Bioethics

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Final Version of Common Rule Announced

January 18, 2017

The long-awaited updated version of the Common Rule – the regulations safeguarding individuals who participate in research – was announced today by the US Department of Health and Human Services. The goal of the revision is to strengthen protections of research participants without adding undue administrative burdens for researchers, particularly in low-risk studies. The Common Rule revisions will inform the expert presentations at the Consortium's research ethics events on March 8-9, consisting of a national conference, "The Future of Informed Consent in Research and Translational Medicine" on March 8 and the University of Minnesota's "Annual Research Ethics Day" on March 9. These events will be webcast; for more information and to register, visit the Consortium's events page. The Annual Research Ethics Day on March 9 will conclude with in-person workshops and trainings on practical research topics. To learn more, visit z.umn.edu/researchtr

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Republican and democratic symbols -- donkey and elephant

New Study Shows How Doctors' Politics May Influence Patient Care

October 11, 2016

Recent research looked at how patient care may be affected by a doctor's political leanings, at least regarding some controversial issues like abortion or firearm safety. An article from the Associated Press explains the methodology of the study, in which Yale University researchers surveyed voter registration records of 20,000 primary care physicians to link them to their party affiliation. The study's authors then surveyed 200 of those doctors about how they'd react to health issues that might come up during a routine physical. Bioethicist Nancy Berlinger of the nonpartisan Hastings Center, who wasn't part of the study, said "this was really an eye-opener," noting these results shed light on implicit bias; when it comes to deeply partisan divides, doctors "can't screen that out just like the rest of us can't screen it out."

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Doctor in patient's room with clipboard

Public Invited to Weigh in on Toughest Medical Ethics Decisions

August 24, 2016

In the aftermath of Hurricane Katrina, health care providers at Memorial Medical Center in New Orleans faced a grim choice: in the midst of a crisis, who among their patients should be evacuated to better conditions? For many in the general public, news coverage (and later a book) about what happened at Memorial was the first time they truly became aware of medical rationing. The first article in a new collaboration between the New York Times and Radio Lab, "Playing God," describes an unusual public debate on the subject being led by Dr. Lee Daugherty Biddison and her colleagues at Johns Hopkins Hospital. Dr. Daugherty Biddison is leading a task force that will "make recommendations for [Maryland] state officials that could serve as a national model." She and her team are holding a series of public forums to hear opinions from laypeople on topics like: should a doctor be able to remove one person from a ventilator to give it to another with a better chance of surviving? During cancer drug shortages, how should doctors choose which patients receive them? Should such decisions be randomized, through a lottery, or based on a patient's age or likelihood of survival? Renowned bioethicist Ruth Faden of Johns Hopkins Berman Institute of Bioethics praised the effort, noting “It’s a novel and important attempt to turn extremely complicated core ethical considerations into something people can make sense of and struggle with in ordinary language.”

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Donald Trump

The Ethics of Diagnosing Trump from Afar

August 16, 2016

The current election cycle is raising challenging questions about the role of psychiatric diagnosis in public debate, one reminiscent of arguments during the 1964 candidacy of Barry Goldwater. According to the New York Times, "In the midst of a deeply divisive presidential campaign, more than 1,000 psychiatrists declared the Republican candidate unfit for the office, citing severe personality defects, including paranoia, a grandiose manner and a Godlike self-image. . . . After losing in a landslide, the candidate sued the publisher of Fact magazine, which had published the survey, winning $75,000 in damages. But doctors attacked the survey, too, for its unsupported clinical language and obvious partisanship." In 1973, the American Psychiatric Association adopted what is commonly known as the Goldwater Rule, which "prohibits psychiatrists from offering opinions on someone they have not personally evaluated." However, some mental health workers feel Donald Trump and his ideology are so dangerous they're ethically required to speak out, pointing out the aspects of his behavior they find concerning: racism, manipulation, narcissism, hypermasculinity and an inability to deal appropriately with anger. Despite the Goldwater Rule, a manifesto written by University of Minnesota psychology professor William Doherty has been signed by 2,200 mental health professionals; Prof. Doherty says he believes the current election is exceptional, noting "What we have here is a threat to democracy itself." Read the complete article here

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Gender card from Nagano winter olympics confirming an athlete is female.

Rio Olympics Raise New Questions About Sex-testing Athletes

August 4, 2016

Controversies about athletes' gender have been part of the Olympic Games since the "Nazi Olympics" in Munich, 1936. That's the year two runners, Stella Walsh of Poland and Helen Stephens of the United States, were rumored to be men because of their "remarkable athleticism, 'male-like' muscles and angular faces," according to the New York Times Magazine. 80 years later, our culture seems to be more aware of the complex nature of gender expression, but woman athletes are still subjected to testing to insure they're sufficiently female. Concerns abound that high levels of testosterone can provide an unfair advantage for women competing against other women. In the current Rio Olympics two runners, Caster Semenya of South Africa and Dutee Chand of India, have been required to undergo "gender verification" and have been subject to unwanted, intrusive media attention as a result. A new article in JAMA reviews the history of gender determination in Olympic sport and discusses the science behind what are termed "disorders of sex development," which can lead to intersex people being raised as a gender that doesn't necessarily match their chromosomes. For this year's games, rules around gender verification have been suspended, so Semenya and Chand will be able to compete. 

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Disability and End-of-life Medical Options

July 26, 2016

In an editorial in today's MinnPost, Bobbi Jacobsen, who has lived with amyotrophic lateral sclerosis (ALS) for 20 years, commemorates the passage of the Americans with Disabilities Act 26 years ago today by calling upon "the leaders of major disability organizations. . . to recognize that we want to be empowered in our end-of-life medical options, too." The article was written to raise awareness and support for Minnesota's Compassionate Care Act, which is modeled on an Oregon law that permits aid in dying but not assisted suicide. Jacobsen notes that the former only applies to terminally ill people: "Medical aid in dying applies to people who want more than anything to live, but a deadly disease is ending their lives." The bill was introduced in the Minnesota state legislature during the last session and was heard by the Senate Health Committee. It was withdrawn before a vote was taken, but is expected to be introduced again during the next session, which begins in January, 2017. 

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Illustration of egg and sperm

Weak Sperm Bank Regulations Cause Havoc for Some Users

July 25, 2016

Because frozen sperm is lightly regulated, some users have had their lives upended because of lost vials, misleading donor descriptions, misappropriation, and careless record keeping. An article in the New York Times describes some of the worse cases, in which women have been inseminated with sperm carrying highly heritable, serious illnesses without their knowledge or consent. Bioethicist Arthur Caplan, PhD (New York University) notes, “Even in New York, when they inspect [sperm banks], they’re looking at hygienic conditions not record-keeping. Nobody confirms that you have what you say you have. It’s absurd that we have these materials so valuable that people pay to store them, but we run it like a 19th-century grocery.” While the official position of the American Society of Reproductive Medicine is that no further regulation is needed, several lawsuits are moving forward, and the Donor Sibling Registry has become an crucial resource for families who used the same donor to connect and share information.  

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Cesar DeLeon

Force Feeding of Inmate Can Go Forward, Judge Rules

July 15, 2016

A request by Cesar DeLeon to discontinue force feeding has been denied by Circuit Court Judge Steven Bauer. DeLeon is one of several Wisconsin prisoners who began a hunger strike in early June to protest long-term solitary confinement, which in the case of one of the strikers has lasted more than 25 years. In his suit, DeLeon cited free-speech and religious grounds and accused a prison guard of withholding water during the force feeding procedure, which is necessary to avoid food and liquids being aspirated. Prof. Steven Miles, MD, of Consortium member the Center for Bioethics was interviewed for an article by the Wisconsin Center for Investigative Journalism. Miles notes that "force feeding of prisoners is condemned by most major medical groups, including the American Medical Association and the International Committee of the Red Cross. The World Medical Association has declared that 'the forced feeding of hunger strikers is unethical and is never justified,' calling the practice 'inhuman and degrading.'” Miles asserts that "prisoners’ refusal to eat should not be viewed in medical terms alone, saying 'A hunger strike is fundamentally a form of political expression by persons or groups which have exhausted other forms of political expression.'" 

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Prof. Wolf Lectures on Genomics and Public Health

May 11, 2016

Consortium Chair Susan M. Wolf, JD, lectured yesterday at Boston University's School of Public Health. Her topic was the current status of legal and ethical guidelines, as well as the development of best practices, related to translational genomics – issues given greater urgency in light of the federal Precision Medicine Initiative, which launched last year. For more than a decade, Prof. Wolf has led groundbreaking research on return of results (RoR) from genomic testing to research participants, patients, and their families. In her talk at Boston University, she delved into the public health implications of RoR and identified areas needing further study, including the blurring of boundaries between research and clinical applications of genomic scans; difficulties with properly interpreting gene variants; and the need to augment unrepresentative or inadequate data sets to insure they represent well vs. unwell populations and reflect gender and ethnic diversity. Video of the lecture and the following Q&A can be viewed here.  

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Prince Rogers Nelson

Actions Before Prince's Death Raise Medical Ethics Questions

May 6, 2016

An article in today's Minneapolis Star Tribune reports, "the attempted emergency delivery of an opioid antidote to treat Prince’s addiction before he died has raised medical ethics and legal questions." Immediately before the rock star's death, his representatives contacted a California addiction specialist, Andrew Kornfeld, in hopes he could help address Prince's dependence on narcotic painkillers. The doctor sent his son, a pre-med student, to Minnesota with a drug commonly used to treat opioid addiction; the son was the person who called 911 the morning of Prince's death. According to the Star Tribune, "As a doctor licensed in California and federally registered to prescribe controlled substances, Kornfeld would have had authority to prescribe medication to Prince in Minnesota. However, he or an associate would have needed to conduct an in-person exam before prescribing or administering a controlled substance." It's not clear whether an appointment with a Minnesota physician, scheduled for later the day Prince died, was intended to fulfill that requirement. The situation raises at least two legal questions: "Whether the younger Kornfeld had the legal authority to carry a controlled substance from California to Minnesota," and whether "Minnesota’s 'good Samaritan' law, [which] allows people to render aid in a medical emergency," would apply.

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Dr. Stacy Kahn lecturing

Nationally-renowned Speakers Discuss Limits of FMT

March 8, 2016

At a Consortium-hosted lecture today, pediatrician Stacy Kahn (University of Chicago) spoke about the challenges of helping patients make the right decisions about Fecal Microbiome Transplantation (FMT). The therapy, while proven effective in the treatment of recurrent Clostridium difficile infections, has not yet been definitively shown to cure inflammatory bowel diseases. Dr. Kahn described parents, desperate to help a sick child, who are persuaded by information they find on the Internet to try do-it-yourself FMT, despite the risks and lack of data. She was joined by Byron Vaughn, MD, and Alexander Khoruts, MD, of the University of Minnesota's Microbiota Therapeutics Program, for a lively discussion about the reasons FMT may not be as promising for other conditions as it is for treating C. difficile. Dr. Khoruts recently co-authored, with Michael Sadowsky, PhD (University of Minnesota), a Nature Microbiology editorial cautioning about the use of FMT in clinical or domestic settings that may not allow for the proper administration of the therapy. The final lecture in the microbiome series, Microbiota-targeted Therapies from Probiotics to Transplants: New Regulatory Challenges, will be presented by Diane E. Hoffman, JD, MS – registrations are currently being accepted. 

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Prof. Don Postema

"Ethics, the Electronic Health Record, and Karl Marx"

March 14, 2016

On Friday, March 11, Don Postema, PhD described how Karl Marx can help us understand the alienation providers experience when working with electronic health records (EHRs). While EHRs are intended to improve the efficiency and safety of health care practices, they have raised concerns about confidentiality issues related to data theft and the computer’s intrusion into the clinician-patient relationship. Dr. Postema, HealthPartner's Program Director of Medical Ethics, discussed these challenges and asked, "can the EHR be humanized?" His lecture was sponsored by Consortium member the Center for Bioethics; more information here

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Steve Miles

Lectures Series on Human Participant Research Announced

December 18, 2015

Consortium faculty member Steven Miles, MD, of the University's Center for Bioethics will be offering a new, 15-week lecture series beginning January 19, 2016. The series, Standards for Research with Human Participantsis designed to foster better understanding and compliance when conducting human participant research. Miles, an eminent bioethicist, will present a broad set of legal and regulatory topics, including informed consent, vulnerable persons, conflicts of interest and research misconduct. Lectures offer succinct overviews of a topic and provide bibliographical links to relevant University, NIH and international standards. Each individual lecture qualifies for Continuing Medical Education (CME) or Continuing Nursing Education (CNE) credits or fulfills Responsible Conduct of Research (RCR) requirements. The full series of 15 lectures can be taken for academic credit. For registration details related to all three types of credit, visit the Center for Bioethics website.

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Teen hurt playing football

Football Concussion Safety Guidance Inadequate, Say Two U Professors

November 11, 2015

A forthcoming editorial in the January, 2016 issue of the American Journal of Bioethics (already posted online) responds to recent football safety recommendations for children and teens from the American Academy of Pediatrics (AAP). Dr. Steven Miles of Consortium member the Center for Bioethics, and Dr. Shailendra Prasad, who specializes in family medicine and community health, co-authored the commentary, which states that the AAP guidelines don't go far enough. They cite increased understanding of the dangers of concussion, especially for young people who are more susceptible than adults to long-term damage from head trauma. Miles and Prasad conclude by calling on "the medical community [to] help students, schools and society leave a sport on which the sun is setting." 

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Research lab with test tubes

Unintended Consequences: Culture Wars Drove State Stem Cell Research Funding

November 6, 2015

When President George W. Bush restricted federal funding for embryonic stem cell research in 2001, he wasn't looking to expand state funding of this research, but that's exactly what happened. An article in Kaiser Health News recounts how, after the ban, several states started their own stem cell programs or offered economic incentives to local scientists and companies. While these efforts haven't yet produced any miracle cures because of the amount of research still to be done, Jakub Tolar, director of Consortium member the Minnesota Stem Cell Institute, notes that potential results are worth the wait. “We started on drugs a hundred years ago. Then we went to monoclonal antibodies – biologicals,” he said. “We are now getting ready to use cells as a third way of doing medicine. We are at a historical sweet spot.” The U's Stem Cell Institute was established in 1999, before the ban on research with embryonic cells, and is the world's first interdisciplinary institute dedicated to stem cell research.