aaliyah eaves , jd , llm , phd , hec-c
Adjunct Assistant Professor at University of Louisville School of Public Health and Information Sciences
University of Louisville School of Public Health and Information Sciences
https://www.linkedin.com/company/ulsphis
Department of Health Management and Systems Sciences
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Adjunct Assistant Professor
Dinsmore & Shohl LLP
https://www.linkedin.com/company/dinsmore-&-shohl-llp
Life Sciences regulatory attorney and bioethics consultant helping clients strategically traverse ethically fraught complex business decisions with significant liability implications. Responsible for providing precise and effective legal analysis for healthcare providers and clients developing new technologies in an evolving and highly regulated healthcare industry.
Louisville, Kentucky Area
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Partner: Healthcare Practice Group (Life Sciences)
American Board of Medical Specialties (ABMS), Ethics and Professionalism Committee
Chicago, Illinois, United States
Committee Member
US Army
https://www.linkedin.com/company/us-army
Creative problem-solver and skilled negotiator of legal disputes, healthcare conflicts and complex crosscutting policy decisions. Responsible for delivering healthcare resolution services, investigative reviews, compliance audits, medical error disclosure and adverse event mediation/negotiation with patients and clinical staff, ethics consultations and professional development training to faculty and staff at US Department of Defense medical treatment facilities in Europe.
Landstuhl Regional Medical Center, Landstuhl, Germany
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Healthcare Resolutions Specialist
FDA
https://www.linkedin.com/company/fda
Experienced advisor on national and international regulatory rules and policies. Liaison responding to substantive and procedural questions from industry and staff related to agency oversight, clinical research, legal liability, policy development and ethics issues. Responsible for providing cogent and timely regulatory guidance as a senior level policy advisor and bioethics consultant in the Center for Devices and Radiological Health (CDRH), Office of the Center Director (OCD).
Washington D.C. Metro Area
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Policy Advisor: Office of the Center Director, Center for Devices and Radiological Health
U.S. Department of Veterans Affairs
https://www.linkedin.com/company/department-of-veterans-affairs
Collaborative change-agent guiding patient safety projects and leading risk mitigation programs. Responsible for managing the medical center Risk Management and Patient Advocate Programs for the Quality, Patient Safety and Risk Office at a large tertiary care research medical center. Co-Investigator for $2.45M adverse event disclosure program training grant.
Lexington, Kentucky Area
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Risk Management & Patient Advocate Program Manager
Jefferson County Attorney's Office
https://www.linkedin.com/company/jeffcocolorado
Represented the Commonwealth of Kentucky and successfully prosecuted criminal cases in Jefferson County District Court. Created an effective and efficient case management system that significantly improved convictions.  Achieved the first 100% conviction rate for the office.
Louisville, Kentucky Area
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Assistant County Attorney
Franklin and Hance, P.S.C
Provided legal assistance for named partner in a busy medical malpractice and personal injury litigation law firm.  Contributed legal research, analysis and appellate pleadings and motions to defend a verdict in a complex pharmaceutical product liability case.
Louisville, Kentucky Area
Law Clerk
Doctor of Philosophy – PhD
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Saint Louis University
https://www.linkedin.com/school/saint-louis-university/
JD
University of Kentucky J. David Rosenberg College of Law
LLM
Indiana University Robert H. McKinney School of Law
BFA
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Carnegie Mellon University
https://www.linkedin.com/school/carnegie-mellon-university/
Given the recent FDA guidance for investigational studies using plasma from recovered COVID-19 patients (issued September 2, 2020), some healthcare networks are considering asking recovered patients to donate their plasma. Legal and ethical concerns have been raised about the appropriateness of asking patients to take on additional risk when the proposed treatment has uncertain benefits. Amid muddled politician messaging about what works against COVID-19, some urge a cautious approach. They worry official institutional promotion of experimental treatments may later be disproven and seriously undermine public trust in proven interventions, such as a vaccine.  Ethicists worry about the possibility of therapeutic misconception or biases that impact outcomes given the crises conditions that justify emergency authorization for the use of unproven therapies.

These are essential legal and ethical questions to consider before implementing a policy for COVID-19 convalescent plasma.
Using plasma from recovered COVID-19 patients
Medical News
http://www.medicalnews.md/using-plasma-from-recovered-covid-19-patients/
Legal Alert
FDA Warns Consumers to Stop Using THC Vaping Products Amid Ongoing Investigation into Lung Injuries
Dinsmore & Shohl LLP
https://www.dinsmore.com/publications/fda-warns-consumers-to-stop-using-thc-vaping-products-amid-ongoing-investigation-into-lung-injuries/
Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report-the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research-we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care.
DOI: 10.1016/j.annemergmed.2015.10.026
Confronting Ethical and Regulatory Challenges of Emergency Care Research with Conscious Patients
ANN EMERG MED
https://www.annemergmed.com/article/S0196-0644(15)01425-0/fulltext
Many patients suffering adverse events in health care turn to the legal system to learn what happened to them and to seek compensation. Health care providers have ethical, professional, and legal duties to disclose the harmful effects of care to the patient, regardless of how small the risk. The purpose of open disclosure is to explain what happened to the patient and to seek a just outcome for patient and provider. This article explores our experience of managing and implementing an open disclosure program in an acute and chronic tertiary care facility with university affiliation in the Veterans Health Administration.
DOI: 10.1016/j.suc.2011.11.001
Open Disclosure of Adverse Events: Transparency and Safety in Health Care
SURG. CLIN. N. AM
https://www.sciencedirect.com/science/article/pii/S0039610911001496?via%3Dihub
https://www.linkedin.com/in/dan-zinsmaster-88b8436
Columbus, OH
Dan Zinsmaster
Partner at Dinsmore & Shohl LLP
https://www.linkedin.com/in/karen-gaunt-79264214
Cincinnati, OH
Karen Gaunt
Partner, Director of Trademark, Copyright & Brand Strategies Group at Dinsmore & Shohl LLP
https://www.linkedin.com/in/kelsey-haught-parsons-0a5b19101
South Charleston, WV
Kelsey Haught Parsons
Labor and Employment Attorney at Dinsmore & Shohl LLP
https://www.linkedin.com/in/randy-roach-89958814
Houston, TX
Randy Roach
Partner, Roach Newton LLP & Adj Prof Appellate Law UT&UH
https://www.linkedin.com/in/christiane-ayesse-8a49091b8
Orlando, FL
Christiane Ayesse
--
https://www.linkedin.com/in/amber-kean-9741b355
Memphis, TN
Amber Kean
Shelby County Schools Teacher
https://www.linkedin.com/in/anita-ho-4804835a
United States
Anita Ho
Bioethicist and Health Services/Policy Researcher
https://www.linkedin.com/in/bethroxland
New York, NY
Beth E. Roxland J.D., M.Bioethics
Strategic Advisor on Law, Policy & Bioethics | Pandemic & Vaccine Policy | Stem Cell, Regenerative Medicine and Gene Therapies | Clinical Trials & Industry Ethics
https://www.linkedin.com/in/lisa-langford-ba16758
Prospect, KY
Lisa Langford
Attorney at Louisville Metro Government
https://www.linkedin.com/in/daniel-sulmasy-68a99a156
Washington, DC
Daniel Sulmasy
Hellegers Professor of Biomedical Ethics, Georgetown University; Director, Kennedy Institute at Georgetown University
https://www.linkedin.com/in/ann-langford-3353693b
United States
Ann Langford
--
https://www.linkedin.com/in/barbara-unseld-0033b531
United States
Barbara Unseld
Retired Educator
https://ca.linkedin.com/in/louis-sutker-71a30917
Victoria, BC
Louis Sutker
Interim Rabbi
https://www.linkedin.com/in/jerry-eaves-6932608a
Greensboro, NC
Jerry Eaves
Sports Professional
https://www.linkedin.com/in/camlowellmatthews
Prospect, KY
Cameron Matthews
Seeking license to become Customs Broker
https://www.linkedin.com/in/anne-cecile-baer-porter-b03104aa
Tacoma, WA
Anne-Cecile Baer Porter
Staff Chaplain with Multicare
https://www.linkedin.com/in/alex-kalter-64367736
United States
Alex Kalter
Intellectual Property Counsel at SHINE Technologies
https://www.linkedin.com/in/bernadette-ayesse-3a5655140
Orlando, FL
Bernadette Ayesse
Student at University of Central Florida
https://www.linkedin.com/in/nico-nortje-phd-497884181
Houston, TX
Nico Nortje, PhD
Director for Goals of Care and End-of-Life; 
Clinical Ethicist; 
Assistant Professor - Univ of Texas MD Anderson Cancer Center
https://www.linkedin.com/in/ivan-mayerhofer-1767595
Cornelius, NC
Ivan Mayerhofer
Associate Chaplain for Buddhist Programs, Director of the Meditation Initiative, and Coordinator of Interfaith Programs at Davidson College