Tag: biomedical research

Bioethics Blogs

A Feminist Neuroethics of Mental Health

By Ann E. Fink
Ann Fink is currently the Wittig Fellow in Feminist Biology at the University of Wisconsin–Madison, with an appointment in Gender and Women’s Studies and concurrent affiliations with Psychology and the Center for Healthy Minds. Her research in cellular and behavioral neuroscience has appeared in the Journal of Neuroscience, Journal of Neurophysiology, PNAS and other journals. Ann’s interdisciplinary work addresses the ethics of neuroscience in relation to gender, mental health and social justice. 

Emotionality and gender are tied together in the popular imagination in ways that permeate mental health research. At first glance, gender, emotion, and mental health seem like a simple equation: when populations are divided in two, women show roughly double the incidence of depression, anxiety, and stress-related disorders1-3. Innate biological explanations are easy to produce in the form of genes or hormones. It could be tempting to conclude that being born with XX chromosomes is simply the first step into a life of troubled mood. Yet, buried in the most simplistic formulations of mental illness as chemical imbalance or mis-wiring is the knowledge that human well-being is a shifting, psychosocial phenomenon. Learning and memory research offers a treasure trove of knowledge about how the physical and social environment changes the brain. Feminist scholarship adds to this understanding through critical inquiry into gender as a mode of interaction with the world. This essay explores how a feminist neuroethics framework enriches biological research into mental health. 
Problems with “Biology-from-birth” stories 
What if understanding gender and health isn’t a tale of two gonads (or genitalia, or chromosomes)?

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

Lessons from the West African Ebola epidemic

Conventional wisdom—and an article in the Journal of Medical Ethics reviewed on this blog two years ago—advise that health research should not be conducted during times of crisis. Yes, such conditions compromise the controlled environments that studies typically require to produce reliable results, but they can also threaten the ethical integrity of research. Without institutional mechanisms to hold them accountable, investigators may cut corners, violate standards of privacy and informed consent, and even endanger participants. Disruption in the normal function of medical services can also apply pressure on individuals unable to access care by traditional means to seek it out by participating in risky research. And even if one assumes that researchers display honesty beyond reproach, it is still unreasonable to expect that they would be able to keep their cool in the midst of widespread panic and social collapse. But there is a fly in the ointment, at least when it comes to crises caused by epidemics. Public health organizations are first-responders at these moments, but they would be dead in the water without relevant data collected under real-world conditions to guide their actions. In this situation, the precautionary principle alone is not enough to stop a study altogether. In fact, it could be argued that an absolute prohibition against biomedical research in such situations may itself be unethical. The question then becomes, not whether, but how to guarantee ethical research during outbreaks?

The Ethics Review Board (ERB) of Médecins Sans Frontières (MSF) had to contend with this question during the 2014 Ebola epidemic. They recently chronicled their experience in the April issue of Public Health Ethics.

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

NIH Family Members Giving Back: Kafui Dzirasa

Caption: Kafui Dzirasa (front center) with the current group of Meyerhoff Scholars at University of Maryland, Baltimore County.
Credit: Olubukola Abiona

Kafui Dzirasa keeps an open-door policy in his busy NIH-supported lab at Duke University, Durham, NC. If his trainees have a quick question or just need to discuss an upcoming experiment, they’re always welcome to pull up a chair. The donuts are on him.

But when trainees pop by his office and see he’s out for the day, they have a good idea of what it means. Dzirasa has most likely traveled up to his native Maryland to volunteer as a mentor for students in a college program that will be forever near and dear to him. It’s the Meyerhoff Scholars Program at the University of Maryland, Baltimore County (UMBC). Since its launch in 1988, this groundbreaking program has served as a needed pipeline to help increase diversity in the sciences—with more than 1,000 alumni, including Dzirasa, and 270 current students of all races.

Upon graduating from UMBC in 2001 as a Meyerhoff Scholar, Dzirasa was accepted into the M.D./Ph.D. Program at Duke with a focus in neurobiology. Dzirasa rarely had time to visit Baltimore 300 miles away, but he stayed in touch with everyone. After finishing his scientific and residency training and landing a position at Duke as an assistant professor, Dzirasa knew he had to give back. The Meyerhoff Scholars Program had helped him rise as a college track star, an Academic All-American, student body president, and, now, as an established scientist who is studying the brain and mental illness and frequently speaks on panels for public understanding of science.

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

Chimpanzees First Animal to Display Markers of Alzheimer’s

Researchers at Kent State University have found that aged chimpanzees develop brain characteristics that resemble those found in brains of humans with early Alzheimer’s disease. Nature has suggested that the “findings from humanity’s closest relatives could help researchers to understand why people develop dementia, as well as suggest that caretakers of aging, captive chimpanzees watch them closely for behavioural changes.”

Until the research was published in Neurobiology of Aging, it was widely thought that only human suffered from the disease and its severe symptoms of dementia. Neurological markers of the disease include plaques of amyloid-β proteins, tangles of tau protein and the complete loss of neurons.

The research team examined 20 brains of chimpanzees that had died between ages 37 and 62, assessing the regions typically affected in Alzheimer’s patients. They found that contrary to prior belief that only human primates can have both plaques and tangles in their brains, damaged brains of chimpanzees also contain both.

The United States has not permitted biomedical research on chimpanzees since 2015, but some researchers believe that such research could be highly valuable for aging human and animal populations alike.

The post Chimpanzees First Animal to Display Markers of Alzheimer’s appeared first on Global Bioethics Initiative (GBI).

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

Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

July 20, 2017

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Excluding mums-to-be from clinical studies is unfair and could be potentially harmful, researchers have said.

Pregnant women are often ruled out of participating in clinical trials because they’re classified as a “vulnerable” group, and this creates a knowledge void around the impact of drugs taken during pregnancy and “unfairly excludes” them from taking part in clinical studies, concluded researchers writing in the ‘Journal of Medical Ethics’.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” the researchers wrote.

… Read More

See Also – Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’

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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

Reflections on “Voracious Science, Vulnerable Animals” by John P. Gluck

Voracious Science, Vulnerable Animals is Dr. John Gluck’s account of his transformation from primate researcher to animal research ethicist. It challenges readers to consider the “voracious” pursuit of new discoveries in biomedical research, the justification for using primates and other animals in that pursuit, and the role of IACUCs in promoting ethical animal use.

The post Reflections on “Voracious Science, Vulnerable Animals” by John P. Gluck appeared first on Ampersand.

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

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

July 18, 2017

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In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

… Read More

Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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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

Rethinking the Belmont Report? Yes!

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. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Emily Caldes, MA, CIP and Jennifer B McCormick, Ph.D., MPP

As noted by Friesen, Kearns, Redman and Caplan in their review of the Belmont Report, the Belmont Commission tackled the difficult task of distinguishing research from practice. The report defines research activities as those intended to develop or contribute to generalizable knowledge, and it defines practice as activities intended to enhance the well-being of particular individuals or groups of individuals.

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

Ethical Challenges in the Development and Review of Genetics Research

From sequencing the human genome to discovering the underlying causes of many diseases, genetic research has the ability to profoundly influence the health of individuals and populations. However, despite genomics’ exceptional capacity to contribute to our understanding of disease, the nature of genetic research introduces many ethical considerations that may not arise in other types of biomedical research.

The post Ethical Challenges in the Development and Review of Genetics Research appeared first on Ampersand.

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

Helping or hacking? Engineers and ethicists must work together on brain-computer interface technology

A subject plays a computer game as part of a neural security experiment at the University of Washington. Patrick Bennett, Author provided

In the 1995 film “Batman Forever,” the Riddler used 3-D television to secretly access viewers’ most personal thoughts in his hunt for Batman’s true identity. By 2011, the metrics company Nielsen had acquired Neurofocus and had created a “consumer neuroscience” division that uses integrated conscious and unconscious data to track customer decision-making habits. What was once a nefarious scheme in a Hollywood blockbuster seems poised to become a reality.

Recent announcements by Elon Musk and Facebook about brain-computer interface (BCI) technology are just the latest headlines in an ongoing science-fiction-becomes-reality story.

BCIs use brain signals to control objects in the outside world. They’re a potentially world-changing innovation – imagine being paralyzed but able to “reach” for something with a prosthetic arm just by thinking about it. But the revolutionary technology also raises concerns. Here at the University of Washington’s Center for Sensorimotor Neural Engineering (CSNE) we and our colleagues are researching BCI technology – and a crucial part of that includes working on issues such as neuroethics and neural security. Ethicists and engineers are working together to understand and quantify risks and develop ways to protect the public now.

Picking up on P300 signals

All BCI technology relies on being able to collect information from a brain that a device can then use or act on in some way. There are numerous places from which signals can be recorded, as well as infinite ways the data can be analyzed, so there are many possibilities for how a BCI can be used.

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.