Category: Informed Consent

(Institute for the feeble-minded, Lincoln, Ill. / Library of Congress)

Why Buck v. Bell Still Matters

The Petrie-Flom Center Staff Leave a comment

By Jasmine E. Harris

In 1927, Buck v. Bell upheld Virginia’s Eugenical Sterilization Act, authorizing the state of Virginia to forcibly sterilize Carrie Buck, a young, poor white woman the state determined to be unfit to procreate.

In less than 1,000 words, Justice Oliver Wendell Holmes, writing for all but one of the Justices of the Court, breathed new life into an otherwise fading public eugenics movement.

More than 70,000 people (predominantly women of color) were forcibly sterilized in the twentieth century.

Buck is most often cited for its shock value and repeatedly, for what is, perhaps, its most famous six words: “Three generations of imbeciles are enough.” While this may be the most provocative language in the opinion, it is not the most noteworthy.

Read More

Minneapolis, MN / USA - May 26 2020: Black Lives Matter, "I Can't Breathe" Protest for George Floyd.

Expendable Lives and COVID-19

The Petrie-Flom Center Staff Leave a comment

By Matiangai Sirleaf

Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).

“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.

Read More

Syringe and vials of vaccine.

Racial Inclusivity in COVID-19 Vaccine Trials

The Petrie-Flom Center Staff Leave a comment

By Colleen Campbell

Recent calls for racial inclusivity in vaccine trials, which often rely on genetic rationales while emphasizing medical distrust among African Americans, unfortunately lack an equally robust critique of medical racism and the ongoing reasons for this distrust.

Even though race lacks genetic meaning, the COVID-19 discourse is rife with biological notions of race. Because of “[g]enetics related to racial differences” African Americans must be involved in clinical trials, said Dr. Larry Graham in an NBC News article. He continued: “We must be sure it works in Black folks.” For this reason, companies like biotech firm Moderna are enlisting Black religious leaders to heavily recruit African American participants. They are also exploiting networks previously used for HIV clinical trials.

Read More

an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

Beatrice Brown Leave a comment

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

Read More

Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

Beatrice Brown Leave a comment

By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

Read More

Zoom in of a dashboard focusing on the "App Store" widget

Can Bedside Consent Apps Improve Informed Consent During Childbirth?

Alexa Richardson Leave a comment

By Alexa Richardson

Informed consent in childbirth is under fire by advocates, who stress that there is a widespread absence of meaningful informed consent during birth. While informed consent in medical settings always poses challenges, informed consent in childbirth raises particular concerns. Labor unfolds in real-time, and people are heavily reliant on their provider for information during birth. Providers may not adequately seek informed consent out of a belief that they should make decisions in the fetal interest, rather than the parent. Furthermore, laboring people make choices that are more than medical: birth is a value-laden process entwined with beliefs about parenting, life-meaning, and fetal interests.  A new solution is on the table that could help improve the process of informed consent in childbirth: guided decision-making apps. This year, multiple mobile apps are in the works that would assist laboring people and clinicians in real-time decision-making during labor and birth.

Read More

Surrealist black and white photograph of a person wearing a bowler hat and button down shirt. Ther person's face is obscured totally by a tiny cloud

DNA Phenotyping Experiment on Uighurs Raises Ethical Questions About Informed Consent

Beatrice Brown Leave a comment

By Beatrice Brown

On December 3, The New York Times broke shocking news: China has been using the DNA of Uighurs, a Muslim minority group who have been facing increased persecution, to create an image of a person’s face using a process called DNA phenotyping. The Uighur men were living in Tumxuk (a city in the Xinjiang region), which The New York Times notes being described by Chinese state news media as “one of the gateways and major battlefields for Xinjiang’s security work.” The New York Times introduced many troubling ethical issues, including the potential for increased social surveillance and thus increased “state discrimination” of this vulnerable ethnic minority, but here, I wish to focus on the issue of informed consent.

Informed consent is essential to conducting ethical research. Premised on respecting the autonomy of participants, informed consent requires that participants understand the research that they are consenting to be involved in, including potential risks and benefits of the research. However, what exactly constitutes true, valid informed consent to research is a contentious issue. There are two concerns about the validity of the informed consent process in this DNA phenotyping experiment. Read More

Blurred image of a patient in critical condition in the ICU ward.

“An Act Improving Medical Decision Making:” An Argument in Favor of MA House Bill 3388 and Senate Bill 843

Beatrice Brown Leave a comment

By Beatrice Brown

On September 10, 2019, the Joint Committee on Judiciary at the Massachusetts State House heard testimony regarding House Bill 3388 and Senate Bill 843, “An Act Improving Medical Decision Making.” The Massachusetts Medical Society (MMS) was among those testifying in favor of the act. As noted by MMS, Massachusetts is one of only five states in the U.S. that does not have a default surrogate consent statute for incapacitated patients without a health care proxy. The intent of a default surrogate consent statute is “to provide legal authority for health care decision-making through a non-judicial rule of law where no guardian or agent had been appointed.”

Without such a statute in place, this means that a patient who is incapacitated and has not declared a health care proxy must await treatment while a guardian is appointed by the courts. This may be a lengthy, time-consuming process that physically drains hospitals’ resources and emotionally drains families. By contrast, these default surrogate consent statutes establish a list of surrogates that can be appointed by physicians to make decisions in lieu of the incapacitated patient. For example, in the Massachusetts bills, the following persons are listed as candidates who may be appointed as surrogates: the person’s spouse, unless legally separated; the person’s adult child; the person’s parent; the person’s adult sibling; and any other adult who satisfies the requirement of subdivision seven of the bill which states, “The person’s surrogate shall be an adult who has exhibited special care and concern for the person, who is familiar with the person’s personal values, who is reasonably available, and who is willing to serve.” Read More

Photograph of a woman lying in a hospital bed holding her newborn wrapped in a blanket

Where Are the Legal Protections for People Mistreated in Childbirth?

Alexa Richardson Leave a comment

By Alexa Richardson

A new study indicates that 28.1% of women birthing in U.S. hospitals experienced mistreatment by providers during labor, with rates even higher for women of color. The multi-stakeholder study, convened in response to World Health Organization efforts to track maternal mistreatment, included more than 2,000 participants, and defined mistreatment as including one or more occurrences of: loss of autonomy; being shouted at, scolded, or threatened; or being ignored, refused, or receiving no response to requests for help. The study newly highlights the lack of legal protections available to for pregnant and birthing people who experience these kinds of mistreatment by providers.

Campaigns like Exposing the Silence have chronicled the outpouring of people’s harrowing birth stories, riddled with abuse and violations of consent. In one typical account, a user named Chastity explained:

I had a room full of student doctors, an OB I never met come in and forcibly give me extremely painful cervical exams while I screamed for them to stop and tried to get away. They had a nurse come and hold me down. There was at least 10 students practicing on me. I was a teen mom and my partner hadn’t gotten off work yet so I was all alone.

Another user named Abriana recounted:

As I was pushing, I got on my side and it was then that I started to feel pain much different from labor pains. I asked, ‘What is going on?’ The nurse replied, ‘I am doing a perineal rub.’ I immediately said, ‘Please stop doing that. You are hurting me.’ The nurse argued, ‘It will help you’ and didn’t move. I asked her again to please stop. I then yelled, while pushing, ‘Get your hands out of me!’ The nurse continued.

The traditional modes of seeking legal recourse have little to offer those who experience these kinds of mistreatment.

Read More

Photograph of a doctor holding a headset sitting in front of a laptop

Navigating Sensitive Hospital Conversations in the Age of Telemedicine

Adriana Krasniansky Leave a comment

By Adriana Krasniansky

On March 5, 2019, a terminally ill patient from Fremont, California, learned that he was expected to die within several days. The doctor who delivered the news did so via a robotic video teleconferencing device. 

Ernest Quintana, a 79-year-old patient with a previously-diagnosed terminal lung condition, was taken to the Kaiser Permanente Fremont Medical Center emergency room after reporting shortness of breath. His 16-year-old granddaughter, Annalisia Wilharm, was with him when a nurse stopped by and said that a doctor would visit shortly to deliver Mr. Quintana’s results. 

The video below, recorded by Ms. Wilharm, shows Mr. Quintana’s consultation with a critical care doctor through an Ava Robotics telepresence device—in which the doctor explains Mr. Quintana’s rapidly worsening condition and suggests transitioning to comfort care. Ms. Wilharm and her family chose to share the video with local media and on Facebook, inciting a debate around the legal and ethical challenges of using telemedicine in critical care conversations. 

Read More