MENU

Ethical Challenges in Early Phase Brain Device Research

Presented at: Neuroscience 2020
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Neuroethics Staff, Neurological Institute, Associate Director, Neuroethics Program, Center for Bioethics, Cleveland Clinic Center for Bioethics
    BIOGRAPHY

Abstract

Early phase clinical trials investigating novel applications of neural devices, such as deep brain stimulation (DBS) devices, pose ethical challenge during the recruitment of human subjects and in supporting ongoing informed consent over the course of research participation. As these clinical trials end, research participants face complicated decisions about the surgical removal or post-trial use of investigational brain implants. Drawing from qualitative research into the experiences of research participants who have exited from early phase clinical trials in deep brain stimulation, this session will highlight ethical considerations related to participant motivations for enrolling in research, understanding of study procedures at the time of initial informed consent, the process of exiting from research, decisions about device removal or post-trial device use, and concerns about access to long-term follow-up care. Ethical safeguards and approaches to involving ethicists in the earliest stages of clinical research will be proposed. This presentation will also reflect upon the development of evidence-based guidelines to support best practices in informed consent and robust standards for the ethical design and conduct of early phase clinical trials in DBS and other implanted brain devices.

Learning Objectives:
1. Enhance awareness and understanding of ethical challenges that arise in early phase brain device research.
2.Describe practical and ethical challenges in obtaining initial and ongoing informed consent to early phase research participation.
3.Reflect on ethical safeguards that should be in place and the role of ethicists in supporting best practices in brain device research.

 


Show Resources
You May Also Like
SEP 14, 2021 7:00 AM PDT
C.E. CREDITS
SEP 14, 2021 7:00 AM PDT
Date: September 14, 2021 Time: 7am PDT, 10am EDT, 4pm CEST A conventional thermal cycler has long been a commodity product in the lab and end-point PCR techniques can be completed almost wit...
JUN 09, 2021 7:00 AM PDT
C.E. CREDITS
JUN 09, 2021 7:00 AM PDT
Date: June 9, 2021 Time: 09 June 2021, 7am PDT, 10am EDT, 4pm CEST cells with dramatic implications on the validity of past cell culture related research. The fact that at least 509 cell lin...
JUL 15, 2021 8:00 AM PDT
C.E. CREDITS
JUL 15, 2021 8:00 AM PDT
Date: July 15, 2021 Time: 8:00am (PDT), 11:00am (EDT) High dimensional full spectrum flow cytometry grants unprecedented access to previously unattainable parameters in cellular biology. Flu...
OCT 12, 2021 9:00 AM PDT
C.E. CREDITS
OCT 12, 2021 9:00 AM PDT
Date: October 12, 2021 Time: 9:00am (PDT), 12:00pm (EDT) SCIEX’s next-generation Biologics Explorer software is an innovative platform for the comprehensive and deep characterization o...
NOV 30, 2021 10:00 AM PST
C.E. CREDITS
NOV 30, 2021 10:00 AM PST
Date: November 30, 2021 Time: 10:00am (PDT), 1:00pm (EDT) The prevalence of thyroid disease worldwide has served as a catalyst for healthcare providers to study various tools and methods to...
SEP 29, 2021 11:00 AM PDT
C.E. CREDITS
SEP 29, 2021 11:00 AM PDT
Date: Septembr 29, 2021 Time: 11:00am (PDT), 2:00pm (EDT) 3D cell models are becoming increasingly popular for studying complex biological effects, tissue functionality, and diseases. While...
Loading Comments...
Show Resources