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Funded by National Institutes of Health.

Funding Years: 2014-2019.

Randomized controlled trial (RCT) results diffuse into clinical practice slowly - the average time from trial completion to widespread adoption of a new treatment is nearly 20 years. These delays result in suboptimal treatment for patients with neurological diseases. In light of these delays and the enormous societal value of NINDS clinical trials findings, NINDS has recognized the need to accelerate implementation by promoting research to translate trial findings into routine care (T2 translational research). This application seeks to optimize translation of NINDS trials by personalizing clinical trial results ad addressing barriers to translation for clinicians and policy-makers. Using translational research methods, we can move from one-size-fits-all evidence-based medicine towards personalized medicine by estimating treatment benefit for individual patients. Other translational methods can evaluate and address stakeholder concerns that hinder translation. Because clinicians are often skeptical of trial results, changing practice requires convincing them not only that a treatment works in an RCT or that it works in academic medical centers, but that it will work for their patients. Similarly, if policy-makers and payers can be convinced that a new treatment is a good value (e.g., a favorable cost-benefit ratio), they can use their considerable influence on the healthcare delivery system to facilitate translation. Specifically, we will use translational research methods to address three important issues essential to improving trial translation: 1. estimating individual-level outcomes using multivariable outcome prediction 2. Estimating the impact of real world circumstances on outcomes using simulation analyses and 3. Cost effectiveness analysis. Results from these analyses can influence clinicians and policy-makers directly or through the use of tools, such as websites and mobile applications. This proposal has two key objectives. First, we will adapt translational research methods to clinical trials by addressing essential translation-relevant questions for the Carotid Revascularization Endarterectomy versus Stenting (CREST) trial. Second, we will develop a model to concurrently perform similar translational analyses in the Neurology Emergency Treatment Trials (NETT) network. These objectives will be addressed through 3 specific aims: 1. to estimate the expected net benefit of carotid endarterectomy (CEA) vs. carotid artery stenting (CAS) for individual patients in the CREST trial using refined multivariable outcome prediction methods. 2. To estimate the impact of personalized decision-making and real world circumstances (e.g., differing complication rates) on the net benefit of CAS vs. CEA for real world patients using simulation analyses. 3. To assess the feasibility of performing concurrent translational and cost analyses in NETT trials by evaluating a process implementation model in newly initiated and recently completed NETT trials. Dr. Burke has a unique background as a vascular neurologist with training in Translational research methodology through the highly regarded Robert Wood Johnson Clinical Scholars Program. In this proposal, Dr. Burke will develop the additional expertise in clinical trials, multivariable outcome prediction, simulation analyses and cost analyses to become a leader and independently-funded investigator in neurological translational research working to develop a new generation of NETT trials better designed to effectively inform real world clinical practice and improve patient outcomes. This proposal capitalizes on unique environmental strengths at the University of Michigan. Most importantly, Dr. Burke will be supported by an outstanding multi- disciplinary mentorship team including Dr. William Barsan the NETT Clinical Coordinating Center (CCC) principal investigator and a research leader in the emergency treatment of neurological diseases, Dr. Rodney Hayward a Professor of Internal Medicine and a pioneer in translational research and Dr. Lewis Morgenstern, a leader in neurological translational research. All three mentors have excellent track records in mentoring junior faculty and transitioning junior faculty to independence. In addition, Dr. Burke will have te opportunity to participate in a unique hands-on clinical trials immersion through the NETT to gain experience in clinical trial design, management and implementation. Finally, the University of Michigan has recently built the largest academic Translational Research center in the United States (the Institute for Health Policy and Innovation) which will support the advanced statistical methods required for this proposal.

PI(s): James Burke

Lauren Smith recently gave a lecture on medical ethics at the Michigan State Medical Society.

Research Topics: 

Funded by the Greenwall Foundation

In spite of strong evidence showing it offers no clinical benefit and increases the likelihood of unnecessary cesarean delivery, Electronic Fetal Monitoring remains part of routine care given to nearly all patients in labor in the US. Using observations and interviews the research team will identify the barriers to the implementation of this evidence and organize a deliberative meeting with key stakeholders to translate the project’s findings into practical strategies for more ethical and judicious use of EFM.

PI: Raymond De Vries

CBSSM Co-Is: Lisa Harris & Kayte Spector-Bagdady

Registration is now open for the April 25, 2017 CBSSM Research Colloquium & Bishop Lecture in Bioethics. This event is free and open to the public. Registration is encouraged, as it will help us to estimate numbers for catering and lunch. Please RSVP by April 18th.

The keynote address is the Bishop Lecture in Bioethics, an endowed lectureship made possible by a gift from the estate of Ronald C. and Nancy V. Bishop.  Norman Daniels, PhD will present the Bishop Lecture with a talk entitled: “Universal Access vs Universal Coverage: Two models of what we should aim for."

Norman Daniels, PhD is Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health in the Department of Global Health and Population at the Harvard School of Public Health.

Location: Great Lakes Room, Palmer Commons, 100 Washtenaw Ave, Ann Arbor, MI 48109
 
Click here to register for the Colloquium!

Click here for the Colloquium Schedule and Presentation Abstracts.

The August 2016 issue of AMA Journal of Ethics features commentaries by Christian Vercler, Lauren Smith, and Andrew Shuman.

"Is Consent to Autopsy Necessary? Cartesian Dualism in Medicine and Its Limitations"
Commentary by Megan Lane and Christian J. Vercler

"I Might Have Some Bad News: Disclosing Preliminary Pathology Results"
Commentary by Michael H. Roh and Andrew G. Shuman

"Requests for VIP Treatment in Pathology: Implications for Social Justice and Systems-Based Practice"
Commentary by Virginia Sheffield and Lauren B. Smith

http://journalofethics.ama-assn.org/site/current.html

Research Topics: 

2017 Bishop Lecture featuring Norman Daniels, PhD

Tue, April 25, 2017, 11:15am
Location: 
Great Lakes Room, Palmer Commons, 100 Washtenaw Ave, Ann Arbor, MI 48109

The 2017 Bishop Lecture in Bioethics was presented by Norman Daniels, PhD, Mary B Saltonstall Professor and Professor of Ethics and Population Health in the Department of Global Health and Population at Harvard School of Public Health. Dr. Daniels presented a talk entitled, "Universal Access vs. Universal Coverage: Two models of what we should aim for." The Bishop Lecture served as the keynote address during the CBSSM Research Colloquium.

Abstract: We contrast two models of health care insurance, the Universal Coverage model underlying the Affordable Care Act and the Universal Access model underlying the (now withdrawn) American Health Care Act. Our goal is to evaluate the strongest argument for the Universal Access model. That model suggests that if people have real choices about health care insurance, some will buy it and some will not, and no one should be mandated to buy it. We argue that the Universal Access model presupposes that people can afford insurance, and that means subsidizing it for millions of people as the Universal Coverage model underlying the ACA does. These costs aside, the strongest argument for the Universal Access model is that giving people true choice may make the population level of well-being higher. Some people will have other priorities that they prefer to pursue, especially if they can free ride by enjoying the benefits of a system that provides health care without their contributing to it. If the additional costs that third parties have to pay as a result of the increase in real choice are significant, then the strongest argument for Universal access fails: the benefits of choosing not to be insured are outweighed by the imposed costs on others from these choices.

Norman Daniels, PhD is Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health in the Department of Global Health and Population at the Harvard School of Public Health. Formerly chair of the Philosophy Department at Tufts University, his most recent books include Just Health: Meeting Health Needs Fairly (Cambridge, 2008); Setting Limits Fairly: Learning to Share Resources for Health, 2nd edition, (Oxford, 2008); From Chance to Choice: Genetics and Justice (2000); Is Inequality Bad for Our Health? (2000); and Identified versus Statistical Lives (Oxford 2015). He has published 200 peer-reviewed articles and as many book chapters, editorials, and book reviews. His research is on justice and health policy, including priority setting in health systems, fairness and health systems reform, health inequalities, and intergenerational justice. A member of the IOM, a Fellow of the Hastings Center, and formerly on the ethics advisory boards of the CDC and the CIHR, he directs the Ethics concentration of the Health Policy PhD at Harvard and recently won the Everett Mendelsohn Award for mentoring graduate students.

  • Click here for the video recording of the 2017 Bishop Lecture.

Announcement of Position: Clinician Ethicist

Announcement of Position: Clinician Ethicist


Background
The Program in Clinical Ethics within the Center for Bioethics and Social Sciences in Medicine (CBSSM) represents an expansion of existing services designed to promote a culture of patient-centered excellence by developing a comprehensive set of ethics-related activities. The aims of this program are to: liaise with and provide support to the adult and pediatrics ethics committees; streamline clinical ethics consultation; assist with ethics-related policy development on a regular and proactive basis; organize and administer structured educational programs in clinical ethics; and coordinate empiric research with relevance to clinical ethics within CBSSM.


Program Organization
The Program in Clinical Ethics is co-directed by the chairs of the adult and pediatric ethics committees and consultation services, Christian J. Vercler, MD MA and Andrew G. Shuman, MD. A dedicated clinician ethicist will manage the program on a daily basis. A cadre of eight faculty ethicists will rotate on service throughout the year and work closely with the clinician ethicist. Trainees and students will rotate as well. Dedicated administrative support will be organized through CBSSM.


Position
One individual will serve as the program’s clinical ethicist. This individual will serve as the “first responder” and contact person for all ethics consults during business hours, ensure continuity with consults, and work in conjunction with faculty ethicists. The role will include arranging team/family meetings, ensuring follow-ups on all consults, and arranging additional consultations as needed for selected cases. He/she will also regularly review relevant institutional policies and attend all ethics committee meetings. Another major component of this role will be to organize and participate in educational efforts and preventative ethics rounds. This position will provide $50,000 of direct salary support annually, to be distributed and allocated in conjunction with their home department. The initial appointment will last two years and is renewable.


Qualifications
Candidates are expected to be employees or faculty at UMHS with a master’s or equivalent terminal degree in their field; any professional background is acceptable. Direct experience with clinical ethics consultation is required. Familiarity with ethics education and related clinical research would be helpful. Excellent organizational and communication skills across multidisciplinary medical fields are required. Candidates are expected to have qualifications that meet the standards outlined by The American Society for Bioethics and Humanities (ASBH) for accreditation for clinical ethics consultants.


Application Process
Candidates will be vetted, interviewed and chosen by a nomination committee. Candidates are asked to submit:

  • Curriculum vitae or resume
  • One page maximum summary of (1) education/training related to ethics consultation; (2) clinical ethics consultation experience; and (3) motivation/interest in the position
  • Letter of support from Department Chair/Division Head/Center Director or equivalent
  • Submit formal application via email to: valkahn@med.umich.edu


Timeline

  • Application is due December 11, 2015 with interviews shortly thereafter
  • Appointment will take effect January 1, 2016


Contacts

  • Co-Directors of the Program in Clinical Ethics: Christian J. Vercler, MD MA & Andrew G. Shuman, MD
  • Administrative contact: Valerie Kahn – valkahn@med.umich.edu 734 615 5371

Bioethics Grand Rounds: Janice Firn, MSW; Andrew Shuman, MD; Christian Vercler, MD

Wed, January 27, 2016, 12:00pm
Location: 
UH Ford Amphitheater & Lobby

"Implementation of the Program in Clinical Ethics"

Janice Firn, MSW; Andrew Shuman, MD; Christian Vercler, MD

Abstract: The Program in Clinical Ethics within the Center for Bioethics and Social Sciences in Medicine represents an expansion of existing services designed to promote a culture of patient-centered excellence by developing a comprehensive set of ethics-related activities at UMHS. We will introduce and outline the projects and services available to all members of the UMHS Community.

Funded by Department of Health and Human Services - National Institutes of Health Subcontracts

Funding Years: 2014.

Promoting physical activity and decreasing sedentary behavior are key goals in the fight against cancers; physical activity is associated with lower risk of several cancers [1-10], and lower overall morbidity and mortality [11-26]. Thus, theory-driven initiatives to change these behaviors are essential [1-10, 26-40]. PQ#3 highlights the necessity for new perspectives on the interplay of cognitive and emotional factors in promoting behavior change. Current theories, which focus primarily on predictors derived from self-report measures, do not fully predict behavior change. For example, recent meta-analyses suggest that on average, variables from the Theory of Planned Behavior account for ~27% of the variance in behavior change [41, 42]. This limits our ability to design optimally effective interventions [43], and invites new methods that may explain additional variance. Our team has shown that neural activation in response to health messages in hypothesized neural regions of interest can double the explained variance in behavior change, above and beyond self-reports of attitudes, intentions, and self-efficacy [44, 45]. We now propose a next leap, inspired by PQ3, to identify how cognitive and affective processes interact in the brain to influence and predict behavior change. Our core hypothesis is that the balance of neural activity in regions associated with self-related processing versus defensive counterarguing is key in producing health behavior change, and that self-affirmation (an innovative approach, relatively new to the health behavior area [46]) can alter this balance. Self-affirmation theory [47] posits that people are motivated to maintain a sense of self-worth, and that threats to self-worth will be met with resistance, often i the form of counterarguing. One common threat to self-worth occurs when people are confronted with self-relevant health messages (e.g. encouraging less sedentary behavior in overweight, sedentary adults). This phenomenon speaks to a classic and problematic paradox: those at highest risk are likely to be most defensive and least open to altering cancer risk behaviors [48]. A substantial, and surprisingly impressive, body of evidence demonstrates that affirmation of core-values (self-affirmation priming) preceding messages can reduce resistance and increase intervention effectiveness [46, 49-53]. Uncovering neural mechanisms of such affirmation effects [46], has transformative potential for intervention design and selection. To test our conceptual assumptions and core hypothesis we will: (1) Identify neural signals associated with processing health messages as self-relevant versus counterarguing; (2) Test whether self-affirmation alters the balance of these signals; (3) Use these neural signals to predict physical activity behavior change, above and beyond what is predicted by self-report measures alone. Our approach is innovative methodologically (using fMRI to understand and predict behavior change), and conceptually (self-affirmation may dramatically increase intervention effectiveness). Benchmarks will include objectively measured decreases in sedentary behavior in affirmed vs. control subjects (using accelerometers), and increases in predictive capacity afforded by neuroimaging methods, compared to self-report alone.

PI(s): Thad Polk

Co-I(s): Lawrence An, Sonya Dal Sin, Kenneth Resnicow, Victor Strecher

Sacha Montas, JD, MD

Faculty

Dr. Montas is a Clinical Lecturer in the Department of Emergency Medicine. Dr. Montas holds a law and medical degrees from the University of Michigan and a Master of Bioethics from the University of Pennsylvania. He has been a member of the University of Michigan Adult Ethics Committee since 2009. His research interest is in the intersection of Law and Medicine, and Bioethics, with a focus on the influence of the legal system and legal norms on patient-physician communication and decision making.

Last Name: 
Montas

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