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Research Ethics

Research Ethics Service

The Research Ethics Service, led by Kayte Spector-Bagdady, JD, MBioethics and Raymond De Vries, PhD within the Center for Bioethics and Social Sciences in Medicine, aims to enable a culture of normative, empirical, and educational inquiry to serve as the ethical backbone of research at Michigan Medicine. Its three areas of focus include:


1. Education: providing instruction on Research Ethics and Responsible Conduct of Research;
2. Consultation: offering a consulting service for colleagues with questions about the ethical conduct of research; 
3. Research: using a variety of methods to study issues in Research Ethics.


Research Ethics and Responsible Conduct of Research Education

Coursework and independent projects into research ethics and the responsible conduct of research may be available upon request. Current courses include the Responsible Conduct of Research for K Awardees (RCR4K) Implementation Package offered through the Michigan Institute for Clinical & Health Research (MICHR) and Legal Rules and Ethical Issues for Clinical Research (HMP 540) through the Clinical Research Design and Statistic Analysis Masters Program at the UM School of Public Health.


Research Ethics Consultation Service

Personalized Research Ethics Consultation may be available during normal business hours for investigators across Michigan Medicine designing or conducting their own research protocols. For further information or to request a consultation please contact kaytesb@med.umich.edu.


Mixed Methods Research into Human Subjects Research Ethics

The Program in Research Ethics also supports a vibrant mixed-methods empirical program for research on human subjects research ethics.

Internet Survey Lab

Overview

The Internet Survey Lab at the Center for Bioethics and Social Sciences in Medicine (CBSSM), led by Dr. Brian Zikmund-Fisher, facilitates the programming of complex experimental designs, using the graphical and interactive capabilities of the Internet. CBSSM has extensive experience in developing, programming and conducting survey research using Internet-based methodologies. 

Why We Use the Internet

A key advantage of Internet surveys is that they can shape and direct a user's experience in response to computer generated randomization and/or respondents' own answers to questions earlier in the survey. Additionally, page and answer order can be truly randomized as appropriate to limit cognitive biases. The unique advantage of Internet surveys, however, is that many different types of stimuli can be randomized or varied; static visual images, movies, or sounds can all be used in addition to text. Furthermore, the nature of the browser interface enables user-directed interactivity, such as user-adjustable risk communication graphics, that provide unique opportunities for both knowledge communication and response assessment.

Using the Internet to conduct survey research is also very efficient: we can develop and test surveys in only a few months' time, and once a survey is ready, large scale data collection (e.g., 1500-3000 completed surveys) can be completed in only 2-3 weeks.  Such surveys can also be cost effective, since while significant effort goes into development, creation, and testing of the survey, almost no personnel effort is required for data collection, entering, coding, or cleaning.  In addition, oftentimes several small surveys can be combined into a single instrument, creating further efficiencies.

Sometimes, our studies use large, demographically diverse samples obtained through commercial survey research firms. This methodology allows us to tailor the population being surveyed on multiple demographic variables (e.g., sampling only women age 40-75 for a study about breast cancer treatments) and provides us with ample statistical power to conduct multi-factorial experimental tests. Other times, we use more inexpensive samples from Amazon Mechanical Turk (MTurk) for quick pilot testing or to enable rapid, iterative testing of designs. Regardless, the use of randomized designs ensures high internal validity for the research despite the use of an Internet-only sample.

CBSSM Surveys

CBSSM has had considerable success using this methodology, publishing multiple manuscripts in highly regarded peer-reviewed journals. Studies that have used this methodology have addressed a variety of topics, including:

  • The use of pictographs to display risk (20082008, 2014) including in comparison to other graphical formats (2008, 2010, 2010). 
    Note: to create your own pictographs, see www.iconarray.com.
  • Misprediction of happiness between younger and older adults (2005)
  • Elicitation of utility and willingness to pay (200720072008)
  • Research ethics, e.g., participation of mentally vs. medically ill in research (2005)
  • Risk communications that emphasize incremental risks instead of absolute risks (2008)
  • Simplifying risk communications about adjuvant therapy options (2008).
  • Effect of risk labels on prenatal screening decisions (2007).
  • Time-insensitivity in people's understanding of survival curves (20052007)
  • Self-other discrepancies in medical decisions (20062008)
  • Sequential vs. all at once presentations of risk information (2011)
  • Testing of animated or interactive risk graphics (2011, 2012, 2014)
  • Optimal levels of precision in risk communications (2011, 2012)
  • Framing of health promotion messages (2012)
  • Exploration of role of narratives in decision making (2010)
  • Values Clarification (2015)
  • Intuition and Deliberation in Decision Making (2015)

Contact Us

For questions about our methods or inquiries about potential Internet survey research collaborations, please contact Brian Zikmund-Fisher at bzikmund@umich.edu.

In a recent UofMHealth blog, Geoffrey Barnes weighs the pros and cons of Warfarin and Pradax, two atrial fibrillation medications.

The blog can be found here.

Darin Zahuranec’s survey study, “Variability in physician prognosis and recommendations after intracerebral hemorrhage” published in Neurology found that physicians vary substantially in ICH prognostic estimates and treatment recommendations. This study suggests that variability could have a profound effect on life and death decision-making and treatment for ICH.


Several CBSSM-affiliated faculty and alumni were co-authors: Angie Fagerlin, Meghan Roney, Andrea Fuhrel-Forbis, and Lewis Morgenstern.


http://ihpi.umich.edu/news/survey-severe-stroke-prognoses-differ-depending-doctor

Lauren Smith, MD

Faculty

Dr. Lauren Smith is a Clinical Associate Professor in the Department of Pathology at the University of Michigan specializing in hematopathology.  She has been a member of the University of Michigan Adult Ethics Committee since 2005 and also serves as a Chair of the Michigan State Medical Society Ethics Committee.  Her research interests include ethical issues in clinical medicine and pathology.

 
Research Interests: 
Last Name: 
Smith

2014 CBSSM Research Colloquium and Bishop Lecture (Myra Christopher)

Thu, May 15, 2014 (All day)
Location: 
Vandenberg Meeting Hall (2nd floor), The Michigan League, 911 N. University, Ann Arbor, MI

2014 CBSSM Colloquium and Bishop Lecture featuring Myra Christopher

The Center for Bioethics and Social Sciences in Medicine (CBSSM) Research Colloquium was held Thursday, May 15, 2014 at the Vandenberg Meeting Hall (2nd floor), The Michigan League, 911 N. University Ave, Ann Arbor, MI 48109.
 

The CBSSM Research Colloquium featured the Bishop Lecture in Bioethics as the keynote address.  Myra Christopher presented the Bishop Lecture with a talk entitled: "The Moral Imperative to Transform the Way Pain is Perceived, Judged and Treated." Myra Christopher holds the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics.

The 2014 Research Colloquium presenters:

  • Andrew G. Shuman, MD, Assistant Professor, Department of Otolaryngology, University of Michigan: "When Not to Operate: The Dilemma of Surgical Unresectability"
  • Phoebe Danziger, MD, University of Michigan Medical School: "Beliefs, Biases, and Ethical Dilemmas in the Perinatal Counseling and Treatment of Severe Kidney Anomalies"
  • Kathryn L. Moseley, MD, MPH, Assistant Professor, Pediatrics and Communicable Diseases, University of Michigan: "Electronic Medical Records: Challenges for Clinical Ethics Consultation"
  • Helen Morgan, MD,  Department of Obstetrics and Gynecology, University of Michigan: "Academic Integrity in the Pre-Health Undergraduate Experience"
  • Tanner Caverly, MD, MPH, Health Services Research Fellow, Ann Arbor VA Medical Center and Clinical Lecturer, University of Michigan: "How Transparent are Cancer Screening & Prevention Guidelines about the Benefits and Harms of What They Recommend?"
  • Susan D. Goold, MD, MHSA, MA , Professor of Internal Medicine and Health Management and Policy, School of Public Health, University of Michigan: "Controlling Health Costs: Physician Responses to Patient Expectations for Medical Care"
 

 

2011 CBSSM Research Colloquium

Fri, May 20, 2011 (All day)

The second annual Bioethics Research Colloquium was held Friday, May 20, 2011, at the Alumni Center.  The Colloquium was jointly sponsored by the Center for Bioethics and Social Sciences in Medicine and the Center for Ethics in Public Life. 

The majority of the colloquium was devoted to presentations of research in or about bioethics conducted by University of Michigan faculty, fellows and students.  Presentations focused on theoretical, empirical, and critical approaches to understanding and resolving ethical issues in health care and the life sciences.

Presenters:

  • Apurba Chakrabarti, Department of Cellular, Molecular, and Developmental Biology: A bureaucratic framework of IRBs: Understanding how cultural forces influence the contemporary IRB bureaucracy.
  • Nathaniel Adam Tobias Coleman, Department of Philosophy: Online sexual racism and the prevalence of HIV among black MSM. 
  • Susan Dorr Goold, MD, MHSA, MA, Department of Internal Medicine: Market failures, moral failures, and health reform (keynote).
  • Henry Greenspan, PhD, Residential College, LSA: Temptation and trespass in the pharmaceutical industry: Incentivizing ethical self-regulation. 
  • Lisa H. Harris, MD, Department of Obstetrics and Gynecology: Obstetrician-gynecologists' objections to and willingness to help patients obtain abortion in various clinical scenarios: A national survey. 
  • Aisha T. Langford, MPH, Comprehensive Cancer Center: The misdiagnosis of the minority problem in cancer clinical trials: Is our focus on medical mistrust causing harm? 
  • Naomi Laventhal, MD, Department of Pediatrics and Communicable Diseases: Innovative therapies in the newborn intensive care unit: The ethics of off-label use of therapeutic hypothermia.
  • Erika Manu, MD, Department of Internal Medicine: Resident attitudes and experience with palliative care in patients with advanced dementia.
  • Karen M. Meagher, Department of Philosophy (MSU): Considering virtue: Public health and clinical ethics.
  • Andrew Shuman, MD, Department of Otolaryngology: The right not to hear: The ethics of parental refusal of hearing rehabilitation.
  • Lauren Smith, MD, Department of Pathology: Pathology review of outside material: When does it help and when can it hurt? 

CBSSM recently hosted the 2014 Research Colloquium held Thursday, May 15, 2014 at the Vandenberg Meeting Hall (2nd floor), The Michigan League, 911 N. University Ave, Ann Arbor, MI 48109.

The CBSSM Research Colloquium featured the Bishop Lecture in Bioethics as the keynote address.  Myra Christopher presented the Bishop Lecture with a talk entitled: "The Moral Imperative to Transform the Way Pain is Perceived, Judged and Treated." Myra Christopher holds the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics. The Bishop Lecture is made possible by a generous gift from the estate of Ronald C. and Nancy V. Bishop.

The 2014 Research Colloquium presenters included:

  • Andrew G. Shuman, MD, Assistant Professor, Department of Otolaryngology, University of Michigan: "When Not to Operate: The Dilemma of Surgical Unresectability"
  • Phoebe Danziger, MD, University of Michigan Medical School: "Beliefs, Biases, and Ethical Dilemmas in the Perinatal Counseling and Treatment of Severe Kidney Anomalies"
  • Kathryn L. Moseley, MD, MPH, Assistant Professor, Pediatrics and Communicable Diseases, University of Michigan: "Electronic Medical Records: Challenges for Clinical Ethics Consultation"
  • Helen Morgan, MD,  Department of Obstetrics and Gynecology, University of Michigan: "Academic Integrity in the Pre-Health Undergraduate Experience"
  • Tanner Caverly, MD, MPH, Health Services Research Fellow, Ann Arbor VA Medical Center and Clinical Lecturer, University of Michigan: "How Transparent are Cancer Screening & Prevention Guidelines about the Benefits and Harms of What They Recommend?"
  • Susan D. Goold, MD, MHSA, MA , Professor of Internal Medicine and Health Management and Policy, School of Public Health, University of Michigan: "Controlling Health Costs: Physician Responses to Patient Expectations for Medical Care"

This month’s Bioethics Grand Rounds features Alan Tait, Ph.D., endowed professor and director of clinical research, Department of Anesthesiology.

He will present at the Ford Auditorium at noon on May 22.

Please feel free to bring your lunch and join us for a lively discussion of medical ethics. The Bioethics Grand Rounds is sponsored by the UMHS Adult Medical Ethics Committee and the Program of Society and Medicine. This educational session is open to all faculty and staff and members of the public.

CME and CEU credit is available.

Web Address: http://www.med.umich.edu/adultethics

Supporting information for: 2017 CBSSM Research Colloquium and Bishop Lecture (Norman Daniels, PhD)


"Setting priorities for Medicaid: The views of minority and underserved communities"
Presenter: Susan Goold, MD, MHSA, MA


Co-authors: Lisa Szymecko, JD, PhD; H. Myra Kim, ScD; Cengiz Salman, MA; A. Mark Fendrick, MD; Edith Kieffer, MPH, PhD; Marion Danis, MD, Zachary Rowe, BBA


Setting priorities for state Medicaid programs challenges policy makers. Engaging beneficiaries affected by tradeoffs could make allocations more just and more sensitive to their needs. 

Academic-community partnerships adapted the simulation exercise CHAT (CHoosing All Together) to engage community members in deliberations about Medicaid spending priorities.  After an informational video about Medicaid, individuals and deliberating groups choose from a menu of spending options constrained by limited resources. We randomly assigned participants from low-income communities throughout Michigan to participate in CHAT with (n=209) or without group deliberations (n=181) in English, Spanish or Arabic. Data collection included pre- and post-CHAT individual priorities and group priorities.

Low-income participants ranged from 18 to 81 years old (Mean 48.3); 61.6% were women. Over half (56.7%) self-identified as white, 30.8% African-American, 17.3% Hispanic, 9.2% Native American, and 12.1% Arab, Arab-American or Chaldean. Most (65.9%) had a chronic condition and 30.3% reported poor or fair health.

Before CHAT, most participants prioritized eligibility consistent with Medicaid expansion. They also prioritized coverage for a broad range of services. Most accepted daily copays for elective hospitalization (71.6% deliberators, 67.9% controls) and restricted access to specialists (60.2% deliberators, 57.4% controls). Deliberators were more likely than controls to increase, after deliberations, what they allocated to mental health care (between arm difference in allocation=0.22, p=.03) and eligibility (between arm difference in allocation=0.18, p=.04). Deliberating groups also prioritized eligibility; only 3 of 22 chose pre-expansion eligibility criteria, and 9 of 22 chose to expand eligibility further.

Members of underserved communities in Michigan put a high priority on Medicaid expansion and broad coverage. When given the opportunity to deliberate about priorities,  participants increased the priority given to expanded eligibility and coverage for mental health services.


"How Acceptable Is Paternalism? A Survey-Based Study of Clinician and Non-clinician Opinions on Decision Making After Life Threatening Stroke"
Presenter: Kunal Bailoor, MD Candidate


Co-authors: Chithra Perumalswami, MD, MSc; Andrew Shuman, MD; Raymond De Vries, PhD; Darin Zahuranec, MD, MS


Complex medical scenarios may benefit from a more paternalistic model of decision making. Yet, clinicians are taught to value patient autonomy, especially at the end-of-life. Little empirical data exist exploring opinions on paternalism.

Methods: A vignette-based survey exploring surrogate decision making after hemorrhagic stroke was administered to clinicians (faculty, residents, and nurses) at an academic health center, and non-clinicians recruited through a university research volunteer website. The cases involved an urgent decision about brain surgery, and a non-urgent decision about continuation of life support one week after stroke. Respondents rated the acceptability of paternalistic decision making, including clinicians not offering or making an explicit recommendation against the treatment, on a 4 point Likert scale.

Results: Of 924 eligible individuals, 818 (649 non-clinicians, 169 clinicians) completed the survey (completion rate 89%).  A minority of respondents (15.3%) found it acceptable not to offer surgery. Most believed it was acceptable to make an explicit recommendation that would likely result in death (73% for avoiding surgery, 69% for stopping the ventilator). Clinicians were more likely than non-clinicians to consider not offering surgery acceptable (30% vs 11%, p<0.0001). Clinicians were more likely to consider recommendations against surgery acceptable (82% vs 71%, p=0.003) and to consider recommendations to discontinue the ventilator acceptable (77% vs 67%, p=0.02). There were no differences between the nurse and physician acceptability ratings (p=0.92).

Conclusions: Clinicians and the lay public differ on the acceptability of paternalistic decision making. Understanding these differences are vital to improving communication between clinicians, patients, and families.


"Ethical Challenges Faced by Providers in Pediatric Death: A Qualitative Thematic Analysis"
Presenter: Stephanie Kukora, MD


Co-authors: Janice Firn, PhD, MSW; Patricia Keefer, MD; Naomi Laventhal, MD, MA
 

Background: Care providers of critically ill patients encounter ethically complex and morally distressing situations in practice. Though ethics committees guide ethical decision-making when conflicts arise in challenging cases, they rarely address routine needs of individual providers. Without ethics education, providers may lack skills necessary to resolve these conflicts or insight to recognize these dilemmas.

Objective: We sought to identify whether providers remark on ethical dilemmas/moral distress without being specifically prompted, when asked to comment on a recent in-hospital pediatric death. We also sought to characterize the nature of dilemmas or distress if found.

Methods: Providers involved in a deceased child’s care in the 24 hours prior to death were electronically surveyed. Questions included demographic information and free-text response. Free-text responses were thematically analyzed in Dedoose.

Results: There were 307 (35%) free-text responses in 879 completed surveys (33% total response rate), regarding the deaths of 138 patients (81% of in-hospital pediatric deaths) from November 2014 to May 2016. Multidisciplinary care team members from diverse hospital units were represented. 52 respondents described ethical challenges and/or moral distress. Disagreement/regret was a major theme, with subthemes of futility, suffering, and “wrong” medical choice made. Failure of shared decision-making was also a major theme, with subthemes of autonomy and best interest, false hope, denial, and misunderstanding/disagreement between the family and medical team. Some providers revealed personal ethical struggles pertaining to their role, including medication provision for pain at the end of life, struggling to be “truthful” while not divulging information inappropriate for their role, and determining when providing comfort care is ethically permissible.

Discussion/Conclusion: Providers experience ethical conflicts with pediatric end-of-life care but may be unwilling or unable to share them candidly. Education assisting staff in identifying and resolving these dilemmas may be helpful. Further support for providers to debrief safely, without criticism or repercussions, may be warranted.


"Capacity for Preferences:  An overlooked criterion for resolving ethical dilemmas with incapacitated patients"
Presenters: Jason Adam Wasserman, PhD; Mark Navin, PhD
 

Clinical bioethics traditionally recognizes a hierarchy of procedural standards for determining a patient’s best plan of care. In broad terms, priority is given first to autonomous patients themselves and then to surrogates who utilize substituted judgments to choose as they believe the patient would have chosen. In the absence of good information about what the patient would have wanted, clinical ethicists typically retreat to the “best interest” standard, which represents a relatively objective assessment designed to maximize benefits and/or minimize harms.  In this paper, we argue that “capacity for preferences” is a conceptually distinct and morally salient procedural standard for determining a patient’s best plan of care.  We build our argument on the grounds that 1) that many patients who lack decisional capacity can nevertheless reliably express preferences (an empirical claim); 2) these preferences are distinct from best interest and not reducible to best interest considerations; 3) that capacity for preferences, at a minimum, has moral valence for situations in which best interest is undetermined (and we argue this happens more frequently than commonly recognized); and, finally, 4) that capacity for preferences in incapacitated patients lacking reliable or valid surrogates might even subvert a best interest course of action in some cases.  Some precedent for our analysis can be found in the concept of pediatric assent. However, the idea that patient preferences matter morally has broad application for adult patients, including for those with advanced dementia and other mental illnesses that preclude capacity for decision-making.

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