Hot Topics: Informed Consent

Blog Posts (40)

February 16, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

by Steven H. Miles, MD

Bioethicist Steven Miles suggest that making the new Common Rules regulations easy to read is as important as the content

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.…

February 15, 2017

Beyond the Destination LVAD

There are many forms of life sustaining treatment available to patients thanks to advances in medical technology. When a person’s physiology weakens or fails, devices may be attached or implanted to take over for organs that can no longer bear the workload of processing, moving, or taking in the elements needed to keep a body alive. Conceptually, this is appealing to a society that is as averse to death as are those of us here in the US. But we still struggle to accommodate the range of needs that crop up when function is compromised. As an ethicist, the general trend in my work suggests that the more advanced the technology, the more questions it raises when it comes time to talk about halting the mechanical support. Among the more advanced tools for sustaining physiological function is the Left Ventricular Assist Device, or LVAD, which maintains the circulatory function for persons with severe heart failure.

There is little doubt that individuals who are eligible for the device can experience remarkable quality of life gains whether they move on to receive a heart transplant or receive the implant as a destination treatment. Recipients of LVADs can typically return to their daily activities, and enjoy a level of independence not previously possible for persons with otherwise lethal heart conditions. However, these patients are not just like everyone else when complications arise. Decisions about how best to manage long term care for persons who have LVADs can be unexpectedly complex, most notably when the patient lives outside a major metropolitan city center. In particular, securing services when such patients suffer non-cardiac health complications after having the device implanted can be difficult. Consider a patient who is stable with a destination LVAD who develops end stage renal disease and requires hemodialysis. Outpatient dialysis centers can be fearful about safely managing the ongoing dialysis treatment for a patient when they do not have experience with ventricular assist devices. The same may apply to residential care centers when a patient needs a period of rehab for an injury unrelated to the heart failure diagnosis. Perhaps the most challenging circumstance involving resources for LVAD patients who experience age related cognitive decline and need nursing home level care due to confusion, impulsivity, and routine self-care deficits. There are no clear restorative goals, but the need for custodial care can quickly exceed what was once possible at home, but the LVAD is usually unfamiliar to small town nursing homes and can be a barrier to securing long term residential care.

This issue raises an important justice question for LVAD candidates. Should consent for LVADS, when known to be destination devices, include information about the limitations in assuring other types of services? If so, how do we assure that this information is delivered in a way that does not discriminate against patients from more remote areas while favoring those who live near facilities that routinely care for LVAD patients? 

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 17, 2017

‘Goodness of Fit Ethics’ to Promote Health Research for LGBT Youth

This past November, Public Responsibility in Medicine and Research (PRIM&R), a non-profit organization dedicated to the study and advancement of the highest ethical standards in the conduct of research, held its annual Advancing Ethical Research (AER) Conference featuring Dr. Celia B. Fisher, Director of the Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute … More ‘Goodness of Fit Ethics’ to Promote Health Research for LGBT Youth
January 6, 2017

BioethicsTV (January 2-6, 2017): Violating promises, coma v. PVS, transplant evaluation, and whether to abort

by Craig Klugman, Ph.D.

Pure Genius (Season1; Episode 10- 1/5). In this episode, Dr. Channarayapatra is working with a patient in lung failure.…

December 19, 2016

BioethicsTV: Pure Genius Proudly Ignores the Rules

by Craig Klugman, Ph.D.

“We’re Bunker Hill, since when do we follow the rules” sums up the attitude of this poor-performing medical drama that kicks ethics, law, and regulation to the curb on a weekly basis.…

December 7, 2016

TEDxFordhamUniversity: Lesson in Bioethics Given by Golden Girls | Dr. Elizabeth Yuko

As one of the most groundbreaking sitcoms of all time, The Golden Girls introduced a range of bioethical issues on the show regarding medicine, the human body and women’s health. In this TEDx Talk, Dr. Elizabeth Yuko, a Fordham University Center for Ethics Education  fellow and adjunct professor, discusses how influential Golden Girls was, and still is, … More TEDxFordhamUniversity: Lesson in Bioethics Given by Golden Girls | Dr. Elizabeth Yuko
December 1, 2016

BioethicsTV (November 2016): Informed consent, HIV organ transplants, Forgiveness, Assisted Suicide, Treating Prisoners, Undue Influence in Consent, and Failure to Vaccinate

by Craig Klugman, Ph.D.

Grey’s Anatomy (Season 13, Episode 9). A building collapses when a landlord has failed to make necessary repairs a year after an earthquake.…

October 28, 2016

BIOETHICS TV 10/27 – Modern miracles, body hacking, and sex trafficking

by Craig Klugman, Ph.D.

Pure Genius (Seasons 1, Episode 1)

This new TV show might be the ethicists worst nightmare. The show opens with Dr.…

October 18, 2016

BioethicsTV: 10/11-10/17 – Assaulting demented patients, sex trafficking, and surrogate decision-making

by Craig Klugman, Ph.D.

An occasional column examining the ethical issues raised in television medical dramas.

On Code Black (Season 2; Episode 3) the most important ethical issue was very brief, not taking more than about 2 minutes of screen time.…

August 25, 2016

Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world.…

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Published Articles (27)

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

When are primary care physicians untruthful with patients? A qualitative study Stephanie R. Morain, Lisa I. Iezzoni, Michelle M. Mello, Elyse R. Park, Joshua P. Metlay, Gabrielle Horner & Eric G. Campbell

American Journal of Bioethics: Volume 17 Issue 2 - Feb 2017

LVAD-DT: Culture of Rescue and Liminal Experience in the Treatment of Heart Failure Frances K. Barg, Katherine Kellom, Tali Ziv, Sarah C. Hull, Selena Suhail-Sindhu & James N. Kirkpatrick

American Journal of Bioethics: Volume 17 Issue 2 - Feb 2017

CPR and Ventricular Assist Devices: The Challenge of Prolonging Life Without Guaranteeing Health David Magnus & Danton Char

American Journal of Bioethics: Volume 17 Issue 1 - Jan 2017

Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies Katrina Karkazis & Jennifer R. Fishman

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Does promoting research advance planning in a general elderly population enhance completion of a research directive and proxies' predictive ability? a randomized controlled trial Gina Bravo, Lise Trottier, Marie-France Dubois, Marcel Arcand, Danièle Blanchette, Anne-Marie Boire-Lavigne, Maryse Guay, Paule Hottin, Julie Lane, Suzanne Bellemare & Karen Painter

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

A pilot study of neonatologists' decision-making roles in delivery room resuscitation counseling for periviable births Brownsyne Tucker Edmonds, Fatima McKenzie, Janet E. Panoch, Douglas B. White & Amber E. Barnato

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Clarifying ethical responsibilities in pediatric biobanking Merle Spriggs & Craig L. Fry

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Experimental evidence showing that physician guidance promotes perceptions of physician empathy Daniel Russell Hans, Priyanka Dubé & Jason Adam Wasserman

American Journal of Bioethics: Volume 16 Issue 8 - Aug 2016

The Curious Case of the De-ICD: Negotiating the Dynamics of Autonomy and Paternalism in Complex Clinical Relationships Daryl Pullman & Kathleen Hodgkinson

American Journal of Bioethics: Volume 16 Issue 8 - Aug 2016

Reason, Emotion, and Implanted Devices John D. Lantos

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News (21)

February 10, 2017 9:00 am

Brain researchers fight National Hockey League’s demand for records (Science)

A pair of Boston University (BU) brain researchers is pushing back against demands by the National Hockey League (NHL) that they release data, brain pathology slides, and interview records of former NHL players and their families. The scientists accumulated the records during their research on chronic traumatic encephalopathy (CTE), a neurodegenerative disease that has been linked to repetitive head trauma.

January 20, 2017 9:00 am

How Science Is Helping Us Understand Gender (National Geographic)

A “neutral space” is a hard thing for a teenager to carve out: Biology has a habit of declaring itself eventually. Sometimes, though, biology can be put on hold for a while with puberty-blocking drugs that can buy time for gender-questioning children.

January 20, 2017 9:00 am

New Common Rule on the Federal Policy for the Protection of Human Subjects (Federal Register)

The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

October 21, 2016 8:00 am

The dangers of euthanasia-on-demand (Chicago Tribune)

If the Dutch Cabinet gets what it wants, citizens who feel they have a “completed life” soon will be able to request public support for help in ending their lives. It is a frightening precedent that other nations ought not follow, and a policy the Dutch ought to reject.

September 22, 2016 8:00 am

Belgium minor first to be granted euthanasia (BBC News)

A terminally ill 17-year-old has become the first minor to be helped to die in Belgium since age restrictions on euthanasia requests were removed two years ago, officials say.

April 27, 2016 8:00 am

Letters Telling Women About Breast Density Are Often Too Darn Dense (NPR)

Over the past decade, states have passed laws intended to help women understand the results of their breast cancer screening mammograms if they have dense breasts. But those notifications can be downright confusing and may, in fact, cause more misunderstanding than understanding.

March 9, 2015 6:28 pm

Seeing medical records might ease hospital patients’ confusion

Letting patients see their medical records while they’re in the hospital might ease worry and confusion without extra work for doctors and nurses, a small study suggests.

August 20, 2014 4:21 pm

California lawmakers pass bill banning inmate sterilizations

California lawmakers sent a bill to ban sterilization surgeries on inmates in California prisons to Governor Jerry Brown on Tuesday, after media reports and a later audit showed officials failed to follow the state’s rules for obtaining consent for the procedure known as tubal ligation from incarcerated women.

April 23, 2014 1:46 pm

Would you share your DNA info to advance medicine?

The provocative question of how “big data” will affect medicine and patient privacy is getting a lot of attention at the National Institutes of Health.

December 20, 2013 1:58 pm

The Supreme Court’s terrible—and dangerous—ruling this week on the Fifth Amendment.

On Monday, in a case called Salinas v. Texas that hasn’t gotten the attention it deserves, the Supreme Court held that you remain silent at your peril. The court said that this is true even before you’re arrested, when the police are just informally asking questions.

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