Tag: guidelines

Bioethics Blogs

Zika in India and Public Health Ethics

Chhanda Chakraborti argues for a more ethically aware public health response to the to Zika in India.

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On May 27, 2017, Indian newspapers reported that the WHO confirmed three cases of Zika virus in Ahmedabad, Gujarat, India. The first case, in November 2016, involved a 34-year-old woman, who tested positive for Zika after she delivered a baby at B. J. Medical College. The second case, in January 2017, involved a a 22-year-old woman in her 37th week of her pregnancy. The third case, in February 2017, involved a 64-year-old man who was identified during a random monitoring and surveillance activity conducted by the B. J. Medical College.

In February 2016, the Minister of Health proclaimed that India’s Ministry of Health and Family Welfare had adopted several actions and countermeasures to prevent the spread of Zika. However, the alerts and guidelines about Zika, that were created in consultation with the World Health Organization (WHO), only became publicly available on the Ministry’s website after media reports of Zika in India. In May 2017, the WHO asserted that India’s Ministry of Health has taken the necessary steps to address the situation. These steps include sharing national plan and guidelines on Zika with the States, setting up an Inter-Ministerial task force, displaying Zika- related information for travellers in the airports.

B. J. Medical College, Ahmedabad

Beyond the media reports and the statements issued by the Ministry and the WHO, there has been little public discussion about Zika in India. The local neighbourhood Ahmedabad, as well as the Ahmedabad Municipal Corporation (which is responsible for public health in the area) reportedly were unaware of the Zika cases until these were publicized by the media. In sharp contrast, there are regular public updates on Dengue and Chikangunya cases in India.

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

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.

Bioethics News

Tweet Revenge

June 14, 2017

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For many, the essence of gathering at conferences is the sharing of scientific information, a peek at interesting research in progress.

The policy, new this year and unusual for scientific conferences, is the most public manifestation yet of the tension between the drug and medical device companies that help sponsor the ADA’s flagship programs on one side and researchers and patients on the other.

The New England Journal of Medicine doesn’t consider this a problem. Some researchers on Twitter pointed to NEJM guidelines that state “online posting of an audio or video recording of an oral presentation at a medical meeting, with selected slides from the presentation, is not considered prior publication,” according to Medscape.

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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

When “neuro” met “ethics”

Two short words increasingly often appear in combination with names of professional fields and scientific disciplines: neuro and ethics. Here are some examples: Neuromusicology, neurolaw, neuropedagogy. Bioethics, nursing ethics, business ethics.

Neuro… typically signifies that neuroscience sheds light on the subject matter of the discipline with which it combines. It can illuminate what happens in the brain when we listen to music (neuromusicology). What happens in the brain when witnesses recall events or when judges evaluate the evidence (neurolaw). What happens in children’s brains when they study mathematics (neuropedagogy).

…ethics (sometimes, ethics of…) typically signifies that the discipline it combines with gives rise to its own ethical problems, requiring ethical reflection and unique ethical guidelines. Even war is said to require its own ethics of war!

In the 1970s, these two words, neuro and ethics, finally met and formed neuroethics. The result is an ambiguous meeting between two short but very expansive words. Which of the two words made the advance? Where is the emphasis? What sheds light on what?

At first, ethics got the emphasis. Neuroethics was, simply, the ethics of neuroscience, just as nursing ethics is the ethics of nursing. Soon, however, neuro demonstrated its expansive power. Today, neuroethics is not only the “ethics of neuroscience,” but also the “neuroscience of ethics”: neuroscience can illuminate what happens in the brain when we face ethical dilemmas. The emphasis thus changes back and forth between neuroethics and neuroethics.

The advances of these two words, and their final meeting in neuroethics, reflects, of course, the expansive power of neuroscience and 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

Samaritan Ministries and Ectopic Pregnancies

As I was reading Laura Turner’s Buzzfeed essay about Christian health sharing ministries this past week, I was startled to discover that Samaritan Ministries, the insurance alternative my husband uses, does not cover expenses related to ectopic pregnancies.

In Section VIII of the Samaritan Ministries Guidelines, “Needs Shared by Members,” Ectopic Pregnancies is listed as the ninth item under “Miscellaneous Items Not Shared.” The guidelines state:

“Expenses related to the termination of the life of an unborn child are not publishable. The removal of a living unborn child from the mother which results in the death of the child is a ‘termination of the life of the child’ unless the removal was one for the primary purpose of saving the life of the child, or improving the health of the child. This means that the removal from the mother of an unborn child due to an ectopic pregnancy (outside the normal location in the uterus) is not publishable unless the member states they believed the child was not alive before the procedure. Considerations of the health or life of the mother does not change that the removal of a living unborn child from the mother may be a termination of life.”[1]

Ectopic pregnancy occurs when a fertilized egg implants outside of the uterus, most commonly in one of the fallopian tubes.[2]  The condition is highly dangerous to the mother, who is at risk of internal rupturing and blood loss.[3]  While there are different classifications of ectopic pregnancies and a few different methods of treatment, Turner approximates the cost of surgery to save the life of the mother to be around $15,000.

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

Nevada Amends Uniform Determination of Death Act

In a sign of things to come, Nevada has

Justice Pickering

amended the Uniform Determination of Death Act (UDDA).  Expect other states to make similar amendments soon.  On Friday, June 2, Governor Sandoval signed A.B. 424.  

The bill was a direct response to the problems identified by the Nevada Supreme Court in the Aden Hailu case.  I discussed that case here and posted case materials here.

The UDDA requires that clinicians determine brain death in accordance with guidelines set forth by either the American Academy of Neurology or the Pediatric Section of the Society of Critical Care Medicine. The statute identifies the guidelines by name: “Evidence-based Guideline Update: Determining Brain Death in Adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology” and “Guidelines for the Determination of Brain Death in Infants and Children: An Update of the 1987 Task Force Recommendations.” 

Furthermore, recognizing that the guidelines might be updated, the statute preserves flexibility. It requires that clinicians determine brain death in accordance with the “subsequent revisions approved” by the guidelines authors.

Explicitly referencing specific guidelines eliminates the need to determine whether these guidelines qualify as “accepted medical standards.” This has been a significant problem. Since adoption of the UDDA in the early 1980s, there has been significant variability in the brain death determination guidelines followed by hospitals across the United States.

At least in Nevada, that variability should be eliminated by the new statute. By unambiguously identifying which guidelines are authoritative, the statute eliminates uncertainty over which medical standards are “accepted.”

Nevertheless, the new statute does not amend another UDDA requirement: that “for legal and medical purposes, a person is dead if the person has sustained an irreversible cessation of .

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 – May 2017 by Livia Garofalo

Please enjoy the article round-up for the month of May! This post was put together in collaboration with Ann Marie Thornburg.

American Ethnologist

Plant matters: Buddhist medicine and economies of attention in postsocialist Siberia

Tatiana Chudakova

Buddhist medicine (sowa rigpa) in Siberia frames the natural world as overflowing with therapeutic potencies: “There is nothing in the world that isn’t a medicine,” goes a common refrain. An exploration of sowa rigpa practitioners’ committed relations with the plants they make into medicines challenges human-centric notions of efficacy in anthropological discussions of healing. Their work of making things medicinal—or pharmacopoiesis—centers on plants’ vital materialities and requires attention to the entanglements among vegetal and human communities and bodies. Potency is thus not the fixed property of substances in a closed therapeutic encounter but the result of a socially and ecologically distributed practice of guided transformations, a practice that is managed through the attentive labor of multiple actors, human and otherwise. In Siberia, pharmacopoiesis makes explicit the layered relations among postsocialist deindustrialization, Buddhist cosmologies, ailing human bodies, and botanical life.

Annals of Anthropological Practice

Special Issue: Continuity and Change in the Applied Anthropology of Risk, Hazards, and Disasters

Disaster vulnerability in anthropological perspective 

A.J. Faas

In the study of disasters, the concept of vulnerability has been primarily employed as a cumulative indicator of the unequal distributions of certain populations in proximity to environmental and technological hazards and an individual or group ability to “anticipate, cope with, resist and recover” from disaster (Wisner et al. 2004). This concept has influenced disaster research as a means to question how natural, temporary, and random disasters are and focused analysis on the human-environmental processes that produce disasters and subject some populations more than others to risk and hazards.

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 Very Early Embryo & Its Moral Signifiance

by Andrew J. Prunty

As technology and biological research continue to develop in the twenty-first century, it is necessary to address and further define the ethical considerations of embryonic research and the appropriate rights that may limit the extent of human research on zygotes, blastocysts, and fetal scientific advancement. Because the area of harvesting embryonic stem cells remains significantly undefined, both legally and morally, there are vastly different opinions between researchers and bioethicists, mainly because of ethical limitations, on the rights that should be granted to cells with the potential to develop into human beings and the consequences of neglecting significant scientific research or advancement.

Current laws in the United States differ at the federal and state level, but there is no consistency in recognizing human embryos as humans, or affording them the same legal rights granted to a child; in fact, legal precedent actually detracts certain rights from developing embryos, favoring a human’s ability to destroy a potential human being (i.e. Roe v. Wade[i]) or the categorization of embryos as property (i.e. Davis v. Davis[ii], A.Z. v. B.Z.[iii], Marriage of Dahl[iv], or Reber v. Reiss[v]). These case law samples suggest the courts’ inability to reach a conclusion as to what is the status of an embryo.

The debate is not only circumscribed to matters of research, but to fundamental controversial and intertwined issues of bioethics such as: when life begins, embryonic stem cells, fetal rights, abortion, et cetera. All these topics are contentious and when one topic arises, they begin to comingle.

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

Unbefriended and Unrepresented: Better Medical Decision Making for Incapacitated Patients Without Healthcare Surrogates

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals is an immense problem in ethics and patients’ rights. Some commentators describe caring for the unbefriended as “one of the most difficult problems in medical decision making.” Others call it the “single greatest category of problems” encountered in bioethics consultations.

Appropriately, this problem is getting more attention. Major policy reports from both legal and medical associations have focused on decision making for the unbefriended. Perhaps most notably, the elite mainstream media has repeatedly covered the problem of the unbefriended in the United States. Decision-making for the unbefriended has also been the primary topic of recent day-long or multi-day conferences, both themed, subject-specific conferences, and individual sessions at several national and regional professional association meetings.

Finally, the problem of the unbefriended has received increasing attention not only in the meeting halls of conferences, but also in the pages of academic literature. New articles have been printed in law journals, medical journals, nursing journals, long-term care journals, and bioethics journals.

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

Unbefriended and Unrepresented: Better Medical Decision Making for Incapacitated Patients Without Healthcare Surrogates

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals is an immense problem in ethics and patients’ rights. Some commentators describe caring for the unbefriended as “one of the most difficult problems in medical decision making.” Others call it the “single greatest category of problems” encountered in bioethics consultations.

Appropriately, this problem is getting more attention. Major policy reports from both legal and medical associations have focused on decision making for the unbefriended. Perhaps most notably, the elite mainstream media has repeatedly covered the problem of the unbefriended in the United States. Decision-making for the unbefriended has also been the primary topic of recent day-long or multi-day conferences, both themed, subject-specific conferences, and individual sessions at several national and regional professional association meetings.

Finally, the problem of the unbefriended has received increasing attention not only in the meeting halls of conferences, but also in the pages of academic literature. New articles have been printed in law journals, medical journals, nursing journals, long-term care journals, and bioethics journals.

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.