Curt Beckwith, MD
Timothy Flanigan, MD
The Special Populations Core (SPC) promotes research among vulnerable and underserved populations in order to advance the study of opioid use disorder and overdose. The SPC supports the overall mission of the COBRE Center on Opioids and Overdose by building infrastructure to recruit and retain vulnerable and underserved individuals as participants in research studies; building capacity in the ethical conduct of research with vulnerable populations; and promoting research among populations most impacted by opioids and overdose. The SPC provides resources for junior investigators as they transition to research independence.
The overarching goal of the SPC is to build a sustainable resource that serves to support investigators across Rhode Island to address the practical challenges posed when conducting opioid and overdose research involving vulnerable and underserved populations. In order to accomplish this, the near-term goal of the SPC is to support Project Leaders to: develop appropriate study design, recruit and retain opioid-involved study subjects within the Emergency Department, Opioid Treatment Programs (OTPs), hospital/clinics/perinatal offices, correctional facilities, and other venues; navigate the ethical considerations of engaging vulnerable populations; apply for Institutional Review Board approval and other regulatory oversight; and convene Data Safety Monitoring Boards; as well as to establish and maintain a Community Advisory Board, and develop educational and mentoring forums relevant to research surrounding opioid use disorders and overdose.
- Promote and support best practices related to research study design to facilitate recruitment and retention of vulnerable and underserved populations as study participants in criminal justice or medical and treatment settings (i.e. prison/jail, emergency department, OTPs, perinatal care offices)
- Promote and support ethical conduct of research among vulnerable populations
- Support provided as part of this specific aim includes: support for regulatory and human subjects protections compliance; consultation for obtaining Certificates of Confidentiality; consultation on preparation of protocols for IRB and Office of Human Subjects Protections review, as required for research involving prisoners; and convening and administering data safety monitoring boards for COBRE-supported projects.
- Develop training modules (seminars, webinars, course curriculum and other materials) to promote clinical and translational research among populations most impacted by opioids and overdose, and in settings most appropriate to engage these populations, to prepare and engage COBRE Investigators and researchers throughout the Brown University and Rhode Island community
- Facilitate access to patient populations
- Provide guidance in appropriate study design for disadvantaged and hard-to reach populations
- Provide research staff trained in best practices of recruitment and retention
- Support for development of data collection protocols and Standard Operating Procedures
- Negotiate various recruitment settings
- Guidance in human subject’s protection and regulatory oversight of research conducted among vulnerable populations
- Establishment and convention of Community Advisory Boards and Data Safety Monitoring Boards and engagement of community partners