Hot Topics: Informed Consent

Blog Posts (45)

March 31, 2017

BioethicsTV: Aggressive Treatment Chosen for Patients at the End of Life

by Craig Klugman, Ph.D.

This week’s Thursday night medical TV was all about end of life decision-making and delved into the questions of how much aggressive treatment is too much, what happens when physicians lose clinical distance, and who makes decisions for patients.…

March 24, 2017

Bioethics & Wine

I never thought I’d have the opportunity to use this blog title. Never, that is, until I stumbled across a company called Vinome, a California start-up that offers a curated wine service based on a customer’s individual taste profile. What makes this wine subscription service unique is not its price (although, at around $65 a bottle, it’s just a bit outside of the typical price-per-bottle for many wine club members). At Vinome, your taste profile includes not only a list of questions about your preferences, but also information from DNA sequencing from the saliva sample you provide to the company. The company website proclaims this is “A little science and a lot of fun,” but experts are skeptical about whether there is any science involved at all.

Holding aside the question of scientific plausibility, companies touting direct-to-consumer genetic screening for ancestry, medical issues, or just plain fun include information in the fine print that would give any bioethicist pause. While the Vinome website requires patrons to check the box indicating “I have read and understand the Vinome Informed Consent” prior to ordering, that “informed consent” is only available if the customer voluntarily clicks on the informed consent link. Buried at the bottom of the informed consent screen is a sentence that reads:

 

“You allow Vinome to retain your data as part of Vinome’s secure research database, for use by Vinome or its research affiliates, in an effort to improve and expand services. If any commercial product is developed as a result of the use of your data, there will be no financial benefit to you.”

 

In case the business interests are still unclear, here is more from their Terms of Service:

 

“By submitting DNA to Vinome, you grant Vinome a perpetual, royalty-free, world-wide, transferable license to use your de-identified DNA, and to use, host, sublicense and distribute the anonymous resulting analysis to the extent and in the form or context we deem appropriate on or through any media or medium and with any technology or devices now known or hereafter developed or discovered.”

 

That’s quite a sweeping consent, and one of which I suspect most customers will never be aware. Individuals who are just hoping for some scientific guidance on whether to buy the merlot or the syrah are also unwittingly sending their genetic information into the stream of commerce to be collected, analyzed, bought, sold, and mined for data. We might be willing to give up some of our personal information in exchange for cheaper groceries, but buying and selling our spending habits seems a lot less invasive than doing the same to our DNA. Despite our best efforts, genetic information can never truly be de-identified – DNA itself is our best identifying information.

Direct-to-consumer marketing of genetic screening has seen much growth in the past few years. In addition to Vinome, the consumer genomics firm Helix has partnered with several entities to offer services, including National Geographic (offering ancestry tracing), ExploraGen (offering “personalized epicurean experiences”), and Invitae (offering interpretation of genetic screening to provide “actionable findings” related to various diseases – requires clinician authorization). While use of genetic information in research is heavily regulated and a source of ongoing debate, should consumers of commercial genetic testing be protected as well? Are these customers aware of the information they are freely giving, and the myriad ways their most personal information may someday be used? And how does informed consent fit into this middle ground between medicine and commerce? It seems to me, at the very least, the consumer should be required to give explicit consent beyond merely “checking the box” – whether such consent could ever really be “informed” is another question altogether.

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.

March 22, 2017

Texas Considers Letting Doctors Lie to Patients

by Craig Klugman, Ph.D.

The Texas Senate just passed a new bill (SB 25) that would shield doctors from a lawsuit if a baby is born with a disability even if the doctor knew of the concern and chose not to tell the parents.…

February 24, 2017

BioethicsTV: Substituted Judgment

by Craig Klugman, Ph.D.

On Grey’s Anatomy (Season 13, Episode 14) two cases lead to questions about who makes decisions for patients.…

February 21, 2017

Studying “Friends”: The Ethics of Using Social Media as Research Platforms

by Sandra Soo-Jin Lee, Ph.D.

Social media is increasingly creating the contours of many Americans’ daily lives as a medium that is simultaneously intimate and powerfully public.…

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.…

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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 (24)

April 6, 2017 9:00 am

Trump Completes Repeal of Online Privacy Protections From Obama Era (Washington Post)

President Trump on Monday signed a congressional resolution to complete the overturning of internet privacy protections created by the Federal Communications Commission during the Obama administration. The change will allow broadband internet service suppliers, such as cable and telecommunications companies, to track and sell a customer’s online information with greater ease.

March 23, 2017 9:00 am

San people of Africa draft code of ethics for researchers (Science)

The San people of Southern Africa are among the closest living relatives of our hunting and gathering ancestors. Scientists have flocked to study their age-old rituals and ancient genetic fingerprints. Now, after more than a century of being scrutinized by science, the San are demanding something back. Earlier this month the group unveiled a code of ethics for researchers wishing to study their culture, genes, or heritage.

March 20, 2017 9:00 am

Informed Patient? Don’t Bet On It (New York Times)

As doctors, our goal is to help you, of course, and to do no harm. But we may actually hurt you, irreversibly. Not that this happens frequently, but it might. How does that sound? Ready to take the plunge? The secret is that informed consent in health care is commonly not-so-well informed. It might be a document we ask you to sign, at the behest of our lawyers, in case we end up in court if a bad outcome happens. Unfortunately, it’s often not really about informing you.

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.

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