The scholarship of the Center can be grouped roughly into three sections, focusing on the clinical setting, the ethics of research, and the implications of advances in genetics and genomics.
- Healing Relationships in Medicine (Larry Churchill, PI, with Roy Elam and David Schenck)
Funded by the Eben Alexander Fund, VUMC and the Baptist Healing Trust, this project involves interviewing 50 practitioners drawn from allopathic and complementary and alternative medicine to identify the specific skills that facilitate the establishment of trusting and compassionate relationships with patients, and the incorporation of the findings into medical education. Larry Churchill and David Schenck will publish the findings from this study in a book entitled “Healers,” forthcoming from Oxford University Press.
- Patients’ Understandings of the Therapeutic Alliance (Larry Churchill, Joseph Fanning and David Schenck)
This project is a companion piece to the qualitative interviews published as Healers (Schenck and Churchill), and involves interviews with 58 patients with a wide range of maladies, such as cancer, diabetes, metabolic syndrome, mental illness, and also a sampling from patients in hospice care. Our aim is to determine those features of clinician relationships that patients view as most effective in establishing and sustaining a therapeutic alliance. The findings will be published under the title What Patients Teach; The Everyday Ethics of Health Care (Oxford University Press, forthcoming).
Genetics and Society
- Returning Research Results of Pediatric Genomic Research to Participants (Ellen Wright Clayton, PI)
The specific aim of this project is to determine what criteria should govern return of individual results of pediatric genomic research, using analysis of US law and international guidelines regarding decision making for and by minors as the foundation. This issue, which has received remarkably little attention, must be resolved if this research, which is vital to understanding the contributions of genetic variation to the health of children, is to proceed. In order to develop these criteria, it will be necessary to draw upon a host of ethical, legal, and sociocultural factors, using standard legal analytic tools.
- There is a long tradition within genetics, embodied in policy statements, such as those by the American Society of Human Genetics, the American College of Medical Genetics, and the American Academy of Pediatrics, of performing genetic tests on minors only when the results would alter the minor’s immediate medical care. These limits are justified in part by the claim that, in the absence of need for immediate intervention, the minor should be allowed to decide about genetic testing upon reaching adulthood.
- More generally, decisions regarding the health care of children are treated differently from those of adults because children, as a matter of law, typically cannot make their own health care decisions. Procedurally, ethical and legal decision making authority, instead, is allocated among: 1) Parents, who have broad authority to make choices among available options that affect their children. The scope of parental permission for their children’s care, however, is not as broad as their discretion with regard to their own health care; 2) Clinicians who have an independent obligation to the welfare of the minor, which is bounded by the standards of clinical practice as well as legal requirements; 3) Minors who many hold have an increasingly important ethical and legal voice as they mature; and 4) In cases of abuse, neglect, or need to protect public health, the state. Substantively, defining the minor’s best interest is often contested. One issue that is particularly challenging is deciding what weight should be given to various potential benefits from returning results, ranging from immediate benefit to the minor’s health or reproductive information for the minor’s later use to benefits that redound primarily to the family unit as a whole or exclusively to the parents or even to other minors of the same age or with the same condition.
- Research involving minors is subject to more legal and ethical requirements and limitations than apply to adults.
This project brings together three internationally known lawyers, each of whom has written extensively about legal and policy issues in genomics research and in pediatrics, as well as an internationally known pediatrician-philosopher as a consultant, to define the applicable legal rules and to develop guidelines for returning results of genomic research involving minors.
- Assessing Patient and Community Perspectives on an Opt-Out Electronic Medical Record (EMR) DNA Research Resource (Ellen Wright Clayton, PI, with Kyle Brothers, Dan Morrison, and Larry Churchill)
BioVU is a Vanderbilt research resource based on de-identified data collected from Vanderbilt’s electronic medical record and residual clinical blood samples. Faculty members in the Center for Biomedical Ethics and Society have served as key advisors in the development and implementation of this research resource, providing both empirical examination of community perspectives on this form of research and conceptual exploration of the research ethics issues related to genomic research. Empirical studies included “Assessing Parent Perspectives on the Inclusion of Children in the BioVU DNA Biobank,” “Assessing Patient Awareness of the BioVU DNA Databank,” “Computer Survey on Vanderbilt Faculty and Staff Perspectives on BioVU,” and “The Nashville Health Survey: Perspectives on Genomic Research.”
- Genetics and Religion (Larry Churchill and Ellen Wright Clayton, PIs with Mark Bliton, Elizabeth Heitman, Joshua Perry) Completed
This project explores the ways in which religious beliefs and new understandings of genomics influence each other through a combination of: A. rigorous analyses of the interaction between religious and genetic concepts as these are articulated by scholars and in the media; and B. empirical studies that explore the ways in which religious beliefs are articulated by patients and research participants as they understand and interface with genetics in both therapeutic and investigational medical contexts views as well as the experiences of the clinicians and ministers who care for them.
- Impact of Newborn Screening on Families, (Ellen Wright Clayton, PI) Completed
Interview parents whose children have received abnormal newborn screening results to assess the following hypotheses: Receiving abnormal screening results will affect levels of parental stress as well as their utilization of health care and early intervention services; 2.Referral to metabolic centers will improve parental responses to abnormal screening results; 3. Many parents will value learning in the newborn period about serious disorders that affect their children whether or not they can be effectively treated.
- Examining the Impact of Genetic Testing for Pulmonary Arterial Hypertension (Ellen Wright Clayton, as a part of Genetic and Environmental Pathogenesis of PPH, Jim Loyd, PI) Completed
Interview individuals who have PAH or are at risk for developing it as well as laypeople and clergy to whom they turn for support to learn how people make decisions about testing for these incompletely penetrant mutations. Most earlier work has focused on highly penetrant disorders such as Huntington disease and cancer predisposing mutations. The findings of this study will increase our understanding of the decision processes that will be more common for complex disorders.
- The Social Construction of Benefit (Larry Churchill, PI at Vanderbilt site; Gail Henderson, PI for overall project)
This project extends the research of 1RO1 HG 02087-01 to establish a relational exchange model for research vulnerability, a threshold for "reasonable prospect of benefit" from research participation, and map the implications of both for genetic research with children.