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Ethics of Integrating Research and Clinical Care

  • Overview
  • Register
  • Faculty
  • Schedule
Add to Calendar Ethics of Integrating Research and Clinical Care 3/23/2017 7:00:00 AM 3/24/2017 11:45:00 AM America/New_York For More Details: https://cchmc.cloud-cme.com/course/courseoverview?EID=17764 Description: https://cctst.uc.edu/bioethics2017Join us for the conference Ethics of Integrating Research and Clinical Care, March 23-24, 2017 at Cincinnati Children’s Sabin Education Center. Co-sponsors are the CCTST and Cincinnati Children's Ethics Center. Featured presentations will include:• Are Randomized Clinical Trials Comparing Standard of Care Treatments Truly Minimal Risk?Scott Kim, MD, PhD, Department of ... Cincinnati Children's Main Campus false MM/DD/YYYY


Date & Location
Thursday, March 23, 2017, 7:00 AM - Friday, March 24, 2017, 11:45 AM, Cincinnati Children's Main Campus

Target Audience
Specialties - Hospitalist, Research, Surgery

Overview

https://cctst.uc.edu/bioethics2017

Join us for the conference Ethics of Integrating Research and Clinical Care, March 23-24, 2017 at Cincinnati Children’s Sabin Education Center.  Co-sponsors are the CCTST and Cincinnati Children's Ethics Center.  Featured presentations will include:

•    Are Randomized Clinical Trials Comparing Standard of Care Treatments Truly Minimal Risk?
Scott Kim, MD, PhD
, Department of Bioethics, National Institutes of Health
 
•    First In Human Trials and Safety Assessment for Rare and Orphan Diseases
Andrew Mulberg, MD,
Amicus Therapeutics (former Deputy Director of FDA)

•    Notification and Authorization of Alternative Approaches in Pragmatic Clinical Trials of Commonly Used Medical Practices
Kevin Weinfurt, PhD,
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine

Podium and poster submissions will focus on all aspects of the intersection of research and clinical care, including emerging study  methodologies; advances in technology; evaluating risk; and patients’ access, rights and expectations.

Interested in a vendor table? Contact Jim Flessa: [email protected]



Registration

Registration Fee:
$100 ($125 after 3/8)
Residents & Fellows: $50
Students (Full Time): $25*
*For the first 30 students registered. Additional student rate will be $50.



Accreditation

CME: Cincinnati Children’s Hospital Medical Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Cincinnati Children’s designates this live activity for a maximum of 10.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CIP:  Conference sessions that meet the criteria in the Certified IRB Professional (CIP) recertification guidelines are eligible as accredited continuing education units.  Conference participants who hold the CIP® credential who wish to apply the 10.5 credits from this program toward CIP recertification may submit their Certificate of Attendance as documentation of their participation. This program has received advance recognition from the CIP Council.

CRP: The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 10.75 hours of credit.



Credits
AMA PRA Category 1 Credits™ (10.75 hours), CME - Non-Physician (Attendance) (10.75 hours)


Keywords:

Armand H. Antommaria, MD
Director, Ethics Center; Lee Ault Carter Chair of Pediatric Ethics
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
William Ball, MD
MD
Cincinnati Children's
Cincinnati, OH
Holly Bante, PhD, Administrator
Assistant Vice President for Ethics in Industry Engagement
University of Cincinnati
Cincinnati, OH
DonnaMaria E Cortezzo, MD, Physician
Associate Professor, Division of Neonatology & Pulmonary Biology
Cincinnation Children's Hospital Medical Center
West Chester, OH
Michelle Dickey, APRN, Nurse Practitioner
APRN
Cincinnati Children's
Cincinnati, OH
Kim Downing
UC
Cincinnati, OH
Brandon Foreman, MD
Assistant Professor
University of CincinnatiOH
Robert W Frenck Jr., MD, Physician
MD
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
James Geller, MD, Physician
Professor of Pediatrics, Cancer and Blood Diseases Institute
Cincinnati Children's
Cincinnati, OH
James Greenberg, MD, Physician
Co-Director, Perinatal Institute
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
James Heubi, MD, Physician
MD
Cincinnati Children's
Cincinnati, OH
Margaret Hostetter, MD
Professor Emerita
University of Cincinnati
New York, NY
Alex Huffman, PhD (in progress), Student
Graduate Assistant
University Of Cincinnati Philosophy Department
Cincinnati, OH
Richard F Ittenbach, PhD, Statistician
Professor, Biostatistics and Epidemiology
Cincinnati Children?s
Cincinnati, OH
Scott Y Kim, MD, PhD, Physician
Senior Investigator
NIH
Bethesda, MD
Laura Lentz
Christopher Lindsell, PhD, Researcher
PhD
University of Cincinnati
Cincinnati, OH
Mike Linke, PhD, Administrator
Adjunct Professor of Medicine, Department of Internal Medicine
University of Cincinnati
Cincinnati, OH
Jason McMullan, MD
Professor
University of Cincinnati
Cincinnati, OH
Andrew E Mulberg, MD, Physician
Vice President
Amicus Therapeutics, INC
Cherry Hill, NJ
Melanie Myers, PhD
Professor, Division of Human Genetics
Cincinnati Children's
Cincinnati, OH
Faculty Photos
David G Russell, J.D., Legal
Assistant Professor
Cincinnati Children's Hospital Medical Center
Cincinnati , OH
Sharon Sauter, MS, Researcher
MS
Cincinnati Children's
Cincinnati, OH
George Shaw, MD, PhD
Jane Strasser, PhD, Administrator
Associate Vice President, Office of Research Integrity
University of Cincinnati
Cincinnati, OH
Rachel Thienprayoon, MD, Advocate
MD
CCHMC
Cincinnati, OH
Todd Timney, MFA, Communication Designer
Assistant Professor
University of Cincinnati
Cincinnati, OH
Kevin Weinfurt, PhD, Professor
Duke Clinical Research Institute/Duke University
Durham, NC

Thursday, March 23, 2017
Registration & Breakfast
7:30AM - 8:15AM
Welcome
8:15AM - 8:30AM
Richard F Ittenbach, PhD, Statistician
Introductory Session: Living on the Thin Gray Line: Standards of Care, Risk, and Regulatory Holes in Acute Care Research
8:30AM - 9:00AM
Jane Strasser, PhD, Administrator
Jason McMullan, MD
Featured Presentation: Are Randomized Clinical Trials Comparing Standard of Care Treatments Truly Minimal Risk?
9:00AM - 10:15AM
Richard F Ittenbach, PhD, Statistician
Scott Y Kim, MD, PhD, Physician
Break
10:15AM - 10:30AM
Phase I Chemotherapy Trials for Children and Adolescents: Who benefits?
10:30AM - 11:40AM
Armand H. Antommaria, MD
James Geller, MD, Physician
Rachel Thienprayoon, MD, Advocate
Networking Lunch
11:40AM - 1:00PM
Late Breaking Session: Revisions to the Common Rule: How Does it Imact Me? (Room D2.40)
12:10PM - 1:00PM
Mike Linke, PhD, Administrator
Armand H. Antommaria, MD
Holly Bante, PhD, Administrator
Poster Session
12:10PM - 1:00PM
Featured Presentation: Notification and Authorization of Alternative Approaches in Pragmatic Clinical Trials of Commonly Used Medical Practices
1:00PM - 2:15PM
Holly Bante, PhD, Administrator
Kevin Weinfurt, PhD, Professor
Ethical Considerations with Research Involving Vulnerable Populations: The Maternal Fetal Dyad
2:15PM - 3:30PM
DonnaMaria E Cortezzo, MD, Physician
Evaluation and Communication of Risk for Clinical Research in the NICU
2:15PM - 3:30PM
Mike Linke, PhD, Administrator
Hypothesis Generation Clinical Research: The Problem and Requirement For Risk
2:15PM - 3:30PM
James Greenberg, MD, Physician
Risk Assessment in Clinical Research: Legal and Regulatory Considerations and the Problem of Hindsight Bians
2:15PM - 3:30PM
David G Russell, J.D., Legal
Break
3:30PM - 3:50PM
Breakout Session 1: Ancillary-Care Obligations and the Partiality of the Partial Entrustment Model: A Reply to Henry Richardson (Room D2.22)
3:50PM - 5:00PM
James Heubi, MD, Physician
Alex Huffman, PhD (in progress), Student
Breakout Session 1: Ethical Implications of Providing Oral Human Papillomavirus Results to Individuals with Fanconi Anemia (Room D2.22)
3:50PM - 5:00PM
James Heubi, MD, Physician
Sharon Sauter, MS, Researcher
Breakout Session 2: Providers' Response to Receiving Unsolicited Pharmacogenetics Research Results for Pediatric Patients (Room D2.40)
3:50PM - 5:00PM
Joel Tsevat, MD
Melanie Myers, PhD
Breakout Session 2: There is More to Understanding than Better Forms (Room D2.40)
3:50PM - 5:00PM
Joel Tsevat, MD
Richard F Ittenbach, PhD, Statistician
Breakout Session 3: Pediatric Assent: Just Because They Don't Say "No" Doesn't Mean "Yes" (Sabin Auditorium)
3:50PM - 5:00PM
Armand H. Antommaria, MD
Robert W Frenck Jr., MD, Physician
Breakout Session 3: Using a Patient Centered Approach to Improve Pediatric Assent Forms (Sabin Auditorium)
3:50PM - 5:00PM
Armand H. Antommaria, MD
Michelle Dickey, APRN, Nurse Practitioner
Todd Timney, MFA, Communication Designer
Kim Downing
Guest Reception, Open to all Registrants
5:00PM - 6:00PM
Friday, March 24, 2017
Breakfast
7:15AM - 8:00AM
Welcome
8:00AM - 8:10AM
Margaret Hostetter, MD
Featured Presentation: First in Human Trials and Safety Assessment for Rare and Orphan Diseases
8:10AM - 9:25AM
James Heubi, MD, Physician
Andrew E Mulberg, MD, Physician
Rare Disease Treatment Trials: Hope for Patients with Diseases with no Existing Treatment
9:25AM - 10:20AM
James Heubi, MD, Physician
Richard F Ittenbach, PhD, Statistician
Laura Lentz
Break
10:20AM - 10:40AM
Breakthroughs in Technology
10:40AM - 11:40AM
Holly Bante, PhD, Administrator
Commercialization Conundrums: Emerging and Evolving Ethical Conflicts as Technology Moves to Testing
10:40AM - 11:40AM
Christopher Lindsell, PhD, Researcher
Research and Clinical Use of New Technologies in the Neuroscience ICU
10:40AM - 11:40AM
Brandon Foreman, MD
SENSE: Bioethics Quandaries in Neurological Medical Devices
10:40AM - 11:40AM
George Shaw, MD, PhD
Closing Remarks
11:40AM - 11:45AM
Richard F Ittenbach, PhD, Statistician


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