Tag: research subjects

Bioethics Blogs

Fetal tissue and commerce

You may have seen in the general press that Indiana University is asking a federal judge to declare unconstitutional that state’s law banning research on the remains of aborted fetuses.  I noticed an article in the Wall Street Journal (subscription required).  An open-access account can be found here.

I oppose abortion, but I can imagine for the sake of argument that, if one allows for abortion, that it might be claimed that the tissue of an aborted unborn human could ethically be donated for research.  It seems to me that such an argument would construe this donation to be similar to donation of organs for transplantation.  In this case, the mother would be speaking for her (newly-deceased) unborn to make the decision, since the aborted one would not have decision-making capacity.

For such an action to be remotely ethical, donation of tissue could not in any way influence the decision to have an abortion–as, indeed, federal restrictions on fetal tissue research currently require.  There should be no profit to the donor or the abortion provider in the process.  In light of the Planned Parenthood brouhaha over this subject, I might suggest that the researchers seeking the tissue for research be required to bear any costs for the preparation of the tissue.  And something like the dead donor rule for organ transplantation would have to apply.  But that’s probably a trivial point in this case.  Never mind that the dead donor rule itself is under attack these days.

I imagine it’s clear that I don’t find this argument very persuasive. 

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

Advances in Neuroscience Strengthen Ethical Opposition to Harmful Experiments on Dogs

Guest Post: Jarrod Bailey, Cruelty Free International, London, UK.

Paper: Advances in Neuroscience Imply that Harmful Experiments in Dogs are Unethical

More than 200,000 dogs are used in harmful experiments every year worldwide, in research into human and animal diseases and in the testing of new drugs and agrochemicals. This continues despite significant public opposition to it, and of increasing scientific evidence of its poor human relevance and misleading nature. From a utilitarian perspective, these alter the harm-to-benefit balance of using dogs in experiments. If experiments on dogs cause more suffering than is commonly appreciated, and if they are not delivering the human benefits that are claimed of them, then these experiments must be reconsidered by those who fund, license, and conduct them.

But how do we know how much dogs can suffer, and how much joy they can experience and are thus deprived of in a laboratory? Many would argue that it is simply obvious that dogs have impressive cognitive capabilities, as well as experiencing positive and negative emotions. This is not enough for science, of course, which seems unable or unwilling to accept sentience in nonhumans as it does for humans, based on weight of evidence. For many years, efforts to understand the minds of dogs in more detail have centred on ethological research which, while extremely valuable, does have some associated, widely acknowledged caveats. It can only go so far, especially for those for whom the evidence it produces can perhaps never be sufficient to warrant a change of attitude and behaviour towards dogs.

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: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts

This week’s Research Ethics Roundup looks at the first known US-based attempt of changing the DNA of embryos with CRISPR, the results of a large-scale wellness study, why researchers are challenging the notion that pregnant women are a “vulnerable” research population, and why European researchers are choosing to be transparent about their research with animals.

The post Research Ethics Roundup: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts 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?

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 Ibrahim Garba, MA, JD, LLM, Elizabeth Hall-Lipsy, JD, MPH, Leila Barraza JD, MPH

Norms supporting ethical research have been part of international human rights law from the start. The Doctors Trial in 1947 convicting 23 Nazi physicians and officials accused of euthanasia and unethical medical experiments produced the Nuremburg Code. The Code became a blueprint for subsequent human subject protection frameworks, most notably the World Medical Association’s Ethical Principles for Medical Research Involving Human Subjects (i.e.,

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.

Bioethics Blogs

Dear Mr. President: It’s Time for Your Bioethics Commission

by Craig Klugman, Ph.D.

Last week, seven Democratic members of the U.S. House Representatives sent a letter to the White House asking President Trump to appoint a director to the Office of Science and Technology Policy (OSTP), position that normally serves as the presidential science advisor. The impetus for writing the letter was a communication from the Deputy National Science Advisor that two hoax reports, that tried to undermine climate change, were circulating through the West Wing as “science.” The Congresspersons state “Where scientific policy is concerned, the White House should make use of the latest, most broadly-supported science…Relying on factual technical and scientific data has helped make America the greatest nation in the world.” Among the signers are a PhD in math and a PhD in physics. They hold that the U.S. faces strong questions that revolve around science, both opportunities and threats, and the need for a scientist who can understand and explain the importance of objective fact to the chief executive is essential.

This article led me to think that the U.S. also faces a lot of issues regarding health and medicine and their impact on society. Consider the task of creating a new health plan, CRISPR/CAS-9, in vitro gametogenesis, the threat of Zika, extra uterine gestational systems, legalized marijuana, digital medicine—pharmaceutical computing for treating disease, head transplants, and DYI science are among the bioethical issues that will effect policy in the coming few years. Thus, it is time for President Trump to call for his Presidential Bioethics Commission.

The last bioethics advisory body ended in January 2017, although many of the staff are still winding down the office and archiving the many reports and papers produced.

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

All we like SHEEFs, Part 2

Carrying on with last week’s musings…

In thinking further, I think my attempt was confused by conflating the moral status of a SHEEF—a synthetic human entity with embryo-like features, something more than a clump of cells of human origin, but less than a human being—with reasons why I might want to hold that nobody should ever make certain sorts of SHEEFs.

Again, SHEEFs are human, not non-human.  But they may not command a “right to life” in every instance.

I would return to a statement I made last week, that any totipotent human entity, that is, any human entity capable of developing into a full human being under the right circumstances, should be accorded a full human right to life from the moment he or she comes into existence.  We other humans ought to give him or her a chance to live, care for him or her as one of us, grant him or her any research protections extended to human research subjects in general, and so on.  So-called human “embryos in a dish” would be in this group.

The same cannot be said for individual human cells, including human gametes formed from cells like induced pluripotent stem cells.  There may be arguments why those ought not to be produced, but that is for another time.

I would not say that a laboratory-created or sustained human heart, for example, ought to be protected from instrumental uses, including destruction for the research enterprise.  I think I would want to argue that we humans ought not make such a thing as part of a human-non-human animal hybrid, but again, that’s a different argument.  

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

Breakthrough Immunotherapies Seem Like a Dream Come True for Children with Leukemia

Guest Post: Nancy Jecker, Aaron Wightman, Abby Rosenberg, Doug Diekema

Paper: From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

A breakthrough therapy to cure cancer in children suffering from acute lymphoblastic leukemia (ALL) is a dream for many families.  New immunotherapies appear to make this dream a reality. Such therapies use a person’s own immune cells to recognize and combat their disease. In the largest study to date of ALL patients treated with a form of immunotherapy known as Chimeric Antigen Receptor (CAR) T-Cell therapy, a 93% remission rate was reported. Such results are a glimmer of hope for those whose prognoses were previously considered very poor.

However, the good news is tempered by the fact this potentially lifesaving experimental therapy may not be available to everyone who might benefit. And demand is growing as word spreads. Since CAR T-cell therapy for ALL is available only through clinical trials, do patients have a right to participate? How should we choose among medically suitable candidates?

We have faced these questions before. Most recently, with ZMapp to treat Ebola Virus Disease, azidothymidine (AZT) to treat HIV and AIDS, and Immunitab (Gleevac) to treat Chronic Myleogenous Leukemia. Are patients suffering from devastating, life-threatening diseases entitled to breakthrough therapies?

In a recent paper, we argue that benefit is a continuum, from the complete uncertainty associated with standard research, to an intermediate stage where evidence of benefit mounts and reaches a peak, to a final stage of clearly demonstrated benefit that is sufficient to gain approval for clinical applications.

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 Semantics of Therapy, Part II

A previous blog post of “The Semantics of Therapy” posed three questions about the human genome being a “patient” to be treated. One reader found the post “provocative and disturbing” and called for further explanation and discussion of the questions posed. That will take some time and several postings.

The first of the questions to be considered is this: If the “patient” is a genome, to whom does the researcher answer?   An answer from recent history may shed some light on this important issue.

33 infertile couples underwent a novel procedure at New Jersey’s Saint Barnabas Medical Center during the years 1996-2001. Embryologist Jacques Cohen used cytoplasmic transfer–ooplasm from the oocytes of fertile women was transferred into the eggs of infertile women–in the hope of establishing pregnancies in the latter. The outcome was 13 pregnancies and 17 babies from the Saint Barnabas experience (see accounts here and here).

According to a 2014 BBC article, one resulting pregnancy, which ended in miscarriage, revealed a missing X chromosome in the fetus. The same anomaly was noted in another child: one of a set of twins from a different pregnancy. Later, one child showed evidence of developmental delay. In 2014, Cohen estimated that the worldwide experience of cytoplasmic transfer between oocytes had resulted in the births of 30-50 babies, although the FDA had effectively stopped the procedure in the U.S. in 2002.

What had the follow-up on the babies born through cytoplasmic transfer been in 2014?

Due to a lack of funding, Cohen says, it hasn’t been possible to find out about how any of the children like Alana who were born from cytoplasmic transfer are doing.

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.