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Research & Innovations

The Department of Bioethics was established in 1984 to coordinate ethics consultation services and provide expertise in health policy. Consistent with the mission of Cleveland Clinic, research conducted by members of the Department of Bioethics aims to improve the quality of patient care. By systematically examining patient values and moral beliefs, members of the Department seek to enhance the many clinical interactions that take place among patients, families, community members and healthcare professionals.

A hallmark of research conducted by the Department of Bioethics is a focus on enhancing the patient experience. This patient-centered approach to bioethics research is evident in all aspects of the department's research, but most especially in the selection of study topics. Projects frequently focus on improving specific clinical practices, such as techniques for obtaining informed consent or communicating more effectively with patients and their families. The NIH has endorsed a major advance in informed consent for clinical trials developed by our research team. Many of these projects employ multidisciplinary methods and involve close collaboration with other research groups at Cleveland Clinic.

Ethics&Novel Therapeutics

Ethics of Control and Consent in Brain Stimulation for Parkinson's Disease

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
Kim Yee, BA, MA: Research Assistant
Sabahat Hizlan, BA, BS: Data Manager

For more information contact:

Ethics of Control and Consent in Patients Undergoing Epilepsy Surgery

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:

An Evaluation of Patient's Decision-making for First Trimester Prenatal Aneuploidy Screening

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

Clinical Research Ethics

Informed Consent in Pediatric Research

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:

Best Practices for Clinical Ethics Consultation

Ethics Consultation Report System

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:

An Ethics Consultation Service: Experiences and Processes

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
Sabahat Hizlan, BA, BS: Data Manager

Benchmarking Ethics Consultation in Neurology and Neurosurgery

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:

Quality Attestation for Clinical Ethics Consultants

In partnership with the American Society for Bioethics and Humanities (ASBH), Cleveland Clinic's Department of Bioethics is leading an initiative designed to build consensus toward quality attestation of clinical ethics consultants. This project is significant because it will lay the foundation for continuous quality improvement in clinical ethics consultation, enhance the maturation of clinical ethics as a discipline, provide a better service to healthcare professionals and institutions who are often "consumers" of ethics consultation and most importantly, improve the quality of healthcare delivered to patients when ethics consultation is requested.

This research supported in part by

The Josiah Macy, Jr. Foundation and The Greenwall Foundation

For more information please contact:

Eric Kodish, MD at 216.444.8720

Research in Ethics Education

Educational Interactivity for Ethics Cases

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: