Tag: human experimentation

Bioethics News

The Hidden Story of Medical Experimentation on Caribbean Slave Plantations

The new book, “Secret Cures of Slaves: People, Plants, and Medicine in the Eighteenth-Century Atlantic,” zeroes in on human experimentation on Caribbean slave plantations in the late 1700s. Were slaves on New World sugar plantations used as human guinea pigs in the same way African-Americans were in the American South centuries later?

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

When Torture Becomes Science

Was the Central Intelligence Agency’s post-9/11 “enhanced interrogation” program an instance of human experimentation?

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

CIA Torture as Human-Subjects Research

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture. Some of us professionally involved in research ethics governance might not agree that norms of that discipline are beyond debate. Also, we might wonder whether ‘exporting’ the norms of research ethics for use in prosecuting torture is likely to be good for research ethics, or will it end with a reversal: Some will begin with the premise that the CIA’s torture/research program is justified by its public-interest objectives. And if the CIA can, er, ‘break new ground’ in the ethics of research, then why can’t others?

The CIA Didn’t Just Torture, It Experimented on Human Beings by Lisa Hajjar (for The Nation)

… No one has been held accountable for torture, beyond a handful of prosecutions of low-level troops and contractors. Indeed, impunity has been virtually guaranteed as a result of various Faustian bargains, which include “golden shield” legal memos written by government lawyers for the CIA; ex post facto immunity for war crimes that Congress inserted in the 2006 Military Commissions Act; classification and secrecy that still shrouds the torture program…

…Rather, because the concept of torture has been so muddled and disputed, I suggest that accountability would be more publicly palatable if we reframed the CIA’s program as one of human experimentation. If we did so, it would be more difficult to laud or excuse perpetrators as “patriots” who “acted in good faith….”

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture.

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

BioethicsTV: Violating confidentialty, ethical decision-making, unapproved human experimentation

by Craig Klugman, Ph.D.

Chicago Med (Season 2; Episode 10): In this episode a heart patient returns from a previous episode when a heart is found for a transplant. However, the patient who is 3 years sober had a couple of alcohol shots that morning upon learning that her friend had died. At a meeting of the transplant committee Dr. Latham—the cardiothoracic attending—says that the rules are clear, she must be sober for 18 months before a transplant. Dr. Charles—the psychiatrist—is conflicted, concerned that he misread the patient but also knowing, as he states, that often it takes a slip before a person with an addiction takes recovery seriously. This meeting shows a contrast between deontological ethics—following the standard without concern for consequences—and ethics of care—focusing on caring and nurturing. After the committee votes against the transplant, Latham seems concerned that he may have missed something and asks Charles why he is conflicted. The response is that the patient seemed to have true regret for her slip. But when the only other matching patient is in San Diego and there is not enough time to get her and the heart together, the decision is made to go ahead with the transplant anyway, rather than let the organ die. Thus, this is a case of having your cake and eating it too: The committee gets to follow the rules, but also gets to be compassionate and caring.

The more concerning ethical challenge in this episode revolves around a jockey who is brought to the ED after collapsing.

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

The ‘P’ Word: Hospital Ethics Committees and Palestinian National Identity by Guy Shalev

Anthropologists like to tell their stories of ‘entering the field,’ whether they are left alone on a tropical beach as their dinghy sails away (Malinowski 1922) or run away from the police into a local’s courtyard (Geertz 1973). These stories are often told to show us, their readers, the distance anthropologists must travel from their own worlds into those of their research subjects. If stories traditionally fall within the thriller or adventure genres, my own is rather more Kafkaesque. And much like the stories from The Trial and The Castle, it is more about the system in which my interlocutors and I live than our own personal stories.

It took me more than six months to get my research with Palestinian physicians approved in two large Israeli hospitals. In a third hospital my access was denied. My ‘entry story’ is thus about my repeated attempts to obtain the approval of three Helsinki Committees (HCs, Israeli hospitals’ research ethics committees) to conduct ethnographic research with Palestinian physicians in Israeli public hospitals. While my research was eventually approved in two of these institutions, correspondence with HC representatives, as well as evidence of their informal moves with institutions’ management, reflect their perceptions of the risk my study posed.

I had already passed the University of North Carolina’s meticulous ethical approval process, and so the very different response of Israeli committees left me bewildered. Had the UNC’s committee overlooked important risks? In fact, the discrepancies between these committees calls into question the very idea of a universal ethical code of research conduct, as the 1964 Declaration of Helsinki aimed to establish.

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

Dangers of an Unscientific Policy Process: Why the UK

Several researchers around the world have now turned the CRISPR genome editing craze towards human embryos, reigniting questions around the feasibility, legality, and morality of creating genetically modified humans. Some have suggested that we look for guidance to the United Kingdom’s policy process for “mitochondrial replacement,” also known as “three-person IVF,” which culminated in the world’s first legalization of a procedure that is technically a form of heritable human genetic modification in 2015.

How did the UK come to enable techniques that arguably contradict a policy in force throughout Europe for more than 15 years?

Having followed the process for several years, I would argue that we can learn a great deal from its history, but more specifically in what not to do moving forward in the CRISPR policy debate. In this blog, I will try to explain why.

I am a UK citizen who generally respects Britain’s regulatory models. However, I believe this process failed to live up to its self-image of openness and transparency. The experience taught me that science and technology hold such ingrained cultural and economic capital that people often hear any concern raised – even when it comes from other scientists – as “anti-science” or “anti-technology.” Moreover, it taught me that simple stories can become so compelling and satisfying that they do not bend, even in the presence of critical new information.

In this case, a consequential law was altered on the basis of a group of scientific methods whose human health and safety consequences have not been vetted, and could end up harming those they were designed to help.

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

World Bioethics Day: Human Dignity and Human Rights

World Bioethics Day: Human Dignity and Human Rights

The first World Bioethics Day, sponsored by the UNESCO Chair in Bioethics, is taking place on October 19. This year’s theme of Human Dignity and Human Rights will be celebrated in 55 countries worldwide (see here for a list of participating countries and here for a list of planned events).

While most countries are hosting one or two World Bioethics Day events, India has planned a whopping 29. The only event scheduled in the United States is at Indiana University Northwest, which will include presentations on bioethics and human rights and a screening of “No Más Bebés,” a documentary about Mexican-American women who were coercively sterilized at Los Angeles County-USC Medical Center in the 1960s and 1970s. (Filmmakers Virginia Espino and Renee Tajima-Peña joined CGS on the UC Berkeley campus in 2016 to screen the film as a part of the Being Human in a Biotech Age series. They were also interviewed for the CGS online series Talking Biopolitics by eugenics scholar and CGS advisory board member Alexandra Minna Stern, see here and on YouTube.)

Human dignity and human rights, in addition to being the theme of this first annual World Bioethics Day celebration, form the primary framework of most of the international and national legislation worldwide that prohibits inheritable genetic modification, also known as human germline modification. The most notable among these is the Council of Europe’s 1997 Convention on Biomedicine and Human Rights (see here for a global list of national legislation banning inheritable genetic modification).

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

Ethics ignored in ‘3-person embryo’ technique

A fertility doctor in Ukraine is using highly controversial mitochondrial manipulation techniques to treat general infertility ahead of peer review and safety checks, according to New Scientist. Two women are 20 weeks pregnant with embryos created using the technique. Dr Valery Zukin, director of the Clinic of Reproductive Medicine in Kiev, says that he secured approval from ethics committees before proceeding. He plans to present preliminary results at the American Reproductive Technology Congress in New York this weekend. 

Dr Zukin’s clinic offers a full range of fertility services, including surrogacy and egg donation. 

Dr Marcy Darnovsky, of the Center for Genetics and Society, in California, points out that is the second time in three weeks that the magazine has broken stories about rogue fertility doctors using the “three-parent embryo” method.

“We appear to be in a race to the bottom, with fertility doctors ignoring evidence that points to long-term safety risks associated with these embryo engineering techniques,” she says. “They are ignoring ongoing policy debates and conducting dangerous and socially fraught experiments on mothers and children. And they appear to be actively seeking a media splash on the way down.”

Although the UK allows these techniques experimentally, it remains controversial both because of inadequate evidence of its safety, and because they produce “germline” or heritable modifications that raise serious social and ethical concerns.

“As many have predicted, allowing ‘3-person IVF’ for mitochondrial disease opens the door to widespread abuse by fertility clinics seeking to sell the latest IVF ‘upgrade’ to the largest possible customer base,” Darnovsky says.

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

Sanitizing the language of clinical trials

Which would you rather participate in: a medical study or a medical experiment? Almost everyone prefers a “study”.

Since perceptions are so important for successful clinical trials, in 1995 the Advisory Committee on Human Radiation Experiments asked people what they associated with an “experiment”. “I envision all kinds of weird things done to the body, and I assume that’s not true, but also I envision a medical experiment maybe… done in a laboratory sealed up somewhere where no one even knows what [is] going on,” replied one person.

Drug companies need volunteers to test products, so the image of medical research is crucial. In 2008, Eli Lilly funded a campaign to rebadge “guinea pigs” as “medical heroes”.

In a provocative essay in The Hastings Center Report, Carl Elliott, a bioethics gadfly, asks hard questions about the ever-more sanitised language of clinical trials. He points out that in the 1960s, bioethicists used language like “experimental subjects,” “human experimentation,” and “experimentation in man.” But nowadays, the word experimentation has disappeared even from key bioethics protocols such as the Helsinki Declaration.

Yet the clinical trials are experiments and sometimes disaster strikes. Earlier this year, for instance, one man died and four others were hospitalised in France in a trial of a drug called BIA 10-2474, which had been created by the Portuguese pharma company Bial.

Even bioethicists have been affected by the slow shift away from the language of risk to the language of altruism. Elliott writes:

The choice to abandon the word “experiment” is emblematic of a larger movement beginning in the 1990s, in which many bioethics scholars moved from being critics of the research enterprise to being its champions.

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

A New Edition of Hastings Center Report Is Now Available

March 2, 2016

Hastings Center Report (vol. 46, no. 1, 2016) is available online by subscription only.

Articles include:

  • “Epigenetics in the Neoliberal ‘Regime of Truth’” by Charles Dupras and Vardit Ravitsky
  • “Balancing Benefits and Risks of Immoral Data” by Oscar A. Zarate, et al.
  • “Whatever Happened to Human Experimentation?” by Carl Elliott
  • “The Pedagogical Challenges of Teaching High School Bioethics: Insights from the Exploring Bioethics Curriculum” by Mildred Z. Solomon, et al.
  • “Pedagogical Support for Responsible Conduct of Research Training” by Misti Ault Anderson

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.