Ethics and Regulatory Workgroup
Ethics and Regulatory Workgroup Membership
Amy Burns, Project Manager
Kim Odam (DoD)
Karen Jeans (VA)
Demonstration Project Membership
Project #11, Susan Hastings and Steven George, Principal Investigators
Project #12, Karen Seal and Will Becker, Principal Investigators
Coleen Hill, Nicole McCamish
Project #13, Christine Goertz, Principal Investigator
Project #14, Julie Fritz and Daniel Rhon, Principal Investigators
Project #15, Alicia Heapy, Principal Investigator
Project #16, Marc Rosen and Steve Martino, Principal Investigators
Project #17, Stephanie Taylor and Steve Zeliadt, Principal Investigators
Project #18, Jeffrey Goodie and Donald McGeary, Principal Investigators
Allison Hancock, Stacey Young-McCaughan
Project #19, Diana Burgess, Principal Investigator
Project #20, Brian Ilfeld, Principal Investigator
Project #14, Shawn Farrokhi and Christopher Dearth, Principal Investigators
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.
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.