: To determine if code status, advance directives, decisions to limit
life support, and end-of-life decision-making were different for ICU patients
with LEP compared to English-proficient patients. 


Methods: Retrospective cohort study of adult ICU patients from
5/31/2011-6/1/2014. 779 (2.8%) of our cohort of 27,523 had LEP. 


Results: When adjusted for severity of illness, age, sex, education, and
insurance status, patients with LEP were less likely to change their code
status from full code to do not resuscitate (DNR) during ICU admission (OR,
0.62; 95% CI, 0.46-0.82; p


Conclusion: Patients with LEP had significant differences and disparities in
end-of-life decision-making. Interventions to facilitate informed
decision-making for those with LEP is a crucial component of care for this
group.


THU 1:30 pm:  “But She’ll Die if You Don’t!”: Understanding and
Communicating Risks at the End of Life (Janet Malek)


Clinicians sometimes decline to offer interventions even if their refusal will
result in an earlier death for their patients. For example, a nephrologist may
decide against initiating hemodialysis despite a patient’s rising creatinine
levels if death is expected within weeks even with dialysis.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Heads Up: Time to Say Goodbye to Football

by Craig Klugman, Ph.D.

Suppose a prescribed drug caused brain damage in 99.1% of people who took it. Would you take the drug? How long before that drug was pulled from the marketplace and the lawsuits against the manufacturer began? What if that drug made the company $7.2 billion per year? What if those who took the drug became celebrities for a brief period of time? Would you consider taking it then? Most rational people would refrain from the medication and the FDA would remove it from the market.

If you substitute the word “football” for “drug,” then you know the results of a new study in

JAMA, which definitively proves that football is bad for one’s health. In the study of 111 brains of former NFL players donated to the researchers, 110 (that’s 99.1% of the sample) showed evidence of chronic traumatic encephalopathy (CTE). Researchers examined a total of 202 donated brains. Ninety-one brains came from non-NFL players including those who played in pre-high school; high school; college, semi-pro, and Canadian Football League. Of those brains 66 showed evidence of CTE (72.5%). The percent of players with CFL increases with the level of football play (which is a substitute for number of years in the sport and number of likely concussions).

Level of PlayPercent of Brains Showing CTE
Pre-High School0%
High School21%
College91%
Semi-Pro64%
CFL88%
NFL99%
*Maez, Daneshvar, Kiernan 2017

The severity of the brain’s CTE was correlated with the level of play as well. One hundred percent of high school player’s brains had mild CTE and 86% of professional players had severe CTE.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Eugenics in Tennessee

A recent news story from my home state of Tennessee brings up questions of informed consent, reproductive ethics, eugenics, opioid abuse, and other bioethical issues.  In May, White County judge Sam Benningfield issued an order that allows inmates to have their sentences reduced by thirty days if they consent to sterilization procedures: vasectomies for men and (reversible) Nexplanon implants for women.  Benningfield’s order is his response to the repeat drug offenders he sees in the courtroom.  He describes the sterilizations as a means to “encourage personal responsibility,” and also states that, “…if you reach two or three people, maybe that’s two or three kids not being born under the influence of drugs. I see it as a win, win.”

This order is less surprising, perhaps, when considered in light of the United States’ very recent history of eugenics and forced sterilizations. As Kyle Sammin writes at The Federalist,

“[Benningfield’s] idea of ‘trying to break a vicious cycle of repeat offenders’ is, nearly word-for-word, an echo of the Supreme Court’s reasoning in Buck v. Bell, the 1927 case that upheld Virginia’s policy of sterilizing state asylum inmates without their consent. The decision by Justice Oliver Wendell Holmes laid out a similar desire to break a cycle of reproduction by people the judge viewed as unworthy of life: ‘It is better…if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind….Three generations of imbeciles are enough.’”

Benningfield’s order deems inmates’ potential future children as unworthy of life because of their parents’ situations.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

July 18, 2017

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In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

… Read More

Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

My Sister’s Keeper: An Assessment of Living Organ Donation among Minors

by Alex Fleming

The 2009 film My Sister’s Keeper, based on Jodi Picoult’s 2004 New York Times bestselling novel which bears the same name, is among other things, a controversial story about a young girl (Anna Fitzgerald) who sues her own parents in order to obtain legal rights to the use of her body. For as long as she can remember, Anna has unwillingly been providing blood and bone marrow to her older and critically ill sister, Kate. As the story unfolds, tension within the family arises as the 13 year-old Anna Fitzgerald becomes fully aware of her reason for existence, so to speak, which is to prevent the death of her older sister by providing a regular supply of blood and bone marrow, which she has done regularly for several years. Later on, as Kate’s condition worsens and her renal function begins to fail, the parents naturally turn to Anna to provide what could be a life-saving kidney transplant for her older sister. The climax of the story begins as Anna confidently and heroically refuses. The story raises a slew of bioethical issues which are beyond the scope of this essay; however, the story sheds light on a topic worthy of discussion: living organ donation among minors.

As the supply of organs suitable for transplantation decreases and the demand for them increases, the question of living organ donation among those yet of age has become a question of greater concern, primarily among those who point to the various ethical implications which such a procedure creates.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Shared Decision Making and Patient Decision Aids

It was a pleasure to participate in the 9th International Shared Decision Making Conference this week.

While ethical and legal principles recognized the doctrine of informed consent 50 years ago, only today are we really moving toward patient-centered…

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Key Information: The Insightful Element

Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”? My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops.

The post Key Information: The Insightful Element appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.