Research and Innovations

The study examines the ethical challenges inherent in participants' considerations of control using Deep Brain Stimulation (DBS) for the treatment of Parkinson's Disease (PD). In order to provide better informed consent it is important to recognize the challenges inherent in the shifting nature of personal control that occurs before and after DBS therapy. The study employs a repeated measures design in which 50 participants with Parkinson's Disease who are undergoing DBS will rate and rank symptom management and personal control with respect to specific individually tailored behaviors.

This research supported in part by:

National Institute of Neurological Disorders and Stroke

The Cleveland Clinic Research Team:

Paul Ford, PhD: Co-Principal Investigator
Cynthia Kubu, PhD: Co-Principal Investigator
Robert Overman, BA: Research Coordinator
Craig Conant, BA: Psychometrist
Kim Yee, BA, MA: Research Assistant
Sabahat Hizlan, BA, BS: Data Manager

For more information contact:

• Paul Ford, PhD

The issues surrounding control are particularly paramount in patients with intractable epilepsy. One of the defining behavioral characteristics of seizures is the patient’s loss of control. Seizures are often characterized by loss of control of movement, language, and emotions and often patients are amnesic for the seizure. Resective neurosurgical procedures continue to raise difficult issues of personal control given the non-reversible nature and potential for direct alterations in cognitive abilities, mood and personality. The study employs a repeated measures design in which thirty-six participants’ ratings and rankings of symptom management and personal control with respect to specific individually tailored behaviors are compared prior to epilepsy surgery and at two time points following surgery.

This research supported in part by:

The Greenwall Foundation

The Cleveland Clinic Research Team:

Paul Ford, PhD: Co-Principal Investigator
Cynthia Kubu, PhD: Co-Principal Investigator

For more information contact:

• Paul Ford, PhD

Recent advances in genomic technologies will soon make high-throughput genotyping more readily available to patients and clinicians. It is already technically and financially feasible to assess known genetic mutations associated with thousands of Mendelian disorders and complex diseases. With this technological capacity, there arises a number of challenging ethical questions with regard to both patient and provider expectations. Our study aims to: (1) describe the attitudes and beliefs of patients and genetic professionals regarding the types of diagnostic possibilities that should be discussed with patients prior to large-scale clinical mutation testing, (2) characterize patients’ and genetic professionals’ beliefs about the types of diagnostic results that should be returned following large-scale clinical mutation testing, and (3) develop practice recommendations for introducing novel genomic testing technologies into patient care in an ethical manner.

This research supported in part by

National Institutes of Health, National Human Genome Research Institute

Select Publications

Foster MW, Sharp RR. Out of sequence: How consumer genomics could displace clinical genetics. Nature Review Genetics (2008) 9(6):419.
Foster MW, Sharp RR. The contractual genome: how direct-to-consumer genomic services may help patients take ownership of their DNA. Personalized Medicine (2008) 5: 399–404.
Foster MW, Mulvihill JJ, Sharp RR. Evaluating the utility of personal genomic information. Genet Med 2009;11:570-574.

Cleveland Clinic Research Team

Richard Sharp, PhD: Principal Investigator
Mary Beth Mercer, MPH: Project Coordinator
Janelle Highland, MA: Clinical Research Assistant
Raakhee Patel, MA: Clinical Research Assistant
Thomas Rehman, MA/MPH.: Clinical Research Assistant

For more information contact:

• Richard Sharp, PhD

This study aims to assess the decision making process that pregnant women undertake when considering the use of newly developed fetal genetic screening tests. First trimester aneuploidy screening, a new test to detect fetal chromosomal disorders (e.g. Down syndrome), was the model used to identify informational needs, values, and factors that play a role in the decision making process. Pregnant women face a unique set of challenges when considering prenatal fetal genetic testing. First trimester screening amplifies these challenges with the short time frame in which patients must obtain and integrate a large amount of medical information to formulate informed and value-consistent decisions in the first weeks of pregnancy. This study seeks to improve the clinical translation of new reproductive genetic technologies through a focus on the informed consent process.

This research supported in part by

The National Institutes of Health (NIH)

Cleveland Clinic Research Team

Ruth M. Farrell, MD, MA: Principal Investigator

For more information contact

• Ruth Farrell, MD

This study aims to characterize patient attitudes and beliefs regarding new treatments for chronic gastrointestinal diseases. The Human Microbiome Project, a five-year NIH initiative to characterize the human microbiome and its role in human health and disease, will likely accelerate the introduction of probiotics, bioengineered probiotics, and clinical metagenomics into the care of patients with chronic gastrointestinal diseases. We will characterize patient understandings of the potential benefits and risks of bioengineered probiotics and clinical applications of metagenomic technologies using data collected during focus groups conducted at the Cleveland Clinic, Mayo Clinic and Johns Hopkins University. This data will subsequently be presented to a Probiotics Working Group who will assist in the development of recommendations for introducing new therapies enabled by the Human Microbiome Project into the care of patients with chronic GI diseases. Results from this study will ultimately inform healthcare providers, educators, and voluntary health organizations on the responsible and successful translation of these new technologies into clinical care.

This research supported in part by:

National Human Genome Research Institute

Select Publications:

Sharp RR, Achkar JP, Brinich MA, Farrell RM. Helping patients make informed choices about probiotics: a need for research. American Journal of Gastroenterology 104 (2009): 809-813.

The Cleveland Clinic Research Team:

Richard R. Sharp, PhD: Co-Principal Investigator
Ruth Farrell, MD: Co-Principal Investigator
Mary Beth Mercer, MPH: Project Coordinator
Margaret Brinich, BA: Clinical Research Assistant
Janelle Highland, MA: Clinical Research Assistant

For more information contact:

• Richard Sharp, PhD

Informed consent, which provides the moral foundation for research involving human subjects, requires careful scientific and ethical analysis. Our research on informed consent aims to develop an empirically informed understanding of the consent process for pediatric cancer research that can be used to enhance informed decision making by parents and patients.  The primary goal of our current project is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials.  The long-term objective will be to improve care for children with refractory cancer and their families by developing a fuller understanding of the Phase I consent communication process, comprehension of parents and older children, and perspectives of clinician-investigators.

This research supported in part by:

The National Cancer Institute and National Institute for Child Health and Human Development

Select Publications:

Joffe S, Fernandez CV, Pentz RD, Ungar DR, Mathew NA, Turner CW, Alessandri AJ, Woodman CL, Singer DA, Kodish E. Involving Children with Cancer in Decision-Making about Research Participation. J Pediatr 2006;149(6):862-8.

Kodish E, Noll R, Ruccione K, Lange B, Angiolillo A, Pentz R, Zyzanski S, Siminoff L, Drotar D. Communication of Randomization in Childhood Leukemia Trials. JAMA 2004; 291: 470-5.

Kodish, ED. Informed Consent for Pediatric Research: Is it Really Possible? J Pediatr 2003; 142: 89-90.

Yamokoski, A.D., Hazen, R.A., Kodish, E.D. (2008). “Anticipatory guidance to improve informed consent: A new application of the concept.”  Journal of Pediatric Oncology Nursing 25 (1): 34-43.

Yap, T.Y., Yamokoski, A., Noll, R., Drotar, D., Zyzanski, S., and Kodish, E. (2009). “A physician-directed intervention: Teaching and measuring better informed consent.”  Academic Medicine 84 (8): 1036-1042.

The Cleveland Clinic Research Team:

Eric Kodish, MD: Principal Investigator

Sabahat Hizlan, BA, BS: Data Manager

Angela Leek, BA: Research Assistant

For more information contact:

• Eric Kodish, MD

This study aims to characterize the relationships between patient advocacy organizations (PAGs) for persons with genetic diseases and clinical researchers. Specifically, we plan to describe the initiation and maintenance of such relationships, intentions for developing future relationships and how these relationships impact the mission of the organizations and research initiatives. This study builds upon several prior studies, including a national survey project examining how PAGs are involved in multiple research related activities. Results from this study will not only describe the relationships between PAGs and clinical researchers but also enable further examination of the ethical issues inherent in these relationships.

The Cleveland Clinic Research Team:

Richard R. Sharp, PhD: Principal Investigator
Mary Beth Mercer, MPH: Project Coordinator
Margaret Brinich, BA: Clinical Research Assistant

For more information contact:

• Richard Sharp, PhD

The Department of Bioethics maintains a multi-year Ethics Consultation Report System (ECRS) that contains reports and summary data filed by Cleveland Clinic ethics consultants for each consultation undertaken at the Cleveland Clinic. The ECRS is an ongoing data registry approved by the Cleveland Clinic Institutional Review Board as a research and quality evaluative tool. It contains data on over 1000 clinical, research, and institutional ethics consults since 2003. The ECRS data are available to approved investigators interested in pursuing bioethics research or quality improvement projects. Compliance with HIPAA and other regulatory guidelines are maintained during use of this secured information to ensure patient and provider confidentiality.

For more information contact:

• Martin Smith, STD

This project provides a retrospective summation of the Cleveland Clinic’s experience and processes for providing 487 ethics consultations during a two-year period (2007 – 2008). Based on queries of an Access data-base where standardized information of 31 data points for each consult is recorded, and based on analyses of free-text narratives written by on-call ethics consultants, aggregated data will be reported. Reported information will include frequency and variability of activities and interventions during consultations (e.g., family and clinical team meetings, bedside conversations.) In addition to activities and interventions, information such as ethical issues triggering consultations, location of consultation activities (e.g., ICU, regular nursing floor, outpatient), documentation, and follow-up with stakeholders will be reported. With this information, directors and staff of established and newly-instituted ECSs will gain insights for 1) rejuvenating and/or maintaining vibrant ECSs, and 2) determining staffing needs and requisite skills necessary for screening and hiring ethics consultants.

The Cleveland Clinic Research Team:

Marty Smith, STD: Principal Investigator
Richard Sharp, PhD: Co-Investigator
Sabahat Hizlan, BA, BS: Data Manager

Partly because of their uncertain nature, decisions concerning neurological and neurosurgical issues are among the most problematic for patients to make. Consequently, bioethics consultations for these types of issues are particularly useful.

Ongoing research by members of the Department of Bioethics staff is evaluating ethics consultations for neurosurgical and neurological issues. Individual consults are analyzed both qualitatively and quantitatively to characterize patient populations, determine common concerns, and review the ethical principles and reasoning used.

This research is supported in part by:

Research Programs Committee of Cleveland Clinic

For more information contact:

• Paul Ford, PhD

A computer mediated approach to a tailored residency ethics interface

The goal of this project is to develop an advanced educational theory and framework for ethics training of neurosurgical residents using a reflective, self-directed case write-up methodology that is practice based.

This research is supported in part by:

Cleveland Clinic Medical Education Fellowship

The Cleveland Clinic Research Team:

Paul Ford, PhD: Principal Investigator

For more information contact:

• Paul Ford, PhD