Ethics and Regulatory Workgroup

 

Ethics and Regulatory Workgroup Membership

Co-chairs

Fred Wright
Joseph Ali

Core Members

Amy Burns, Project Manager
Kim Odam (DoD)
Karen Jeans (VA)

Demonstration Project Membership

Project #11, Susan Hastings and Steven George, Principal Investigators

Maria Jimenez

Project #12, Karen Seal and Will Becker, Principal Investigators

Coleen Hill, Nicole McCamish

Project #13, Christine Goertz, Principal Investigator

Robert Vining

Project #14, Julie Fritz and Daniel Rhon, Principal Investigators

Daniel Rhon

Project #15, Alicia Heapy, Principal Investigator

Alicia Heapy

Project #16, Marc Rosen and Steve Martino, Principal Investigators

Christina Lazar

Project #17, Stephanie Taylor and Steve Zeliadt, Principal Investigators

Alissa Simon

Project #18, Jeffrey Goodie and Donald McGeary, Principal Investigators

Allison Hancock, Stacey Young-McCaughan

Project #19, Diana Burgess, Principal Investigator

John Ferguson

Project #20, Brian Ilfeld, Principal Investigator

TBN

Project #14, Shawn Farrokhi and Christopher Dearth, Principal Investigators

Elizabeth Husson

 

Workgroup Co-Chairs – Qualifications and Experience

Fred Wright, MD, is the VA Connecticut Associate Chief of Staff for Research and Development and a Professor in the Departments of Internal Medicine and Cellular and Molecular Physiology at the Yale School of Medicine. He has over 35 years of experience and is recognized as a national leader in VA in developing and enacting policies and regulations related to the ethical conduct of research, including human subjects protections.

Joseph Ali, JD, is Research Scholar II, Johns Hopkins Berman Institute of Bioethics and Associate Faculty, Johns Hopkins Bloomberg School of Public Health, Department of International Health and Department of Health Policy & Management.  As co-lead of the National Patient-Centered Clinical Research Network (PCORnet) Ethics & Regulatory Task Force, Mr. Ali helped develop research infrastructure supportive of a large national effort to coordinate patient-centered comparative effectiveness research to advance evidence-based medicine.

Workgroup Goals

The Ethics and Regulatory workgroup seeks to identify areas of ethical and regulatory importance and works with the selected pragmatic trial teams to address these complexities within the VA and DoD health care systems. The goals of this workgroup are (1) to develop processes and agreements needed to address regulatory requirements for single and multiple health care systems that provide services to military personnel, veterans and their families, and (2) to identify and disseminate information that facilitates the ethical conduct of pragmatic clinical trials in eligible health care settings, obtaining input from health care system leadership, patients, family members, providers and researchers.

Additional Value-added Expertise

Each of the partnering Centers has considerable experience relevant to the goals and objectives of this workgroup. This is also the case for many of the members of the Stakeholder Advisory Group (SAG), especially our colleagues who are leading the PCORI study in VA settings. Representatives from the partnering Centers and the SAG will be invited to consult and lend their knowledge and experience to the Ethics and Regulatory workgroup.