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Funded by NIH Department of Health and Human Services

Funding Years: 2015-2020

Colorectal rectal cancer (CRC) is the third most common cancer in the US with over 50,000 individuals dying annually from the disease. Despite multiple effective screening tests, CRC screening remains underutilized relative to other cancer screening. A driving factor behind this underutilization among insured populations is the gap that exists between a physician recommendation for care and the patient's receipt of screening. How best to support patients in CRC screening once they have a physician recommendation for care remains unknown. The proposed project will test the effectiveness and impact of a post-visit, patient portal tool, e-Assist, for engaging and supporting primary care patients in their decision making regarding, and ultimately in their obtaining, CRC screening. The tool purposely leverages the cue to action provided by a physician recommendation for care as well as the secure patient portal platform now commonly found within primary care practices. It seamlessly combines important patient-physician decision making content with assistance in removing personal and structural barriers to screening. Our research will answer four overarching questions: (1) Can a post-visit, patient portal tool, e-Assist, increase adherence to physician-recommended CRC screening? (2) How does e-Assist engage primary care patients in the CRC screening decision making process? (3) Are there subgroups of the primary care population for whom e-Assist is more engaging and effective? and (4) What adaptations are needed to e-Assist to improve its reach, and ensure its adoption, implementation, and ultimately its impact on evidence-based CRC screening use among diverse primary care patients and clinics? These questions will be addressed using a two-arm, practical randomized trial supplemented with findings from focus groups and in-depth interviews with patients, clinicians and other clinic staff to ensure a comprehensive understanding of not only program effectiveness and implementation, but the factors driving overall program impact. Results will illustrate how e-tools can be used following an office visit to support both patient decision making, and the dissemination and implementation of evidence-based cancer screening services in primary care.

PI(s): Jennifer Lafata

Co-I(s): Sarah Hawley, Kenneth Resnicow

Funded by Health and Human Services, Department of-Agency for Health Care Research and Quality

Funding Years: 2014-2016

This grant aims to engage communities, particularly underserved communities, in informed deliberations about current and potential changes to Medicaid eligibility, coverage, and cost-sharing. Building on community-based research partnerships state-wide, we will convene a Steering Committee including community leaders, researchers, decision makers in private healthplans and the Michigan Department of Community Health (MDCH) and other stakeholders. We will adapt an innovative, award-winning web-based simulation exercise, CHAT (CHoosing All Together, in which individuals and groups make tradeoffs between competing needs for limited resources. Options in Medicaid-CHAT may include variations in covered benefits; out-of-pocket spending; population health and public health programs; rewards for healthy behaviors; and quality improvement activities. We will facilitate deliberations throughout the state, disproportionately sampling medically underserved communities and balancing locale (urban, suburban, rural and remote rural) and sociodemographic characteristics, ensuring inclusion of particular perspectives, e.g., those with chronic illness and those who are or will soon be eligible for Medicaid coverage or dually eligible.

We will prepare policy briefs describing the views of Michigan citizens about Medicaid eligibility, coverage, and cost-sharing and implications for policy. We aim to communicate Medicaid priorities of communities and the policy implications to state leaders, community leaders, insurers, and other stakeholders. We will examine the impact of public engagement on participants’ knowledge, attitudes, and priorities, and explore the impact on policy decisions.

We will also evaluate the effect of deliberations including a key element of deliberative procedures – representation.

PI(s): Susan Goold, MD, MHSA, MA

Co-I(s): A. Mark Fendrick, MD; Hyungjin Kim, PhD; Richard Lichtenstein, MD

Funded by National Institutes of Health

Funding Years: 2015-2018

Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if thir condition is life-threatening and the experimental therapy is only effective if given right away. To perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an "empirical ethics lab" in which best practices are developed.

PI(s): Robert Silbergleit

Co-I(s): Michael Fetters, Michael Geisser, Adrianne Haggins, Alan Sugar, Sacha Montas

2015 Bishop Lecture featuring Lawrence O. Gostin, J.D., LL.D. (Hon.)

Tue, March 17, 2015, 11:00am
Founders Room, Alumni Center, 200 Fletcher St., Ann Arbor, MI

Bishop Lecture in Bioethics: "Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak" (Keynote Address for the 2015 CBSSM Research Colloquium)

Abstract: The measles outbreak of early 2015 is symptomatic of a larger societal problem–the growing number of parents who decide against vaccinating their children. This failure is causing the resurgence of childhood diseases once eliminated from the United States.
falseThis presentation explores the legal and ethical landscape of vaccine exemptions. While all states require childhood vaccinations, they differ significantly in the types of religious and/or philosophical exemptions permitted, the rigor of the application process, and available review mechanisms. States with relaxed exemption policies disproportionately experience more outbreaks of vaccine-preventable disease.

Vaccine exemptions are an illustration of the “tragedy of the commons,” in which parents choose not to vaccinate their children, relying on the fact that other parents will vaccinate their children, thus providing community immunity. However, the net result of many individual decisions not to vaccinate is the collapse of herd immunity and thus an upsurge in preventable disease and death.
The failure to vaccinate puts others at risk, thus violating an important ethical principle. However, punishing individual parents could entrench political opposition to vaccine policy. The most ethical and effective solution is for state legislatures to tighten vaccination laws, making it more difficult to obtain non-medical exemptions.

Lawrence O. Gostin, J.D., LL.D. (Hon.) is University Professor, Georgetown University’s highest academic rank conferred by the University President. Prof. Gostin directs the O’Neill Institute for National and Global Health Law and is the Founding O’Neill Chair in Global Health Law. He is Professor of Medicine at Georgetown University, Professor of Public Health at the Johns Hopkins University, and Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities. Prof. Gostin is also the Director of the World Health Organization Collaborating Center on Public Health Law & Human Rights.

  • Click here for video-recording of the 2015 Bishop Lecture

Masahito Jimbo, MD, PhD, MPH


Masahito Jimbo is Professor of Family Medicine and Urology at the University of Michigan. Having worked as a family physician in both urban (Philadelphia) and rural (North Carolina) underserved areas, he has first-hand knowledge and experience of the challenges faced by clinicians and healthcare institutions to be successful in providing patient care that is personal, comprehensive, efficient and timely. Initially trained in basic laboratory research, having obtained his MD and PhD degrees at Keio University in Tokyo, Japan, Dr.

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H. Myra Kim, ScD


H. Myra Kim is a Research Scientist at the Center for Statistical Consultation and Research and and Adjunct Professor at the Department of Biostatistics. She received her Sc.D. in Biostatistics from Harvard University in 1995 and worked at Brown University as an Assistant Professor from 1995 to 1997. She has worked at UM since 1997 and has collaborated with various researchers from around the UM community as well as from other universities.

Research Interests: 
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Funded by: NIH

Funding Years: 2016-2020

In the past 30 years, the Incidence of thyroid cancer has tripled. The majority of the rise in thyroid cancer incidence is attributed to an increase in low-risk, well-differentiated thyroid cancer, a disease that has a 10-year mortality close to zero. Our previous work suggests that patients with low-risk thyroid cancer are at risk for overtreatment, defined as the use of Surgical and medical interventions in the absence of a clear survival benefit. The overtreatment of thyroid cancer has inherent costs, both to patient health and to society. The reason for the intensive management and potential overtreatment of low-risk thyroid cancer remains unclear. By using SEER-linked patient and physician Surveys, we plan to understand the Treatment decision making in low-risk thyroid cancer. We hypothesize that knowledge and attitudes influence decision making. Specifically, we anticipate that lack of knowledge of risks of death, recurrence and Treatment complications is associated with Treatment that is more intensive. in addition, we postulate that a general preference for active treatment will also be associated with more intensive cancer Treatment. Although both patient and physician perceptions of Treatment need (i.e., knowledge and attitudes) likely contribute to Treatment intensity, we anticipate that the primary driver will be physicians, even after controlling for their patients' perceptions. This study will serve as the foundation for future Intervention studies. By identifying the specific role of physician and patient knowledge and attitudes toward thyroid cancer Treatment, we will be able to create tailored educational interventions to personalize Surgical and medical care for thyroid cancer patients, thus minimizing overtreatment and its inherent risks and costs. As the rising Incidence, low mortality, and pattern of intensive Treatment make thyroid cancer arguably the best cancer model for overtreatment, this proposed study will also serve as a model to understand overtreatment in other malignancies.

PI: Megan Haymart

CO(s): Brian J. Zikmund-Fisher, PhD & Sarah Hawley, PhD. MPH

Darin Zahuranec, MD

Funded by National Institutes of Health.

Funding Years: 2013-2016.

With the growing importance of biobank research, concerns have been raised about how to protect the interests of donors. The current ethics framework mainly focuses on protecting against risks to donors' welfare and to their privacy. However, there has been little systematic empirical, normative, or policy focus on the non-welfare interests of donors, i.e., concerns about the moral, societal, or religious implications of research using their donation that may affect their willingness to donate. Although important theoretical discussions, mentions in commission reports, and insights from several qualitative studies have drawn attention to the serious nature of these interests, we lack important data for policy development: (1) systematic data on the nature and extent of potential impact of non-welfare interests and (2) high quality (i.e., informed and considered) policy preferences of the public addressing how to balance these non-welfare interests with the promise of biobank research. Our project will fill these gaps with two complementary projects. First, a national survey will assess the contours of the potential impact of non-welfare interests on biobank research, by addressing: what kinds of non-welfare interests substantially affect willingness to donate biological materials?; how common are these interests?; how much do donors want to know about the potential involvement of such non-welfare interests when donating?; how are non-welfare interests affected by such factors as race or ethnicity, socioeconomic status, trust in medical research, religious beliefs and practice, or political orientation? Second, we will obtain considered, informed judgments of the public regarding how to handle the tension between the public good of biobanks and the conflicting non-welfare interests of potential donors, using a democratic deliberation method in which subjects will attend an all-day education and peer deliberation session. The impact of the deliberation will be validated using a randomized, experimental design. In summary, despite the ethical significance of non-welfare interests for biobank research, there is a paucity of systematic data regarding both their potential impact and the potential policy solutions. This project will provide a highly generalizable assessment of the potential impact of non-welfare interests as well as policy recommendations based on informed, deliberative opinions of the general public. Visit the NIH website for more information.

PI(s): Tom Tomlinson, Raymond De Vries 

Co-I(s): Karen Kelly-Blake, H. Myra Kim, Blake J Roessler 

Funded by National Institutes of Health.

Funding Years: 2013-2017.

The clinical management of patients with cancer does not entail a "one size fits all" approach. In fact, studies of the genomic landscape of human cancers have demonstrated that cancers can have a multitude of mutations, a subset of which may be "actionable" with current drugs. Thus, the personalization of therapy for cancer will require molecular characterization of unique and shared genetic aberrations. In particular, patients who have advanced / refractory cancer and are candidates for clinical trials could potentially benefit by identifying eligibility for "targeted" drugs based on the "actionable" genesin their specific tumor. Growing technological advances in genomic sequencing has now made it possible to consider the use of sequence data in a clinical setting. Thus, the translation of high throughput sequencing would support a "personalized" strategy for cancer. However, the translation of clinical sequencing bears unique challenges including identifying patients who could benefit, developing informed consent and human subjects protections, outlining measurable outcomes, interpreting what results should be reported and validated, and how results should be reported. This proposal brings together expertise at the University of Michigan including clinical oncology, cancer genetics, genomic science/bioinformatics, clinical pathology, social and behavioral sciences, and bioethics in order to implement this clinical cancer sequencing project. We have focused our clinical sequencing effort on sarcomas and other rare cancers as this is an area of clinical strength at Michigan. Three integrated Projects have the following themes: Project 1) "Clinical Genomic Study" will identify patients with advanced or refractory sarcoma or rare cancers who are eligible for clinical trials, consent them to the study obtain biospecimens (tumor tissue, germline tissue), store clinical data, and assemble a multi-disciplinary Sequencing Tumor Board to deliberate on return of actionable or incidental genomic results; Project 2) "Sequencing & Analysis" will process biospecimens and perform comprehensive sequencing and analysis of tumors to identify point mutations, copy number changes, rearrangements/gene fusions, and aberrant gene expression under CLIA/CAP guidelines; Project 3) "Ethics & Psychosocial Analysis" will evaluate the clinician and patient response to the informed consent process, delivery of genomic sequence results, and use of genomic results.

PI(s): Arul Chinnaiyan (Main Study PI), Scott Roberts (Project 3 PI)

Co-I(s): Ajjai Alva, Rashmi Chugh, Ray De Vries, Jeffrey Innis, Lakshmi Kunju, Rohit Mehra, Nallasivam Palanisamy, Dan Robinson, Moche Talpaz, Scott Schuetze, David Smith, Elena Stoffel, Scott Tomlins, Brian Zikmund-Fisher