Overview
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
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:
Research Publications
2015
Agatisa PK, Mercer MB, Leek AC, Smith MB, Philipson E, Farrell RM. A first look at women's perspectives on noninvasive prenatal testing to detect sex chromosome aneuploidies and microdeletion syndromes. Prenat Diagn. 2015 Jul;35(7):692-8. doi: 10.1002/pd.4594. Epub 2015 Apr 6. PMID:25800864
Bester JC. Am J Bioeth. Ritual male infant circumcision: The consequences and the principles say yes. 2015;15(2):56-8. doi: 10.1080/15265161.2014.990164. No abstract available. PMID:25674963
Bruce CR, Kostick KM, Delgado ED, Wilhelms LA, Volk RJ, Smith ML, McCurdy SA, Loebe M, Estep JD, Blumenthal-Barby JS. J Card Fail. Reasons Why Eligible Candidates Decline Left Ventricular Assist Device Placement. 2015 Oct;21(10):835-9. doi: 10.1016/j.cardfail.2015.06.008. Epub 2015 Jun 22. PMID:26112460
Bruce CR, Eves MM, Allen NG, Smith ML, Peña AM, Cheney JR, Majumder MA. “Systematizing" ethics consultation services. HEC Forum. 2015 Mar;27(1):35-45. doi: 10.1007/s10730-014-9254-4. PMID:25274503
Dekking SA, van der Graaf R, de Vries MC, Bierings MB, van Delden JJ, Kodish E, Lantos JD. Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy? Pediatrics. 2015 Sep;136(3):566-70. doi: 10.1542/peds.2014-2327. Epub 2015 Aug 17. PMID:26283776
DeWeese J, Macado A, Ford PJ. Ethics of Preventive Timing and Robust Outcomes in Surgical Interventions for Anorexia Nervosa. 2015. American Journal of Bioethics: Neuroscience.
Esplin B, Machado AG, Ford PJ, Beasley K. Applying guidelines to individual patients: Deep brain stimulation for early-stage Parkinson disease. Virtual Mentor. 2015 Jan 1;17(1):13-22. doi: 10.1001/virtualmentor.2015.17.01.ecas2-1501. No abstract available. PMID:25594711
Eves MM, Danziger PD, Farrell RM, Cole CM. Conflicting Values: A Case Study in Patient Choice and Caregiver Perspectives. Narrat Inq Bioeth. 2015;5(2):167-78. doi: 10.1353/nib.2015.0054. PMID:26300149
Farrell RM, Nutter B, Agatisa PK. Patient-centered prenatal counseling: Aligning obstetric healthcare professionals with needs of pregnant women. Women Health. 2015;55(3):280-96. doi: 10.1080/03630242.2014.996724. Epub 2015 Mar 20. PMID:2579405
Farrell RM, Falcone T. Lancet. Uterine transplant: New medical and ethical considerations. 2015 Feb 14;385(9968):581-2. doi: 10.1016/S0140-6736(14)61792-X. Epub 2014 Oct 7. No abstract available. PMID:25303786
Farrell RM, Mercer MB, Agatisa PK, Smith M, Philipson E. Balancing risks: The core of women's decisions about noninvasive prenatal testing. American Journal of Bioethics Empirical Bioethics, 2015;6(1): 42-53; doi: 10.1080/23294515.2014.993098
Ford PJ, Stewart DO, DeMarco JP. Increasing Common Rule Protections: IRB Consensus, Black Box Warnings, and Risk in Equipoise. IRB. 2015 May-Jun;37(3):7-11. No abstract available. PMID:26331185
Ford PJ. Brain Devices: Navigating Collaborations between Industry, Government, and Researchers. 2015. American Journal of Bioethics: Neuroscience (Blog). September 01, 2015.
Harrison KL, Farrell RM, Brinich MA, Highland J, Mercer M, McCormick JB, Tilburt J, Geller G, Marshall P, Sharp RR. 'Someone should oversee it': Patient perspectives on the ethical issues arising with the regulation of probiotics. Health Expect. 2015 Apr;18(2):250-61. doi: 10.1111/hex.12027. Epub 2012 Dec 28. PMID:23279082
Hazen RA, Zyzanski S, Baker JN, Drotar D, Kodish E. Communication about the risks and benefits of phase I pediatric oncology trials. Contemp Clin Trials. 2015 Mar;41:139-45. doi: 10.1016/j.cct.2015.01.015. Epub 2015 Jan 29. PMID:25638751
Hsieh JK, Arias JJ, Sarmey N, Rose JA, Tousi B. Firearms Among Cognitively Impaired Persons: A Cross-sectional Study. Ann Intern Med. 2015 Sep 15;163(6):485-7. doi: 10.7326/L15-5138. No abstract available. PMID:26370021
Johnson LM, Leek AC, Drotar D, Noll RB, Rheingold SR, Kodish ED, Baker JN. Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology. Cancer. 2015 Jul 15;121(14):2439-48. doi: 10.1002/cncr.29354. Epub 2015 Apr 14. PMID:25873253
Kibbe B, Schmitt P, Ford PJ. An ethicist's scope of practice: Equipping stakeholders for closure. Am J Bioeth. 2015;15(1):37-8. doi: 10.1080/15265161.2015.975587. No abstract available. PMID:25562223
Kohn M, Kodish E. Reuniting Through the Medical Humanities: Two Educators, Two Programs. AMA J Ethics. 2015 Jun 1;17(6):491-5. doi: 10.1001/journalofethics.2015.17.6.spec1-1506. No abstract available. PMID:26075974
Marouf FE, Esplin BS. Setting a Minimum Standard of Care in Clinical Trials: Human Rights and Bioethics as Complementary Frameworks. Health Hum Rights. 2015 Jun 11;17(1):E31-42. PMID:26204581
Ralston SJ, Farrell RM. The Ethics of Access: Who Is Offered a Cesarean Delivery, and Why? Hastings Cent Rep. 2015 Jul 28. doi: 10.1002/hast.476. [Epub ahead of print]PMID:26215717
Rose SL and Highland J. The cost of dying among the elderly in the United States: Ethical issues. 2015. The Oxford Handbook of Ethics at the End of Life. Oxford University Press.
Rose SL, Sanghani RM, Schmidt C, Karafa MT, Kodish E, Chisolm GM. Gender Differences in Physicians' Financial Ties to Industry: A Study of National Disclosure Data. PLoS One. 2015 Jun 11;10(6):e0129197. doi: 10.1371/journal.pone.0129197. eCollection 2015. PMID:26067810
Shafran D, Smith ML, Daly BJ, Goldfarb D. Transplant Ethics: Let's Begin the Conversation Anew : A Critical Look at One Institute's Experience with Transplant Related Ethical Issues. HEC Forum. 2015 Jun 9. [Epub ahead of print] PMID:26055878
Thomas SM, Ford PJ, Weise KL, Worley S, Kodish E. Not just little adults: A review of 102 paediatric ethics consultations. Acta Paediatr. 2015 May;104(5):529-34. doi: 10.1111/apa.12940. Epub 2015 Feb 19. PMID:25611088
Weise KL, Gallagher Chief CM, Hynds JA, Secker BL, White BD. Becoming a competent ethics consultant: Up to code? Am J Bioeth. 2015;15(5):56-8. doi: 10.1080/15265161.2015.1021974. No abstract available. PMID:25970395
2014
Abboud H, Mehanna R, Machado A, Ahmed A, Gostkowski M, Cooper S, Itin I, Sweeney P, Pandya M, Kubu C, Floden D, Ford PJ, Fernandez HH. 2014. “Comprehensive, Multi-disciplinary DBS Screening for Parkinson Patients: No Room for “Short Cuts.” Movement Disorders Clinical Practice. DOI:10.1002/mdc3.12090
Arias, Jalayne J., Karlawish, Jason. When Research and Medical Records Meet: Confidentiality in Preclinical Alzheimer’s Studies. Neurology 2014, 25;82(8):725-9.
Bell E, Racine E, Chiasson P, Dufourcq-Brana M, Dunn LB, Fins JJ, Ford PJ, Glannon W, Lipsman N, Macdonald ME, Mathews DJ, McAndrews MP. Beyond consent in research. Revisiting vulnerability in deep brain stimulation for psychiatric disorders. Camb Q Healthc Ethics. 2014 Jul;23(3):361-8.. Epub 2014 May 27.
Bruce CR, Eves MM, Allen NG, Smith ML, Peña AM, Cheney JR, Majumder MA. "Systematizing" Ethics Consultation Services. HEC Forum. 2014 Oct 2.
Bruce CR, Bhimaraj A, Smith ML. Revisiting surrogate consent for ventricular assist device placement. Ann Thorac Surg. 2014 Mar;97(3):747-9.
Bruce CR, Smith ML, Tawose OM, Sharp RR. Practical guidance for charting ethics consultations. HEC Forum. 2014 Mar;26(1):79-93.
Bruce C, Pena A, Kusin B, Allen N, Smith M, Majumder M. An Embedded Model for Ethics Consultation: Characteristics, Outcomes, and Challenges. American Journal of Bioethics, Empirical Bioethics 2014; 5(3): 8-18.
Cole, CM, Falcone, T, Caplan, R, Timmons-Mitchell, J, Jares, K, and Ford, P (2014) Ethical Dilemmas in Pediatric and Adolescent Psychogenic Non-Epileptic Seizures: Ethical Dilemmas. Epilepsy & Behavior, 37: 145-150.
Davis DS, Kodish E. Laws that conflict with the ethics of medicine: What Should Doctors Do? Hastings Cent Rep. 2014 Nov-Dec;44(6):11-4
DeMarco JP, Ford PJ, Patton DJ, Stewart DO. Is there an ethical obligation to disclose controversial risk? A question from the ACCORD Trial. Am J Bioeth. 2014 Apr;14(4):4-10..PMID:24730479
Emre M, Ford PJ, Bilgiç B, Uç EY. Cognitive impairment and dementia in Parkinson's disease: practical issues and management. Mov Disord. 2014 Apr 15;29(5):663-72. doi: 10.1002/mds.25870. Review
Farrell RM, Agatisa PK, Nutter B. What women want: lead considerations for current and future applications of noninvasive prenatal testing in prenatal care. Birth. 2014 Sep;41(3):276-82. doi: 10.1111/birt.12113. Epub 2014 May 14. PMID:24825739
Farrell RM, Falcone T. Uterine transplantation. Fertil Steril. 2014 May;101(5):1244-5. doi: 10.1016/j.fertnstert.2014.03.022. Epub 2014 Apr 13. PMID:24726215
Farrell RM, Metcalfe JS, McGowan M, Weise KL, Agatisa PK, Berg J. Emerging Ethical Issues in Reproductive Medicine: Are Bioethics Educators Ready? Hastings Center Report, Sept-Oct. 2014, 21-28.
Farrell RM, Mercer MB, Agatisa PK, Smith MB, Philipson E. It’s More Than a Blood Test: Patients’ Perspectives on Noninvasive Prenatal Testing. J. Clin. Med. 2014, 3(2), 614-631.
Farrell RM, Pederson H, Padia S. Virtual Mentor. Incorporating genetic testing ancestry results into medical decisions. 2014 Jun 1;16(6):428-33. PMID:24955596
Mercer MB, Agatisa PK, Farrell RM. What patients are reading about noninvasive prenatal testing: An evaluation of Internet content and implications for patient-centered care. Prenat Diagn. 2014 Oct;34(10):986-93. doi: 10.1002/pd.4410. Epub 2014 Jun 11. PMID:24823864
Sutherland S, Farrell RM, Lockwood C. Genetic screening and testing in an episode-based payment model: Preserving patient autonomy. Obstet Gynecol. 2014 Nov;124(5):987-91. doi: 10.1097/AOG.0000000000000471. PMID:25437728
Flamm AL, Kodish E. Empirical Bioethics Research is a Winner, But Bioethics Mission Creep Is a False Alarm. J Clin Ethics. 2014 Fall;25(3):189-93. PMID:25192342
Flamm AL, Smith ML, Mayer PA. Family members' requests to extend physiologic support after declaration of brain death: a case series analysis and proposed guidelines for clinical management. J Clin Ethics. 2014 Fall; 25(3):222-37. PMID:25192347
Flicker LS, Rose SL, Eves MM, Flamm AL, Sanghani R, Smith ML. Developing and testing a checklist to enhance quality in clinical ethics consultation. J Clin Ethics. 2014 Winter; 25(4):281-90.
Hodge, Jr., James G., Lant, Timothy, Arias, Jalayne J., Jehn, Megan. Building Evidence for Legal Decision-making in Real Time: Legal Triage in Public Health Emergencies, Disaster Medicine and Public Health Preparedness 5 (2) (September 2011) (Published by the American Medical Association).
Manne S, Kashy D, Albrecht T, Wong YN, Flamm AL, Benson AB 3rd, Miller SM, Fleisher L, Buzaglo J, Roach N, Katz M, Ross E, Collins M, Poole D, Raivitch S, Miller DM, Kinzy TG, Liu T, Meropol NJ. Knowledge, attitudes, and self-efficacy as predictors of preparedness for oncology clinical trials: a mediational model. Med Decis Making. 2014 May;34(4):454-63.
Mayer PA, Daly BJ. CPR and Hospice: Incompatible Goals, Irreconcilable Differences. Progress in Palliative Care 2014. E-published ahead of print August 2014.
Mercer MB, Agatisa PK, Farrell RM. What patients are reading about noninvasive prenatal testing: an evaluation of Internet content and implications for patient-centered care. Prenatal Diagnosis 2014, 34, 1-8.
Miller VA, Baker JN, Leek AC, Drotar D, Kodish E. Patient involvement in informed consent for pediatric phase I cancer research. J Pediatr Hematol Oncol. 2014 Nov;36(8):635-40.
Miller VA, Cousino M, Leek AC, Kodish ED. Hope and persuasion by physicians during informed consent. J Clin Oncol. 2014 Oct 10;32(29):3229-35.
Shafran D, Kodish E, Tzakis A. Organ shortage: the greatest challenge facing transplant medicine. World J Surg. 2014 Jul;38(7):1650-7.
Smith ML, Luck CL. Desperately seeking a surrogate - for a patient lacking decision-making capacity. Narrat Inq Bioeth. 2014 Summer;4(2):161-9.
Weise KL, Daly BJ. Exploring Accountability of Clinical Ethics Consultants: Practice and Training Implications. AJOB, June 2014; 14(6):34-41.
Bruce CR, Smith ML. Case study. Bad words. Commentary. Hastings Cent Rep. 2014 Mar-Apr;44(2):13-4.
Cole, CM and Dews, TE (2014) Regulating Patient-Provider Communications: New State Mandated Informed Consent Requirements When Prescribing Opioids to Minors. Bio-Quarterly, 24(3): 3-5.
Kohn, M. (2014). Medical Humanities: Origins, Developments, and Recommendations, BioQuarterly, 24(3), 12.
Rose SL, Sanghani RM. Capsule commentary on Frank et al., increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1271. doi: 10.1007/s11606-014-2909-7.
Farrell, R, Cole, CM (2014) Informed Consent In J Emery and M Paraiso (Eds) Office-Based Gynecological Surgical Procedures. Springer: New York. 2014.
Kelly M, Ford PJ. 2014. “Research in Neuroenhancement: Controlled substances and Controlled Procedures,” Handbook of Neuroethics, eds. Clausen J and Levy N. Springer.
