From 1978 to 2009, Ed was head of the U-M Health System Legal Office. In 2009 he moved into the Medical School Department of ObGyn as an Associate Professor to work full-time on issues of sexual rights and reproductive justice. He has teaching appointments in the Medical School, the School of Public Health, the Law School, and LSA Women's Studies. He teaches courses on the legal and ethical aspects of medicine at the Medical School, the rules of human subjects research at the School of Public Health and reproductive justice in LSA and the Law School.. In 2011, Ed went to Ghana and helpe
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Supporting information for: 2015 CBSSM Research Colloquium and Bishop Lecture (Lawrence O. Gostin, J.D., LL.D Hon.)
Natalie Bartnik, MPH, Research Associate, HBHE Genetics Research Group, UM School of Public Health: "Why, how and when oncologists disclose genome sequencing results in clinical practice"
Abstract: Integrating an individual’s clinical history with genome sequencing data can inform diagnostic and treatment strategies tailored to the patient’s mutational landscape. In oncology, precision medicine offers the additional opportunity to characterize novel gene targets for patients with cancer who lack known or viable targets. It is not known whether oncologists communicate sequencing results to patients, or how and why oncologists integrate sequencing profiles into clinical practice. In a survey of 43 oncologists who referred 111 patients to the MIONCOSEQ Study, we found that nearly a quarter of oncologists planned to make changes to their patient’s treatment based on genomic findings. Prominent barriers to the integration of sequencing results into clinical practice were a lack of findings with perceived clinical significance, as well as limitations in locally available clinical trials. The majority of physicians planned to communicate sequencing results to their patients, mostly via in-person clinic visits.
Michele Gornick, PhD, MICHR PTSP Postdoctoral Fellow, VA HSRD Fellow & CBSSM Research Investigator: "Information and deliberation make a difference: The public’s preferences for the return of secondary genomic findings"
Abstract: As genome sequencing becomes a part of clinical practice, how best to disclose sequencing results –including secondary findings-- raises significant issues. Expert consensus panels have been convened to provide recommendations, but what do members of the public want? In order to address this gap, we organized a deliberative democracy (DD) session to educate members of the public on genome sequencing, to engage them in dialogue about the benefits and risks of the clinical implementation of this technology, and to elicit their informed perspectives about policies governing the return of secondary findings. A significant shift in participants’ perspectives on the disclosure of adult onset conditions from the baseline survey, that remained stable after a month follow-up (response rate = 87%; Χ2(1, N=60) = 4.26, p =0.039), suggests the value of education and deliberation for the appreciation of the scientific and ethical complexities of genome sequencing.
Aaron Scherer, PhD, CBSSM Postdoctoral Fellow: "Elephants, Donkeys, and Medicine: Political Differences in Health Risk Perceptions and Adherence to Medical Recommendations"
The relationship between political ideology and health is often relegated to discussions of health care policy. But what if political ideology affects much more than health care policy preferences? I will discuss two studies that provide some initial evidence that political ideology influences our perceptions of health risks and adherence to medical recommendations. In one study examining risk communication strategies, political ideology was related to differences in perceptions of Ebola and influenza risk, as well as willingness to vaccinate against these two infectious diseases. In a second study examining beliefs in medical conspiracies, political ideology was related to differences in self-reported adherence to doctor’s recommendations and prescription use. The psychological differences between conservatives and liberals that may help illuminate why these differences exist will be discussed.
Stephanie Kukora, MD and Nathan Gollehon, MD, Fellows, Division of Neonatal-Perinatal Medicine, Department of Pediatrics, UM Mott Children’s Hospital: "Epidemiology of outpatient prenatal consultation: implications for decision-making and perinatal outcomes"
Abstract: Neonatologists provide anticipatory guidance and support decision-making for complicated pregnancies, in which poor/ambiguous prognostication can lead to over-/under-treatment. Referral to antenatal palliative care consultation (PCC) is not standard; little is known about the basis for referral, and their role in perinatal decision-making.
117 women had outpatient neonatology consultation, with decision-making for 146 fetuses with multiple anomalies/genetic, single major anomaly, or obstetric complications. 18(12%) were given a prognosis of uniform non-survival and 41(28%) had anticipated survival with intervention. Remaining fetuses were given unknown prognoses 87(60%), some qualified “likely survivable” 17(12%) or “likely poor” 33(23%). Most prognoses aligned with outcomes, though outcomes were better than predicted in 3(2%) infants and worse in 10(7%). Mismatches between prognosis and decision occurred in 10(7%) infants who were provided resuscitation despite “non-survival” or “likely poor” prognoses.
23 (19.7%) of the 117 mother/fetus pairs received antenatal PCC. Prognoses included: 11(48%) non-survivable, 11(48%) unknown but likely poor, 1(4%) survivable with surgical intervention. Fetal/neonatal outcome included: fetal demise 5(22%), in-hospital death 16(70%), survival to discharge 2(9%). 22 maternal/fetal pairs with 3(13%) non-survivable and 19(86%) likely poor prognoses were not referred, but had similar outcomes: fetal demise 4(18%), in-hospital death 15(68%), survival to discharge 3(14%). Those with PCC were more likely to choose comfort-care than those without (61% vs. 18%, p < 0.01). Of non-survivors, 94% with PCC died within 4 days while 27% without PCC received >14 days of intensive care.
We identified relatively few cases of mismatch between prognosis and outcome; however, rare cases of prognostic failure warrant caution. Although allowing parents to pursue aggressive neonatal care respects autonomy, it may delay rather than prevent death. Long-term outcomes with and without PCC were similar for infants with poor prognoses, though non-survivors with PCC were more likely to have a comfort care plan and shorter time to in-hospital death.
Minnie Bluhm, PhD, MPH, Assistant Professor, School of Health Sciences, Eastern Michigan University: "Oncologists' decisions about administering late chemotherapy: What makes it so difficult?"
Abstract: Background. An estimated 20-50% of incurable cancer patients receive chemotherapy in the last 30 days of life, although little data support this practice. Continued use of chemotherapy typically precludes hospice enrollment. It may also result in more symptoms, increased use of aggressive treatments, and worsening quality of life. Despite this, few studies have explored oncologists' rationales for administering chemotherapy during the last weeks of life. The purpose of this study is to examine factors that oncologists report influence their decisions about late chemotherapy.
Methods. In-depth individual interviews were conducted with 17 oncologists using a semi-structured interview guide. Interviews were audio-recorded and transcribed verbatim. Transcripts were coded and content analyzed for themes and patterns.
Results. Three key findings emerged. 1) Clinical factors drive oncologists’ late chemotherapy decisions when they point to clear treatment choices, along with patient preferences. When clinical factors are ambiguous, non-clinical factors become more salient. 2) Late chemotherapy is patient-driven. It is used to palliate physical and emotional symptoms and maintain patient hope, even when physical benefit is not expected. 3) Caring for dying patients is difficult and impacts oncologists and their treatment decisions. Difficulties also cited as influences favoring treatment include: emotional exhaustion, difficulty communicating about stopping or not starting chemotherapy, overwhelming sense of responsibility for life and death, feeling badly about the limits of oncology to heal, and prognostic uncertainty.
Conclusions. Findings reveal a nuanced understanding of why it can be so difficult for oncologists to refuse chemotherapy to patients near death. Doing so adds to the existing burden of caring for dying patients. Therefore, at times, oncologists prescribe chemotherapy to simply help everyone feel better, regardless of expected clinical benefits or costs. Future work is needed on the impact of caring for dying patients on oncologists and on supportive interventions that promote optimal treatment decisions.
Danielle Czarnecki, PhD Candidate, UM Department of Sociology: "Moral Women, Immoral Technologies: How Devout Women Negotiate Maternal Desires, Religion, and Assisted Reproductive Technologies"
Abstract: Catholicism is the most restrictive world religion in its position on assisted reproductive technologies (ARTs). The opposition of the Church, combined with the widespread acceptability of ARTs in the U.S., creates a potentially profound moral dilemma for those who adhere to Church doctrine. Drawing on interviews from 33 Catholic women, this study shows that devout women have different understandings of these technologies than non or less religious women. These differences are rooted in devout women’s position of navigating two contradictory cultural schemas (Sewell 1992) —“religious” and “secular”—regarding the meaning of reproductive technologies in the contemporary U.S. Religious schemas provide devout women with different cultural resources that allow them to develop strategies to avoid the use of ARTs. Yet they must still reckon with the ideal of biological parenthood. I show how devout women draw on religious doctrine to find value and meaning in their suffering , to move beyond biological motherhood, and to ultimately achieve a moral femininity. While religion increases the burden of reproduction for devout women, it also provides the cultural resources to resist the financial, emotional, and physical difficulties experienced by women who use ARTs.
Uchenna Ezeibe, MD, Resident Physician, UMHS Department of Pediatrics & Communicable Diseases: "Pediatric Ethics Consultation Service at a Tertiary Hospital: A Retrospective Review"
Abstract: Background: Published data about hospital ethics consultation services focus primarily on adult patients. There is little information on pediatric ethics consultations – specifically whether patient demographics were related to type and prevalence of consults.
Objective: To review recent ethics consults at a large children’s hospital and explore associations with patient demographics.
Design/Methods: We reviewed ethics consults between 7/1/2009 – 12/31/2013 at a Midwest children’s hospital. We used Armstrong Clinical Ethics Coding System 2013©, modified for pediatrics, to code consults. We collected data on patient race, age, and insurance status (private vs. public) as a proxy for socioeconomic status. We used Microsoft Excel 2013© to generate descriptive statistics.
Results:, approximately 321,713 inpatient visits, and 29 ethics consults were reviewed. Most consults (72.5%) concerned inpatients. Of these, 82% originated from 1 of 3 ICUs (neonatal, pediatric, and pediatric-cardiothoracic). The most common reasons for consultation were: 1) treatment-based decision-making (31%),); 2) end-of-life decisions (28%); & 3) substitute decision-making (24%). The mean patient age for treatment-based and substitute decision-making consults were similar at 6.8 and 7.9 years, respectively. Younger patients (mean age: 2.4 years) were involved in end-of-life dilemmas. Patients receiving consults differed from the general patient population in that fewer patients with consults were White (52% vs. 71%) and more were African-American (34.5% vs 9%). Approximately 76% of patients with ethics consults had public insurance compared to approximately 29% amongst all inpatient admissions.
Conclusion: In this single-center retrospective review, we found that African-Americans and patients with public insurance were over-represented in receipt of ethics consultations compared to the general patient population. We also found that dilemmas about end-of-life decisions were more common for younger children. Given our small numbers, strong conclusions cannot be drawn from this data. Nevertheless, our findings do point to areas where communication between family and medical team can be improved.
Supporting information for: 2016 CBSSM Research Colloquium and Bishop Lecture (William Dale, MD, PhD)
Katrina Hauschildt, MA, PhD Candidate, Department of Sociology: “Language and Communication as Professionalization Projects in Clinical Ethics Consultation”
Although sociologists have examined the field of bioethics broadly, less empiric research has explored the process of clinical ethics consultation (CEC) in practice. This paper seeks to describe how UMHS’ CEC service focuses on communication, language, and terminology in professionalizing their membership and broadening the scope of their services. The CEC service established a specific communication standard for its written recommendations that emphasizes specificity and clarity for patients and their families, other providers, and members of the ethics committee. By identifying and reinforcing the importance of language and word choice in their own recommendations, newer members of the CEC are “trained” in how to craft recommendations, develop a specific jargon, and establish communication standards that differ from those used in other aspects of medical practice and documentation. The CEC service is often involved in addressing a variety of communication issues that arise in patient care, and these problems are thusly considered within the professional scope of the CEC service. By establishing the CEC service as an appropriate resource for dealing with communication issues between patients and their care team, the CEC service expands the professional boundaries of their work beyond strictly ethical expertise. The implications of these processes for professionalization and communication may be applicable to CEC services more broadly.
Devan Stahl, PhD, Assistant Professor of Clinical Ethics, Center for Ethics and Humanities in the Life Sciences, MSU: "Is there a right not to know?"
There is a widespread presumption within medicine that terminally ill patients have a “right not to know” their prognosis. Guidelines for giving bad news (SPIKES; ABCDE) all require that the patient be asked first. There may be a dark side to this practice, however: terminally ill patients’ ignorance or denial of their prognosis too often lasts to the very end, one important factor discouraging timely referral and use of palliative and hospice care. Because of a possible link between a right not to know one’s prognosis and the aggressive treatment that patients with advanced illness too often receive at the end of life, the claim that there is a right not to know needs much more serious examination than it has received.
The authors argue that patients with advanced illness do not have a right not to know their prognosis. Withholding prognostic information in deference to a right not to know impedes patients’ capacity to make informed autonomous decisions about their treatment, encourages denial, and increases the likelihood of poor end of life care.
Chithra Perumalswami, MD MSc, Robert Wood Johnson Foundation/Veterans Affairs Clinical Scholar: "Insurance Status of Elderly Americans and Location of Death"
Context: The decision to forego curative treatments (which includes the Medicare Skilled Nursing Facility Medicare benefit) is not financially neutral for terminally ill patients who do not have concurrent insurance (Medicaid or private insurance) in that they are subsequently asked to pay for room and board of the nursing home if they choose the Medicare hospice benefit. The association between insurance status and location of death is currently unknown.
Purpose: To determine whether the concurrent insurance status with Medicare (Medicaid vs. private insurance) of decedents is associated with location of death in a nationally representative survey of elderly Americans.
Methods: Longitudinal analysis of 7,979 decedents aged 50 years or older in the Health and Retirement Study from 2000-2010 (6 biennial waves). We examined associations between insurance status and location of death (home, hospital, nursing home, hospice) using multinomial logistic regression models and adjusting for demographic, socioeconomic, and clinical variables.
Results: Decedents with dual eligible insurance before or at the time of death were significantly more likely to die in a nursing home than to die in a hospital (relative risk ratio (RRR) 2.6; 95% CI, 1.9-3.6, p<0.001).
Those dying in a nursing home tended to be unpartnered (widowed, separated or divorced, never married), cognitively impaired or with dementia. Elderly Americans less likely to die in a nursing home were blacks and Hispanics, individuals with cancer, and those with the highest wealth.
Conclusions: Dual eligible patients are substantially more likely to die in a nursing home than a hospital, and therefore may miss out on valuable services at the end of life, including hospice care. This study may have several implications for current proposed Medicare policy changes to allow patients access to both curative care and hospice care at the same time.
Lauren B. Smith, MD, Associate Professor, Department of Pathology/Ginny Sheffield, UM Medical Student (M3): "Special treatment for the VIP patient: Is it ethical? Is it dangerous?"
The care of VIP patients is often prioritized at medical centers and this prioritization may lead to disparate access to care and patient safety issues. VIP patients may be donors, celebrities, or other physicians. Allowing VIP patients access to earlier care or “special treatment” not only raises social justice issues, but also has been shown to lead to medical error and suboptimal treatment. Ethical considerations will be discussed and recommendations will be presented.
Naomi Laventhal, MD, MA, Assistant Professor, Department of Pediatrics and Communicable Diseases: "Roman Charity Redux: The Moral Obligations of the Breastfeeding Physician"
Female physicians must often reconcile the seemingly contradictory goals of valuing the health and well-being of their patients above all else, and actively mothering young children. One of the fundamental ethical precepts in medicine is for the physician to put the best interests of her patient ahead of her own. For example the Fellowship Pledge of the American College of Surgeons states, “I pledge . . . to place the welfare and the rights of my patient above all else.” The challenge of weighing the needs of one’s own children against those of a patient is painfully acute for the breastfeeding physician. Is it ethically permissible to leave a busy clinic - or a patient in the under anesthesia in the operating room - in order to express breastmilk? Pragmatic strategies, such as mandates for appropriate space and time to pump, offer modest gains. However, we will suggest the need to re-envision the concept of “patient-first”, which is a vestige of the patriarchal hegemony that gave rise to our modern medical ethos, whereby nursing mothers are highly disadvantaged and virtually unable to reach the highest moral ideals of the profession. Is the “right” to breastfeed absolute, or if should it be superseded by the needs of the patient? We will explore whether this issue is deeply personal, to be reconciled by affected individuals, or warrants an “outside-in” approach in which physicians and bioethicists collectively and more philosophically consider whether and how to support women who choose to work and breastfeed.
Archana Bharadwaj, Graduate Student, UM School of Public Health: "Patient understanding and satisfaction regarding the clinical use of whole genome sequencing: Findings from the MedSeq Project"
Background: The expanded use of Whole Genome Sequencing (WGS) has generated excitement due its potential to tailor medical treatment. However, clinical use of WGS poses challenges for informed consent and disclosure of results. Few empirical studies have examined patients’ understanding of and satisfaction with the clinical communication of WGS results.
Methods: The MedSeq Project is a randomized clinical trial examining the impacts of WGS in primary care and cardiology. We analyzed survey data from patients’ initial enrollment and at multiple time points following physician disclosure of results. Domains of interest included understanding of informed consent, subjective understanding, satisfaction with communication of results, and decisional regret.
Results: Survey responses were provided by 202 participants (mean age = 55 years; 51% male; 80% college graduates). At enrollment, participants understood the majority of key facts about the study (mean = 19.6 / 22 items answered correctly), although some incorrectly answered items addressing results to be returned (e.g., 18% believed they would receive their entire DNA sequence. Higher informed consent knowledge scores were associated with female gender and higher genomic knowledge, subjective numeracy, and education levels (all p < .05). After results disclosure, participants had low scores of decisional regret regarding study participation; they also reported high levels of satisfaction with their physicians’ disclosure of results (mean = 5.9 on a 6-point scale), although ~20% of participants reported receiving “too much” information. Satisfaction with communication did not vary by participants’ demographics or other characteristics (e.g. genomic knowledge).
Conclusions: This study suggests that the intervention was well understood by patients, with low levels of decisional regret and high satisfaction with communication. Future research will need to examine these issues in more diverse samples, where misconceptions about the clinical WGS and concerns about information overload may be magnified.
Kayte Spector-Bagdady, JD, MBioethics, CBSSM Postdoctoral Research Fellow: "Direct‐to‐Consumer Biobanking"
23andMe is back on the market as the first direct‐to‐consumer genetic testing company that “includes reports that meet Food and Drug Administration standards for being clinically and scientifically valid.” Its current product includes 36 health‐related carrier‐status reports and consumers’ raw genetic data. But while its front‐end product is selling individual genetic tests online, its back‐end business model is amassing one of the largest privately owned genetic databases in the world.
This article argues that as the Department of Health and Human Services revises its regulation of research with human subjects as well as its proposal to exempt autosomal recessive carrier screens from premarket authorization it should contemplate the intersection of these areas of rulemaking—and consider how enhancing the security of federally funded research but loosening private access to biospecimens will drive more research into the private sector and result in less, not more, protection for human subjects.
Panel Presentation (Susan Goold, MD, MHSA, MA & colleagues): "Community engagement in setting research priorities: Representation, Participation and Evaluation"
We describe a 5-year project that engaged minority and underserved communities throughout the state of Michigan in deliberations about health research priorities to increase community voice in how limited health research resources are allocated. DECIDERS (Deliberative Engagement of Communities in DEcisions about Research Spending) formed a state-wide Steering Committee (SC) to develop a version of the deliberative exercise CHAT for health research priorities, then convened 47 groups to evaluate the tool and describe community research priorities.
Facilitators: Susan Goold and Zachary Rowe, Co-Directors
Panelists: Karen Calhoun, Charo Ledon, Esther Onaga, Lisa Szymecko
Systematizing the Teaching of Medical Ethics in the Undergraduate Medical Years
Medical students at the University of Michigan encounter ethical issues throughout their four years of training. Some are obvious – decisions at the end of life, the allocation of scarce of medical resources, challenges to patient autonomy – others are less obvious – relationships between medical residents and medical students, problems with the “hidden curriculum,” and systemic discrimination in the provision of care. Our goal is to make students aware of the variety of ethical problems in medical care and to equip them to respond to these problems in a wise and responsible manner.
To that end, our curriculum efforts focus on extending the existing curriculum and on making the medical ethics curriculum for undergraduate medical students at UM more systematic and explicit. Because we want students to become well-versed in thinking through ethical dilemmas before they encounter them in their clinical work we weave ethics into the curriculum throughout the 4 years of their undergraduate training. We use the expertise of our CBSSM faculty to create novel curricular components that incorporate our empirical work in bioethics with our particular expertise in decision science.
Increasing Opportunities for Ethics Teaching in the Clerkship Years
We facilitate regular ethics discussions for medical students at the end of their required clinical rotations in Obstetrics and Gynecology (in the third year) and Emergency Medicine (in the fourth year). To facilitate these discussions, students prepare short essays on ethical dilemmas encountered in these clerkships. Students are given a summary of all the issues that came up that rotation, which is used as a starting point for a discussion facilitated by a clinical faculty member trained in ethics. In addition, the Internal Medicine subinternship (an option for fourth year students) includes an ethics discussion at the end of the rotation.
These discussions allow medical students to bring up concerns with ethical dilemmas in a safe environment, teach the students about approaches to ethics, and embed training in ethical decision-making in clinical practice. This is often the first time students learn about the role of the hospital ethics committee and how they can contact them if desired.
“That was unexpectedly awesome!"
-- Medical student after Ob/Gyn ethics discussion
Advanced Medical Therapeutics Ethics Module
All fourth year medical students are required to take an online Advanced Medical Therapeutics course. As part of the course, we created an ethics module that includes multiple cases that present ethical dilemmas. Each case includes pre-recorded videos of faculty discussing the ethical aspects of the case and interactive components requiring students to choose possible solutions to the problem, after which they receive explanations of the pros and cons of their choice.
Medical Ethics Path of Excellence
CBSSM faculty work closely with the medical school to strengthen the medical ethics curriculum for Michigan medical students. Our goal is to make students aware of the broad range of ethical challenges facing 21st century medicine – challenges in clinical care, medical research and the design of health care delivery. Most recently, a team of CBSSM faculty developed the Medical Ethics Pathway of Excellence, an opportunity for students to receive mentored training in ethics throughout their four years of medical school.
Overview of Medical Ethics Pathway to Excellence:
- Introduced in September 2013, the first 10 students were accepted in 2014. Twelve students joined in 2015.
- Students apply to the Ethics Path of Excellence at the end of February during their M1 year, and continue their studies through their M4 year. Students in the POE learn to:
- Identify ethical issues in the organization and delivery of health care
- Implement tools and strategies to address ethical issues
- Continue their professional education and development of the skills required for leadership
- Before applying to the Ethics Path of Excellence, students have the opportunity to attend fourteen interactive lunchtime lectures that review various aspects of ethics in a healthcare setting. Applicants must attend a minimum of five of these lectures.
- Students who want to serve on ethics committees and/or include ethics as part of an academic career are provided with specialized training.
- All students participate in an individualized, independent study, culminating in a capstone project in the M4 year. Often this work includes field work at CBSSM.
Beginning in 2015, the Path of Excellence has been responsible for administering the core ethics curriculum for all of the M1 students. The Ethics Path of Excellence will continue to be a co-curricular activity until 2017 when all students will be required to choose one of the paths offered in the medical school.
“We really want to educate people to be the ethics committee consultants of the future. I think it's pretty unique to have the option of pursuing this extracurricular program because essentially it teaches you leadership skills and how to be a self-directed learner. These are skills you'll really need when you become faculty. Students can take their interest in ethics and pursue it further.”
Lauren Smith, M.D., Associate Professor of Pathology
Lauren Smith is the Director of the Path of Excellence. Andrew Barnosky, Christian Vercler, Ed Goldman, Kathryn Moseley, Janice Firn, Sacha Montas, and Raymond De Vries are core faculty members.
Start Seeing Ethics Lunch Discussions
As part of the Medical Ethics Path of Excellence, we offer lunch time discussions of cutting-edge topics in ethics. The content of these discussions includes topics such as conscientious objection, mandatory vs. optional vaccinations, patient centered care and shared decision making. We have also used these discussions to hold mock ethics committee meetings with discussion of a specific case. Facilitators provide a relaxed atmosphere in which students can feel comfortable asking questions and voicing opinions.
"It is exciting to see medical students engage with the ethical issues that arise in the clinic and the classroom. With encouragement from us they are beginning to see that there is more to medical ethics than just the well-known issues at the beginning and end of life. While these ethical issues are important, there are also moral consequences associated with the mundane aspects of being a student and working with patients." Raymond De Vries, PhD, Director, Ethics Education Initiative
Supporting information for: 2011 CBSSM Research Colloquium
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.
Supporting information for: 2013 CBSSM Research Colloquium and Bishop Lecture (Ruth Macklin, PhD)
PhotoVoice: Promoting individual wellbeing and improving disaster response policies in Japan and beyond
Mieko Yoshihama, PhD, ACSW, LMSW, Professor, School of Social Work, University of Michigan
Co-authors: Yukiko Nakamura, Ochanomizu University Department of Interdisciplinary Gender Studies, Tokyo, Japan; Tomoko Yunomae, Women's Network for East Japan Disaster
Conducted in collaboration with local women’s organizations, PhotoVoice Project is aimed at strengthening gender-informed disaster policies and response in Japan by engaging the very women affected by the disasters in the analyses of their own conditions and advocacy efforts. PhotoVoice, a method of participatory action research, involves participants taking photographs of their lives and communities, followed by a series of small-group discussions about their experiences while sharing their photographs (Wang & Burris, 1997).
After the Great East Japan Disasters of March 11, 2011, a diverse group of women (N=35) in five localities in the most disaster-affected areas of northern Japan participated in PhotoVoice group discussions (4-7 sessions in each location). A significant minority of the participants have been assisting other disaster victims as part of their regular employment or through volunteer effort.
The participants’ photographs and narratives identified various ways in which Japanese sociocultural and structural factors affected women’s vulnerabilities in and after disasters. Traumatic stress and compassion fatigue were prevalent, yet denial and suppression were common response. Facilitated group discussions served as a collective space for grieving the loss and rebuilding their lives. Through repeated group discussions, participants also questioned and identified limitations and failures of the current disaster policies as well as those concerning nuclear energy. Also evident were participants’ increased interest and desire to speak out, similar to the processes of politicalization and conscientization/conscientização (Freire, 1970).
Findings of the project elucidate how individuals respond to trauma, dislocation, and devastation; how individual experiences are influenced by sociocultural and structural forces; and how individuals make sense of disaster and structural inequity, and to formulate action to address them. Findings of the project also suggest that participatory action research such as PhotoVoice could promote participants’ growth and wellbeing by providing space for collective reflections, rebuilding, and action.
Mieko Yoshihama is a Professor of Social Work at the University of Michigan. Dr. Yoshihama's research interests are violence against women, immigrants, mental health, and community organizing. Combining research and social action at local, state, national, and international levels over the last 25 years, Dr. Yoshihama focuses on the prevention of gender-based violence and promotion of the safety and wellbeing of marginalized populations and communities.
Representing torture of women in custody in the U.S.
Carol Jacobsen, MFA, Professor, The University of Michigan Penny Stamps School of Art & Design, Women’s Studies; Human Rights Director, Michigan Women’s Justice & Clemency Project
More than a decade ago, Amnesty International launched its first ever campaign on torture in the U.S. Working with human rights activists, including prisoners, attorneys, artists, and others, the ongoing campaign has focused on the four point chaining, rape, retaliation, medical neglect and other forms of abuse of women occurring in U.S. prisons. As a grassroots, feminist filmmaker working with Amnesty on this issue, in my role as Director of the Michigan Women’s Justice & Clemency Project, and as an educator of visual art, women’s studies and human rights, many questions arise about issues of state and individual power, gender, race, representation, exploitation, censorship and voice as we struggle to make torture a visible and public issue in order to ultimately end it. This presentation will include an excerpt from my film, Segregation Unit.
Segregation Unit, 30 min., 2000
Carol Jacobsen, Director
Narrated by Jamie Whitcomb following her release from prison, the film documents the torture she and many others have suffered (and continue to suffer) in Michigan prisons. The film includes footage shot by guards that was obtained through subpoenas and the Freedom of Information Act in connection with Whitcomb’s successful lawsuit against the State. Co-sponsored by Amnesty International, Segregation Unit is a nonprofit film available free to activists.
Carol Jacobsen is a social documentary artist whose works in video and photography draw on interviews, court files and records to address issues of women's criminalization, censorship and human rights. Her work, co-sponsored by Amnesty International, is represented by Denise Bibro Gallery in New York, and has been exhibited and screened worldwide. She has received awards from the National Endowment for the Arts, the Paul Robeson Foundation, Women in Film Foundation, Rockefeller Foundation and others. Her critical writings have appeared in the New York Law Review, Hastings Women's Law Journal, Signs Journal, Social Text, Art in America and other publications. She teaches Art, Women's Studies and Human Rights at UM, and serves as Director of the Michigan Women's Justice & Clemency Project, a grassroots advocacy and public education effort for freedom and human rights for incarcerated women.
Do non-welfare interests play a role in willingness to donate to biobanks?
Michele C. Gornick, PhD, Postdoctoral Research Fellow, VA Health Science, Research & Development and CBSSM, University of Michigan
Co-authors: Tom Tomlinson, PhD, Kerry Ryan, MA and Scott Kim, MD, PhD
Ethical debate has focused on protecting donor welfare and privacy interests. Little attention has been given to individual donor concerns about the moral, societal, or religious implications of research using their donation. The current study explores the impact of non-welfare interests (NWIs) on participants’ willingness to donate de-identified tissue samples and medical records to biobanks through an experimental online survey (N=1276; 46.3% women; 19.6% racial minority). Participants were more likely to donate to biobanks for NWI topics commonly associated with ‘science’ and medical research (evolution and stem cell research) than unfamiliar uses of biosamples (commercialization/corporate profit and risk assessment by insurance companies). In addition, mode (single vs. multiple scenario) and timing (before vs. after blanket consent) of NWI disclosure affect individual’s willingness to donate. Further, key subject characteristics influence participants’ willingness to donate, even after controlling for NWI scenario assignment (Racial minorities: OR = 0.59, 98% CI 0.34, 0.99, Evangelical Christians: OR = 0.55, 98% CI 0.35, 0.89, Liberal political views: OR = 1.66, 98% CI 1.06, 2.60). These data suggest that NWI issues have complex dimensions that require careful elicitation and evaluation of people’s opinions regarding them. Further, policy recommendations for biobank donation based only on welfare and privacy may neglect other interests that are highly vales by potential donors.
Michele Gornick is a Postdoctoral Research Fellow at the VA Center for Clinical Management Research and the Center for Bioethics and Social Sciences in Medicine at the University of Michigan. She received her PhD in Human Genetics and MA in Statistics from the University of Michigan. Her research is in translational medicine, specifically dealing with ethical issues surrounding the communication of genomic information to cancer patients, physicians and other health care providers.
Which research? Public engagement and opinions about the research use of biobank samples
C. Daniel Myers, PhD, Robert Wood Johnson Scholar in Health Policy Research, Department of Health Management and Policy, School of Public Health, University of Michigan
Daniel B. Thiel, MA, Assistant Director, Life Sciences and Society Program, School of Public Health, University of Michigan
Co-authors: Ann Mongoven, PhD, MPH; Jodyn Platt, MPH; Tevah Platt, MPH; Susan B. King; Sharon L. R. Kardia, PhD
Do potential biobank donors approve of using biobank samples for research, and do they care what kinds of research is done on their samples? We explored this question in various public engagement forums related to the Michigan BioTrust for Health, a recently established state research biobank of de-identified leftover newborn screening bloodspots. Results suggest that that the type of public engagement affects participant responses about whether research using leftover bloodspots is appropriate, and what types of research are should be conducted. In more superficial kinds of engagement participants show nearly-unanimous support for research, support that does not vary greatly across different kinds of research. However, more intensive forms of engagement find somewhat greater skepticism about research, and support that varies according to what aspect of a study is emphasized—target population, disease in question, type of analysis (e.g., genetic or not). Furthermore, more intensive engagements facilitate deeper reflection on the inherently uncertain nature of biobank research applications. This uncertainty brings issues of governance and oversight to the foreground. While there are some areas of broad consensus, there is also widespread disagreement on what kinds of research should and should not be pursued. On a practical level, this variation suggests that singular sources on public opinion may not be adequate to judge public support for biobanking, and that research and policy communities should consider best practices for eliciting educated public opinion on acceptable research. On a more conceptual level, the variety of conceptions of appropriate research uses suggests that informed consent and community oversight processes should account for this pluralistic conception of the public good.
C. Daniel Myers is a Robert Wood Johnson Scholar in Health Policy at the University of Michigan School of Public Health. His research focuses on how political communication affects public attitudes, particularly in the context of public deliberation. He is currently involved in research projects on the role of stories sin political communication as well as on public deliberation about priorities for patient centered outcome research. He received his Ph.D. in Political Science from Princeton University and his B.A. in Political Science from Allegheny College. Starting in 2013 he will be an Assistant Professor of Political Science at the University of Minnesota.
Daniel Thiel is currently the Assistant Director of the Life Sciences and Society Program at the University of Michigan where he wears many hats, including directing a community engagement research project about the Michigan BioTrust for Health. Prior to this position he taught classes in political philosophy, ethics and the philosophy of law at John Jay College in New York City. His research interests are primarily in the fields of bioethics, science and technology studies and social and political philosophy. He completed an M.A. in Philosophy at Stony Brook University and a B.A. in Philosophy at U.C. Berkeley.
Whose sense of public good? Public engagement results from the Michigan BioTrust and ethical implications
Ann Mongoven, PhD, MPH, Assistant Professor, Center for Ethics and Humanities in the Life Sciences and Department of Pediatrics and Human Development, Michigan State University
Co-author: Meta Kreiner, MSc
Can policy-makers assume a consensus on what constitutes “the public good” of a public health biobank? If not, what are the implications for biobank ethical policies? We explore these questions in relationship to public engagement on the Michigan BioTrust. The BioTrust is a recently established state research biobank of de-identified leftover newborn screening bloodspots. BioTrust guidelines require that any research using bloodspots be (a) health research and (b) in the public good. The biobank operates with an opt-out “blanket” presumed consent policy for bloodspots saved before 2010, and an opt-in blanket consent policy for bloodspots saved from 2010 onward.
Community engagement on this issue suggests pluralistic conceptions of what constitutes the public good among Michigan residents. While some types of research generate broad consensus; others generate significant disagreement. Risk/benefit assessments also vary according to both degree and kind, including: potential for scientific/medical advances, economic considerations, and individual or group risk/benefit from biobank participation. Because the bloodspots come from children, some focus on benefits/risks for children; others do not. These results suggest pluralistic conceptions of what constitutes “public good” are at play when citizens assess both if and when the state should use biobank samples for research, and also whether they should allow research on their own children’s bloodspots.
The results also have implications regarding informed consent processes and community oversight for a bloodspot biobank. Lack of consensus on what research is “in the public good” adds empirical weight to ethical requirements that biobanks inform donors before using their bloodspots for research, make lay research descriptions available, include community oversight in biobank governance, and ensure an opt-out mechanism. They suggest the worthiness of considering “by-study” or “tiered” consent options while underscoring their practical challenges. Significantly, even blanket consent and community oversight processes can be improved by acknowledging lack of consensus on what constitutes the public good as a risk of participation.
Ann Mongoven is an Assistant Professor at the Center for Ethics and Humanities in the Life Sciences, Michigan State University. She earned her Ph.D. in religious studies/ethics from the University of Virginia and a M.P.H. from the Johns Hopkins University Bloomberg School of Public Health. Mongoven is also a Michigan State University Lilly Teaching Fellow.
Citizen recommendations for communication about biobank participation and consent: Considering source, message, channel, receiver, and timing
Andrea C. Sexton, BA, Master of Arts Student, Health and Risk Communication, College of Communication Arts and Sciences, Michigan State University
Co-authors: Ann Mongoven, PhD, MPH; Meta Kreiner, MSc
Source, message, channel, and receiver are fundamental factors in models of the communication process. Public and clinical health practitioners must consider these factors in order to design effective health communication. This paper a) reports citizen recommendations for a multi-faceted educational campaign on the Michigan Biotrust; b) analyzes these recommendations by source, message, channel, and receiver characteristics; and c) argues that integrating these recommendations with communication theory suggests both practical strategies for recommendation implementation and extensions of theoretical models of the communication process.
The Michigan BioTrust for health is a state research biobank containing bloodspots leftover after newborn bloodspot screening. In November of 2011, seven deliberative processes engaged a representative sample of Michigan citizens. Five sessions were conducted in-person, each in a different Michigan city. Two sessions were run as Facebook discussion groups.
The primary recommendation from these juries is a multi-faceted campaign to increase public awareness of the BioTrust and its consent processes. The deliberators propose specific suggestions about who should provide information, what content should be communicated, the mediums through which education should occur, and their impressions of citizen responses to current and recommended BioTrust communications.
In addition to identifying source, message, channel, and receiver characteristics, jury participants distinctly emphasize the importance of communication timing. They consider the effect of timing on receivers’ motivation and ability to process information, investigate their options, and ask questions. They also suggest a relationship between timing of communication about the Biotrust and public attitude toward the BioTrust.
Exploring jury participants’ suggestions for education about the BioTrust has implications for clinical interactions, health education curriculums, and mass media campaigns regarding informed consent for biobanks, as well as ethical solicitation of biobank participation. Additionally, emphasis on timing as a key factor in communication may warrant further consideration in theoretical models of the communication process.
Andrea Sexton is a candidate for a Master’s of Arts in Health & Risk Communication at Michigan State University where she is a research assistant in the Center for Ethics and Humanities in the Life Sciences on a project researching community engagement on the Michigan BioTrust for Health. She has also contributed to health communication research on hand washing, health website quality, nutritional labeling, and community engagement in sustainable food system development. Andrea’s research interests include community engagement in health and environmental issues and health and risk decision making. She completed her B.A. in Linguistics & Psychology at the University of Michigan.
Comparing male and female BRCA mutation carriers’ communication of their BRCA test results to family members
Monica Marvin, MS, Associate Director of the Genetic Counseling Program; Genetic Counselor in the Cancer Genetics Clinic; Clinical Assistant Professor; University of Michigan, Department of Human Genetics and Internal Medicine
Co-authors: Heidi Dreyfuss, MS; Lindsay Dohany, MS; Kara Milliron, MS; Sofia Merajver, MD, PhD; Elena Stoffel, MD, MPH; Beverly Yashar, MS, PhD; and Dana Zakalik, MD
Current national guidelines state that patients with positive BRCA results should be urged to notify at-risk relatives. Most research on communication of BRCA results is limited to communication by females and suggests that communication to males occurs less frequently.
The objective of this exploratory study is to identify gender-related characteristics in communication of BRCA results to improve familial communication.
677 individuals who received genetic counseling from three clinics in Michigan were invited to participate. Subjects completed a 34-item survey comprised of novel and previously published questions exploring whom they informed, information shared, method of communication, and factors impacting the decision to undergo testing and disclose results. Communication patterns were examined within the entire cohort and comparisons were made between males and females.
Participants included 35 males and 202 females. Overall greater than 78% of parents shared their test results with at least one of their children with a greater percentage of fathers disclosing to their children than mothers. The disclosure was mostly done in-person and the information shared did not vary much between genders except a greater proportion of mothers with daughter(s) discussed the impact genetics can have on their daughter’s medical management than fathers with their daughter(s). For both males and females, the top reasons for disclosing to children included: 1) wanting to inform them about their risk, 2) feeling the results will impact management, 3) wanting to encourage testing, and 4) having a close relationship.
In genetic counseling, gender of a BRCA mutation carrier does not appear to greatly affect the frequency or method of communication of test results. Furthermore, we found that communication to male and female relatives occurred with a similar frequency. This suggests that current practice effectively enables comprehensive family communication.
Monica Marvin is a Clinical Assistant Professor in the Department of Human Genetics who serves as the Associate Director of the University of Michigan Graduate Program in Genetic Counseling. She also functions as a clinical genetic counselor in the UM Cancer Genetics Clinic. Monica obtained her Masters Degree in genetic counseling from the University of Michigan in 1994. Prior to returning to the University of Michigan in 2005, she worked as a genetic counselor at New Jersey Medical School and Spectrum Health in Grand Rapids, MI. In addition to her work here within the University, Monica is also active in national and state-wide efforts to advance the profession of genetic counseling.
A Gift for All: Everyone has something to give - Approaching dialysis patients about donating their organs
Allyce Smith, MSW, Program Coordinator, National Kidney Foundation of Michigan
Co-authors: Ann Andrews, MPH; Jerry Yee, MD; Holly Riley, MSW; Remonia Chapman; Ken Resnicow, PhD
The organ donor waiting list continues to grow. Individuals with End Stage Renal Disease (ESRD) are not typically viewed, by themselves or their health care team, as potential donors after death. However, ESRD patients are eligible to donate and may obtain a sense of empowerment in knowing they can give, as well as receive. Others feel that asking ESRD patients to sign up on the Donor Registry is unethical. This study will evaluate the effectiveness of using peer mentor to inform dialysis patients about their ability to sign up on the Donor Registry, ultimately increasing their numbers on the Registry.
Using a cluster randomized design, this controlled intervention study is conducted in collaboration with the National Kidney Foundation of Michigan (NKFM), the University of Michigan School of Public Health (UM SPH), Greenfield Health Systems (GHS), Henry Ford Health System, and Gift of Life Michigan. Twelve dialysis units will be randomized to an intervention or comparison group. Participants in the comparison units receive mailings about organ donation while patients in intervention units are assigned peer mentors and meet 7 times over a 4-month period. Peer mentors are individuals with ESRD who have adjusted positively to living with kidney disease and volunteer to lend support to others coping with kidney disease. Peer mentor-patient meetings cover coping with chronic illness and leaving a legacy through deceased organ donation. During the meetings, peer mentors utilize Motivational Interviewing, a person-centered method of guiding patient decision-making and strengthening motivation for change.
The primary outcome is mail/internet registrations on the Donor Registry. Pre/post surveys will be used to evaluate change in organ donation knowledge and attitudes, self-reported donation status, hope for the future, and quality of life.
To date, 150 Greenfield staff, 33 peer mentors, and over 280 patients have participated in 10 dialysis units.
Allyce Haney Smith has been a program coordinator at the National Kidney Foundation of Michigan since 2010. She graduated with her Master’s degree in Social Work from the University of Michigan. She currently coordinates the project, A Gift for All: Everyone Has Something to Give. In this role, Ms. Smith works to help empower patients to become more involved in their own care and end of life decisions.
Putting patient-physician communication in context: An empirical analysis of sequential organization and communication transitions during visits for new diagnoses of early stage prostate cancer.
Danielle Czarnecki, PhD Candidate, Department of Sociology, University of Michigan
Co-authors: Stephen G. Henry, MD; Valerie Kahn, MPH; Wen-Ying Sylvia Chou, PhD, MPH; Angela Fagerlin, PhD; Peter A. Ubel, MD; David R. Rovner, MD, FACP; Margaret Holmes-Rovner, PhD
Background: Patients and physicians typically schedule visits to discuss new diagnoses for which patients have multiple treatment options. How communication is organized during these visits is unknown.
Objective: To investigate the organization of communication tasks and the transitions between these tasks during visits in which patients and physicians discuss diagnosis and treatment of early stage prostate cancer.
Methods: We characterized the sequential organization of 40 visits in which patients received a new diagnosis of early stage prostate cancer. We used transcripts to identify communication tasks and develop a coding system to identify transitions between these tasks. We analyzed a) the organization of communication tasks during these visits and b) how patients and physicians communicate during transitions between tasks.
Results: We identified five major communication tasks, which typically occurred in the following sequence: diagnosis delivery, risk classification, options talk, decision talk, and next steps. Visit organization was physician-driven. Patients resisted physicians’ attempts to transition from a) options talk to decision talk and b) decision talk to next steps by requesting more information about options and clarification about the decision making process, respectively. Physicians showed resistance when patients attempted to discuss decisions before physicians finished discussing treatment options. The overall organization of communication reflected physicians’ focus on delivering a thorough discussion of treatment options. Patient speech was relatively uncommon but increased towards the end of visits. Patients showed some uncertainty about the visit purpose and their role in the decision making process.
Conclusions: In visits discussing new diagnoses of prostate cancer, the overall visit organization and communication during transitions reveal an emphasis on discussing treatment options. Physicians’ focus on discussing options fulfills an important obligation for informed consent, but may not be responsive to patients’ informational or emotional needs.
Danielle Czarnecki is a doctoral candidate in the Department of Sociology at the University of Michigan. Her dissertation research is on religion and assisted reproductive technologies. She examines how infertile Catholic and Evangelical women navigate religious and scientific discourses in their attempts to build families.