Health researchers have studied “stem cell tourism” to clinics in countries such as China, India, Mexico, Thailand, and the Ukraine but more recently, studies have found hundreds of clinics here in the U.S. selling unapproved and unproven stem cell interventions. Many of these clinics do not sell FDA-approved stem cell products or have credible evidence supporting their marketing claims. This direct-to-consumer approach to selling unproven and unlicensed cell-based products prompts troubling concerns about patient safety, the manipulation of hope in advertising, and the gap between the current state of stem cell research and the purported therapies these clinics market. In this talk, the speaker describes the U.S. direct-to-consumer marketplace for stem cell interventions and explore ethical issues related to the increase in U.S. clinics selling stem cell treatments. The presentation also covers regulation of stem cell-based products, FDA enforcement activity, and lawsuits filed by former patients of U.S. stem cell clinics.
Speaker: Leigh Turner, PhD, Associate Professor, Center for Bioethics, Associate Professor, Dept of Pharmaceutical Care & Health Systems, Associate Professor, School of Public Health
We know that what impacts health lies largely outside of normal healthcare delivery. We call these the negative social determinants of health. One in six people with low incomes need legal help to overcome these determinants and improve their health. Restoring food stamps when wrongfully denied to a diabetic can eliminate the need for a kidney transplant. Demanding that a landlord remove mold from substandard housing can reduce the need for emergency asthma care. Such interventions can also reduce overall healthcare costs. Healthcare Legal Partnerships exist to meet needs like these by adding lawyers to the healthcare team in various settings. The University of Minnesota helped pioneer this model of care in the 1990s. The HLP Collaborative in Minnesota was founded by nursing educator Dr. Eileen Weber, who is also an attorney, so HLPs in our region can share best practices and increase awareness, education and outreach of this effective interprofessional care model. Her presentation offers HLP strategies and resources to help those who work to advance health equity.
Speaker: Eileen Weber, DNP, JD, BSN, PHN, RN, Clinical Associate Professor, Population Health and Systems Cooperative
Advance care planning supports patient-centered decision-making by discussing goals, values, and preferences for future medical care. This process involves three key stakeholders: the patient, their surrogate decision-maker, and their clinicians. How do the stakeholder roles change when the patient is an adolescent who has the capacity but not the legal right to make medical decisions? Dr. Jennifer Needle, a Pediatric Intensive Care physician from the University of Minnesota Masonic Children's Hospital and faculty member in the Center for Bioethics, addresses this question from the perspectives of these stakeholders in the context of adolescent advance care planning. She reviews the literature on the benefits and barriers to effective advance care planning, discusses clinician, patient, and surrogate perspectives on medical decision-making in adolescent patients, and discusses future areas of research to support adolescent patients and their families in making informed medical decisions. This event was co-sponsored by the Department of Pediatrics in the University of Minnesota's Medical School.
Speaker: Jennifer Needle, MD, MPH | Assistant Professor, Center for Bioethics, University of Minnesota
In this talk, Dr. Benya discussed the recent National Academies report that examines the effect of sexual harassment on women in scientific, technical, and medical fields in academia. Dr. Benya shared strategies and practices that can be used to prevent and address this discriminatory behavior, and discussed the research that supports these approaches. This event was co-sponsored by the University of Minnesota School of Nursing, The Center for Women in Medicine and Science, and the History of Science, Technology, and Medicine department.
Informed consent requires that research participants understand the study under consideration and appreciate its implications for their interests. Therapeutic misconception – which occurs when individuals confuse the purposes of clinical research with standard clinical care – compromises informed consent. Dr. Bryan A. Sisk expands the discussions beyond therapeutic misconception in clinical trials by explaining multiple ways in which understanding and appreciation of information about a clinical trial can be undermined. He offers a framework of therapeutic misperceptions to assist researchers in managing challenges to the informed consent process. This activity was designed for physicians and other healthcare professionals. By the end of this talk, attendees are able to do the following:
1. Identify two components of decisional capacity
2. Discuss challenges of therapeutic misperceptions in the clinic-research setting
3. Explore a framework of therapeutic misperceptions
3-100 Mayo, U of M East Bank Campus
The background to justice in bioethics revolves around fair access to costly health care resources. Meanwhile, social movements emphasize economic, racial, and identity inequalities within the United States. The demands of climate change add conceptions of justice: environmental justice, intra-specific justice, global inequality, differential responsibility for climate change, and generational justice. How are we to sort out these different emphases? Meanwhile, the rate of climate change is accelerating, and 27 years of negotiations has yielded no actual reduction in global greenhouse gas emissions. While we argue, inevitable misery is mounting up unjustly for young people and future generations.
Speaker: Andrew Jameton, PhD, Affiliate Faculty, Center for Bioethics, UMN; Professor Emeritus, College of Public Health University of Nebraska Medical Center
What truly is a patient's right to self-determine? Can an advance directive take any form? This talk will look at the complexities of autonomous decision making and end of life through the eyes of a young adult expressing her wishes in the form of a tattoo.
Speaker: Nneka Sederstrom, PhD, MPH, MA, FCCP, FCCM, Director, Clinical Ethics Department, Children's Hospital and Clinics of Minnesota and Affiliate Faculty, Center for Bioethics
Prof. Singh provides Ethical, Legal, Social Issues (ELSI) support to the Gates Foundation and its partners on gene drive research and its applications. In short, using a promising new technology called CRISPR/Cas9 to do targeted genome editing on mosquitos so that they produce male offspring (thus driving the species to extinction and, in the process, eliminating the spread of a disease), scientists will soon be field-testing these GM mosquitos in various settings. As you can imagine, this technology raises several ELSI issues
- Do we have the moral right to alter ecosystems?
- How do we deal with non-consensual communities or individuals in a field trial context, how do we engage with communities regarding this technology?
- How do deal with reparations if a field trial goes wrong, etc.
Speaker: Jerome Singh, BA, LLB, LLM, PhD, MHSc, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal (UKZN); Joint Center for Bioethics, University of Toronto
Palliative care is an innovative and growing field focussing on life-threatening illness and on the relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. In this “holistic” approach palliative care differs from science based modern medicine and shows similarities to other “holistic” approaches to the patient as a subject as well as to pre-modern medicine. Professor Vollmann discusses from his ongoing research palliative care exceptionalism and a broader perspective on end of life care and modern medicine and its’ consequences for future health care.
Speaker: Jochen Vollmann, MD, PhD, Professor, Medical Ethics, Director, Institute for Medical Ethics and History of Medicine, and President, Center for Medical Ethics, Ruhr University Bochum, Germany
Waivers of informed consent for research participation are permitted under the Common Rule as well as the Exception from Informed Consent (EFIC) for emergency research rule. We examine waivers as embodiments of legal privilege, which permit actors to violate legal norms in furtherance of greater social goods. The emergency privilege, which allows a caregiver to provide emergency medical care to an incompetent victim of an accident, is the clearest example. But fundamental to the privilege to acting without consent is the presumption that reasonable persons in the patients' position would agree, if capable, and that no evidence exists that the particular patient would not agree. An assessment of what is known about participation and refusal rates in research show that the presumption with respect to standard care is not applicable to research. This suggests that, while researchers may assert the social utility of their studies are high enough to justify waivers,there is reason to suspect that many who would be enrolled under a waiver of consent would not want to be enrolled.Our analysis suggests that waivers should be rare, IRBs and researchers must explicitly address study acceptability, and it should be incumbent upon researchers to establish by clear, sound evidence that proposed studies would be acceptable in the community at large and the target population.
Speaker: Jon Merz, MBA, JD, PhD, Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania