Hot Topics: Informed Consent

Blog Posts (54)

August 2, 2017

Sterilization for Prisoners Is Not New and Shows That Studying History is Essential

by Craig Klugman, Ph.D.

In 1927, Supreme Court Justice Oliver Wendell Holmes ruled that Carrie Buck and her baby could be sterilized because of a perception that they were “mental defectives.” In the 20th century, 32 states had federally funded programs that sterilized “undesirable” populations.…

July 25, 2017

Surgical Bioethics: Is It Different?

By Wydell L. Williams, Jr. Recently I was asked to give a talk on ethics to my surgical colleagues.  The Nevada Chapter of the American College of Surgeons has regular meetings and there are usually one or two speakers giving talks that are relevant to surgeons and their practice.  The speakers are usually academic surgeons […]
July 19, 2017

The Constructed Sex Worker: Clinical Tool or Normalizer of Sexual Objectification

by Craig Klugman, Ph.D.

Sex robots are real and so are the campaigns to free them. In the 2016 HBO series Westworld, viewers are introduced to an old Wild West town which includes a saloon where one can buy a drink, listen to music, or procure the services of an android sex worker.…

July 7, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

June 14, 2017

Trump Opioid Task Force Considers HIPAA Exception for Overdoses

by Craig Klugman, Ph.D.

Confidentiality is one of the sacrosanct principles of medicine. By keeping the secrets that patients share with health care providers, the patient trusts the provider and the provider has the information necessary to diagnose and treat.…

May 31, 2017

Time to Secure Your Implantable Medical Devices from Hackers

by Craig Klugman, Ph.D.

In the last few weeks, a major malware attack (WannaCry) paralyzed computers around the world, including electronic health records at the UK’s National Health Service and at hospitals throughout the world.…

May 8, 2017

Woolgathering: It’s a Bag, It’s a Baby, It’s an Artificial Womb!

by Craig Klugman, Ph.D.

An announcement last week took the science dream of an artificial womb one step closer to science fact: premature lambs were gestated in a biobag (technically an “extra-uterine system”).…

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.…

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Published Articles (33)

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

The Final Rule: When the Rubber Meets the Road P. Pearl O'Rourke

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Examining Provisions Related to Consent in the Revised Common Rule Jeremy Sugarman

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Rethinking the Belmont Report? Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan

American Journal of Bioethics: Volume 17 Issue 6 - Jun 2017

When Respecting Autonomy Is Harmful: A Clinically Useful Approach to the Nocebo Effect John T. Fortunato, Jason Adam Wasserman & Daniel Londyn Menkes

AJOB Primary Research: Volume 8 Issue 2 - Apr 2017

Perspectives of IRB chairs on the informed consent process Eugene I. Kane III & Joseph J. Gallo

AJOB Primary Research: Volume 8 Issue 2 - Apr 2017

Does experience matter? Implications for community consultation for research in emergency settings Victoria M. Scicluna, Mohammed K. Ali, Rebecca D. Pentz, David W. Wright & Neal W. Dickert

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

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News (26)

June 14, 2017 9:00 am

Heaven over hospital: Dying girl, age 5, makes a choice (CNN)

Julianna Snow is dying of an incurable disease. She’s stable at the moment, but any germ that comes her way, even just the common cold virus, could kill her. She’s told her parents that the next time this happens, she wants to die at home instead of going to the hospital for treatment. If Julianna were an adult, there would be no debate about her case: She would get to decide when to say “enough” to medical care and be allowed to die. But Julianna is 5 years old. Should her parents have let her know how grave her situation is? Should they have asked her about her end-of-life wishes? And now that those wishes are known, should her parents heed them?
May 19, 2017 9:00 am

For Tuskegee Syphilis Study Descendants, Stigma Hasn't Faded (The New York Times)

For 40 years starting in 1932, medical workers in the segregated South withheld treatment for unsuspecting men infected with a sexually transmitted disease simply so doctors could track the ravages of the horrid illness and dissect their bodies afterward. Finally exposed in 1972 , the study ended and the men sued, resulting in a $9 million settlement. Twenty years ago this May, President Bill Clinton apologized for the U.S. government. It seemed to mark the end of this ugly episode, once and for all. Except it didn’t.

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.

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