Ethics and Regulatory Work Group

 

Ethics and Regulatory Work Group

Co-chairs:

Fred Wright
Joseph Ali

Project Manager:

Amy Burns

Work Group 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.

Work Group Goals

The Ethics and Regulatory work group 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 work group 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.