Tag: informed consent

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The 2017 Common Rule and the Clinical Ethics of Prolixity

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.

The following is a re-post of Steven Mile’s original February 2017 post.


by Steven H. Miles, MD

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.[i] The new Rules defines the obligations of an enormous number of personnel at the National Institutes of Health as well as virtually any other government agency engaged in research with human subjects. The Rules define the requisite knowledge, training, and work of staff who oversee and conduct clinical research in the United States.

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.

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Is There a Duty to Participate in Biospecimen Research?

July 6, 2017

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In an essay in the May-June 2017 Hastings Center Report, Holly Fernandez Lynch and Michelle N. Meyer assess the impact of the revised Common Rule on biospecimen research. They believe that the proposed “broad consent” approach – which involves participants agreeing to the storage of blood and other biological samples for subsequent use in a broad range of research projects –will rarely be used because of practical challenges in implementing it. In addition, they argue that ethical justifications are not robust enough to encourage researchers to use broad consent. To justify this claim, they write, “Many have argued that there is a duty based in justice and reciprocity to allow one’s biospecimens to be used in this way.” My concern is with the ethical calculus they describe and its use of the idea that people have a duty to participate in medical research.

Bioethicists debate whether there is a duty to participate and how it impacts ethical decision-making. Arguments for the duty to participate have been grounded in both beneficence and justice, but justice is the primary justification being offered here. The justice argument is that since everyone can benefit from medical research then everyone has an obligation to participate. This obligation is most often framed as a prima facie obligation—if no other duty or obligation conflicts, then one should participate in research. In many ways, biospecimen research is the perfect case for a duty to participate. It is a low-risk, potentially high-reward type of research, especially in the case of specimens remaining after a medical test or treatment.

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.

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The Neuroethics Blog Series on Black Mirror: Be Right Back

By Somnath Das
Somnath Das recently graduated from Emory University where he majored in Neuroscience and Chemistry. He will be attending medical school at Thomas Jefferson University starting in the Fall of 2017. The son of two Indian immigrants, he developed an interest in healthcare after observing how his extended family sought help from India’s healthcare system to seek relief from chronic illnesses. Somnath’s interest in medicine currently focuses on understanding the social construction of health and healthcare delivery. Studying Neuroethics has allowed him to combine his love for neuroscience, his interest in medicine, and his wish to help others into a multidisciplinary, rewarding practice of scholarship which to this day enriches how he views both developing neurotechnologies and the world around him. 
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Humans in the 21st century have an intimate relationship with technology. Much of our lives are spent being informed and entertained by screens. Technological advancements in science and medicine have helped and healed in ways we previously couldn’t dream of. But what unanticipated consequences may be lurking behind our rapid expansion into new technological territory? This question is continually being explored in the British sci-fi TV series Black Mirror, which provides a glimpse into the not-so-distant future and warns us to be mindful of how we treat our technology and how it can affect us in return. This piece is part of a series of posts that will discuss ethical issues surrounding neuro-technologies featured in the show and will compare how similar technologies are impacting us in the real world. 

*SPOILER ALERT* – The following contains plot spoilers for the Netflix television series Black Mirror

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.

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Tune Ups to Belmont & Common Rule Need to Consider Community-Engaged Research

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 Eric Wat MA, Nancy Shore PhD, Sarena D Seifer MD, CCPH, Lola Sablan-Santos, Alice Park MPH, Mei-Ling Isaacs MPH, Ahahui Malama I Ka Lokahi, Kelly Edwards PhD, Elaine Drew PhD, John Cooks, Paige Castro-Reyes BS BA, CCPH

We concur with Friesen and colleagues’ (2017) assertion that the Belmont Report requires, at a minimum, a “tune-up” to better reflect the unique ethical values and demands of community-engaged research (CEnR).

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.

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Confronting Medicine in the Holocaust & Beyond

By Hedy S. Wald

Galilee, Israel, May 7-11, 2017. I was privileged to be at the Second International Scholars Workshop on “Medicine in the Holocaust and Beyond.” Why so meaningful?  Why so needed? 140 purposeful, passionate scholars from 17 countries delved into the past history of medicine at its worst in order to inform the future.  From 1933-1945, presumed healers within mainstream medicine (sworn to uphold the Hippocratic Oath) turned into killers (1).  Yes, medical ethics in Nazi-era medical school curricula existed, yet included “unequal worth of human beings, authoritative role of the physician, and priority of public health over individual-patient care”(2).  In Western Galilee College, (Akko), Bar-Ilan University Faculty of Health Sciences (Safed), and Galilee Medical Center and Ghetto Fighters’ Museum, (both in Nahariya), historians, physicians, nurses, medical and university educators, medical students, ethicists and more gathered to grapple with this history and consider how learning about medicine in the Holocaust can support healthy professional identity formation with a moral compass for navigating the future of medical practice with issues such as prejudice, assisted reproduction and suicide, resource allocation, obtaining valid informed consent, and challenges of genomics and technology expansion (3)…

The conference, in essence, served as a lens for the here and now, reinforcing my contention (and others’) that history of medicine in the Holocaust curricula including confronting the Nazi physicians’ and scientific establishment’s euthanasia of “lives unworthy of life,” forced sterilizations, horrific experimentation on their victims, and medicalized genocide (leading to the destruction of a third of the European Jewish population and many others) is a “moral imperative” in healthcare professions education (1,4).

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.

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Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

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.

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From the Director: Informed Consent in the Revised Common Rule

Over the coming months, I’m going to look more closely at a few areas of the revised rule. I won’t be giving tips on implementation, just pointing out some of what I find interesting in a few specific areas. In this post, I’m going to take a deeper dive into the changes around informed consent, an area that, as I mentioned in my preliminary reflections on the rule, I am pretty excited about.

The post From the Director: Informed Consent in the Revised Common Rule 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.

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Human Milk Banking in Guatemala City: All for All

Martha Paynter compares human milk banking practices in Guatemala City and Atlantic Canada.

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Last month, non-profit human milk banking staff and researchers from across the continent met in Dallas for the Human Milk Banking of North America 2017 Symposium to share best practices and new developments. The use of human donor milk is growing and non-profit banks must compete with for-profit enterprises and private milk markets. Human donor milk health and safety standards in North America continue to evolve in response to scientific evidence, epidemiological developments such as Zika, and funding changes including the recent Medicaid coverage for banked milk in New York State. While we adapt processes and goals for milk banking in North America, it is worth examining alternative models of milk bank operations.

In Atlantic Canada, for example, three level-3 Neonatal Intensive Care Units (NICU) provide human donor milk to infants under 1500 grams who are unable to receive sufficient milk from their own mothers. The milk is purchased at approximately $5/ounce, including shipping, from the Northern Star Mothers Milk Bank in Calgary. Northern Star is a private, community-based non-profit business. Milk is collected from healthy volunteer lactating women across Canada who meet donor criteria. Donors may take some medications, but not pharmaceuticals or herbs to promote lactation. Donors ship the frozen milk by courier to Northern Star, where it is pasteurized and distributed to NICUs, inpatients and outpatients across the country according to need and availability. Since opening in 2012, Northern Star has distributed over 500,000 ounces of milk.

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.

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Good Death, or Assisted Suicide?

The Case of Mr. Perry and his Pacemaker

Tarris Rosell, PhD, DMin
Rosemary Flanigan Chair at the Center for Practical Bioethics

NOTE: Dr. Rosell, a bioethics consultant and educator, will present the case of Mr. Perry for ethics discussion and likely debate on Thursday, June 22, 2017 at 7:00 PM in the artfully rebuilt Westport Presbyterian Church, 201 Westport Rd, Kansas City, MO. Bring your perspectives, arguments, and personal stories of moral medical dilemma. Admission is free. All are invited and welcome.

Mr. Perry (not his real name) was 83 years old and had several medical problems. He had spent the past several months in and out of hospitals and rehab. Prior to that, he lived independently in a small Midwestern town. Widowed many years ago, he subsequently enjoyed the company of a lovely lady friend who lived down the street from the Perry home. He had five adult children and numerous grandchildren.

Life should have been relatively good for this octogenarian. But life was not good. Not anymore. “My body is all worn out. I’m worn out. Don’t want to do this anymore, Doc. They say I can’t go home and be safe. And I’m NOT going to a nursing home. No way! Just stop that little gadget that shocks me and the part that keeps my heart going. I want them stopped. Yes, the pacemaker, too. A magnet will stop it, right? Just do it. Please.”

Tired of Fighting

Mr. Perry had a cardiac resynchronization therapy defibrillator (CRT-D) implanted a few years ago. It included an electrical pacing component for heart rhythms, on which the patient was 100% dependent.

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.

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Public Perception and Communication of Scientific Uncertainty

Scientific results are inherently uncertain. The public views uncertainty differently than scientists. One key to understanding when and how scientific research gets misinterpreted is to understand how the public thinks about scientific uncertainty.

A recent paper in the Journal of Experimental Psychology: General explores how laypersons perceive uncertainty in science. Broomell and Kane use principle component analysis to discover three underlying dimensions that describe how the public characterizes uncertainty: precision, mathematical abstraction, and temporal distance. These three dimensions, in turn, predict how people rate the quality of a research field. Precision – loosely defined in this context as the accuracy of the measurements, predictions, and conclusions drawn within a research field – is the dominating factor. One interpretation is that the public is primarily concerned with definitiveness when evaluating scientific claims.

Members of the public lose confidence when fields of study are described as being more uncertain. This is relevant for scientists to consider when communicating results. On the one hand, over-selling the certainty of an outcome can mislead. On the other hand, the public might tend to dismiss important scientific findings when researchers describe uncertainty honestly and openly, as we have seen in the public denial of vaccinations and climate change. Perceptions of a research field do not seem to influence how people view individual studies, so each study should be treated as its own communique.

Broomell et al found some evidence that personal characteristics interpret scientific uncertainty in different ways. Self-identified Republicans are more concerned about expert disagreement, while self-identified Democrats are more concerned with the quality of evidence.

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.