Tag: experimental design

Bioethics Blogs

What can neuroethicists learn from public attitudes about moral bioenhancement?

By Peter Reiner

Dr. Reiner is Professor and co-founder of the National Core for Neuroethics at the University of British Columbia where he is a member of the Department of Psychiatry and the Centre for Brain Health. Dr. Reiner began his research career studying the cellular and molecular physiology of the brain, with particular interests in the neurobiology of behavioural states and the molecular underpinnings of neurodegenerative disease. In 1998, Dr. Reiner became President and CEO of Active Pass Pharmaceuticals, a drug discovery company that he founded to tackle the scourge of Alzheimer’s disease. Upon returning to academic life in 2004, Dr. Reiner refocused his scholarly work in the area of neuroethics, co-founding the National Core for Neuroethics with Dr. Judy Illes in 2007. Dr. Reiner has championed quantitative analysis of public attitudes towards diverse issues in neuroethics including the propriety of cognitive and moral enhancement, the contours of autonomy in the real world, and the neuroethical implications of Technologies of the Extended Mind.

Moral behavior is fundamental to human society. Wherever one goes on the planet, one finds a set of norms that guide behavior, and following these norms is a basic tenet of peaceful coexistence with one’s fellow humans. Despite abundant evidence that the arc of human history trends towards decreased violence (Pinker, 2011), a proxy for moral behavior, scholars have suggested that society might be better off were we to enhance our moral capacities, and that using biological methods to do so is warranted (Douglas, 2008; Persson and Savulescu, 2008). This has engendered a vigorous debate that goes beyond the usual divide between bioconservatives and technoprogressives (Reiner, 2013a); in this arena, even ardent proponents of enhancement technologies have registered dissent (Harris, 2010).

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

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 News

FDA’s Dueling Priorities

FDA’s Dueling Priorities

August 3, 2016

(The Atlantic) – Medical-device companies—unlike drug conglomerates—are predominantly small businesses, and the process of bringing their inventions to market can be prohibitively expensive. After a device is finally cleared, its design may become obsolete within a couple of years. For drug licensing, part of the time burden comes from the FDA’s dueling mandates of safety and efficacy, each of which requires different kinds of tests and controls. Each stage of research emphasizes the two factors to different extents, and these priorities are reflected in the experimental design. The weighting of safety and efficacy priorities remains a subject of debate.

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

ISSCR Releases Updated Guidelines for Stem Cell Science and Clinical Translation

Click here for the full Guidelines document

 

(Press Release via ISSCR)

 

Washington, D.C.; 12 May 2016 – The International Society for Stem Cell Research (ISSCR), the world’s largest professional organization of stem cell scientists, today released newly updated guidelines for stem cell research and the development of new clinical therapies. The new guidance comes at a time when rapidly evolving technologies like gene editing in human embryos and emerging areas of stem cell discovery and its applications are providing unprecedented opportunities to understand human biology and disease, but also raising questions that have social and ethical implications. The guidelines build on widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.

 

“The field of stem cell research is growing at a rapid pace, with scientists and physicians developing new therapies that can help patients around the world who suffer from a wide variety of conditions,” said Sean J. Morrison, Ph.D., ISSCR president and director of the Children’s Medical Center Research Institute at UT Southwestern. “These guidelines are essential to protect the integrity of the research and to assure that stem cell treatments are safe and effective,” he said.

 

The ISSCR developed earlier sets of guidelines that are widely followed by researchers and institutions around the world (Guidelines for the Conduct of Human Embryonic Stem Cell Research, 2006;Guidelines for the Clinical Translation of Stem Cells, 2008).

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

Unintentional discrimination in clinical research: Why the small decisions matter

by Arthur T. Ryan, M.A. and Elaine F. Walker, Ph.D.

Arthur Ryan is a graduate student in clinical psychology at Emory University. His research focuses on understanding the etiology and neuropathology underlying severe mental illness.

Elaine Walker is a Professor of Psychology and Neuroscience in the Department of Psychology at Emory University and is the Director of the Development and Mental Health Research Program, which is supported by the National Institute of Mental Health. Her research is focused on child and adolescent development and the brain changes that are associated with adolescence. She is also a member of the AJOB Neuroscience editorial board.

Arthur Ryan, M.A.
Over the past several decades, there has been a significant effort to minimize bias against individuals based on ethnicity and other demographic factors through the creation of seemingly impartial and objective criteria across a host of domains. For example, when the United States Federal Sentencing Guidelines were created in the 1980’s, one of their primary goals was to alleviate “…unwarranted disparity among offenders with similar characteristics convicted of similar criminal conduct” [1]. Unfortunately, even well-intentioned efforts such as this one can still have a disparate negative impact upon historically marginalized groups, such as the well-documented disproportionate sentencing of black individuals due to differing rules governing offenses committed with crack vs. powdered cocaine [2]. Concerns about such inadvertent bias are not limited to the legal domain. Agencies that fund clinical investigations are paying greater attention to demographic representativeness and access to participation in health-related research.

Let us consider a hypothetical example, drawn from the authors’ own field of research in a US context, of how seemingly objective research design choices can results in biases in access to research participation.

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

In the Journals, June 2015 – Part I by Elizabeth Lewis

Journal of the Royal Anthropological Institute

Deaf Bodies and Corporate Bodies: New Regimes of Value in Bangalore’s Business Process Outsourcing Sector
Michele Friedner

This article ethnographically analyses how groups (and not just individuals) are produced in business process outsourcing (BPO) workplaces. In order to mitigate an unstable labour pool, corporations hire deaf workers to perform identical BPO work regardless of their qualifications and backgrounds. These hiring practices serve to cement existing relationships and produce deaf workers as a group marked only by deafness. This article explores how engaging in the same work articulates with deaf young adults’ ‘sameness work’ to produce ambivalent deaf groups. It also analyses the everyday practices of deaf employees, their relationships with their normal co-workers who ‘love’ them, and the ways that value is reconfigured in the workplace through the existence of disabled workers. This article argues that in contrast to dominant representations of disabled people as unemployable, the (re)inscription of deafness as a source of multiple forms of value begs for a broader analysis of the role of disability in late capitalism.

Bodily Rights and Collective Claims: The Work of Legal Activists in Interpreting Reproductive and Maternal Rights in India
Carolyn Heitmeyer and Maya Unnithan

This article engages with anthropological approaches to the study of global human rights discourses around reproductive and maternal health in India. Whether couched in the language of human rights or of other social justice frameworks, different forms of claims-making in India exist in tandem and correspond to particular traditions of activism and struggle. Universal reproductive rights language remains a discourse aimed at the state in India, where the primary purpose is to demand greater accountability in the domain of policy and governance.

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

Nancy Cartwright on the Limits of RCTs

Guest Post by Bill Gardner @Bill_Gardner

Many researchers and physicians assert that randomized clinical trials (RCTs) are the “gold standard” for evidence about what works in medicine. But many others have pointed to both strengths and limitations in RCTs (see, for example, Austin Frakt’s comments on Angus Deaton here). Nancy Cartwright is a major philosopher of science. In this Lancet paper she provides insights into why RCTs are so highly valued and also why they are by themselves insufficient to answer the most important questions in medicine.

RCTs have been taken to be a gold standard because they are, according to Cartwright, “self-validating.” What this means is that an RCT can establish a causal connection between a treatment and an outcome more or less by virtue of the design.

all features causally relevant to the outcome other than the treatment (and its downstream effects) are distributed identically between treatment and control groups. If the outcome is more probable in the treatment than the control group,… the only explanation possible is that the treatment caused the outcome in some members of that group.

An RCT done right means that correlation between treatment and outcome does imply causation. In most sciences, you need strong theories to understand what the data mean and to justify your causal interpretation of an experiment’s results (see here). There are no control groups in astrophysics. In an RCT, the evidence for the causal effect of the treatment comes from the experimental design and doesn’t depend on your theory about what makes the treatment work.

Because RCTs stand on their own without a superstructure of theory, Cartwright says that RCTs provide “clinchers” to arguments.

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

Genetic Testing For All: Is It Eugenics?

In recent weeks, there’s been talk of three types of genetic testing transitioning from targeted populations to the general public: carrier screens for recessive diseases, tests for BRCA mutations, and non-invasive prenatal testing (NIPT) to spot extra chromosomes in fetuses from DNA in the maternal bloodstream.

Are these efforts the leading edge of a new eugenics movement? It might appear that way, but I think not.

When I began providing genetic counseling 30 years ago at CareNet, a large ob/gyn practice in Schenectady, NY, few patients were candidates for testing: pregnant women of “advanced maternal age” (35+), someone with a family history of a single-gene disorder or whose ethnic background was associated with higher prevalence of a specific inherited disease. Their risks justified the cost and potential dangers of the tests.

Now the picture is rapidly changing as plummeting DNA sequencing costs and improved technologies are removing economics from the equation. It’s becoming feasible to test anyone for anything – a move towards “pan-ethnic” genetic screening that counters the “sickle-cell-is-for-blacks and cystic-fibrosis-is-for-whites” mindset.

So here’s a look at three very different types of genetic tests that are poised to make the leap to the general population. And despite new targets revealed with annotation of human genomes, some of the detection technologies themselves are decades old.

#1: CARRIER SCREENING

Population screening for carriers of single-gene diseases has been around since those for sickle cell disease and Tay-Sachs disease in the early 1970s. We learned a lot from their starkly different results. For years, labs such as Athena Diagnostics, the Baylor College of Medicine Medical Genetics Laboratories, Emory Genetics Laboratory, Ambry Genetics, GeneDx and others have added genetic tests to their rosters, which now cover hundreds of single-gene diseases, from A (Alport syndrome) to Z (Zellweger syndrome).

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

Search, Bias, Flotsam and False Positives in Preclinical Research

Photo credit: RachelEllen 2006)

Photo credit: RachelEllen 2006

If you could change one thing- and only one thing- in preclinical proof of principle research to improve its clinical generalizability, what would it be? Require larger sample sizes? Randomization? Total data transparency?

In the May 2014 issue of PLoS Biology, my co-authors Uli Dirnagl and Jeff Mogil offer the following answer: clearly label preclinical studies as either “exploratory” or “confirmatory” studies.

Think of the downed jetliner Malaysia Airlines Flight 370. To find it, you need to explore vast swaths of open seas, using as few resources as possible. Such approaches are going to be very sensitive, but also prone to false positives.   Before you deploy expensive, specialized ships and underwater vehicles to locate the plane, you want to confirm that the signal identified in exploration is real.

So it is in preclinical research as well. Exploratory studies are aimed at identifying strategies that might be useful for treating disease- scanning the ocean for a few promising treatment strategies. The vast majority of preclinical studies today are exploratory in nature. They use small sample sizes, flexible designs, short study durations, surrogate measures of response, and many different techniques to demonstrate an intervention’s promise. Fast and frugal, but susceptible to bias and random variation.

Right now, the standard practice is to go right into clinical development on the basis of this exploratory information. Instead, we ought to be running confirmatory studies first. These would involve prespecified preclinical designs, large sample sizes, long durations, etc.   Such studies are more expensive, but can effectively rule out random variation and bias in declaring a drug promising.

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

Symposium: Field Research and US Institutional Review Board Policy

This month the Political Science Department, University of Utah, will host a symposium entitled, “Field Research and US Institutional Review Board Policy.” Sponsored by the Betty Glad Memorial Fund, the symposium will take place March 20 [8:45 am – 5:30 pm] and March 21 [9:00 am – 3:30 pm].

The description follows:

US Institutional Review Board (IRB) policy with respect to human subjects was created to protect human participants from harms caused by research. It institutionalizes three ethical principles: respect for persons, beneficence (do no harm), and a just distribution of the benefits and burdens of research. The federal policy has been shaped in light of research following an experimental design, a model that often does not fit the exigencies of field research. This symposium is intended to explore the ethical dimensions of social scientific field research, including those not envisioned in the federal policy.

Symposium Co-Directors
Peregrine Schwartz-Shea, Department of Political Science, University of Utah (psshea@poli-sci.utah.edu)
Dvora Yanow, Wageningen [NL] and Keele [UK] Universities (dvora.yanow@wur.nl)

Keynote speaker: Dr. Zachary Schrag, History and Art History, George Mason University

“‘The Freedoms We Are Committed to Protect’: Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective”

Historian Zachary Schrag is one of the leading scholars exploring US institutional review board policy with regard to the social sciences. Author of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (2010), he has maintained a blog on the topic since 2006: http://www.institutionalreviewblog.com/.

The lead title of his keynote address, “The Freedoms We Are Committed to Protect,” is a line from Ithiel de Sola Pool, a political scientist and founder of MIT’s political science department, who played a key role in the history of IRB policy.

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.