Ethics and Regulatory Work Group
There are many ethical and regulatory complexities related to the conduct of clinical trials, including those that have multisite, embedded, and pragmatic features. The Ethics and Regulatory Work Group aims to identify areas of ethical and regulatory uncertainty and work with the selected pragmatic trial teams and other subject matter experts to address these complexities in the VA and DoD health care systems. The Ethics and Regulatory Work Group also seeks to develop processes and agreements to address regulatory requirements within these health care systems, and to identify and disseminate best practices for ethical conduct of pragmatic clinical trials. The Work Group strives to disseminate lessons learned from the Pain Management Collaboratory relevant to the ethical conduct of pragmatic clinical trials, consistent with good clinical practice.
Chair or Co-Chairs:
Amy Burns
Joseph Ali
Project Manager:
Norman Silliker
Work Group Goals
- identify areas of ethical and regulatory importance in need of consideration and consultation
- 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
- 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, clinicians and researchers.
Work Group Co-Chairs – Qualifications and Experience
Amy Burns, JD, OTR/L, is an attorney for the Department of Veterans Affairs Office of General Counsel, on the Specialty Team Advising Research (OGC STAR) and Associate Research Scientist in Psychiatry at the Yale School of Medicine. Her areas of practice at the VA include research agreements (CRADA, MTA, CDA, federal/non-profit funds for research), research issues (IRB including informed consent and HIPAA authorization, research misconduct, treatment of research injury), issues related to VA non-profits (creation/dissolution/merger, bylaws and policies), and issues related to VA research centers (commercialization, issues related to patent and innovation projects). She has additional experience working 4 years as Deputy Associate Chief of Staff for Research and Development (ACOS/R) at VA Connecticut and 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 Associate Professor, Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health, Department of International Health. Over the past 15 years, 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, addressing signals of mental and behavioral health risk detected during PCTs, monitoring and reporting PCT adverse events, and sharing results from PCTs.
