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:
Amy Burns
Joseph Ali
Project Manager:
Norman Silliker
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
Amy Burns, JD, OTR/L, is the VA Connecticut Deputy Associate Chief of Staff for Research and Development (ACOS/R) and Associate Research Scientist in Psychiatry at the Yale School of Medicine. Her focus at the VA Connecticut is developing and enacting policies and regulations related to the ethical conduct of research, including human subjects protections. She has additional experience working for 8 years in the VA Cooperative Studies Program with a focus on quality assurance of large clinical trials and has worked in developing and implementing risk-based monitoring plans for multi-site pragmatic trials.
Joseph Ali, JD, is Assistant Professor, Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health, Department of International Health. Over the past decade, he has been intimately involved with efforts to advance the design and development of large U.S. patient-centered comparative effectiveness and pragmatic clinical trial (PCT) networks. In addition to serving as co-chair of the Ethics and Regulatory Work Group for the NIH/VA/DOD Pain Management Collaboratory, he serves as a member of the Ethics and Regulatory Core for the NIH HEAL Initiative on Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM), and served as co-lead of the National Patient-Centered Clinical Research Network (PCORnet) Ethics & Regulatory Task Force. His research in this areas has contributed to the anticipatory identification of ethics and regulatory challenges, the ethical assessment of net risk in PCTs, understanding how structural injustice can transfer from health systems to embedded health research, and addressing signals of mental and behavioral health risk detected during PCTs.
