Alden March Bioethics Institute Research
Reproductive Ethics and Technologies
Research on reproductive ethics and technologies has been based, in part, on a NIH Oncofertility Pilot Grant and has encompassed a broad range of topics including embryo and parthenote research, motivations for ovarian transplantations during the last century, legal classification of ovarian tissue used in transplantation, gendered responses of cancer patients to potential infertility, legal mandates for insurance coverage of fertility preservation treatments. This research has been spearheaded by Lisa Campo-Engelstein PhD. Given the interdisciplinary nature of this research, collaborators have come from a variety of disciplines such as philosophy, political science, history, law, medicine, and biology.
Stem Cell Ethics, Clinical Translation, Commercialization, and Stem Cell Tourism
Dr. Zubin Master’s research focuses on the ethical issues of stem cell research. Previous work in this area concentrated on ethical issues related to the moral status of human embryos and the physical and social harms to women as ova providers for stem cell and cloning research. Recent work in this area concentrates on the clinical translation and commercialization of stem cell research and how this may affect scientific integrity. The stem cell research environment has been evolving to move from basic research to performing research with clear translational and commercialization goals. One study aims to explore the perceptions of funders of stem cell research, and stem cell researchers in academia and industry on pressure, safeguards, and economic advantages and disadvantages surrounding the translation and commercialization of stem cell research.
Dr. Master’s work also focuses on ethical issues related to stem cell tourism. Stem cell tourism is a term used to describe potential patients traveling to undergo stem cell interventions as treatment when there is no scientific rationale for offering such treatment. This has led to several cases of severe morbidity and mortality of children and adults. Projects in this area use conceptual and empirical bioethics research methods to better understand intent and self-deception of physicians who offer stem cell treatments, the prevalence of web-based educational material on stem cell tourism and clinical translation, and to determine different ways to stifle stem cell tourism including working with scientists and physicians on the ground. The project examining web-based educational material has a knowledge translation component where a patient pamphlet will be developed to arm potential patients with information on stem cell clinical translation and stem cell tourism. Funding for the development of this booklet comes from a Public Outreach Award funded by the Canadian Stem Cell Network. The various projects under this category involve research collaborators within the US, Canada and abroad.
Research Integrity/Responsible Conduct of Research
Dr. Master has worked on a number of projects related to research integrity as it relates to interdisciplinary or multidisciplinary collaborations. Although much research on research integrity focuses on the natural and applied sciences, very little research focuses on responsible conduct of research issues of multi and interdisciplinary collaborative teams. Using bioethics as a case example, research on this topic uses conceptual and empirical bioethics methods and covers issues surrounding ethical authorship, conflicts of interest, peer review, publication ethics, and hype and public trust. Previous work has focused on understanding authorship guidelines in bioethics journals and to determine the criteria for ethical authorship for conceptual bioethics research. A current study aims to examine conflict of interest policies of bioethics journals as it relates to authors, peer reviewers and editors. Work done under this subject involves collaborators in the US and Canada.
Ethics of Research Involving Humans and Biobanking
Dr. Zubin Master also focuses on the ethical and legal issues of biobanking and biorepository research. Biobanks can alter many traditional research ethics practices including informed consent, withdrawal, and the protection of individual privacy. Work done in this area uses both conceptual and empirical bioethics methods including fixed/Likert scale question surveys, content analysis, and interviews. Previous work analyzed the academic literature to categorize ethical arguments on different models of consent for biobanking in order to determine whether a consensus among academic scholars existed. A previous conceptual project also aimed to determine a strategy to reduce risk of using broad or blanket consent approaches for biobanking through the use of exclusion clauses. Current work focuses on understanding the perspectives of different stakeholder groups (i.e., patients, professionals, researchers) on a range of bioethics issues including informed consent, withdrawal, privacy, return of results, and public trust. Future work on this topic involves conducting interviews to deepen our understanding of reasons, rationales, and values different stakeholders place on many of the research ethics topics related to biobanking.
Dr. Master is also interested in the governance of research ethics as it relates to multisite ethics review. A growing number of clinical research protocols involve many principal investigators performing a study at multiple institutions. Our current model of research ethics review requires that local ethics boards review the research protocol, the informed consent process, and analyze the benefits and risks of research. Yet several reports have shown that the local review of multisite research causes delays, hampers patient and staff recruitment, and causes unnecessary changes in research that may not necessarily better protect participants. In collaboration with researchers in Canada and the UK, a previous research project used a written survey to understand the perspectives of Canadian allergy and asthma researchers on multisite ethics review. A current study aims to better understand the advantages and difficulties of multisite ethics review by evaluating the perceptions of Canadian Research Ethics Boards (equivalent to US Institutional Review Boards) through a fixed/Likert scale question survey followed by interviews. Specifically, the views of Research Ethics Board members, chairs and administrators are being evaluated on the challenges of multisite ethics review and their preferences of various reform strategies to handle multisite research ethics review.
Organ Donation and Transplantation
Research in the area of organ donation and transplantation has primarily been based on two 3-year HRSA-funded grant projects designed to analyze the effect of a hospital-based family support intervention on organ donation consent rates and on the experiences of next of kin during the decision–making process. The program, which was implemented in several geographic regions of the country, entailed support provided by mothers of donors who were trained with the use of simulation in collaboration with local organ procurement organizations. Drawing on their own experiences as bereaved parents, the mothers offered consolation, information, patience and understanding to families facing the death of a loved one. The project was directed by Liva H. Jacoby, Ph.D.
Informed Consent
Drs. Liva Jacoby, Wayne Shelton and John Balint collaborated on a longitudinal study examining the ethical basis for informed consent among patients preparing for bone marrow transplants.
AMBI faculty conducted two surveys regarding public attitudes toward emergency medical research with exception from informed consent. This research which was related to public disclosure about the PolyHeme trial, entailed one survey undertaken with a random sample of community dwellers and another with patients and families in an emergency department.
Preventive Ethics: Family Support Study in the Surgical ICU
Research based on insights gained from many years of ethics consultations in the ICU led to the implementation of a research project in 2006 that introduced a new role in the ICU: the Family Support Coordinator (FSC). The purpose of this new role was to help the ICU team coordinate the care of the most at-risk families, based on the medical severity of the patient. Research to determine the impact of this role was conducted over 2 ½ years using a pre- and post- study design The results show that the FSC had a significant impact on a wide range of family satisfaction issues, and decreased length of stay and cost of care. This research was directed by Dr. Shelton, who has continued to refine the intervention for further research.
Ethics Review Study
Currently, a small study is being conducted in the Medical ICU focusing on those patients that stay beyond 6 days, and for whom there is no plan for discharge. These cases—which often do not receive focused attention—constitute the highest risk for ethical conflicts and extended lengths of stay.
The study was initiated to examine the impact of a brief ethics intervention using a pre- and post- research design. The intervention is being provided as a proactive measure to determine if a critical ethical assessment in each case can identify issues in advance. The research question based on which data is being collected is: Can such an intervention help reduce and possibly preclude conflict down the road, and reduce length of stay? We are also looking at the impact of this intervention on the caregivers, including physicians and nurses, to determine if they find this service helpful to their work. This study is directed by Dr. Shelton.
Palliative Care Education
Research on palliative care education is based on a required one-week rotation for third year medical students at a local hospice program. Qualitative analysis has been undertaken of students’ essays describing their learning experiences. Considered an essential component of medical education, bedside experiences in palliative care have provided students with important clinical and communication skills, as well as personal and professional development.
