Tag: research

Bioethics Blogs

A more ethical form of HIV criminalization

HIV has been criminalized throughout the history of the epidemic, or to be more exact, people living with HIV and their behaviors have been a persistent focus of criminal law. This was undoubtedly due in part to the fact that HIV initially was untreatable and infection (for the vast majority) spelt death. It was terrifying. But it wasn’t just an understandable public health reaction. Criminalization is not necessarily a wise way of controlling an epidemic, as it can be counterproductive, driving underground persons potentially subject to the laws. And there is no way of getting around that those disproportionately affected by HIV (especially in the USA), were considered ‘undesirables’ by many in the public and those leaders they voted for. Criminalization also reflected a moral panic against homosexuals and injection drug users. So, because it was not really based on solid public health principles or scientific evidence in the first place, it is unsurprising that states made laws covering actions highly unlikely to lead to transmission (like spitting or oral sex), fail to take the use of new prevention technologies (PreP, use of antiretrovirals) into account, and often don’t take into consideration the intention to cause harm. What is perhaps more surprising (and depressing) is that many of these laws are still on the books.  

I am thinking that HIV criminalization should not be abolished, but pointed in a better direction. Let me back up. For a few years now, I have been working on a NIH-funded project on the social and ethical dimensions of HIV cure research.

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 Science March: Can science-based advocacy be both nuanced and effective?

By Jennifer Lee

Jenn Laura Lee is a PhD candidate in neuroscience at New York University. She is also a member of the Scientist Action and Advocacy Network (ScAAN.net), which offers pro bono data science and research to organizations seeking to implement positive social change.

I believe in protests. I attend them, I endorse them, and I think that they make a difference. Raising political consciousness in the scientific community in any form seems like a good thing. The Science March moreover seems like a great opportunity for a community of people sharing common livelihood to advocate for the importance of their work in policy-making, as it relates to nuclear non-proliferation, climate change, vaccination, and so on. 
But while I plan to attend the March for Science in New York, I’m hoping to use this article to examine, articulate, and hopefully mitigate the slight unease that’s been growing in me surrounding some of the language that scientists have been using to describe the march (both critics and proponents alike).


Let’s start by pointing out that protests are effective for a number of reasons— they can apply pressure for lawmakers to advance specific aims (for instance, the passing of a bill). They can also act as a springboard for awareness— a starting point for deeper and more nuanced dialogue. In absence of particularly well-defined specific aims, the Science March might function primarily in service of the latter objective, among others.
Critics like Robert Young have tried to pin their unease on bad optics — they worry about a perceived “loss of objectivity,” or the so-called “politicization of science.” These critics fear we will lose our moral high-ground as calm and objective voices of pure reason in the public eye.

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

“Surprise Question” Performs Poorly to Predict Death

New research in the CMAJ shows that the commonly used “surprise question” does not work well.


The surprise question is intended to be a simple and feasible screening test to identify patients with hospice and palliative care needs.  It involves a clinician reflecting on the question,
“Would I be surprised if this patient died in the next 12 months?”



But the surprise question performs poorly to modestly when used to predict death at 6 to 18  months, with even poorer performance among patients with non-cancer illness. The authors conclude that the surprise question should not be used as a stand-alone prognostic tool.

Source: bioethics.net, a blog maintained by the editorial staff of The American Journal of Bioethics.

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 Lesson From the Henrietta Lacks Story: Science Needs Your Cells

It’s often portrayed as a story of exploitation. Henrietta Lacks, a poor, young African-American woman, learned she had terminal cancer. Cells collected from a biopsy of her cancer were cultured without her knowledge or permission to develop a cell line, called HeLa. Over the ensuing decades, research using HeLa cells led to scores of medical advances, saving lives — and making a lot of money for a lot of people, though not for Ms. Lacks’s family

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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

Research Matters: Diverse Voices Who Support the Value of Knowledge

In preparation for the March For Science (to be held in Washington, DC and other locations across the country on April 22), PLOS Pathogens Research Matters Editor Glenn Rall revisits the initial goal of the Research Matters series: an

Source: Speaking of Medicine, blog of the Public Library 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 Blogs

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

Shweder and Nisbett hope for vast deregulation

On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:

in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.

In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”

[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the MomentChronicle of Higher Education, March 12, 2017.

Meyer asks, what’s new?

On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.

On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”

(GIF re-posted here with Meyer’s permission.)

Comments posted to the Chronicle website made similar points.

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

Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market.

The post Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market.

The post Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Do Extended Pluripotent Stem Cells Raise Ethical Issues?

On April 6, the journal Cell published work (subscription or online article purchase required) from the Salk Institute in San Diego, in which scientists have created a new “reprogrammed” stem cell.

These cells are called “extended pluripotent stem cells” or “EPS” cells.  They are different from embryonic stem (ES) cells, which are removed from intact embryos that arise from fertilization—typically requiring specific creation and destruction of an embryo.   Of course, ES cells can be human or non-human, depending on the source.

EPS cells are similar to “induced pluripotent stem cells,” or iPSCs, invented in 2006.  The latter are generated from adult skin cells that have been reprogrammed, using genetic alterations.

EPS cells may be made by reprogramming ES cells or skin cells or, if I understand the work correctly, iPSCs.  In this case, the reprogramming is done with a cocktail of chemicals in the lab.

But EPS cells are more capable than iPSCs.  Unlike iPSCs, which can give rise to many different types of cells but not all—including not a placenta and not an entire intact new individual—EPS cells can do all of that.  They are totipotent, meaning they can make all the cells of an individual from their species.  Moreover, they are quite long-lived in the laboratory.  EPS cells from one species—e.g., humans—can be placed into non-human (e.g., mouse) embryos to make hybrid animals that, it appears, survive quite well and can breed.  And, remarkably, the authors of the Cell paper report (again, if I understand correctly, and I think I do) that they were able to use a mouse EPS cell to give rise to a whole new mouse, not “just” a laboratory tissue hybrid.

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

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

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.