2011 Research Colloquium Abstracts and Speaker Bios

A bureaucratic framework of IRBs: Understanding how cultural forces influence the contemporary IRB bureaucracy

Presenting author: Apurba Chakrabarti, Undergraduate Student, University of Michigan

The Institutional Review Board (IRB) system is almost universally considered dysfunctional. Numerous commentators accuse IRBS of both over-regulation and inadequate protection.  Understanding IRBs within a bureaucratic framework provides a theoretical lens to analyze the genesis and persistence of failings in academic IRBs.  While some authors have used legal approaches, there has been little analysis of the influence of culture on the IRB bureaucracy.  Additionally, there is an absence of literature using the sociology of IRBs approach, where IRBs act as a model to understand bureaucracies in the general terms of organizational theory.  Accordingly, this paper will show that 1) IRBs are a Weberian bureaucracy, 2) a bureaucratic framework of IRBs explain why the contemporary IRB system has a procedural focus and censors research, and 3) IRBs can illustrate new dimensions about how culture influences bureaucracy, as posited in regulation, such as community sensitivity.  This failure is a result of culture-induced goal displacement.  The bureaucratic IRBs respond to the American distrust of government by avoiding real ethics debates and instead have a particularly high focus on more “objective” procedure and paperwork.  Furthermore, a combination of a culture of fear and an expectation of infallible regulatory bodies influences bureaucracies to censor ethically sound, but legally risky research in an effort to protect bureaucratic reputation and prevent legal liability. These examples illustrate how subtle cultural forces influence organizations, as postulated in neoinstitutional theory.  A bureaucratic framework helps address the influence of culture on the IRB bureaucracy, and informs ideas for reform that must not only consider legal and legislative issues, but cultural forces that molded the contemporary IRB system.

Apurba Chakrabarti is a fourth-year undergraduate at the University of Michigan studying cellular and molecular biology.  He is completing an honors thesis in retinal patterning in zebrafish at the Raymond lab in the Department of Molecular, Cellular, and Developmental Biology.  His interests also extend into the social forces influencing the practice of research, including the organization of science and the flaws in the contemporary IRB system.

 

Online sexual racism and the prevalence of HIV among black MSM

Presenting author: Nathaniel Coleman, Graduate Student, University of Michigan

The Sydney-based campaign, www.SexualRacismSux.com, is a unique worldwide campaign against online sexual racism (OSR) among men who have sex with men (MSM).  Sexual racism (SR) is a form of social segregation on the basis of race.  Like all forms of social segregation, SR has two faces: that of exclusion (= spatial segregation) and that of exploitation (= role segregation).  Exclusionary SR consists of the race-based denial of sexual approbation or activity.  For instance, some MSM declare in their online profiles that they are “not into” blacks, or that they will accept “no blacks” for sex.  Exploitative SR consists of the offer of sexual approbation or activity, but only on racially stigmatizing terms.  For instance, some MSM offer sex to blacks only if those blacks fulfill the “ethnosexual stereotypes” of the “Black Mandingo” and the “Savage black top.”  SR reduces a black MSM’s freedom to define himself sexually, for he is restricted to either (a) no sex at all, (b) sex only with others similarly excluded and exploited, or (c) sex only in which he “plays along with” ethnosexual stereotypes.  Option (a) denies a black MSM a basic human function.  Option (b) renders the sexual networks of black MSM relatively more tightly interconnected such that if HIV enters one part of the network, it is likely to spread more rapidly throughout.  Option (c) causes a black MSM who can’t or won’t perform ethnosexual stereotypes to experience low sexual self-confidence.  He is likely to consider himself to have inferior “bartering power” in the marketplace for sex with MSM.  This may cause him (a) to offer unprotected anal intercourse (UAI) as a unique selling proposition, or (b) to give in more readily to demands to engage in UAI.  This argument suggests that those who wish to halt the disproportionately high prevalence of HIV among black MSM should collaborate with www.SexualRacismSux.com.

Nathaniel Adam Tobias Coleman is a doctoral candidate in moral, social, and political philosophy at the University of Michigan.  He is a Fellow at the University of Michigan’s Center for Ethics in Public Life, a member of the Society for the Philosophy of Sex and Love, and a member of the Society for the Scientific Study of Sexuality.  Nathaniel is working under the supervision of Prof. Elizabeth Anderson.  His doctoral dissertation is entitled, The Duty to Miscegenate: From Sexual Racism to Cross-racial Companionship.  

 

Temptation and trespass in the pharmaceutical industry: Incentivizing ethical self-regulation

Presenting author: Henry Greenspan, PhD, University of Michigan

Certain structural features of the pharmaceutical industry are conducive to ethical trespass: the difficulty of developing successful new drugs; the limited time of patent exclusivity; the “blockbuster model” in which most companies rely on a very small number of drugs for a large percentage of annual sales; and the “evidence-free zone” (Gale) between product launch and before many potential adverse effects are shown. Within this business model, companies are induced to “make hay while the sun shines,” and many of the best known ethical problems follow: marketing violations like promotion for unapproved and unproven applications; failure to flag or investigate suspected problems; selective publication; tendentious research design; collusion with corruptible healthcare professionals; and, occasionally, outright data suppression and fraud.  In the meantime, studies show that most external sanctions - including criminal penalties, FDA surveillance, and product liability lawsuits - are relatively ineffective deterrents, and they always arise after the damage is done.  We have no choice, therefore, but to rely primarily on company self-regulation.  A company will always know more, and know sooner, about its products than any external regulator and draconian external sanctions only make it more likely for a company to externalize regulation on to “the cop,” which consistently results in ethical disaster (Braithwaite).  So the question becomes how to positively incentivize companies’ ethical self-regulation.  A number of potential avenues will be suggested, including “perks” like extended patent protection; ethical ratings of companies that have real-world consequences (in preferential contracts with pharmacy benefit managers, for example, along the model of “no sweat” apparel contracts); and the impact of a documented record of ethical excellence on employee productivity and consumer (including physician) loyalty.

Henry Greenspan, PhD, is a psychologist and playwright in UM's Residential College who has been writing and teaching about the Holocaust and other genocides for almost three decades. His most recent book is On Listening to Holocaust Survivors: Beyond Testimony, a second and expanded edition of the 1998 On Listening. This past January he co-led the "Hess Seminar for Professors of Holocaust Course" at the United States Holocaust Museum, the sixth such seminar the museum has offered. He was appointed Fulbright Visiting Research Chair at Concordia University in Montreal for Winter 2012. In between, he has been teaching about ethics, politics, and pharma for the past eight years and organized some of the Health Policy Forum programs on pharma-related topics. 

 

Obstetrician-gynecologists’ objections to and willingness to help patients obtain abortion in various clinical scenarios: A national survey

Presenting author: Lisa H. Harris, MD, PhD, University of Michigan

Co-authors: Farr Curlin, MD, University of Chicago; Ken Rasinski, PhD, University of Chicago; Alexandra Cooper, PhD, Duke University; Anne Drapkin Lyerly, MD, MA, University of North Carolina

Background: Despite debate about abortion ethics and conscientious objection, we know little about obstetrician-gynecologists’ views, or their manifestation in clinical practice.  Methods: We analyzed results of a national survey of 1800 U.S. obstetrician-gynecologists.  We presented respondents with seven scenarios in which a woman sought abortion.  For each, we asked if respondents morally object, and if they would help the patient obtain an abortion.  We analyzed demographic correlates of objection and assistance.  Results: Objection varied by scenario, from 82% in the case of sex selection to 16% in a patient with a potentially fatal cardiopulmonary condition.  Female ob-gyns were more likely to object to abortion in one or more scenarios (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.0 to 2.3). excluding sex selection, objection was less likely in female(OR 0.66, 95% CI 0.49-0.89) and Jewish ob-gyns (OR 0.3; CI 0.1-0.8), and more likely among those practicing in the South or Midwest (OR 1.8, CI 1.2-2.7; OR 2.0; CI 1.3-3.0), who had Catholic or Protestant-evangelical affiliation (OR 2.6, CI 1.6-4.1; OR 4.0, CI 2.4-10), or who indicated religion was fairly, very, or most important in their life (OR 1.7, CI 1.0-2.8; OR 3.4, CI 2.1-5.6; OR 14.9, CI 7-31.4).  With the exception of sex selection, more than 80% would help a patient obtain abortion in all scenarios.  Approximately two-thirds (57-70%) of objecting ob-gyns would help the patient obtain abortion, regardless of scenario.  Excluding sex selection, assistance despite objection was more likely among female ob-gyns (OR 2.1, CI 1.3-3.3), and less likely among those from the South or for whom religion was very important (OR 0.3, CI 0.2-0.6; OR 0.2, CI 0.1-0.6).  Conclusions: Most ob-gyns help patients obtain an abortion even if they have moral objection.  Willingness to help patients varies by clinical context and physician characteristics.

Lisa H. Harris, MD, PhD, is an Assistant Professor in the Department of Obstetrics and Gynecology at the University of Michigan.  She received her MD from Harvard University and completed her residency at the University of California, San Francisco, later obtaining a PhD in American Culture from the University of Michigan.  Dr. Harris has focused her clinical, research, teaching and advocacy career on reproductive justice, reflecting her overarching goal of working at the intersection of medicine, culture, and politics. She also serves on the faculty of the Department of Women’s Studies.

 

The misdiagnosis of the minority problem in cancer clinical trials: Is our focus on medical mistrust causing harm?

Presenting author:  Aisha T. Langford, MPH, University of Michigan

Co-authors: Scott Kim, MD, PhD, University of Michigan

Cancer is the second leading cause of death in the United States and costs the nation approximately $263.8 billion in patient care.  Less than 5% of adults with cancer participate in cancer clinical trials.  Of those who do participate, African Americans are underrepresented despite bearing the greatest cancer burden.  While there are many reasons for lower participation among African Americans, medical mistrust dominates the literature and is often used in reference to the U.S. Public Health Service Syphilis Study at Tuskegee.  Tuskegee did expose structural inequalities and racism in research; however, knowledge of Tuskegee has not been empirically associated with lower enrollment among African Americans, nor can it account for the full range of issues that contribute to medical mistrust.  A person’s experience with the healthcare system and medical providers over time is what increases or reduces trust.  The data suggest that minorities are just as willing to participate in health research when provided equal access.  The Minority-Based Community Oncology Programs and the SELECT trial are prime examples of this.  While mistrust is real, its role may be overstated and a distraction form more pressing issues such as: 1) Access/proximity of clinical trials to minority communities, 2) Patient-provider communication about research, 3) Provider bias in offering clinical trials, 4) Protocol design and eligibility criteria, 5) Better training and rewards for clinical trial faculty/staff, 6)Organizational transparency in research, 7) Community engagement outside of health system walls, and 8) Diversity and cultural competency among healthcare organizations.  Nicholson et al. demonstrated that disparities framed messages have a negative impact on African Americans’ intention to use the healthcare system.  Given this, we should be cautious about perpetuating mistrust assumptions, as they may be causing more harm than good.  Appropriate “solutions” to minority participation are dependent on a correct diagnosis of the underlying problem.

Aisha Langford, MPH, has been the Director of Community Outreach for the U-M Comprehensive Cancer Center since July 2007.  Prior to that time, she held positions in health communications, adult literacy, and public relations.  Ms. Langford holds a Masters Degree in Public Health, Department of Health Behavior & Health Education, from the University of Michigan.  She works with local African American churches and community organizations to implement Body and Soul, a National Institutes of Health/American Cancer Society collaboration to disseminate cancer control interventions.  Ms. Langford also works closely with Cancer Center faculty, staff, and UMHS units as appropriate to enhance health disparities research and participation by under-represented minorities in cancer clinical trials.  She serves on a variety of internal and external committees related to community outreach, minority health, and clinical trials.

 

Innovative therapies in the newborn intensive care unit: The ethics of off-label use of therapeutic hypothermia

Presenting author: Naomi Laventhal, MD, University of Michigan

Co-authors: John Barks, MD, University of Michigan; Scott Kim, MD, PhD, University of Michigan

Neonatologists, like other physicians, are under pressure to use therapies supported by scientific evidence.  In the newborn intensive care unit (NICU) this is an especially thorny issue because seemingly benign but untested treatments have resulted in serious injury, yet the drive to do something for patients at risk for poor outcomes is very strong.  We examine the case of therapeutic hypothermia (TH) for hypoxic-ischemic encephalopathy (HIE), a therapy with demonstrated efficacy for full-term infants in reducing death and disability, but unproven efficacy in pre-term infants.  Clinical trials for pre-term infants are planned; meanwhile guidelines advise against off-label use.  Anecdotal evidence suggests “off-label” TH use may be common.  Here we examine arguments for and against such practices.  Arguments favoring off-label TH use include the lack of alternatives for a disease with terrible outcomes, and the “biologic plausibility” that theses uses TH will be safe and effective. More generally, limiting physicians to therapies supported by randomized control trial (RCT) data would unreasonably constrain clinical practice, and “innovative” practices can be an important driver of progress.  But even if parents are fully informed of the uncertain benefits, this may not be a “nothing to lose” scenario.  Surviving infants treated with off-label TH may have a higher incidence of severe neurologic impairment; this redistribution of poor outcomes may be unacceptable to parents and neonatologists alike.  Premature infants treated with TH may also be more vulnerable to the serious potential adverse effects and have greater mortality. From a societal standpoint, off-label TH use may delay completion or compromise quality of RCTs, resulting in pre-term infants with HIE undergoing risky, ineffective treatment unnecessarily.  We believe that arguments against off-label use of TH are stronger than those favoring it, given the individual and societal risks.  Using this case study, we will discuss a general framework for dealing with “innovative” therapies in the NICU.

Dr. Naomi Laventhal joined the University of Michigan in August 2009, after completing her residency in pediatrics, fellowships in neonatology and clinical medical ethics, and a master’s degree in public policy at the University of Chicago.  In the Holden Neonatal Intensive Care Unit at C.S. Mott Children’s Hospital, she cares for critically ill newborns, provides prenatal consultation for parents expecting to deliver premature infants, and teaches neonatal-perinatal medicine and bioethics to residents and medical students.  Her research is in neonatal clinical research ethics, and her current work focuses on attitudes of parents and health care providers regarding newborn infants as research subjects.

 

Resident attitudes and experience with palliative care in patients with advanced dementia

Presenting author: Erika R. Manu, MD, University of Michigan

Co-authors: Cathy Berkman, PhD, ACSW, Fordham University; Patricia Mullan, PhD, University of Michigan; Caroline Vitale, MD, University of Michigan

Purpose: To explore medical residents’ experience, attitudes and self-perceived confidence about end-of-life care in advanced dementia.  Methods: E-mail survey to all second, third and fourth-year residents in Internal Medicine, Medicine/Pediatrics, and Family Medicine at University of Michigan.  Queried residents’ experience, attitudes and self-perceived confidence approaching end-of-life discussions in patients with dementia, compared to heart failure and metastatic cancer.  Results: Surveys were e-mailed to 120 residents; 61 completed surveys were received after an initial e-mailing and one follow-up email reminder to non-responders, yielding a 51% response rate.  Sixty percent of respondents reported no formal training in estimating prognosis in patients with dementia.  Ninety-eight percent of respondents reported participating in family meetings addressing goals of care in the terminally ill.  Fifty-four percent of respondents agreed they felt confident eliciting patient/surrogate wishes regarding life-sustaining treatments in patients with advanced dementia, with 49% reporting this for patients with heart failure, and contrasting with 84% who agreed feeling confident eliciting wishes in patients with metastatic cancer.  Residents anticipate the need to elicit wishes of patients/surrogates of patients with advanced dementia (67%), heart failure (65%), and metastatic cancer (74%) in their future career. While only 37% feel confident assessing adequacy of caregiver support for their older patients, 82% anticipate they will be required to assess caregiver needs in their future career.  Conclusion: Medicine residents are actively involved discussing goals of care in terminally ill patients.  Despite this experience, they appear to have the lowest confidence in eliciting patient/surrogate wishes in dementia (vs. heart failure and metastatic cancer) and low confidence in assessing caregiver needs, yet believe these skills are important to attain.  These findings elucidate existing educational gaps in resident training and call attention to the need for enhanced education centering on optimal care of patients with advanced dementia.

Dr. Erika Manu is currently a fellow in Advanced Geriatrics at the VA Healthcare System and Clinical Lecturer in the Department of Internal Medicine, Division of Geriatric Medicine, at the University of Michigan.  She graduated from medical school in 1995 from the University of Medicine and Pharmacy, Timisoara, Romania.  She then completed an internship and residency in Physical Medicine and Rehabilitation in Romania before relocating to the United States in 2000.  In 2009, she graduated from the Internal Medicine residency program at St. Joseph Mercy Hospital in Pontiac, MI.  Her interests are focused on developing a career as a clinician educator with a focus on teaching and curriculum development that covers geriatric palliative care concepts in older adults with a strong commitment to the idea of enhancing medical resident knowledge and skills as they care for patients with dementia and other advanced chronic illnesses.

 

Considering virtue: Public health and clinical ethics

Presenting author: Karen M. Meagher, Graduate Student, Michigan State University

As bioethicists increasingly turn their attention to the profession of public health, many candidate frameworks have been proposed, often with an eye toward articulating the values and foundational concepts that distinguish this practice from curative clinical medicine.  First, I will argue that while these suggestions for a distinct ethics of public health are promising, they arise from problems with contemporary bioethics that must be taken into account.  Without such cognizance of the impetus for public health ethics, we risk developing a set of ethical resources meant exclusively for public health professionals, thereby neglecting implications for curative medical ethics and the practice of bioethics more broadly.  Secondly, I will present reasons for thinking some of the critiques of dominant contemporary bioethics can be met by a virtue ethics approach.  I present a virtue ethics response to criticisms that concern 1) increased rigor in bioethics discourse, 2) the ability of normative theory to accommodate context, and 3) explicit attention to the nature of ethical conflict. I conclude that a virtue ethics approach is a viable avenue for further inquiry, one that leads us away from developing ethics of public health in a vacuum and has the potential for overcoming certain pitfalls of contemporary bioethics discourse.

Karen M. Meagher is currently a PhD candidate in the Department of Philosophy at Michigan State University (MSU).  Her interests include public health ethics, philosophy of risk, and virtue ethics.  She previously taught at the University of Michigan-Flint in the Department of Public Health and Health Sciences.  She currently serves on the MSU and State Institutional Review Boards (IRBs) and is employed as a graduate assistant at MSU’s Center for Ethics and Humanities in the Life Sciences.

 

The right not to hear: The ethics of parental refusal of hearing rehabilitation

Presenting author: Andrew G. Shuman, MD, University of Michigan

Co-authors: Serena Byrd, BS, University of Michigan; Sharon Kileny, MD, University of Michigan; Paul R. Kileny, PhD, University of Michigan

Objective: To explore the ethics of parental refusal of auditory-oral hearing rehabilitation.  Study Design: Case study with medical ethical discussion and review.  Methods: Two young brothers present with severe-to-profound congenital sensorineural hearing loss.  The parents, both of whom have normal hearing and work as sign language interpreters, have decided to raise their children with American Sign Language as their only form of communication.  They have chosen not to pursue cochlear implantation nor support the use of hearing aids.  Discussion: This case raises significant questions concerning whether hearing rehabilitation should be mandated, and if there are circumstances in which parental preferences should be questioned or overridden with regard to this issue.  In addition, legal concerns may be raised regarding the possible need to file a report with child protective services. While similar cases involving the deaf community have historically favored parental rights to forego hearing rehabilitation with either cochlear implants or hearing aids, we explore whether conclusions should be different because the parents in this care are not hearing impaired.  Conclusions: The ethics of parental rights to refuse hearing augmentation are complex and strikingly context-dependent.  A comprehensive appreciation of the medical, practical and legal issues is crucial prior to intervening in such challenging situations.

Dr. Andrew Shuman is the chief resident surgeon in the Department of Otolaryngology, Head and Neck Surgery at the University of Michigan Hospitals.  Originally from New York, he is a 2002 graduate with high honors from the University of Michigan’s College of Literature, Science, and the Arts, and graduated with honors in 2006 from the University of Michigan Medical School.  He is pursuing sub-specialized fellowship training in head and neck surgical oncology.  Dr. Shuman has lectured and published in the areas of otolaryngology, emergency medicine, neurosurgery, and medical ethics.  His current research interests include clinical outcomes and ethical issues in head and neck cancer patients.

 

Pathology review of outside material: When does it help and when can it hurt?

Presenting author: Lauren B. Smith, MD, University of Michigan

Purpose: Pathology review is performed for patients when care is transferred to a tertiary care center after diagnostic tissue has been obtained.  While it has many benefits, this practice can lead to unforeseen difficulties in doctor-patient communication and patient well-being, especially if a diagnosis is overturned or modified years after treatment.  The aim of this analysis is to identify clinical situations in which pathology review can result in challenging discussions between patients and oncologists.  Methods: Representative case scenarios are presented in the subspecialty area of hematopathology.  Analysis of the clinical benefits and possible harm to patients, pathologists, and treating oncologists that may ensue from pathology review is performed.  Results: Pathology review may result in a valuable second opinion and expert sub-classification.  However, problematic situations may arise with pathology review, especially if the patient has already undergone definitive treatment and is referred to an academic institution in remission.  Difficulties can also arise when patients do not understand the limitations of diagnosing disease on small biopsies.  The patient may receive a different diagnosis or it may become apparent that the diagnosis could have been made more expeditiously.  These discrepancies must be communicated to the patient and may cause confusion and distress.  Conclusion: Pathology review can be beneficial or potentially harmful depending on the clinical situation.  Preliminary recommendations are provided for selecting cases for review.  Limiting pathology review to certain clinical situations and encouraging patients to get second opinions prior to initial treatment at local referral centers may be helpful in minimizing reassignment of diagnoses after definitive treatment.

Dr. Lauren Smith received her medical degree, pathology residence training, and hematopathology fellowship training at the University of Michigan.  She joined the University of Michigan faculty in 2007.  Dr. Smith is actively involved in the clinical hematopathology services including histopathology, flow cytometry and hemoglobin electrophoresis.  She has been a member of the adult ethics committee since 2005 and she serves on the adult ethics committee consultation service.  Her research interests include ethical issues in pathology.