Ethics and Regulatory Work Group

There are many ethical and regulatory complexities and challenges related to the conduct of clinical trials, including those of multisite, embedded, and pragmatic nature. The Ethics and Regulatory Work Group aims to identify areas of ethical and regulatory uncertainty and work with the selected pragmatic trial teams to address these complexities in the VA and DoD health care systems. Another goal of the Ethics and Regulatory Work Group is to develop processes and agreements to address regulatory requirements within these health care systems, and to identify and disseminate processes and best practices for ethical conduct of pragmatic clinical trials. To support dissemination of lessons learned from the Pain Management Collaboratory, the members of the Work Group are developing a first-of-its-kind, comprehensive toolkit of items relevant to the ethical conduct of pragmatic clinical trials consistent with good clinical practice and standards for the protection of human subjects research participants.

Chair or Co-Chairs:

Fred Wright

Joseph Ali

Project Manager:

Amy Burns

Work Group Goals

  • identify areas of ethical and regulatory importance
  • work with the selected pragmatic trial teams to address these complexities within the VA and DoD health care systems
  • 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
  • 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.

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.